ISO 9001 Internal Audit
- Thread starter qcman
- Start date
Any answer here would be just speculation. There are many Mr. Magoos out there working as third party auditors who can’t find a haystack on top of a needle.
And, those who might notice it, can be very forgiving and understanding or be draconian about. There is no consistency in third party auditing.
Do you mean that you perform a single large internal audit every year - copying a single 3rd party audit? If so I’d say that you’ve tied your wrists to your ankles. Change your QMS documentation. Perhaps issue a ‘temporary process change’ stating that the annual audit was delayed due to some real justifiable reason and that you are changing your procedure to a more realistic and achievable approach. I’d advise risk based scheduling as determined by QA that doesn’t lock you into a specific time frame or frequency. Some processes will need to be audited frequently maybe every quarter and some will be so controlled and monitored by metrics that only an infrequent audit would be necessary - maybe every 3 years
Being a relatively small company one annual doesn't seem like that big of a deal. Been doing it since the early QS days. I have considered breaking it up though as you suggest. Issuing a temporary change was what I was asking about.
OK. Bu a relatively small company I would think that you are continually monitoring and aware of what people are doing so an internal audit isn’t finding too many surprises? In that case an annual whole enchilada audit is probably just an exercise in checking the box?
toniriazor
Involved In Discussions
Would it be possible for you to share what was out of your control, so during the entire year your QMS department did not perform the system audit? Maybe the answer, if this will be a NC during 3rd party audit or not lies there? Also if you don't do it and is due probably an auditor would follow then your risk and opportunities analysis and see if you have addressed that?
Jane's
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Hi, we are a small company and do the same, one big annual IA. We were not only late one calendar year, we completely missed the IA (did it in March of next year instead of November of that year), and for that received a finding the next year, despite a memo we put on file that this deviation is approved by the top management.
Try with changing the language of your quality objective that drives the process, assuming you have one, or your IA procedure, to say “IA’s to be conducted with frequency of 12 months +/- 5.5 months, and you may avoid a finding. I hope that helps.
Threads like this one just provide more anecdotal evidence that, as we approach 40 years of ISO 9001, organizations still derive no business benefits of internal audits, because, if they did, top management would be the first ones ensuring these events took place. Sad state of affairs for the industry out there.
The standard REQUIRES (not suggests) that internal audits MUST be planned/scheduled taking into consideration, status, importance and past performance. Irrespective of the organization size, a full cycle of internal audit in one full swoop does not comply with that requirement. As I mentioned several years ago here in this space, the CB community (myself included) is also to blame for allowing totally ineffective internal audits to fester in the business world.
The standard REQUIRES (not suggests) that internal audits MUST be planned/scheduled taking into consideration, status, importance and past performance. Irrespective of the organization size, a full cycle of internal audit in one full swoop does not comply with that requirement. As I mentioned several years ago here in this space, the CB community (myself included) is also to blame for allowing totally ineffective internal audits to fester in the business world.
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