Praxis Consulting delivers end-to-end consulting across the full spectrum of ISO Management System Standards—covering governance, risk, compliance, sustainability, digital trust, and sector-specific excellence—enabling organizations to implement, integrate, and transition management systems aligned with global best practices..

ISO Management System Consulting Services

End-to-End ISO Implementation, Transition & Integration

Praxis Consulting provides comprehensive ISO management system consulting services to organisations across India, GCC, and global markets. We support implementation, transition, integration, and audit readiness for all major ISO Management System Standards aligned with the Annex SL Harmonised Structure.

Our ISO Consulting Expertise Covers:

  • Quality, Environment & Occupational Safety
  • Information Security, Privacy & AI Governance
  • Business Continuity & Risk Management
  • ESG, Sustainability & Compliance Systems
  • Sector-specific ISO frameworks (IT, Pharma, Education, Food)

Why Choose Praxis Consulting?

  • Expertise across 40+ ISO Management System Standards
  • Integrated Management System (IMS) specialists
  • Transition support for ISO 9001:2026, ISO 14001:2026, ISO 19011:2026
  • Practical, audit-ready, regulator-aligned solutions
  • Industry-specific consulting approach

Industries We Serve

IT & SaaS • Pharma & Healthcare • Education • Manufacturing • Infrastructure • Food & Beverage • ESG-driven Enterprises • Startups & MSMEs

Our ISO Consulting Services Include:

  • Gap Analysis & Readiness Assessment
  • Documentation & Process Design
  • Risk & Compliance Frameworks
  • Training & Awareness Programs
  • Internal Audits & Certification Support
  • Integrated & Multi-Standard Implementation

ISO 9001:2015 Quality Management System (QMS) Advisory Services | Praxis Consulting

Governance-Led Quality Management for Sustainable Business Performance

ISO 9001:2015 is the world’s most widely adopted Quality Management System (QMS) standard. It provides a structured framework to consistently meet customer, statutory, and regulatory requirements—while strengthening continual improvement and operational performance.

Issued by the International Organization for Standardization, ISO 9001:2015 integrates quality management with risk-based thinking, stronger governance oversight, and alignment to strategic objectives.

At Praxis Consulting, we advise organizations on applying ISO 9001 as a governance and risk management tool—not as a checkbox certification exercise. Our approach ensures quality management strengthens operational discipline, accountability, and decision-making across the enterprise.

Our ISO 9001 Advisory Approach

Praxis Consulting supports Boards, leadership teams, and operational management in embedding ISO 9001 requirements into existing governance, risk, and performance frameworks. Our advisory is structured, outcome-driven, and aligned with enterprise objectives.

Our services focus on:

  • Aligning quality management with business strategy and risk appetite
  • Integrating ISO 9001 with enterprise risk management (ERM) and internal controls
  • Designing systems that are practical, auditable, and scalable
  • Enabling management ownership rather than consultant dependency

What ISO 9001:2015 Delivers

When implemented effectively, ISO 9001:2015 enables organizations to:

  • Establish consistent, controlled, and repeatable processes
  • Improve customer satisfaction and service reliability
  • Reduce errors, rework, and operational inefficiencies
  • Strengthen governance oversight and management accountability
  • Identify risks and improvement opportunities proactively
  • Support regulatory readiness and third-party assurance expectations

Key Benefits of ISO 9001:2015

External benefits

  • Enhanced credibility with customers, regulators, and partners
  • Reduced customer audits due to system maturity and transparency
  • Easier qualification for approved supplier and vendor programs
  • Improved access to domestic and international markets
  • Stronger positioning in tenders, bids, and commercial evaluations

Internal benefits

  • Reduced defects, corrective actions, and warranty exposure
  • Clear roles, responsibilities, and process ownership
  • Improved cross-functional communication and coordination
  • Regular internal audits that identify risks before escalation
  • Higher employee engagement through structured involvement
  • Better management visibility over performance and controls

ISO 9001 as a Governance and Risk Tool

ISO 9001:2015 explicitly promotes risk-based thinking, making it a natural extension of governance and enterprise risk frameworks. When aligned with broader GRC structures, the standard supports:

  • Operational resilience and continuity
  • Compliance with regulatory and contractual obligations
  • Performance monitoring through objective metrics
  • Evidence-based decision-making for leadership

Praxis Consulting helps translate these requirements into practical governance mechanisms—ensuring ISO 9001 strengthens oversight, control effectiveness, and organizational performance.

Sector-Specific Quality Standards We Support

In addition to ISO 9001:2015, Praxis Consulting provides advisory support for sector-specific quality and service management standards, including:

ISO 10002:2018 — Customer Satisfaction & Complaint Handling

Supports the design and operation of transparent, effective complaint-handling processes that enhance customer trust, enable continual improvement, and strengthen governance oversight.

ISO/TS 29001:2010 — Oil, Gas & Petrochemical Sector

Applies quality management principles to high-risk supply chains in the petroleum, petrochemical, and natural gas industries, focusing on process integrity and risk reduction.

ISO 29990:2010 — Learning & Training Service Providers

Establishes quality requirements for non-formal education and training providers, ensuring learner satisfaction, service consistency, and continual improvement.

ISO 9001:2015 QMS for Agile Software Development | Praxis Consulting

Deliver software faster—without sacrificing quality, governance, or customer confidence. Praxis Consulting helps software development organizations implement ISO 9001:2015 Quality Management Systems (QMS) that align with Agile, Scrum, and DevOps delivery models while meeting customer, regulatory, and enterprise assurance expectations.

ISO 9001:2015 is an internationally recognized QMS standard developed by the International Organization for Standardization (ISO). For software organizations, it provides a structured, risk-based framework that supports iterative delivery and continual improvement—without constraining agility or innovation.

Why ISO 9001 for Agile Software Development?

Agile software development is designed to respond to rapidly changing customer and business requirements. ISO 9001:2015 complements Agile by establishing disciplined processes for planning, execution, review, and improvement—so delivery remains consistent, measurable, and scalable as teams grow.

With the right implementation, ISO 9001 strengthens your software delivery governance while preserving the flexibility Agile teams need.

Applicability to Software Development Organizations

ISO 9001:2015 is applicable to any organization involved in:

  • Software design and development
  • Application maintenance and support
  • Product engineering and SaaS platforms
  • Software implementation and integration services

Many government agencies, regulated industries, and large enterprises require ISO 9001 certification as a prerequisite for vendor qualification, contract award, and long-term engagement. A well-implemented QMS can become a commercial differentiator—especially in competitive bids and enterprise procurement.

How ISO 9001:2015 Supports Agile and Modern Delivery Models

When aligned with Agile principles, ISO 9001:2015 strengthens governance across the software development lifecycle by enabling:

  • Controlled yet flexible development and delivery processes
  • Stronger sprint planning, backlog management, and release governance
  • Effective project and programme management oversight
  • Improved quality assurance, testing, and defect management
  • Better configuration, change, and version control
  • Reduced rework, cycle time, and delivery risk
  • Continual improvement through retrospectives, reviews, and corrective actions

Praxis Consulting helps translate ISO 9001 requirements into practical Agile-compatible controls—so your QMS supports delivery rather than slowing it down.

Integration with Software and IT Governance Frameworks

ISO 9001:2015 integrates effectively with widely adopted software and IT governance frameworks, including:

  • Agile and Scrum frameworks — supporting iterative delivery and customer feedback loops
  • DevOps practices — enabling consistency across development, testing, and deployment
  • ISO/IEC 27001 — aligning quality management with information security controls
  • ISO/IEC 20000-1 — supporting service management and operational delivery
  • CMMI — enhancing process maturity and capability development
  • COBIT — strengthening governance, control objectives, and management oversight

Together, these frameworks help software organizations balance speed, quality, security, and compliance—and create confidence for customers and auditors.

Benefits of ISO 9001:2015 for Software Development Companies

ISO 9001:2015 certification and implementation can deliver tangible business and operational benefits, including:

  • Increased market credibility and competitive advantage
  • Improved customer satisfaction and retention
  • Stronger governance over project delivery and SDLC processes
  • Clear definition of competency requirements and skills development
  • Improved internal and external quality-related communication
  • Reduced defects, rework, and delivery delays
  • Better use of resources and lower operational costs
  • A structured, auditable approach to continual improvement

ISO 9001:2015 as a Governance Tool for Software Organizations

What distinguishes ISO 9001:2015 is its emphasis on an organization’s ability to define, implement, monitor, and continually improve its management system. For software development organizations, this translates into:

  • More predictable delivery outcomes
  • Transparent controls and decision-making
  • Increased stakeholder and customer confidence
  • Scalable growth across multiple teams and products
  • Stronger operational discipline—without compromising Agile ways of working

Praxis Consulting focuses on making ISO 9001 work in real software environments—aligning it to Agile ceremonies, DevOps pipelines, engineering practices, and product governance.

ISO 9001:2015 & ISO 7101 Healthcare Quality Management System Consulting | Praxis Consulting

Healthcare organizations are under constant pressure to improve patient safety, clinical quality, and operational performance—while meeting regulatory, insurer, and accreditation expectations. Praxis Consulting helps hospitals, clinics, diagnostic centres, and healthcare service providers implement an integrated quality framework using ISO 9001:2015 and ISO 7101.

Together, ISO 9001:2015 and ISO 7101 provide a robust, internationally aligned approach to healthcare quality management, governance, and patient-centred care:

  • ISO 9001:2015 establishes a risk-based Quality Management System (QMS) that applies across healthcare operations (clinical and non-clinical).
  • ISO 7101 is the first ISO standard specifically developed for healthcare organizations, with a stronger focus on patient safety, clinical quality, and system-wide performance.

Who This Service Is For

Our ISO 9001:2015 + ISO 7101 advisory and implementation support is designed for:

  • Hospitals and multi-specialty healthcare systems
  • Clinics and outpatient centres
  • Diagnostic and imaging centres
  • Specialty care providers
  • Healthcare support services and integrated care networks

If you need measurable quality outcomes, stronger governance, and a structured approach to continual improvement, these standards provide a scalable foundation.

