Ultimate Guide to ISO 13485-2016 Certification and Compliance

What exactly is ISO 13485:2016?

ISO 13484 is a stand-alone quality management standard evolved from the ISO 9000 series. ISO 13485 is a process-based concept for a regulated medical apparatus manufacturing environment that is based on ISO 9000. This is more regulatory in nature and necessitates a well-documented QMS.

ISO 13485 assists medical device manufacturers in developing a quality management system that determines and maintains the effectiveness of their procedures. The consistent design, development, production, installation, and distribution of medical equipment ensures the safety of their intended purpose.

Who requires ISO 13485:2016 Certification?

Because it is a requirement for doing business, many companies have adopted ISO 13485. It complies with several global laws, including CE marking of medical equipment under the US Food and Drug Administration (FDA) and European directive requirements that medical device producers establish and maintain quality systems.

Medical apparatus manufacturers and suppliers of medical devices, medical device distributors and importers, and service providers for medical devices such as installation, technical support, and QMS services are the most obvious candidates for ISO 13485:2016 certification.

How does ISO 13485:2016 Certification help your company?

ISO 13485 is the gold standard for quality in the medical instrument business, and it can help your organization’s image and credibility.

 This certification demonstrates to your clients that you pay close attention to quality and have a solid structure in place to ensure it. Your QMS is a tremendous marketing tool, and in many countries, suppliers are required to demonstrate compliance, which opens up a huge opportunity.

Enhance your processes:

Using this process method, it is easy to identify areas for improvement. You will be able to identify and eliminate waste within and between processes, reduce errors, and avoid rework, resulting in increased efficiency and cost savings.

Improved employee engagement:

When employees are challenged to improve their own processes, they not only contribute their greatest information, but they also feel happier and more invested in the success of the firm. Employee comprehension in producing quality products and services, as well as their full devotion, aids in enhancing efficiency and productivity.

Improve customer happiness:

The ISO 13485:2016 standard is built around achieving customer pleasure. It is possible to achieve this through understanding client wants and expectations. Consumers are aware of their desires and demands, and many would not engage a supplier that lacks sufficient credentials. Above all, ensuring the pleasure of your present consumers encourages them to return, which helps to market your services to new clients, ultimately leading to more revenue.

Quality Management systems that are ISO 13485:2016 compliant follow a risk management approach that involves an assessment to identify and estimate the risk, as well as the implementation of risk controls and strategies with the goal of eliminating hazardous circumstances throughout the product realization.

Heavily emphasizes sterility and cleanliness in the production environment, which promotes efficiency and productivity.

How Can I Obtain ISO 13485:2016 Certification?

Design your quality system as follows:

ISO 13485 part 5.4.2 includes a need for quality planning. It is not enough to simply produce a quality manual; you must also have a documented quality plan in place before you can apply modifications to your QMS. Your quality plan includes the selection of an ISO Consultant. The consultant you select must be well-versed in your industry.

Compliance with regulatory requirements

US medical device businesses should follow FDA 21 CFR 820 when designing their quality plan.

• Fill out the ISO 13485 application form, either in soft or hard copy, and submit it.
• •An ISO 13485 auditor will assess your application form, and if accepted, a quotation for ISO 13485 certification will be supplied.
• After receipt of the ISO 13485:2016 Certification fee, an ISO 13485 audit plan will be given, and the audit will be undertaken (stage-1).
• Upon the successful completion of the stage-1 audit, you will be summoned for the stage-II audit plan.
• The auditor will suggest ISO 13485:2016 certification to your organization if the audit is successful.
• The Certification authority will decide whether to give ISO 13485:2016 certification based on the auditor’s advice and audit findings.
• The revised version 13485:2016 places a strong emphasis on risk management and risk-based decision making, as well as adjustments related to rising regulatory obligations for supply chain organizations.