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    ISO-13485-blog

    All posts by: Strahinja Stojanovic

    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
    When you are developing a Quality Management System (QMS) it is necessary to assign and document the roles and responsibilities...
    When you are developing a Quality Management System (QMS) it is necessary to assign and document the roles and responsibilities of your management system. ISO 13485 highlights this as shown primarily in the requirements of...
    How to perform management review according to ISO 13485
    Many companies see Management Review as an unpleasant necessity for maintaining compliance with ISO 13485. If used properly, however, this...
    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 management review, either through...
    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...
    List of mandatory documents required by ISO 13485:2016
    The new ISO 13485 is based on ISO 9001:2008, which means that the requirements for documentation are based on the...
    The new ISO 13485 is based on ISO 9001:2008, which means that the requirements for documentation are based on the requirements of the previous version of ISO 9001, with the addition of documents specific to...
    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...