How ISO 9001:2015 and ISO 7101 Strengthen Healthcare Quality

By implementing ISO 9001:2015 alongside ISO 7101, healthcare organizations can:

  • Establish an integrated healthcare quality management system covering clinical and non-clinical processes
  • Improve clarity of roles, responsibilities, and accountability across care pathways
  • Strengthen coordination and communication between departments and clinical teams
  • Set measurable quality, safety, and performance objectives aligned with patient outcomes
  • Monitor, measure, and report effectiveness through structured reviews and audits
  • Drive continual improvement in systems, processes, and healthcare delivery outcomes

Praxis Consulting ensures your quality system is practical for frontline teams and effective for leadership oversight.

Why Healthcare Organizations Adopt ISO 9001:2015 and ISO 7101

ISO 9001:2015 helps identify systemic risks, process breakdowns, and control gaps. ISO 7101 deepens the focus on patient safety, clinical governance, and care quality. Together, they help organizations:

  • Identify critical interfaces between processes, departments, and healthcare professionals
  • Streamline workflows and optimize clinical and operational resources
  • Prevent errors, adverse events, and service failures before they occur
  • Establish mechanisms for early detection and resolution of errors and incidents
  • Ensure documented processes are followed, effective, and consistently applied
  • Focus on the needs and expectations of patients, caregivers, and providers
  • Sustain high levels of patient satisfaction and trust
  • Facilitate compliance with healthcare regulations, accreditation standards, and quality certifications

Benefits of ISO 9001:2015 + ISO 7101 for Healthcare Organizations

The combined application of ISO 9001:2015 and ISO 7101 delivers measurable benefits across governance, care delivery, and compliance:

  • A structured framework for evaluating and improving healthcare processes
  • Identification and mitigation of systemic risks and quality breakdowns
  • Hospital-wide adoption of recognized best practices supported by documentation
  • Improved documentation, records management, and traceability
  • Reduced errors caused by patient hand-offs and communication gaps
  • Enhanced patient care, safety, and satisfaction as primary objectives
  • Greater staff awareness of responsibilities within the healthcare quality system
  • Stronger confidence among patients, communities, insurers, and regulators
  • A solid foundation for meeting healthcare accreditation and regulatory requirements

Healthcare organizations certified to ISO 9001:2015 and aligned with ISO 7101 often experience simpler, faster, and less costly preparation for future audits, inspections, and accreditation assessments.

ISO 9001:2015 and ISO 7101 as a Platform for Continual Improvement

What distinguishes ISO 9001:2015 and ISO 7101 from many other healthcare standards is their emphasis on the organization’s ability to establish, implement, maintain, and continually improve an effective healthcare quality management system.

Together, they embed a culture of:

  • Governance and accountability
  • Evidence-based improvement and performance monitoring
  • Patient-centred care
  • Consistent implementation across departments and care pathways

Praxis Consulting Approach

Praxis Consulting works with leadership and clinical teams to translate ISO requirements into healthcare-ready systems that support daily operations, patient outcomes, and governance oversight.

Our support can include:

  • Current-state assessment and gap analysis (ISO 9001:2015 + ISO 7101)
  • Integrated quality system design across clinical and support functions
  • Role clarity, accountability mapping, and governance structures
  • Objective setting, monitoring, audits, and management review enablement
  • Continual improvement programs to sustain performance over time

ISO 13485:2016 Quality Management System (QMS) for Medical Devices | Praxis Consulting

Medical device companies operate in one of the world’s most regulated, risk-sensitive industries—where product safety, traceability, validation, and regulatory compliance are non-negotiable. Praxis Consulting helps organizations implement and strengthen ISO 13485:2016, the internationally recognized Quality Management System (QMS) standard for medical devices, to support audit readiness, market access, and consistent quality outcomes across the product lifecycle.

ISO 13485:2016 demonstrates an organization’s ability to consistently meet customer, regulatory, and statutory requirements applicable to medical devices across global markets.

What is ISO 13485:2016?

ISO 13485:2016 is the internationally recognized QMS standard for organizations involved in:

  • Design and development of medical devices
  • Manufacture and production
  • Installation and servicing
  • Related services supporting medical devices

Published by the International Organization for Standardization, ISO 13485 is process-focused rather than product-focused. It places strong emphasis on:

  • Risk management across the lifecycle
  • Design controls and verification/validation
  • Supplier qualification and supplier management
  • Traceability and documentation control
  • Process validation and quality assurance controls
  • Post-market activities and feedback mechanisms

While ISO 13485 certification supports regulatory compliance, organizations must also comply with applicable technical standards and jurisdiction-specific medical device regulations.

ISO 13485 and Risk Management in Medical Devices

Risk management is a central pillar of ISO 13485:2016. The standard requires medical device organizations to adopt a lifecycle approach to risk, aligned with ISO 14971 (Application of Risk Management to Medical Devices).

This includes:

  • Identification and evaluation of risks related to device safety and performance
  • Implementation of risk controls across design, manufacturing, and supply chain processes
  • Evaluation of residual risks and benefit–risk acceptability
  • Ongoing risk monitoring through post-market surveillance and feedback mechanisms

By integrating ISO 13485 with ISO 14971, organizations establish a defensible, regulator-ready framework for managing product, process, and patient safety risks.

Alignment with Medical Device Regulations (MDD / MDR)

ISO 13485:2016 is widely recognized as a foundational quality system for regulatory compliance and readiness, including alignment with:

  • EU Medical Device Directive (MDD) and EU Medical Device Regulation (MDR)
  • CE Marking requirements in Europe
  • Expectations of notified bodies and national regulators
  • Contractual and supplier qualification requirements of global healthcare manufacturers

ISO 13485 certification does not replace regulatory approval. However, it significantly strengthens your organization’s ability to demonstrate compliance readiness, control technical documentation, and maintain regulatory discipline.

Benefits of ISO 13485:2016 for Medical Device Organizations

ISO 13485:2016 delivers measurable business, regulatory, and operational benefits, including:

  • Global recognition of quality and regulatory best practices in the medical device industry
  • Access to regulated markets where ISO 13485 is a contractual or regulatory expectation
  • A systematic framework for monitoring, measuring, and analyzing processes and customer feedback
  • Structured corrective and preventive actions (CAPA) to ensure intended outcomes
  • Improved regulatory confidence through documented, auditable controls
  • Reduced errors, waste, and product failures through risk-based controls
  • Faster and more predictable time-to-market for global product launches
  • Improved efficiency, cost control, and resource utilization

ISO 13485 as a Governance and Compliance Tool

Beyond certification, ISO 13485:2016 functions as a governance and compliance framework for medical device organizations. When integrated with regulatory requirements, post-market surveillance, vigilance reporting, and supplier controls, it supports:

  • Stronger management oversight of product safety and compliance
  • Improved accountability across design, manufacturing, and distribution
  • Sustainable compliance with evolving regulatory expectations

Praxis Consulting helps you operationalize ISO 13485 so quality is embedded into decision-making—not treated as a documentation-only exercise.

Praxis Consulting ISO 13485:2016 Services

We support medical device manufacturers, product companies, and supply chain partners with practical ISO 13485 implementation and improvement.

Our ISO 13485 consulting and advisory support can include:

  • ISO 13485:2016 gap assessment and implementation roadmap
  • QMS design, documentation control, and process standardization
  • Risk management alignment with ISO 14971 across the lifecycle
  • Design controls support (planning, inputs/outputs, verification/validation, change control)
  • Supplier qualification and supplier performance governance
  • Traceability, validation, nonconformance, and CAPA strengthening
  • Post-market feedback and continual improvement mechanisms
  • Internal audits, management review enablement, and certification readiness support.

ISO 21001: Management System for Educational Organizations (EOMS) Consulting | Praxis Consulting

Governance-Led Quality and Inclusiveness for Educational Institutions

Educational organizations are expected to deliver high-quality learning outcomes while meeting rising expectations for governance, transparency, accessibility, and learner satisfaction. ISO 21001 is an international management system standard developed by the International Organization for Standardization specifically for educational organizations. It provides a structured framework to enhance learner satisfaction, strengthen institutional governance, and ensure the delivery of accessible, equitable, and high-quality educational services across diverse learning environments.

Praxis Consulting advises educational institutions on implementing ISO 21001 as a strategic governance and quality framework—not merely as a certification requirement. Our approach integrates educational quality, risk management, social responsibility, and continual improvement into the core operations of learning organizations.

What ISO 21001 Covers (EOMS Scope)

ISO 21001 applies to organizations delivering educational products and services, including:

  • Schools and early childhood education providers
  • Universities and higher education institutions
  • Vocational and technical training institutes
  • Professional training and coaching organizations
  • Corporate learning and development providers

The standard focuses on aligning educational objectives with learner needs, stakeholder expectations, and broader societal responsibilities.

Our ISO 21001 Advisory Approach

We support Boards, academic leadership, and senior management teams in embedding ISO 21001 into institutional governance and operational frameworks.

Our advisory services focus on:

  • Leadership accountability and educational governance
  • Learner-centred service design and delivery
  • Risk-based planning and performance evaluation
  • Integration with existing management and quality systems
  • Evidence-based decision-making and continual improvement

Praxis Consulting emphasizes implementation that is practical for educators and administrators—built around how your institution actually operates.

Structure and Key Requirements of ISO 21001

ISO 21001 follows the Annex SL high-level structure, ensuring compatibility with other ISO management system standards. In addition, it includes education-specific requirements addressing:

  • Design and development of educational services
  • Curriculum development, review, and control
  • Assessment design and evaluation mechanisms
  • Monitoring learner satisfaction and educational outcomes

Annex A (Normative) introduces additional requirements, including those applicable to early childhood education. Annexes A, B, and E provide extensive guidance and educational context to support effective implementation.

Inclusive Education and Accessibility

A defining feature of ISO 21001 is its strong emphasis on inclusive and equitable education. The standard promotes:

  • Leadership commitment to inclusiveness and social responsibility
  • Accessible facilities that meet the needs of all learners
  • Curriculum adaptation and instructional flexibility
  • Respectful, non-deficit-based language for learners with special needs

ISO 21001 aligns closely with the principles of Universal Design (UD) and Universal Design for Learning (UDL), supporting accessible learning environments regardless of ability, background, or circumstance.

Benefits of ISO 21001 for Educational Organizations

Implementing ISO 21001 enables institutions to achieve:

  • Improved learner satisfaction and engagement
  • Clear governance structures and management accountability
  • Consistent, well-designed educational services and curricula
  • Enhanced inclusiveness and accessibility
  • Better alignment with regulatory and accreditation expectations
  • Transparent performance monitoring and review
  • A structured platform for continual institutional improvement

ISO 21001 as a Governance and Risk Management Tool

Beyond educational quality, ISO 21001 functions as a governance and risk management framework. It helps educational institutions identify operational, reputational, and compliance risks while ensuring educational services remain ethical, equitable, and outcome-focused.

