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This document provides general guidance for use by audit teams when executing the audit process described by the 9101:2016 standard, when conducting 9100:2016 audits.
This guidance is not intended to add to, subtract from, or in any way modify the stated requirements, but to provide examples and thought stimulation i.e. “things to consider”, when asking questions and identifying objective evidence.
NOTES:
• The guidance contained within this document can also be useful when preparing and planning an audit during the certification cycle.
• Acceptable means of compliance are not limited to those items listed in this document.
• Any issues identified during audits are to be documented against 9100:2016 requirements.
• 9100:2016 clause 0.3 describes the process approach developing, implementing, and improving the effectiveness of a Quality Management System
• 9101:2016 clause 0.2 describes the process approach when evaluating an organizations QMS
• Further ISO guidance is also available as follows:
o Process approach for management systems - ISO/TC 176/SC2/N544R3
o Application of ISO 9001:2015 management system - ISO Technical Specification ISO/DTS 9002
• This document DOEs not provide guidance for the additional requirements defined by 9110 and 9120.
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