Quality Systems Part 2, QS Strategy
FDA, ISO 13485, Quality System, Strategy
In previous Device Tip, I gave an overview of a Quality System that results in happy Customers. So the next thing I often get asked is, “how do I develop such a Quality System and where do I start?”
Assuming you’ve read this tip or are already familiar with either the FDA Quality System Regulation (QSR) or ISO 13485, you know there are about (26) processes that constitute a complete Quality System. Your company may have less due to the fact there may be some processes that you don’t do. You might also have some processes performed by outside contract resources, but you will still need to ensure that those contract resources meet all the QS requirements of the QSR and possibly ISO 13485 if you plan to sell your products outside the U.S.
So, how do you do it? Here’s my tip:
Determine the overall strategy for your company’s Quality System, including your company and any other companies that will perform part(s) of your company’s Quality System.
The QS strategy needs to address two aspects:
- Where your company’s products will be sold; and
- What Suppliers or Contract resources who perform part(s) of your company’s Quality System.
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Where your company’s products will be sold will determine the applicable Standards and Regulations to which your QS will need to comply. This typically includes:
- the FDA Quality System Regulation (QSR)
- ISO 13485 (the actual Standard published by ISO)
- EN ISO 13485 (the version of ISO 13485 Harmonized for the EU)
- Other versions of ISO 13485 used by other countries or country-groups
The Suppliers or Contract resources who will perform part(s) of your company’s Quality System will determine:
- What elements of the overall QS your company will perform completely, and thus will be completely responsible for;
- What elements of the overall QS each Supplier or Contract resource will perform completely, and thus will be completely responsible for;
- What elements of the overall QS will be performed partially by a Supplier or Contract resource and partially by your company, and thus will be a shared responsibility.
At the end of the day, your company is ultimately responsible for all elements of the QS for your products. Therefore, in cases where either a Supplier or Contract resource will perform completely, or in cases where there is a shared responsibility, your company will need to establish a Quality System agreement that stipulates who does what, and what documentation and other controls will be in place on an ongoing basis to ensure the over QS conforms with the applicable Standards and Regulations.