For leadership teams, ISO 21001 provides a structured mechanism to link strategy, quality objectives, learner outcomes, and continual improvement into one coherent system.

Why Praxis Consulting

Praxis Consulting is trusted for governance-led implementation approaches that go beyond template-driven certification.

What distinguishes our approach:

  • Governance-first, learner-centric advisory model
  • Experience across education, compliance, and risk management
  • Practical, implementable solutions aligned with institutional realities
  • Independent advisory focus—built for sustainable ownership, not dependency

Ready to Strengthen Educational Governance and Quality?

Engage Praxis Consulting to implement ISO 21001 (EOMS) as a strategic framework for educational excellence, inclusiveness, and accountability.

Share your institution type (school/university/training provider), number of campuses, and whether you are pursuing certification or improvement-only—so we can recommend a tailored implementation roadmap.

ISO 15378:2017 Consulting Services | Praxis Consulting

Quality Management Systems for Primary Packaging Materials for Medicinal Products (GMP-Aligned)

Pharmaceutical primary packaging is not “just packaging”—it directly impacts drug safety, efficacy, and patient health. Global pharma customers and regulators expect packaging manufacturers to operate with GMP discipline, strong traceability, validated processes, and robust quality oversight.

Praxis Consulting helps manufacturers of primary packaging materials for medicinal products implement ISO 15378:2017 as a regulator-ready, GMP-aligned quality and risk management framework—not merely a certification exercise.

ISO 15378 is an internationally recognised quality management system standard developed by the International Organization for Standardization (ISO). It defines GMP-aligned quality system requirements, applied in conjunction with ISO 9001:2015, to support consistent compliance with customer, regulatory, and international pharmaceutical expectations.

What is ISO 15378:2017?

ISO 15378:2017 specifies requirements for a Quality Management System (QMS) for organizations involved in the design, manufacture, and supply of primary packaging materials for medicinal products, including:

  • Plastic packaging components
  • Glass containers and vials
  • Rubber stoppers and closures
  • Aluminium foils and blister packaging
  • Other materials in direct contact with medicinal products

What makes ISO 15378 unique is that it integrates Good Manufacturing Practice (GMP) principles directly into the ISO 9001 quality management framework—making it highly relevant for regulated pharmaceutical supply chains.

ISO 15378 is also fully certifiable, supporting supplier qualification and market access requirements for global pharma customers.

Why ISO 15378 is Critical for Pharmaceutical Packaging Manufacturers

Primary packaging materials must consistently meet strict quality and cleanliness requirements. ISO 15378 helps organizations demonstrate the ability to:

  • Consistently meet pharmaceutical customer requirements
  • Comply with GMP, regulatory, and pharmacopeial expectations
  • Control contamination, mix-ups, and critical quality risks
  • Ensure traceability, validation, and process integrity
  • Withstand audits by pharmaceutical clients and regulators

For many organizations, ISO 15378 becomes a practical foundation for customer audit success, improved process control, and reduced deviation and recall risk.

Praxis Consulting – ISO 15378 Advisory Approach

Our consulting approach is risk-based, GMP-aligned, and audit-focused, supporting organizations across implementation, certification, and continual improvement. We work closely with leadership, Quality, Production, Engineering, and Supply Chain teams to ensure the QMS is usable on the shop floor and defensible in audits.

Our ISO 15378 services include:

  • ISO 15378 gap assessment and GMP readiness review
  • Integration of ISO 9001:2015 with GMP requirements
  • Process mapping and risk-based controls for packaging operations
  • Supplier qualification and material traceability systems
  • Documentation, SOPs, and validation support
  • Internal audits and certification preparedness
  • Regulatory and customer audit support

We ensure your quality management system is practically implementable, inspection-ready, and aligned with pharmaceutical expectations.

Key Requirements Addressed Under ISO 15378

ISO 15378 strengthens ISO 9001:2015 with GMP-specific controls, including:

  • Risk management across packaging design and manufacturing
  • Cleanliness, hygiene, and contamination control
  • Process validation and change management
  • Control of nonconforming product and deviations
  • Corrective and preventive actions (CAPA)
  • Management responsibility and quality culture
  • Continuous monitoring, measurement, and improvement

These requirements align closely with pharmaceutical GMP regulations and global regulatory expectations—supporting consistent outcomes and strong audit evidence.

Benefits of ISO 15378 Implementation

Organizations implementing ISO 15378 commonly achieve:

  • Stronger compliance with GMP and regulatory requirements
  • Increased trust from pharmaceutical customers
  • Reduced quality risks and product recalls
  • Improved process control and operational consistency
  • Enhanced audit readiness for customer and regulatory inspections
  • Global recognition and competitive advantage
  • A structured framework for continual improvement

ISO 15378 as a Risk Management and Compliance Framework

Beyond quality assurance, ISO 15378 functions as a risk management system for pharmaceutical packaging. It enables organizations to proactively identify, assess, and control risks related to:

  • Product contamination and integrity
  • Process deviations and failures
  • Supplier and material risks
  • Regulatory non-compliance
  • Reputational and business continuity risks

This makes ISO 15378 a critical element of pharma supply chain governance—especially for organizations supplying regulated and international markets.

Why Praxis Consulting?

  • Deep expertise in pharmaceutical quality, GMP, and ISO systems
  • Governance-led, risk-based implementation approach
  • Practical solutions aligned with real manufacturing operations
  • Strong focus on audit readiness and regulator expectations
  • Independent advisory support—beyond checklist certification

Ready to Strengthen GMP Compliance for Pharmaceutical Packaging?

Partner with Praxis Consulting to implement ISO 15378:2017 as a robust, certification-ready quality management system that meets global pharmaceutical, regulatory, and customer expectations.

Share your packaging type (plastic/glass/rubber/foil), number of production sites, and target markets—and we’ll propose a tailored ISO 15378 implementation roadmap.

ISO 18788 Certification Consulting | Security Operations Management System (SOMS) | Praxis Consulting

Ensure Professional, Compliant, and High-Quality Security Services

In today’s complex security environment, organizations that conduct—or contract—security operations must maintain the highest standards of professionalism, legal compliance, and respect for human rights. Praxis Consulting helps security providers and corporate security functions implement ISO 18788, a globally recognized framework for a Security Operations Management System (SOMS)—so security services are delivered safely, consistently, and with strong governance.

Whether you are a private security company, a security contractor, or an organization managing security operations across sites and supply chains, ISO 18788 provides a structured way to improve performance and build stakeholder trust.

What is ISO 18788?

ISO 18788 establishes requirements and guidelines for organizations performing or contracting security operations. It provides a structured approach to:

  • Establish, implement, operate, monitor, review, and improve a Security Operations Management System (SOMS)
  • Ensure compliance with applicable laws and regulations
  • Uphold human rights and ethical conduct in security operations
  • Continuously develop and enhance security services to meet client expectations

By aligning with ISO 18788, organizations demonstrate a clear commitment to professional security operations—while safeguarding client, community, and stakeholder interests.

Why Your Organization Needs a Security Operations Management System (SOMS)

Implementing ISO 18788 is not just about certification. It is a practical route to operational excellence and risk control—especially in high-stakes environments where security failures can lead to legal exposure, reputational damage, and harm to people.

Key reasons to adopt ISO 18788 include:

  • Legal and regulatory compliance
    Identify and adhere to applicable laws, licensing requirements, contractual obligations, and regulatory expectations for security operations.
  • Business continuity support
    Integrate security operations with core business functions and supply chain requirements—supporting resilience and continuity.
  • Effective management controls
    Establish, maintain, and improve a system that drives operational consistency, documentation discipline, and accountable execution.
  • Reputation protection
    Demonstrate commitment to quality, safety, and human rights—strengthening trust with clients, authorities, and communities.

ISO 18788 supports your ability to consistently deliver high-quality security services that meet customer needs while improving credibility with external stakeholders.

Key Benefits of ISO 18788 Certification

Achieving ISO 18788 certification can deliver tangible advantages:

  • Assured reliability: Demonstrates dependable, professional security operations
  • Enhanced corporate governance: Strengthens management controls and accountability
  • Increased credibility: Enhances your organization’s reputation and market confidence
  • Customer satisfaction: Drives consistent improvement in service quality
  • Operational success: Builds trust and confidence among clients, authorities, and communities

Why Choose Praxis Consulting for ISO 18788 Certification?

Praxis Consulting specializes in guiding organizations through the ISO 18788 certification journey with practical, tailored support for security companies, contractors, and corporate security teams.

We help you:

  • Conduct a gap analysis and certification readiness assessment
  • Implement a SOMS aligned with ISO 18788 requirements
  • Train staff on compliance, human rights, and operational excellence expectations
  • Prepare for audits and achieve certification efficiently

Our focus is to help you build a SOMS that works in real operations—not a template system that collapses under audit or field conditions.

ISO/IEC 20000-1 Consulting Services | Praxis Consulting

Deliver consistent, high-quality IT services that meet customer expectations—every time. Praxis Consulting helps information technology service providers design, implement, and improve a Service Management System (SMS) aligned to ISO/IEC 20000-1, the international standard for IT service management.

Whether you’re preparing for first-time certification, transitioning from informal processes, or strengthening mature service operations, we guide you through a practical, audit-ready approach that improves performance—not just documentation.

What is ISO/IEC 20000-1?

ISO/IEC 20000-1 can be used by any IT service provider to demonstrate its ability to meet unique service requirements of customers. Meeting the standard shows that your organization is capable of:

  • Designing services to meet business and customer needs
  • Delivering services reliably and consistently
  • Improving services through continual improvement practices

At its core, ISO/IEC 20000-1 requires a structured Service Management System (SMS)—a set of interconnected elements used to direct and control service management activities across the organization.

What is an IT Service Management System (SMS)?

A Service Management System for information technology is a collection of interacting elements that enable effective planning, delivery, control, and improvement of services.

