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Operational Procedures for ISO 13485:2016

bme007

Starting to get Involved
#1
Hi there,
I recently took a job in a small medical company that produce class I & II devices per contract requirement. We are the manufacturing who make the product per customer design and requirement. I was asked to implement & get the ISO13485:2016 certified. I understand the company quality manual and company procedure are two different document. I know every company has their own functional and operation, but I like to see if anyone could help provide some leads.
  • Showing some procedure samples (not the quality manual) that meet ISO13485:2016 requirement.
  • The company is currently using QuickBooks & other MS words for document and records. Does these require software validation?
  • Is the company allowed to get the ISO certified again if they get a “NC” and how often is it?
Thanks.
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
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!
 

bme007

Starting to get Involved
#3
Jen. Wow! That is a very well advice. I understand that is what I need to do, but any samples from anyone would also do some help, at least give me some idea.
I did spent sometime searching in this forum & google, but failed to find what I like to see. I hope someone here can help sharing some existing samples.
Appreciate your input.
Just curious: are you what you said in your title " Quality and Auditing expert"?
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#7
I would also suggest you becoming a certified lead auditor for ISO 13485 via SAE or similar.
 
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