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Audit process according to ISO 9001:2015

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Guest user Created:   Jan 12, 2016 Last commented:   Jan 12, 2016

Audit process according to ISO 9001:2015

Now ISO 9001 2015 published, I want to know the audit process in absence of manual,procedure, records. How to define the risk in processes, it is logical question.
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ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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StrahinjaS Jan 12, 2016

Answer:

The audit process haven't changed in the new version of the standard, however the requirements are changed and now the auditor must put some extra effort to conduct the audit.

The manual is gone, that is true but the requirements for documents and records remained although they are differently formulated. When there is a phrase "maintain as a documented information" it means that the document is required, on the other hand, if there is a phrase "retain documented information as an evidence", it means that the record is required. For more information see: New approach to document and record control in ISO 9001:2015 https://advisera.com/9001academy/blog/2015/06/30/new-approach-to-document-and-record-control-in-iso-90012015/

Regarding the risks in processes, you will need to examine the process and determine what can go wrong and in what stage of the process. Although it is not a requirement, you can use some of the methodologies for risks assessment, for example FMEA (Failure Mode Effect Analysis) or FTA (Fault Tree Analysis) and the can be of great help.

For more information see Methodology for ISO 9001 Risk Analysis https://advisera.com/9001academy/blog/2015/09/01/methodology-for-iso-9001-risk-analysis/ or watch the free webinar How to implement risk management in ISO 9001:2015 https://advisera.com/9001academy/binar/how-to-implement-risk-management-in-iso-90012015-free-webinar/
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Jan 12, 2016

Jan 12, 2016

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