These elements include all the components you need to operate services with confidence, such as:

  • Policies and service management objectives
  • Processes and procedures
  • Documents, templates, and records
  • Roles, responsibilities, and governance structures
  • Resources and tools required to plan, operate, monitor, and improve services

In simple terms: an SMS ensures your services are planned, designed, implemented, deployed, monitored, measured, reviewed, maintained, and continually improved—in a controlled, repeatable way.

Why ISO/IEC 20000-1 Matters for Your Business

ISO/IEC 20000-1 goes beyond IT operations. It helps align IT services with business strategy while improving control, visibility, and accountability.

Key benefits of ISO/IEC 20000-1 implementation

  • Align IT services with business strategy
    Ensure service planning and delivery support organizational goals—not just technical outputs.
  • Built on the Plan–Do–Check–Act (PDCA) cycle
    ISO/IEC 20000-1 is structured around PDCA, representing a shift from ad-hoc processes to managed, measurable, and improvable processes.
  • Identify and mitigate risks to reduce costs
    A strong SMS helps detect service risks early—reducing rework, outages, and inefficiencies, leading to cost savings.
  • Formal roles, responsibilities, and accountability
    Establish a clear framework for ownership at every level, including governance for organizational process assets and continual improvement.
  • Baseline against industry best practices
    Implementing ISO/IEC 20000-1 gives your organization a recognized benchmark to compare against leading service management practices.
  • Competitive advantage through consistent service delivery
    Certification signals reliability and maturity, helping you win customer trust, improve reputation, and deliver cost-effective services that enhance your bottom line.

Praxis Consulting ISO/IEC 20000-1 Services

Praxis Consulting provides end-to-end support to help you build an ISO/IEC 20000-1 aligned SMS that is both effective for your teams and ready for certification audits.

Our ISO/IEC 20000-1 consulting support can include:

  • ISO/IEC 20000-1 readiness assessment and gap analysis
  • SMS design and implementation roadmap
  • Policy, process, procedure, and documentation development
  • Roles, responsibilities, and governance framework setup
  • Metrics, monitoring, measurement, and review mechanisms
  • Risk identification, controls, and continual improvement planning
  • Internal audit support and management review preparation
  • Certification readiness and audit support (Stage 1 & Stage 2)

Who ISO/IEC 20000-1 is For

ISO/IEC 20000-1 applies to any organization that provides IT services, including:

  • Managed Service Providers (MSPs)
  • IT departments delivering internal services
  • Cloud and infrastructure service providers
  • Application support and service desk organizations
  • Digital and IT-enabled service companies

If you deliver IT services and need consistent outcomes, measurable performance, and customer confidence—ISO/IEC 20000-1 is a strong fit.

Ready to Implement ISO/IEC 20000-1 with Confidence?

Praxis Consulting helps you move from scattered practices to a structured Service Management System that improves service quality, lowers risk, and strengthens customer trust.

If you want, share:

  1. your industry, 2) number of services/locations, and 3) whether you’re aiming for certification—
    and I’ll tailor this landing page with sharper keywords, service packages, FAQs, and CTAs for your target market.

ISO 22000 Food Safety Management System (FSMS) Consulting | Praxis Consulting

Food safety is non-negotiable—and customers, regulators, and buyers increasingly expect proof that you control risks across the entire food chain. Praxis Consulting helps food-related organizations implement and improve ISO 22000 Food Safety Management Systems (FSMS) so you can consistently deliver safe products, meet legal requirements, and strengthen confidence across your supply chain.

ISO 22000 is an international standard created to help ensure the safe supply of foodstuffs worldwide—from farm to fork—covering every link in the supply chain.

What is ISO 22000?

ISO 22000 specifies the requirements for a Food Safety Management System that is intended to be universally applicable to all food-related organizations—regardless of size, complexity, or role in the supply chain.

The standard primarily addresses food safety concerns and includes requirements for HACCP in accordance with Codex Alimentarius principles, supported by:

  • A system of management (structured, controlled processes)
  • Manufacturing best practices (Prerequisite Programmes / PRPs)
  • Stronger interactions within the supply chain

Because ISO 22000 applies to a broad range of activities, it is by definition generic—making it a strong foundation for organizations operating across different markets and product categories.

Who ISO 22000 Applies To (All Food-Related Organisations)

ISO 22000 requirements are intended to be applicable across the food chain, including:

  • Crop and primary source producers
  • Food manufacturers and processors
  • Transport and storage operators
  • Retail and food service outlets
  • Suppliers and service providers within the food chain, including:
    • Equipment manufacturers
    • Packaging manufacturers and suppliers
    • Other supporting organizations impacting food safety

If your operations can affect food safety at any stage—ISO 22000 can apply to you.

ISO 22000 vs BRC Certification: Which Should You Choose?

Both ISO 22000 and BRC Global Standards are designed to be audited by accredited third-party certification bodies. However, they serve different market needs:

BRC (UK retail-driven, highly prescriptive)

  • Developed specifically to support compliance with the United Kingdom’s “due diligence” laws
  • Divided into distinct sectors
  • Requirements are often highly detailed and prescriptive

ISO 22000 (global, supply-chain wide, generic structure)

  • Designed as a common, internationally applicable standard
  • Generic format makes it adaptable across many food chain activities
  • Unlikely to replace BRC in UK markets where BRC is deeply embedded
  • Attractive to retailers and buyers outside the UK seeking a common standard that can be applied across the supply chain—sometimes supplementing or replacing ISO 9001 as the baseline alternative

Praxis Consulting can help you decide whether ISO 22000, BRC, or a combined approach is best based on your buyers, geography, and product risk profile.

System Prerequisites: What You Need Before Implementing ISO 22000

To implement ISO 22000 effectively, organizations must first identify the risks inherent in their specific processes using HACCP principles established by Codex Alimentarius. These controls must then be embedded into a formalized management system alongside:

  • Relevant industry codes of good practice
  • Applicable legal and regulatory requirements
  • Prerequisite Programmes (PRPs) / good manufacturing practices

ISO 22000 includes cross-references to help integrate requirements with other management system standards (commonly including ISO 9001). For implementation guidance, organizations often refer to ISO/TS 22004.

Benefits of ISO 22000 Certification & Implementation

By complying with ISO 22000 requirements, an organization should be able to:

  • Plan, implement, operate, maintain, and update a Food Safety Management System aimed at providing safe products for their intended use
  • Demonstrate compliance with applicable statutory and regulatory food safety requirements
  • Evaluate and assess customer requirements and demonstrate compliance with food safety expectations
  • Improve interactions within the supply chain through defined controls and communication
  • Communicate food safety issues effectively to suppliers, customers, and other relevant stakeholders

Additional business advantages commonly associated with a robust FSMS include:

  • Reduced risk exposure that may contribute to lower insurance premiums
  • Stronger customer confidence and advantage in the marketplace
  • Enhanced brand credibility and improved standing with buyers and stakeholders

Praxis Consulting ISO 22000 FSMS Services

Praxis Consulting supports food-related organizations with practical ISO 22000 implementation that strengthens real controls—not just paperwork.

Our ISO 22000 consulting support can include:

  • ISO 22000 gap assessment and implementation planning
  • HACCP alignment to Codex Alimentarius principles
  • Prerequisite Programmes (PRPs) development and improvement
  • FSMS documentation, process design, and control implementation
  • Supply chain communication and food safety issue escalation frameworks
  • Internal audit support and certification readiness preparation
  • Ongoing improvement support to maintain and update your FSMS

Ready to Build a Stronger Food Safety Management System?

Whether you’re a producer, manufacturer, logistics provider, retailer, or supplier, Praxis Consulting can help you implement ISO 22000 in a way that improves safety performance, strengthens compliance, and builds buyer confidence.

ISO 22301 Business Continuity Management System (BCMS) Consulting | Praxis Consulting

Consider what happens if your business operations are lost, destroyed, corrupted, burned, flooded, sabotaged, or misused. For many organizations, a serious disruption—whether physical or digital—can trigger prolonged downtime, financial loss, reputational damage, regulatory exposure, and in worst cases, business failure.

Praxis Consulting helps organizations implement and improve an ISO 22301 Business Continuity Management System (BCMS) so you can respond effectively to disruptions such as natural disasters, cyber incidents, and data breaches, while safeguarding critical services, customers, and business interests.

ISO 22301 is applicable to organizations of any size—large or small—and in any industry sector.

What is ISO 22301?

ISO 22301 is the international standard for business continuity. It emphasizes:

  • Understanding continuity and preparedness requirements
  • Establishing business continuity policies and objectives
  • Implementing and operating controls and measures to manage continuity risks
  • Monitoring, reviewing, and improving BCMS performance and effectiveness

A well-designed ISO 22301 BCMS helps ensure your organization can continue delivering priority products and services during disruption—and recover within acceptable timeframes.

What ISO 22301 Covers

ISO 22301 provides a structured approach that can encompass:

  • Disaster recovery
  • Business recovery
  • Crisis management
  • Incident management
  • Emergency management
  • Contingency planning

This gives leadership and teams a unified framework for preparedness, response, and recovery—rather than isolated, ad-hoc plans.

Why Implement ISO 22301 with Praxis Consulting?

Business continuity is not just an IT issue. It’s an organization-wide capability that requires clarity on priorities, responsibilities, dependencies, and decision-making under pressure.

Praxis Consulting supports you in building a BCMS that is practical, auditable, and aligned to your operating reality—so your continuity program strengthens resilience and improves readiness across people, processes, and systems.

Benefits of ISO 22301 (BCMS) Implementation

Increase contracting opportunities

Both public and private sectors increasingly recognize the value of ISO 22301 and may require it from suppliers. Many organizations include ISO 22301 compliance or certification expectations in tenders and contracts across the supply chain—making BCMS maturity a competitive differentiator.

Increase confidence of stakeholders and customers

ISO 22301 builds confidence by demonstrating you have effective continuity controls. This reassurance matters to customers, regulators, partners, investors, and internal stakeholders who depend on your reliability.

Identify potential risks and failure points

A BCMS helps you develop a clear view of how your organization operates, where internal and external risks exist, and where systems, processes, or people may fail—so you can prioritize mitigations before disruption occurs.

Demonstrate due diligence

Management often uses alignment to—or certification against—an international standard to demonstrate due diligence, especially when addressing governance expectations and risk management oversight.

Improve employee motivation and participation

When processes are defined and tested, employees feel more confident in their roles during incidents. Awareness of their contribution to business continuity can increase engagement and job satisfaction. Achieving certification to an internationally recognized standard is also a meaningful milestone for teams.

