Hello bme007,
We have been asked for examples of procedures so many times, and the response is always the same: I could do a Google search and find some for you, but what good would it do you for me to supply documents that likely do not represent what goes on in your organization at all?
If you are already producing Class I and Class II medical devices, the absolute wrong thing would be to write procedures and force yourselves into doing what they say "Because ISO says so" and someone is trying to "get the company certified." Uncounted opportunities for a well-functioning QMS are lost due to this cart-before-the-horse approach because the QMS is everything and everyone performing in support of customer satisfaction, not the champion "doing quality." Instead, I suggest:
Step 1) Familiarize yourself with the standard.
Step 2) Familiarize yourself with current processes and practices.
Step 3) Compare current processes and practices against the requirements of the standard.
Step 4) Review your organization's business plan if it exists.
Step 5) Identify complaints and warning letters, if any.
Step 6) Obtain a copy of
ISO 9001:2015 in Plain English as well as
ISO 9002. These should help explain the standard upon which ISO 13485 is based.
Step 7) Identify gaps between what is happening now and ISO 13485 requirements.
Step 8) Form a plan to address what you found in 7)
Step 9) Present your proposal project to management for review, approval and funding.
Step 10) Execute your project.
Software validation requirements are generally referring to software used for testing the products you make. I would welcome any other Covers feedback on that point.
Certification happens in two stages:
Stage 1 is a review of documentation to confirm you have a functioning QMS. It is possible the CB would want to send someone to visit for this, but the visit would be short. You would be expected to produce evidence of functioning processes, including a round of internal audits, corrective actions and Management Review(s).
Stage 2 is the visit for certification. Your complete QMS would be reviewed. There would be an expectation to see some completed nonconformances, but having one or more open nonconformances should not halt your process unless they are about a major gap or issue that would result in a Major from the CB (meaning the issue has not been fixed yet):
1) Something that could result on bad product being released to a customer.
2) A complete lack of some required process, such as no audits done or no management reviews held.
3) Some issue that is system-wide, such as lack of evidence of personnel determined competency all over the place.
Consider contacting an accredited registrar now, as they can give you good information on what to expect and how much it would cost.
I hope this helps!
