How do I get ISO 13485 accreditation?
6 steps to ISO 13485:2016 certification
- Planning the quality system. Section 5.4.
- Meeting regulatory requirements. While developing your quality plan, U.S. medical device companies must comply with FDA 21 CFR 820.
- Implementing design controls.
- Documents, records, and training.
- Management processes.
- The Certification audit.
What does it mean to be ISO 13485 certified?
ISO 13485 was written to support medical device manufacturers in designing a QMS that establishes and maintains the effectiveness of their processes. It ensures the consistent design, development, production, installation and delivery through to disposal of medical devices that are safe for their intended purpose.
Is ISO 13485 the same as ISO 9001?
ISO 9001 is the international standard which provides specifications for a quality management system which can be applied at any organization regardless of industry, product or service, or company size. ISO 13485 is a comprehensive management system specifically for the manufacture of medical devices.
Who can apply for ISO 13485 certification?
Suppliers or external parties who provide goods, including quality management system-related services to such entities, may apply for ISO 13485 Certification. What are the requirements of ISO 13485 for Implementation and Certification? As per the ISO 13485 :2016 Standard, the requirements for implementation are given as ,
How long does an ISO 13485 certificate last?
The initial ISO 13485 certificate will be issued with a three-year expiration, and the certificate is typically received about one month after the acceptance of your corrective action plan.
What is ISO 13845 and who needs it?
ISO 13845:2016 is beneficial for many organizations, and can be used by suppliers and external parties that are involved with providing medical device products.
Does ISO 13485 align with ISO 9001?
While ISO 13485:2016 remains a stand-alone document, it aligns with ISO 9001:2008. (Yes, 2008, not 2015.) This is because it does not follow the high-level structure (Annex L) of the latest version of ISO 9001 (which is 9001:2015).