Drive continuous enhancement

Like other ISO management system standards, ISO 22301 emphasizes continual improvement—helping your organization strengthen readiness year after year and amplify the benefits over time.

Praxis Consulting ISO 22301 BCMS Services

Praxis Consulting provides end-to-end support to help you implement ISO 22301 in a way that works in real incidents—not just on paper.

Our ISO 22301 consulting services can include:

  • ISO 22301 gap assessment and readiness review
  • BCMS scope definition, policy, and objectives
  • Risk identification and continuity requirements analysis
  • Controls and measures design for continuity risk management
  • Incident, crisis, and emergency management structure alignment
  • Performance monitoring, internal audit support, and management review preparation
  • Certification readiness support and continual improvement planning

ISO/IEC 27001 Information Security Management System (ISMS) Consulting | Praxis Consulting

Information is globally accepted as a vital asset for most organizations. Protecting the confidentiality, integrity, and availability of corporate and customer information is essential to maintaining competitive edge, cash-flow, profitability, legal compliance, and commercial image.

Praxis Consulting helps organizations implement, improve, and maintain an ISO/IEC 27001 Information Security Management System (ISMS) so your information remains appropriately protected—regardless of how it is stored, shared, or processed.

Why is Information Security Needed?

It’s easy to imagine the consequences if information is lost, destroyed, corrupted, burned, flooded, sabotaged, or misused. In many cases, security failures can (and have) contributed to the collapse of companies.

ISO/IEC 27001 is intended to help organizations manage these risks systematically—moving from ad-hoc security practices to a structured, auditable management approach.

What is ISO/IEC 27001?

ISO/IEC 27001 is a specification for the management of information security. It is applicable to all sectors of industry and commerce and is not confined to information held on computers.

It addresses security of information in whatever form it is held, including:

  • Printed or written on paper
  • Stored electronically
  • Transmitted by post or email
  • Shown on films or presentations
  • Spoken in conversation

Whatever form the information takes—or the way it is shared or stored—ISO/IEC 27001 helps ensure it is appropriately protected through defined policies, controls, responsibilities, and continual improvement.

The Core Principles of Information Security (CIA)

Information security can be characterized as the preservation of:

  • Confidentiality: ensuring access to information is appropriately authorized
  • Integrity: safeguarding the accuracy and completeness of information and processing methods
  • Availability: ensuring authorized users have access to information when they need it

An ISO/IEC 27001-aligned ISMS helps you operationalize these principles across your organization.

Key ISO/IEC 27001 Control Areas Covered

ISO/IEC 27001 contains multiple control objectives and controls. Praxis Consulting helps organizations implement and govern security controls across areas such as:

  • Security Policy Management
  • Corporate Security Management
  • Personnel Security Management
  • Organizational Asset Management
  • Information Access Management
  • Cryptography Policy Management
  • Physical Security Management
  • Operational Security Management
  • Network Security Management
  • System Security Management
  • Supplier Relationship Management
  • Security Incident Management
  • Security Continuity Management
  • Security Compliance Management

These controls help ensure security is not only defined—but managed, monitored, and improved over time.

Benefits of Implementing ISO/IEC 27001 (ISMS)

While benefits vary by organization, ISO/IEC 27001 implementation commonly supports:

Interoperability

A general benefit of standardization: security approaches across diverse parties are more likely to fit together when aligned to a common framework—helpful in supply chain, partner, and customer contexts.

Assurance

Leadership gains assurance about the quality and consistency of information security practices when a recognized framework is followed.

Due diligence

Compliance with—or certification against—an international standard is often used to demonstrate due diligence to customers, stakeholders, auditors, and regulators.

Benchmarking

Organizations use ISO/IEC 27001 as a benchmark to evaluate their current security maturity and track progress against peers or industry expectations.

Awareness

Implementing ISO/IEC 27001 often increases security awareness across teams by clarifying responsibilities, required behaviors, and the “why” behind controls.

Alignment between IT and business

Because ISO/IEC 27001 typically involves both business management and technical staff, it often improves IT–business alignment and strengthens decision-making around risk, priorities, and investment.

Praxis Consulting ISO/IEC 27001 Services

Praxis Consulting supports organizations across the lifecycle of ISO/IEC 27001 adoption—helping you build an ISMS that is practical, scalable, and audit-ready.

Our ISO/IEC 27001 consulting services can include:

  • ISO/IEC 27001 gap assessment and implementation roadmap
  • ISMS scope definition and risk-based planning
  • Policy and governance structure development
  • Asset, access, and supplier relationship security alignment
  • Incident management and security continuity support
  • Internal audits, management review support, and certification readiness
  • Continual improvement planning to sustain your ISMS year after year

ISO 26000 Social Responsibility (ISO SR) Advisory Services | SA8000 Readiness Support | Praxis Consulting

Build Credible Social Responsibility, Stronger Governance, and Sustainable Business Practices

Social responsibility is no longer optional for organizations operating in global supply chains and stakeholder-driven markets. Customers, employees, communities, regulators, and investors increasingly expect evidence of ethical conduct, human rights respect, fair labour practices, and transparent governance.

Praxis Consulting helps organizations use ISO 26000 (ISO SR) as a practical, governance-led guide to integrate social responsibility into organizational values and day-to-day practices. We also support organizations seeking SA8000 alignment and certification readiness by strengthening auditable workplace accountability systems.

What is ISO 26000 (ISO SR)?

ISO 26000 is an International Standard developed by the International Organization for Standardization (ISO) that provides guidelines for social responsibility (SR). It became available on 1 November 2010. Its mission is to contribute to global sustainable development by encouraging businesses and other organisations to embrace social responsibility and mitigate negative impacts on:

  • Workers and workplaces
  • Natural environments
  • Communities and broader society

Important: ISO 26000 is guidance, not certification

ISO 26000 is a voluntary guidance standard. It does not include the requirements associated with standards offered for certification. Because there is no “certificate” at the end, organizations must be intentional in how they adopt ISO 26000.

ISO recommends statements such as: “We used ISO 26000 as a guide to integrate social responsibility into our values and practices.”

Praxis Consulting helps you convert ISO 26000 guidance into measurable policies, operating controls, and governance mechanisms that stand up to stakeholder scrutiny.

ISO 26000 Fundamental Principles and Core Subjects

ISO 26000 is built around widely accepted principles and focus areas that underpin socially responsible behavior.

The Seven Key Principles of Social Responsibility

  • Accountability
  • Transparency
  • Ethical conduct
  • Respect for stakeholder interests (individuals or groups impacted by the organization or able to influence it)
  • Observance of the rule of law
  • Respect for international behavioural standards
  • Human rights observance

The Seven Core Subjects to Consider

  • Governance of organisations
  • Rights of the individual (human rights)
  • Workplace customs (labour practices)
  • Environment
  • Ethical business practices (fair operating practices)
  • Consumer concerns
  • Participation and development of the community

Praxis Consulting helps you assess your current state against these principles and subjects, identify gaps, and build an SR roadmap aligned to your operations and stakeholder expectations.

SA8000: Auditable Social Accountability Certification (Workplace Focus)

For organizations that require an auditable certification standard for workplace social accountability, SA8000 is a globally applicable option.

SA8000 is a certification standard developed in 1997 by Social Accountability International. It encourages businesses to develop, maintain, and implement socially responsible workplace practices. It also provides a common language and measurement standard for social compliance and can be applied across industries and geographies.

Praxis Consulting supports SA8000 readiness by helping you build the policies, controls, training, documentation, and evidence needed for certification audits.

SA8000 Performance Criteria (Workplace Compliance Areas)

SA8000 requires compliance with key performance criteria, including:

  • Child Labor: No use or support of child labour; procedures to remediate when children are found working; support for education; controls for young workers.
  • Forced and Compulsory Labor: No forced labour; no deposits; no withholding wages/documents; freedom of movement after work; freedom to terminate employment; no trafficking.
  • Health and Safety: Safe and healthy work environment; prevention of accidents; OSH leadership and training; risk detection and response; accident documentation; PPE and medical attention; protections for new and expectant mothers; hygiene facilities.
  • Freedom of Association & Collective Bargaining: Respect union rights and collective bargaining; non-interference; education on rights; non-discrimination; representative access.
  • Non-Discrimination: No discrimination in hiring, pay, training, promotion, termination, or retirement; no harassment or coercion; no pregnancy or virginity testing.
  • Disciplinary Practices: Dignity and respect; no corporal punishment or mental/physical abuse; no inhumane treatment.
  • Working Hours: Compliance with law; normal workweek (excluding overtime) not exceeding 48 hours; rest days; overtime voluntary and limited; required overtime only via collective bargaining agreement.
  • Remuneration (Living Wage Focus): Wages sufficient for basic needs and discretionary income; no disciplinary deductions; clear wage communication; proper payment methods; overtime premiums; controls against improper labour-only arrangements.

How Praxis Consulting Helps (ISO 26000 + SA8000)

Our approach is governance-led and practical—helping you move from statements to systems.

ISO 26000 Advisory Services

  • SR gap assessment against ISO 26000 principles and core subjects
  • Stakeholder mapping and prioritization of material SR topics
  • SR governance model (roles, accountability, oversight, escalation)
  • Policy development (ethics, human rights, labour practices, community)
  • Integration into management systems and business processes
  • Roadmap and action plan for measurable SR improvement

SA8000 Readiness & Audit Support

  • SA8000 gap assessment and workplace compliance diagnostics
  • Documentation and control framework (policies, procedures, records)
  • Training programs and awareness for leaders and site teams
  • Internal audit preparation and corrective action support
  • Supplier and contractor social compliance controls (as applicable)

Benefits of Using ISO 26000 and SA8000

Organizations that adopt ISO 26000 guidance and/or prepare for SA8000 often achieve:

  • Stronger social responsibility governance and accountability
  • Improved credibility with customers, buyers, and stakeholders
  • Reduced labour and human rights risk across operations and supply chains
  • Better workplace practices and employee confidence
  • More transparent communication of SR commitments and actions
  • A practical foundation for sustainable development contributions

ISO 28000 Supply Chain Security Management System (SMS) Consulting | Praxis Consulting

Supply chains face increasing threats—tampering, theft, sabotage, unauthorized access, and other intentional acts that can disrupt operations and harm people, products, and property. ISO 28000 was developed to help organizations improve supply chain security through a structured, risk-based Security Management System (SMS).

