With all the focus on the 9001 family of standards it hard to believe we have less than 8 months until ISO 13485:2003 expires and all medical device organization in the supply chain will need to have completed their transition to ISO 13485:2016.
Here at NQA we are on track to complete all our transitions on schedule, with around half our clients already transitioned we are pleased to say 100% success to date, not bad when thinking we did not start until late in 2016, but were one of the pioneers and received one of the first ANAB scope extensions to include this new requirement.
As mentioned previously with over 50% of our certificated clients transitioned we are now tending findings and typical non-conformances. To date I am pleased to say we have had zero major findings raised against the transitional process, many findings related to the following areas of the requirements:
- Failing to consider, document and record exclusions to requirements fully with QMS
- Not fully understanding customer requirements, risks, and impacts on medical device
- Not full documenting/understanding medical device risks at organization and down stream
- Not consider value added processes on downstream/end user
- Incomplete medical device records
- Not full documenting medical device requirements/processes/procedures
- Validation of software used in the control, management, or validation process
- Supplier management and communications regarding the medical device/impact of contracted service, and supply chain security.
We continue to expand our pool of general Medical Device auditors and we are pleased to confirm a growth in capability in pharmaceutical, research, clinical diagnostics as well as our growing pool of specialist to handle those “odd” requests from the support industry (we have registered one of the first medical translational to ISO 13485:2016).
We offer a full range of accreditation service without the baggage of a notified body/registrar, we can offer local auditors resources across the world including Europe, China, South America, Canada. Unlike other certification bodies, we have resources available to ensure your transition goes a seamlessly as possible.
Please contact our customer service department or business unit with any questions, we will be pleased to help or provide you with a cost effective registration solution for new or currently certified organizations just like you.
Don’t forget the end of ISO 13485:2003 is coming soon!