How do I check my ISO 13485 certification?

To find the approved certified bodies for ISO certificates, you can go to the IAF website (International Accreditation Forum). This is an international organization where the accredited bodies are registered. This organization ensures that its accreditation body members are doing the right job.

What is the current version of ISO 13485?

ISO 13485:2016
The current version is ISO 13485:2016, which was published in March of 2016 (thus the: 2016). It is NOT a standard for products. It does not define product quality. This is a process-based standard: you use it to control your processes, then your end product should meet the desired results.

What is the difference between ISO 13485 and 21 CFR 820?

ISO 13485 is a global standard that is voluntary in the US but required in some countries. ISO 13485 will become the FDA’s mandatory QMS April of 2019. 21 CFR 820 is applicable to manufacturers of finished medical devices sold in the United States, including imported products.

What are ISO 13485 requirements?

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Who needs ISO 13485 certification?

Any company involved in the supply chain of medical devices needs ISO 13485 certification. This is particularly true for those that design, develop, manufacture, and distribute these types of products. Even local regulations in various countries require businesses to gain certification.

Who uses ISO 13485?

Who is ISO 13485 for? ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.

What does ISO 13485 mean?

Medical devices — Quality management systems
ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical …

What do you need to know about ISO 13485?

ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

When did medical devices transition to ISO 13485?

A free brochure with tips for getting started with ISO 13485, requirements for quality management systems related to medical devices. Learn more about how to transition from ISO 13485:2003 to ISO 13485:2016 in this transition planning guidance document [PDF] developed by the technical committee.

What does The Cofepris stand for in ISO 13485?

The cofepris is the body assigned to its control, verification and to grant the records of compliance to the companies that implement this Standard of Good Manufacturing Practices. This standard is partially in line with ISO 13485: 2003 and ISO 9001: 2008.

When did the third edition of ISO come out?

The third and most current edition of the standard was published by ISO in 2016. (4) Since the March 2019 expiration of the three-year grace period that followed the unveiling of ISO 13485:2016, device companies have been required to be in full compliance with current standards.

How do I check my ISO 13485 certification? To find the approved certified bodies for ISO certificates, you can go to the IAF website (International Accreditation Forum). This is an international organization where the accredited bodies are registered. This organization ensures that its accreditation body members are doing the right job. What is the current…