Regarding ISO 9001: 2008 (or 2015) auditing, I have always been trained that a work instruction when implemented as supporting the QMS can be audited as it is supporting the effectiveness of the QMS. I was recently told by a business owner that not only is that not true, he does not have to show me his work instruction. I would like to reply with a clear technical response. Can anyone share their view on this?
Thank you for your question. Of course you know you’re right. It sounds like you have a major nonconformance against Clause 5.1 on your hands.
A Fellow of the American Society for Quality
Devos Associates Inc.
ISO 9001:2015 clause 7.5.1b states the following :
The organization’s quality management system shall include: documented information determined by the organization as being necessary for the effectiveness of the quality management system/
Documented information includes both procedures and records see appendix A.3 (Documented information).
Since the work instructions are supporting the QMS, it is part part of the QMS, and can be audited as part of both the internal audit and external audit. It appears that part of the confusion may be caused by a lack of understanding of the new term “documented information.”
John G. Surak, PhD
– Providing food safety and quality solutions –
A member of Stratecon International Consultants