Praxis Consulting helps organizations design, implement, and improve ISO 28000-aligned supply chain security management systems that strengthen resilience, support stakeholder confidence, and provide audit-ready governance over security controls.

What is ISO 28000?

ISO 28000 defines a set of security management requirements for organizations that are part of a local, national, or international supply chain. Since almost all organizations belong to a supply chain in some way, ISO 28000 applies to virtually all organizations—regardless of size, sector, or operating model.

ISO 28000 can help organizations protect:

  • People (employees, contractors, visitors, drivers, and partners)
  • Products (goods in transit and storage)
  • Property (facilities, vehicles, equipment, and infrastructure)

The standard expects your organization to establish a Security Management System (SMS) that complies with its requirements—and then to use that system to protect your supply chain against intentional harm.

Who ISO 28000 Applies To

ISO 28000 is relevant to organizations across the full supply chain ecosystem, including:

  • Exporters and importers
  • Airports, seaports, terminals, and logistics hubs
  • Organizations moving products by air, sea, rail, or road
  • Logistics providers, storage operators, transportation companies, and service providers
  • Manufacturers, shippers, wholesalers, and distributors

If your organization handles goods, operates facilities, or depends on transportation and logistics, ISO 28000 provides a practical framework for supply chain security governance.

What is a Security Management System (SMS) in ISO 28000?

A Security Management System (SMS) is a network of interrelated and interacting elements that combine to resist, fend off, or withstand unauthorized acts designed to cause intentional harm or damage to the supply chain.

These SMS elements include:

  • A security management policy
  • Objectives, targets, and security programs
  • Procedures, plans, practices, and processes
  • Security controls and monitoring methods
  • Documents and records for evidence and accountability
  • Defined roles, responsibilities, authorities, and relationships
  • Resources needed to implement and sustain supply chain security

In practice, an ISO 28000 SMS helps ensure your security measures are not ad-hoc— but planned, implemented, controlled, reviewed, and continually improved.

Why Implement ISO 28000 with Praxis Consulting?

Praxis Consulting helps you build an ISO 28000-aligned SMS that is practical for operations and defensible for audits, customer expectations, and security governance.

Organizations adopt ISO 28000 to:

  • Reduce exposure to theft, tampering, sabotage, and unauthorized access
  • Improve supply chain security consistency across sites and partners
  • Strengthen accountability through defined roles and responsibilities
  • Improve control over security-related documentation and records
  • Increase confidence among customers, regulators, and supply chain stakeholders
  • Support business continuity by reducing disruption risk

Praxis Consulting ISO 28000 Services

We support organizations through the full ISO 28000 implementation lifecycle—from readiness assessment to operationalization and continual improvement.

Our ISO 28000 consulting services can include:

  • ISO 28000 gap assessment and security readiness review
  • SMS scope definition and security policy development
  • Risk-based security control design for supply chain operations
  • Procedures and documentation development (plans, records, roles, controls)
  • Governance design: roles, responsibilities, authority, and escalation paths
  • Monitoring, measurement, review, and internal audit support
  • Certification readiness support and continual improvement planning

ISO 37001 Anti-Bribery Management System (ABMS) Consulting & Certification Support | Praxis Consulting

Bribery risk is a board-level issue in the age of transparency. Investors, business associates, employees, shareholders, and regulators expect clear evidence that leadership has taken effective measures to prevent, detect, and address bribery across the organization.

Praxis Consulting helps organizations implement and improve an ISO 37001 Anti-Bribery Management System (ABMS) and prepare for independent third-party certification—strengthening governance, reducing misconduct risk, and demonstrating due diligence.

ISO 37001 is applicable to organizations of all sizes and across all sectors.

What is ISO 37001?

ISO 37001 is a certification standard for Anti-Bribery Management Systems, published in 2016. It was created to assist organizations in establishing and maintaining a proactive anti-bribery system and contains requirements that reflect internationally recognized anti-bribery best practices. ISO 37001 supersedes British Standard 10500.

The standard sets minimum requirements and provides supporting guidance to implement controls that are practical, auditable, and governance-led.

Why ISO 37001 Matters for Your Organization

No organization can afford to take bribery risk lightly. Beyond financial loss, bribery can lead to:

  • Criminal and civil exposure
  • Contract cancellations and debarment risk
  • Reputational damage and loss of customer trust
  • Investor concern and reduced enterprise value
  • Internal cultural harm and reduced employee confidence

Implementing ISO 37001—and achieving certification through a third-party independent auditor—helps demonstrate that your organization has taken appropriate steps to prevent bribery at all levels.

Benefits of ISO 37001 Certification

Implementing ISO 37001 can deliver significant governance and risk management benefits:

  • Establishes minimum requirements for an anti-bribery management system and provides supporting guidance
  • Demonstrates to management, investors, business associates, employees, and stakeholders that appropriate anti-bribery measures are in place
  • Reduces the risk of malpractice through structured controls and oversight
  • Helps demonstrate due diligence in the event of a disagreement or investigation
  • Uses an ISO management system structure similar to ISO 9001, ISO 14001, and ISO 45001—making it easier to integrate with existing systems
  • Certification audits can highlight improvement opportunities and strengthen how the ABMS works in real operations

ISO 37001 Integration with Existing Management Systems

ISO 37001 is structured similarly to other ISO standards, enabling streamlined integration with established management systems. Praxis Consulting helps organizations align ISO 37001 with existing governance and controls to reduce duplication and improve adoption, especially where ISO-based systems are already in place.

Praxis Consulting ISO 37001 Services

Praxis Consulting provides practical implementation and certification readiness support tailored to your organization’s risk profile, operating footprint, and stakeholder expectations.

Our ISO 37001 consulting support can include:

  • ISO 37001 gap assessment and bribery risk readiness review
  • ABMS scope definition, anti-bribery policy development, and governance design
  • Risk-based control framework implementation aligned to ISO 37001 requirements
  • Roles, responsibilities, accountability, and reporting mechanisms
  • Training and awareness programs to support a strong anti-bribery culture
  • Documentation and evidence preparation for certification audits
  • Internal audit and management review support
  • Certification audit readiness support and continual improvement planning

Certification Partners and Auditing

ISO 37001 certification is issued by accredited third-party certification bodies. If you already have an audit partner or are selecting one, Praxis Consulting can help you prepare for a value-adding certification process by ensuring your system is implementable, auditable, and aligned with internationally recognized practices.

ISO 44001:2017 Collaborative Business Relationship Management (CBRM) Consulting | Praxis Consulting

Collaborative delivery models, outsourcing, and outcome-based contracting are now central to how organizations operate. As reliance on external parties grows, so does the need for structured relationship governance—so partnerships create value rather than risk.

Praxis Consulting helps organizations implement ISO 44001:2017, the international standard for Collaborative Business Relationship Management (CBRM). ISO 44001 defines requirements for effectively identifying, developing, and managing collaborative business relationships within and between organizations—and is applicable to any organization regardless of type, size, or location.

“As businesses increase their reliance on external parties to deliver solutions and increase their use of outcome-based contracting, the emphasis on collaborative working will grow,” notes the Institute for Collaborative Working—highlighting why ISO 44001 is increasingly relevant across sectors.

What is ISO 44001:2017?

ISO 44001:2017 is a management system standard that enables organizations to:

  • Establish a consistent approach to selecting and managing business partners
  • Improve relationship governance, accountability, and performance oversight
  • Strengthen collaboration behaviors and ways of working
  • Create measurable value from partnerships, alliances, and supplier relationships
  • Reduce risk in complex, multi-party delivery environments

ISO 44001 is based on British Standard BS 11000 and conforms to the ISO High Level Structure, making it easier to integrate with other ISO management systems already in place.

Who ISO 44001 Applies To

ISO 44001 supports organizations managing collaborative relationships of many kinds, including:

  • Strategic partnerships and alliances
  • Joint ventures and consortium delivery
  • Key supplier and subcontractor relationships
  • Public–private partnerships and outcome-based contracts
  • Cross-functional internal collaborations in large enterprises

Business relationships come in many shapes and sizes—from long-term partnerships to one-off transactions. ISO 44001 helps organizations maximize the value of each relationship through consistent governance and lifecycle management.

ISO 44001 Relationship Lifecycle: The 8 Stages

ISO 44001 addresses eight stages of the relationship lifecycle (based on BS 11000):

  1. Operational consciousness
  2. Knowledge
  3. Internal evaluation
  4. Selection of a partner
  5. Collaborating
  6. Creating value
  7. Remaining united
  8. Execution of the exit strategy

Praxis Consulting helps you embed these stages into practical procedures, governance checkpoints, and performance reviews—ensuring collaboration is intentional, measurable, and sustainable.

Benefits of ISO 44001 Implementation

Organizations implementing ISO 44001 commonly achieve:

  • Stronger governance over partner selection, relationship management, and performance
  • Improved collaboration outcomes in complex delivery and outcome-based contracting
  • Reduced supplier and partnership risk through clearer roles, responsibilities, and controls
  • Better communication and issue resolution between organizations
  • Increased value creation through aligned objectives and shared improvement initiatives
  • More consistent relationship practices across departments, regions, and projects
  • Clearer exit planning to protect service continuity and reduce disruption

Praxis Consulting ISO 44001 Services

Praxis Consulting provides advisory and implementation support to help organizations operationalize ISO 44001 in a way that improves real relationship performance—not just documentation.

Our ISO 44001 consulting services can include:

  • ISO 44001 readiness assessment and gap analysis
  • Relationship governance framework design (roles, accountability, decision rights)
  • Partner evaluation and selection criteria development
  • Collaboration processes, controls, and lifecycle procedures
  • Value creation planning and performance measurement approach
  • Internal audits, management review enablement, and continual improvement planning
  • Integration support with existing ISO management systems (where applicable)

ISO 14001 Environmental Management System (EMS) Consulting | Praxis Consulting

Organizations face increasing expectations to control environmental impacts, comply with environmental laws, and demonstrate responsible operations to regulators, customers, and communities. ISO 14001 is the leading international standard in the ISO 14000 family that specifies the requirements for an Environmental Management System (EMS)—a structured framework that helps organizations manage and continually improve environmental performance.

Praxis Consulting helps organizations design, implement, and improve ISO 14001-compliant EMS programs that are practical, auditable, and embedded into everyday operations—not standalone documentation.

