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News | January 17, 2010

PBL Recertified for Latest ISO 9001:2008 and Newly Certified for ISO 13485:2003 for Medical Devices

by PBL

Pacific BioLabs was certified by Intertek to the latest ISO 9001 standard (the new 2008 version) in December, 2009. Additionally, PBL achieved certification to ISO 13485:2003 for medical devices.

What This Means To You

    • ISO 9001:2008 certification means that Pacific BioLabs has implemented a quality management system. A quality management system differs from quality control. This means that instead of simply rejecting bad quality items from delivery or use, the company has implemented a systematic structure of written procedures, training of personnel, formal design of processes and implementation of continual improvement processes which ensures that all operations are performed consistently.
    • ISO 9001:2008 requires a focus on the customer’s needs and

– Planning what is to be done and providing evidence of those plans (e.g., written procedures).

– Performing what is written in the plans and providing evidence that it was done (e.g., a signed document describing the activities performed and results obtained).

– Checking the work and providing evidence of the check (e.g., an inspection record created when someone is watching work being done).

– Improving the activities to help the customer and providing evidence that the improvement is effective (e.g., a design change to help the customer better use the product).

    • ISO 13485 is the internationally recognized quality management system standard for the manufacture of medical devices.

– ISO 13485 compliance is required to achieve compliance to European regulatory requirements and CE marking.

– ISO 13485 means that (in addition to the requirements in ISO 9001:2008) the quality management system considers the regulatory environment of the medical device (for example, in the United States, this means the requirements of 21CFR820 are implemented; in the EU, this means the requirements of the MDD (Medical Device Directive) are implemented.

– ISO 13485 goes beyond ISO 9001:2008 and includes provisions for risk management in product development and delivery, a process that has been the focus of many new FDA directives.

– ISO 13485 goes beyond ISO 9001:2008 and includes requirements for documentation and validation of sterility assurance activities for medical devices.


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