Control of Records in your ISO9001-2008 Quality Management System

Most of my posts do not go into excruciating detail on one aspect of the ISO9001-2008 quality standard. Recently I had a discussion with a colleague about a potential nonconformance in a company’s records control process, so I thought I’d examine it here.

Section 4.2.4 of the ISO9001-2008 quality standard is a pretty small bit of the standard. It’s only 3 sentences. I don’t want to violate any copyright here, so I’ll paraphrase.

If you want to be in compliance to ISO9001-2008, you have to keep records as evidence that you’re conforming to requirements of the standard. You must have a procedure to control your records. Your quality system records must be legible, and your records must be “readily identifiable and retrievable”.

In the audit situation discussed with the colleague, records were kept in large boxes piled on top of each other, nearly reaching the ceiling. Completed tags were thrown into these boxes over the years, but with no real organization. In general, the older tags were near the bottom of the box, and the more recent ones on top. But its just a jumble of tags in each box, and it could take some time to find a particular record.

Per, the word “readily” means “promptly; quickly; easily. Originally I maintained that since (in my opinion) it appeared that records could not be located quickly and easily, that the company did not meet this particular section of ISO9001-2008. My colleague disagreed with me on this point. I had not yet asked the company representative to find any particular record. It is possible that the company employee might have some sixth sense, or might have so much experience retrieving records at the company that he would be able to quickly find anything I was looking for.

I had to think about it a minute, and then I realized my colleague was correct. I did not write up a nonconformance at that point. Of course, later in the audit I asked to see a particular record, and the person responsible for the process took about 45 minutes to find the record I asked for. Now I had concrete evidence of a nonconformance. Most of the ISO9001-2008 quality standard is subject to interpretation. Taking the word “readily” literally, I can not consider a record to be readily identifiable and retrievable if it takes 45 minutes to locate.

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