What is ISO 14001?

Of all the standards in the ISO 14000 series, ISO 14001 is the standard that specifies requirements for an organization’s EMS. An EMS is a tool that enables an organization of any size or type to control the impact of its activities, products, or services on the environment.

A central component of an ISO 14001 EMS is the EMS documentation that controls the interaction of core elements in the system and provides third-party auditors with the key information needed to understand environmental controls and governance in place.

Like ISO 9001, the key to successful ISO 14001 implementation is having documented procedures that are implemented and maintained—so environmental goals are integrated into company-wide activities.

 

What ISO 14001 Requires (Core EMS Elements)

An ISO 14001 Environmental Management System typically includes:

  • A documented Environmental Policy made available to the public
  • Procedures for ongoing review of environmental aspects and impacts of products, activities, and services
  • Establishing environmental objectives and targets consistent with the policy
  • Operational controls and documented procedures to manage significant impacts
  • Routine internal audits to identify and address nonconformities
  • A management review process to ensure top management involvement in EMS assessment and improvement
  • Continuous improvement through structured review, corrective action, and updates

Praxis Consulting supports you in building an EMS that aligns with your operational realities and is ready for certification audits and regulatory scrutiny.

Benefits of ISO 14001 Implementation

Implementing ISO 14001 can deliver strong compliance, operational, and reputational value.

Compliance and assurance benefits

  • Provides assurance that you meet—and will continue to meet—legal and corporate policy requirements
  • Supports compliance with environmental laws and regulations
  • May result in fewer surveillance visits from regulatory agencies
  • Improves relationships with regulators; organizations often report quicker access to technical support and more supportive engagement

Business and market benefits

  • Demonstrates to business partners, regulators, and the community that you are environmentally responsible
  • Increases competitiveness in tenders and supplier qualification programs
  • Reduces environmental liability and risk exposure
  • Can reduce costs through potentially lower insurance rates

Operational excellence benefits

  • Increases profits through process improvements and better resource control
  • Streamlines operations through greater operational efficiency and energy conservation
  • Captures institutional knowledge by ensuring EMS information is properly documented, communicated, retained, and reviewed at least annually

Culture and safety benefits

  • Increases awareness and participation by improving environmental communication internally and externally
  • Creates a clear avenue to raise environmental issues and strengthens environmental performance culture
  • Delivers safety benefits by reviewing controls for significant operations, including emergency preparedness and response—often identifying meaningful safety improvements

Praxis Consulting ISO 14001 EMS Services

Praxis Consulting provides end-to-end ISO 14001 consulting support to help you implement an EMS that performs in real operations and stands up to audits.

Our ISO 14001 services can include:

  • ISO 14001 gap assessment and readiness review
  • Environmental aspects and impacts identification and evaluation support
  • EMS policy, objectives, targets, and program development
  • Process and procedure development aligned to operations
  • Internal audit support and management review enablement
  • Corrective action and continual improvement planning
  • Certification readiness and audit support

ISO 45001:2018 gives clearer direction to an occupational health and safety management system. ISO 45001:2018 is an audit/certification specification, not a legislative requirement or a guide to implementation. It should be noted that ISO 45001:2018 does not state specific performance criteria, or give detailed specifications for the design of a management system. Instead, the system is geared towards reducing and preventing accidents and accident-related loss of lives, resources, and time.

ISO 45001:2018 has been developed to be compatible with the ISO 9001 (Quality) and ISO 14001 (Environmental) management systems standards. It is its hope that any organization that implements OHSAS 18001:2007 can easily integrate it with other quality, environmental or occupational health and safety management systems. The ISO 45001:2018 Specification follows the Plan-Do-Check-Review cycle, with a concurrent emphasis on continual improvement. This model aligns well with the structure of other management system documents such as ISO 14001, thus aiding the progress of integrated management systems.

The elements of ISO 45001:2018 includes Policy and commitment, Hazard identification, risk assessment & risk controls, Legal requirements, Objectives and Programs, Organization and personnel, Training, Communication and Consultation, Documentation and records, Operational Controls, Emergency Readiness, Measurement and monitoring, Accident and incident investigation, corrective and preventive action, Audit and Review, and Application and

BENEFITS

Most organizations pursue ISO 45001:2018 certification to qualify for a tender or to achieve preferred supplier status: e.g. for a Local Authority. However, there are many other benefits that can be gained, including:

  • Reduced risk to employees, customers and suppliers.
  • Reduction in the costs associated with accidents at work.
  • Enhanced staff morale and motivation.
  • Demonstrate legal compliance.
  • Reduced insurance premiums.
  • Competitive advantage.
  • Enhance status.

In a competitive market, your customers are looking for more than just keen pricing. Organizations need to demonstrate that their delivery is managed efficiently and responsibly and that they can provide a reliable service: free of the downtime associated with work-related accidents and incidents.

An effective occupational health and safety management system promotes a safe and healthy working environment by providing a framework that allows your organization to identify and control its health and safety risks, reduce the potential for accidents, aid legislative compliance and improve overall performance.

In addition, ISO 45001:2018 is designed to be compatible with other management system standards such as ISO 9001 (Quality), ISO 14001 (Environmental) and ISO 27001 (Information Security). All or any combination of these complementary standards can be integrated seamlessly. They share many principles, so choosing an integrated management system can provide you with outstanding value for money.

It can be used by any organization at a strategic or organizational level regardless of its type, activity or size. It can be applied towards the achievement of any and all types of objectives at all levels and areas within an organization related to the risk. It can be used to help manage processes, operations, functions, projects, programs, products, services, and assets. ISO 31000 defines a set of guidelines.

ISO 31000 is used by a wide range of  stakeholders, including people who need to:

  • Establish a risk management policy.
  • Ensure that risk is managed properly.
  • Manage and control risk within an organization.
  • Evaluate risk management practices and processes.
  • Develop risk management procedures and guides.

BENEFITS

When properly implemented and applied, ISO 31000 will help you to:

  • Better organizational  ability to identify threats and opportunities.
  • Encourage personnel to identify and treat risk.
  • Help you allocate and use risk treatment resources.
  • Develop your risk management controls.
  • Improve loss prevention and incident management activities.
  • Improve the overall resilience of your organization.
  • Increase the likelihood that risk related objectives are achieved.
  • Improve operational efficiency and effectiveness.
  • Improve the effectiveness of your governance activities.
  • Improve  your organization’s enviromental, health and safety performance.
  • Encourage and support continuous organizational learning.
  • Comply with legal and regulatory requirements.
  • Improve the trust and confidence of your stakeholders.
  • Enhance both mandatory and voluntary reporting.

The standard specifies the requirements for establishing, implementing, maintaining and improving an energy management system, whose purpose is to enable an organization to follow a systematic approach in achieving continual improvement of energy performance, including energy efficiency, energy security, energy use and consumption. The standard aims to help organizations continually reduce their energy use, and therefore their energy costs and their greenhouse gas emissions. The system is modeled after the ISO 9001 Quality Management System and the ISO 14001 Environmental Management System (EMS).

Governments increasingly want to reduce the Greenhouse Gas Emissions of their citizens and industries, and are imposing legislative mechanisms to compel carbon reduction more and more frequently. A significant feature in ISO 50001 is that there is no quantitative targets specified – an organization chooses its own then creates an action plan to reach the targets. With this structured approach, an organization is more likely to see some tangible financial benefits. Furthermore, Organizations of all types and sizes increasingly want to reduce the amount of energy they consume

BENEFITS

  • Reduce costs,
  • Reduce the impact of rising costs,
  • Meet legislative or self-imposed carbon target, and
  • Enhance the organization’s reputation as a socially responsible organization.

According to WHO – Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. The main risks are: unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects. GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product.

According to the International Pharmaceutical Excipients Council (IPEC) of Europe The supply chain of a pharmaceutical excipient starts at the point of manufacture and continues until used by the finished product manufacturer. Apart from the manufacturer, other parties may be involved in the chain, including distributors, transporters and warehousing companies, forwarding agents, traders, and brokers. Although some of these parties do not have direct contact with the product (e.g., transporters), those that do (e.g., re-packagers, processers, samplers, testers) require a higher level of control and Good Distribution Practice (GDP) to be applied.

ISOmantra offers a comprehensive simulated Inspection. We identify the areas where the current compliance status needs to be improved. The Audit Report will summaries the GAP between the requirements laid down in the different legislations and Guidance documents and contains recommendations to close the GAP.

According to the International Pharmaceutical Excipients Council (IPEC), as IPEC-Americas and IPEC Europe and the Pharmaceutical Quality Group (PQG), the quality of excipients is critical to assure the safety, quality and efficacy of medicines. Excipients have a wide range of applications and are essential components of the drug product formulation. Characteristics that excipients impart to formulated drug products include cosmetic appearance, stability and delivery of the active ingredient. Therefore, applying appropriate Good Manufacturing Practice (GMP) principles to excipients is essential. In contrast to finished dosage forms and Active Pharmaceutical Ingredients (APIs), there are no specific GMP regulations for excipients. In addition, there are a large number of applications of this diverse range of materials which makes the development of excipient GMP guidelines challenging. However, there is a general expectation that excipients are manufactured to recognised GMP principles.

IPEC – PQG Good Manufacturing Practice Guidelines FOR PHARMACEUTICAL EXCIPIENTS proposes GMP appropriate for the manufacture of excipients. The text of the guidelines aligns with the corresponding clauses in ISO 9001:2008. This Guide proposes to make an essential contribution to the wider understanding and attainment of good manufacturing practice appropriate for the excipient supply industry. Excipient manufacturers and their customers can be assured that excipients manufactured according to this Guide will meet internationally accepted good manufacturing practice principles.

ISOmantra offers a complete conformity assessment solution for IPEC – PQG GMP for Pharmaceutical Excipients including training, auditing and certification services. It is also possible to integrate your existing management systems of other standard such as ISO 9001 and ISO 14001, and saving you valuable time and resources.

 

Cosmetics – Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices

·   Good Manufacturing Practices (GMP) – ISO 22716

·   Council Directive 76/768/EEC

The European Union’s new Regulation (EC) No 1223/2009 requires cosmetic products to be manufactured according to Good Manufacturing Practices (GMP).

A manufacture of cosmetics can demonstrate compliance with GMP by implementing the International Standard ISO 22716:2007.

