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Production and service provision process in ISO 13485
Clause 7.5 of ISO 13485, which deals with requirements for production and service provision, causes a lot of confusion. The...
Clause 7.5 of ISO 13485, which deals with requirements for production and service provision, causes a lot of confusion. The main reason for this is the fact that the standard aims to define requirements applicable...
How to define roles and responsibilities within an ISO 13485-based QMS
Updated: August 29, 2023 When you are developing a Quality Management System (QMS), you need to assign and document the...
Updated: August 29, 2023 When you are developing a Quality Management System (QMS), you need to assign and document the roles and responsibilities within your management system. ISO 13485 highlights this need, as shown primarily...
How to perform an ISO 13485 management review
Updated: September 30, 2023 Many companies see management review as an unpleasant necessity for maintaining compliance with ISO 13485. If...
Updated: September 30, 2023 Many companies see management review as an unpleasant necessity for maintaining compliance with ISO 13485. If used properly, however, this is far from the truth. Regardless of how you organize your...
What are the consequences of noncompliance with ISO 13485 for manufacturers of medical devices?
Today’s business owners have a wide array of concerns, not the least of which is turning a profit in what...
Today’s business owners have a wide array of concerns, not the least of which is turning a profit in what can be a volatile economy. However, financial success is of little consequence if the government...
Mandatory documents required by ISO 13485
Updated: September 19, 2023. The new ISO 13485 is based on ISO 9001:2008, which means that the ISO 13485 2016...
Updated: September 19, 2023. The new ISO 13485 is based on ISO 9001:2008, which means that the ISO 13485 2016 documentation requirements are based on the requirements of the previous version of ISO 9001, with...
Infographic: What’s new in the 2016 revision of ISO 13485
To get a better overview of the relationship between ISO 9001 and ISO 13485, see this article: ISO 9001 vs....
To get a better overview of the relationship between ISO 9001 and ISO 13485, see this article: ISO 9001 vs. ISO 13485.   The new 2016 revision of ISO 13485, the leading international standard for...