5 Tasks for Implementing ISO 13485

In a recent blog post on Medical Device Academy, Brigid Glass shares "12 Important Tasks for Implementing ISO 13485."

I've listed five of her twelve tasks to include into your plan.


Stephanie Wiseman
  1. Select a certification body and schedule your certification audits (i.e., Stage 1 and Stage 2). If you want to place devices on the market in the EU, Japan, or Canada, make sure your certification body meets the specific regulatory requirements for that market.
  2. Document training on the procedures comprising the quality system. A signed form indicating that employees [have] "read and understand" the procedures is not enough. Training records should include evidence of effectiveness of training, and you should be able to demonstrate competency of the people performing those procedures.
  3. You must complete at least one full quality system internal audit. Timing of your internal audit should be late enough in the quality plan… that most elements of your quality system have been implemented. However, you want to allow enough time to initiate CAPAs in response to internal audit findings before your Stage 1 audit. If your internal auditor(s) have been heavily involved in the implementation of the quality system, you may need to hire an external consultant to perform your first internal audit.
  4. You need to complete at least one management review, which can be done just before the Stage 1 audit. My preference, if there is time, is to have at least two management reviews. The first review might occur three months before the Stage 1 audit, just before you plan to perform an internal audit of the management processes. There may be limited data to review at that time, but this first review provides an opportunity to train top management on their roles and responsibilities during a management review.
  5. If product design is within the scope of your QMS, which is typical of legal manufacturers, but not for contract manufacturers, then you must establish a design control procedure(s). Product development projects often operate in a time frame that is longer than your implementation project, and you may need ISO 13485 certification as part of the regulatory approval process.

Make sure you check out Glass's complete list.

Do any of these surprise you? Are any often neglected in your ISO 13485 plan?

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Stephanie Wiseman, Community Editor, UBM

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