5 Stepping Stones to Successful ISO 13485 Certification

1. 5 Stepping Stones to Successful ISO 13485 Certification

2. ISO 13485 defines a set of requirements for the medical device manufacturers to formulate their QMS (quality management system) to ensure the expectations of customers (healthcare institutions, hospitals, clinics, pathologies, pharmaceutical distributors) are met. If you are a manufacturer of medical devices, then getting ISO 13485 certification will help to demonstrate your competency to deliver top-quality products to the customers. However, achieving ISO certification can be a big concern for manufacturers. The next slides will describe how to successfully certify your manufacturing company. ISO 13485 Certification for Medical Device Industry

3. 5 Steps to Gain ISO 13485 Certification Here are some key steps that will help your medical device manufacturing company get certified with ISO 13485 standard. Meet Regulatory Requirements Plan the QMS Implementation and Training Management Review Certification Audit

4. Plan the QMS: The preliminary part of the ISO 13485 standard requirements include the planning and implementation of the QMS. There should be a manual or document that explains the QMS, how it operates, its processes, and its outcomes. Meet Regulatory Requirements: While developing the QMS, make sure it complies with the particular regulatory requirements of the medical device industry. Implementation and Training: The next crucial step is to provide training for the employees and get them familiar with the QMS processes. Training should be provided regarding the core processes, such as materials purchasing, production, testing, and distribution. Management Review: Management should periodically review the performance of the QMS with an internal audit. This review will evaluate the quality of the medical devices, and discuss minimized risks or errors in the products. Certification Audit: This is the last step, and should be executed by an external certification agency that you have chosen to grant you ISO 13485 certification. They will perform thorough audits to ensure that each of the standard’s requirements is met by the QMS.

5. Key Takeaway All the above steps are needed to help the QMS achieve compliance with the ISO 13485 certification. From preparing the QMS to continually reviewing the system, these are systematic processes that ensure all the quality expectations of the medical device equipment are met. Customer satisfaction is enhanced as a result of a compliant QMS, which brings on more sales opportunities for a manufacturer.

6. About the Company Compliancehelp Consulting LLC is a top-rated agency that assists organizations in diverse fields with certification to their respective quality assurance standards, including ISO 9001, AS9100, TL 9000, and ISO 13485 standards. It provides consulting and compliance services at the most affordable rates to meet the limited certification budget of the clients.

7. Contact Us Compliancehelp Consulting, LLC 877-238-5855 5686 South Redwood Rd, 84123 Salt Lake City, Utah https://www.quality-assurance.com info@quality-assurance.com

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