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.