Benefits of ISO 13485
Some of the most appealing advantages are the ability to:
1. Contract with Larger Organizations
Many large medical device companies prefer to cooperate with ISO 13485-certified vendors. Certification has become even more valuable since the 2016 update. Large corporations are now responsible for ensuring that any subcontractors meet ISO 13485 criteria; subcontractors that already hold the certification are likely to be prioritised.
2. Show Commitment to High Quality
ISO 13485 and ISO 9001 are both regarded as markers of a company’s dedication to quality. Obtaining a quality management accreditation shows consumers and regulators that your organisation places a high importance on quality.
3. Increase Potential Market
International medical device standards, such as ISO 13485, are developed to ensure that medical equipment in diverse locations display the same dependability and quality. If you’re thinking about exporting your products, ISO 13485 certification can help. It is the first stage toward regulatory approval in large areas such as the EU and Canada, and it also indicates the product’s quality to prospective buyers.
4. Assist Personnel in Obtaining Relevant Information
The documentation criteria in this standard are intended to guarantee that all members of a development team have constant access to the information they require, potentially reducing the time and cost involved with product development.
5. Broaden and Strengthen Business Knowledge
Clients also tell us that recording the processes related with their medical equipment aids in the development of a consolidated knowledge base. This knowledge can aid in the identification of problems, the improvement of the product, and the streamlining of the manufacturing process. It also facilitates the process of onboarding new employees.
6. Improve Customer Satisfaction
A medical device QMS enables you to produce more consistent quality in your products and services, making them more reliable and capable of meeting the expectations of your customers. This improved quality boosts consumer happiness.
7. Gain More Clients
Many corporations prefer to collaborate with medical device organisations that have ISO 13485 certification, and some require it of all companies with whom they engage. This is owing, in part, to the fact that, according to the most recent edition of ISO 13485, corporations are responsible for ensuring that any subcontractors with whom they operate comply with ISO 13485 criteria. ISO 13485 accreditation allows you to earn more business because of these preferences and standards.
8. Make it easier to obtain ISO 9001 certification
Many businesses are ISO 13485 and ISO 9001 certified. If your company is ISO 13485 certified, obtaining ISO 9001 certification is much easier. These two standards’ requirements are generally compatible. While ISO 9001 has a few criteria relating to business clauses that ISO 13485 does not, you will have previously completed the majority of the work.