ISO 22716 presents a management systems approach to documenting and regulating the production, control, storage, and shipment of cosmetic products. The standard’s guidelines will provide your organization with practical methods for managing the many factors that can affect product quality. These guidelines cover the quality aspects of the product, but as a whole do not cover safety aspects for the personnel engaged in the plant, nor do they cover aspects of protection of the environment. The guidelines in ISO 22716:2007 are not applicable to research and development activities and distribution of finished products.

This is an asset management system standard designed to assist businesses in managing their assets and their usage more effectively. This standard was created primarily to give organisations greater control over their daily operations by allowing them to earn a higher rate of return on their assets while minimising risk.

ISO 55001:2014 directs an organization’s efforts toward enhancing overall asset management in order to meet business and legal requirements while also satisfying stakeholders. It not only saves time and money, but also optimises asset utilisation while adding value to your business.

This standard is intended to assist businesses and organisations in enhancing their current and future performance. This assists the business in aligning its objectives with the pre-defined asset management objectives, thereby assisting the business in achieving its objectives. Assets are not only an investment for the business; they can also become a drain on the business’s resources at times. This highlights the critical importance of a business keeping a close eye on how its assets are managed.

ISO 55001:2014 enables a business to demonstrate significant organisational growth by efficiently carrying out the following activities:

  • Asset management that is effective
  • Risk management
  • Enhancing the financial performance of the organisation as a whole
  • ISO 55001:2014 is critical in demonstrating an organization’s ability to run a streamlined operation that is both asset-light and efficient. The following are some of the benefits of ISO 55001:
  • Possessing a demonstrated ability to manage assets effectively can give you an edge over competitors and assist you in meeting the conditions and compliance requirements of prospective partners and clients.
  • It provides the business with comprehensive information and control over the assets’ lifecycle.
  • It enables process improvement by maximising asset utilisation.
  • It improves operational efficiency through cost savings from redundancies and more efficient asset utilisation.
  • increases the business’s overall profitability.
  • assists the business in determining how legal and regulatory compliance can be improved.

Capturing both the costs and revenue associated with physical infrastructure investment is critical. When assets are overused, they will fail, resulting in delays, repairs, and replacements. However, if the asset is idle, valuable capital is being held in an inefficient manner. By implementing an asset management system effectively, organisations can reduce their total cost of ownership over the asset’s lifecycle and increase the efficiency and effectiveness of investment, maintenance, and disposal decisions. This would contribute to the growth of the business by coordinating initiatives, processes, resources, and functional contributions. Additionally, it would mitigate the risk of interruptions or delays caused by safety incidents.

Concerning R2v3 and RIOS Responsibly Recycled Materials. The Rv3 standard complies fully with the Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal (the “Basel Convention” or “Convention”). R2v3 mandates practises that go beyond current international legal requirements for the export of used electronic equipment for material recovery or reuse in a number of areas.

  • Under a slew of international agreements, including the Basel Convention, legal requirements governing the classification, collection, and management of used equipment and e-waste are evolving in a number of countries and at the global level.
  • R2v3 requires recyclers to develop, implement, and maintain a legal compliance process that complies with all applicable environmental, health, and safety, and data security requirements.
  • An R2v3 electronics recycler must implement and maintain an Environmental, Health, and Safety Management System (“EHSMS”) that is certified to an accredited management system standard, such as RIOS or a combination of ISO 14001 and ISO 45001.
  • R2v3 requires recyclers to positively identify, document, and track all international shipments of end-of-life (“EOL”) and untested equipment that contains Focus Materials. EOL equipment containing Focus Materials would be considered hazardous waste under the laws of some countries.

Taken together, these requirements ensure that R2v3 certified recyclers have the information and management system infrastructure necessary to ensure compliance with applicable local, national, and international legal, regulatory, and/or statutory requirements.

ISOmantra provides R2:v3 and RIOS Responsible Recycling Advisory Services. These services include the following:

  • A comprehensive front-end analysis of your facility
  • Management Systems for the Environment, Health, and Safety
  • Strategies for Reuse, Recovery, and Disposal
  • Compliance with all applicable environmental, occupational health and safety, and data security laws
  • Best Practices to ensure worker protection as well as the health and safety of the general public
  • Effective supply chain management of downstream focus materials
  • Reliable repair and maintenance of reusable equipment and components
  • Establishment of an R2v3-compliant data tracking and destruction process
  • Establishing the documentation systems required to demonstrate compliance with the R2v3 Standard.

IATF 16949:2016 is a global quality management standard for automobiles. Curated by members of The International Automotive Task Force (IATF) in 1999, the International Organization for Standardisation (ISO) has since approved three editions of this certification for industry use, the most recent of which was published in 2016.

This management certification programme aims to develop a standardised set of methods and techniques for processes and product development in collaboration with manufacturers in the global automotive industry. The IATF 16949 certification programme is focused on continuous improvement, waste reduction, variation reduction, and defect prevention in automotive processes, ensuring that everything manufactured meets exceptionally high customer standards and supply chain efficiency.

The IATF 16949 standard covers nearly every aspect of automotive processes, including the design, development, production, installation, and servicing of automotive products and devices.

When used in conjunction with ISO 9001, this quality management system maintains close communication with the ISO 9001 platform and is capable of bridging the gap between automotive processes and customer-specific automotive requirements.

WHO ARE THE INTERNAL AID TRAFFIC FORCES (IATF)?

The International Automotive Task Force is a group of automotive manufacturers who work together to enhance and improve their processes and production lines for global consumers of their products.

Their goals are as follows:

  • To define and develop consensus on international fundamental quality system requirements, primarily for direct suppliers of production materials, product or service components, or finishing services to participating companies (e.g., heat treating, painting and plating).
  • To develop policies and procedures for the IATF’s third party registration scheme in order to ensure global consistency.
  • To provide appropriate training to meet the requirements of ISO/TS 16949 and the IATF registration scheme.
  • To develop formal relationships with appropriate bodies in order to further the IATF’s objectives.

WHICH ENTITIES REQUIRE IATF 16949 CERTIFICATION?

If your organisation is a part of the automotive supply chain, your contractors, clients, or governing bodies may expect you to adhere to IATF 16949 regulations. Existing certification holders must reapply every three years to ensure their processes continue to meet the required quality management standard.

A quality management system certified to IATF 16949 will assist you in continuously monitoring and managing quality throughout your business, allowing you to identify areas for improvement and ensure that everything runs smoothly. This is the quality system required by international automotive businesses to operate at the highest level.

A sustainability report is an organizational report that gives information about economic, environmental, social and governance performance. Sustainability reporting is not just report generation from collected data; instead it is a method to understand, internalize, measure, improve and communicate their economic, environmental, social and governance performance and an organization’s commitment to sustainable development in a way that can be demonstrated to both internal and external stakeholders

What we offer:

  • In-house training on sustainability reporting
  • Workshops on preparing sustainability reports including: stakeholder identification, materiality testing for indicators
  • Consulting on data management and sustainability reporting monitoring systems
  • Consulting on authorship of sustainability reporting
  • Sustainability report preparedness audits – ensuring that reports are ready for external assurance
  • Independent third party assurance on sustainability reports

Compliance management systems — Requirements with guidance for use

ISO 37301 is a management system standard of Type A that specifies the requirements and guidelines for establishing, developing, implementing, evaluating, maintaining, and continuously improving a compliance management system (CMS). A CMS enables organisations to take a structured approach to meeting all compliance obligations, including those that are mandatory, such as laws, regulations, court rulings, permits, and licences, as well as those that are voluntary, such as internal policies and procedures, codes of conduct, standards, and agreements with communities or non-governmental organisations.

ISO 37301 is applicable to all organisations regardless of their size, nature, or degree of complexity. CMS is founded on the values of integrity, sound governance, proportionality, openness, accountability, and sustainability.

As is the case with the majority of management system standards, ISO 37301 adheres to the ISO-developed high-level structure (HLS). The HLS structure defines the commonly used terminology and definitions, as well as the clause sequence (1–10), in which the CMS requirements are defined in clauses 4–10. The HLS enables organisations to integrate multiple management systems, which means they can use a CMS as a stand-alone management system or integrate it with other existing management systems.

Why is ISO 37301 critical for businesses?

Consistent compliance with compliance obligations is a requirement, not an option, for organisations seeking growth and long-term success. A CMS built on the ISO 37301 requirements and guidance provides organisations with a set of tools (policies, processes, and controls) for establishing and maintaining a compliance culture.

Organizations that use an ISO 37301-compliant content management system (CMS) commit to sound corporate governance standards, best practises, and ethical behaviour. The CMS, on the other hand, cannot entirely eliminate the risk of noncompliance. ISO 37301’s requirements and guidance assist organisations in identifying and responding to noncompliance in this regard. In some jurisdictions, the presence of a CMS can be interpreted as an indication of an organization’s diligence and commitment to compliance, which can aid in mitigating legal liability and reducing penalties for violations of applicable laws.

ISO 37301 establishes requirements for competence, communication, and awareness. By adhering to these requirements, organisations ensure that top management’s vision is translated and ingrained in the behaviour of managers and employees. ISO 37301 also requires and encourages the establishment of succinct and effective policies, procedures, and controls that establish a compliance culture and high ethical and integrity standards within organisations.

ISO 37301 outlines the path to compliance, which begins with the top-down setting of the organization’s tone. The organization’s governing body and top management demonstrate their commitment to a strong compliance culture through a compliance policy and the establishment of compliance objectives at various levels. Additionally, the governing body and top management must demonstrate leadership and commitment by allocating necessary resources, establishing a compliance function, and clearly defining roles and responsibilities. Above all, the governing body and top management should demonstrate their commitment to the CMS in a proactive and visible manner through their actions and decisions.

The advantages of implementing ISO 37301 in a business

By implementing a content management system (CMS) based on ISO 37301, organisations can:

  • Conduct a formal third-party assessment of their CMS’s conformance
  • Create a positive compliance culture
  • Address compliance concerns expeditiously and effectively
  • Maintain their reputation and integrity by preventing and detecting unethical behaviour.
  • Enhance commercial opportunities and sustainability
  • Consider the requirements and expectations of internal and external stakeholders.
  • Establish strong and mutually beneficial relationships with regulators
  • Increase third-party confidence in the organization’s ability to sustain success
  • Increase customer confidence and loyalty

ISO 42001:2023

Next Step

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