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Would you like to know what 3rd party auditors are looking for when auditing how your company complies with quality system standards like ISO 9001:2015? What are 3rd party auditors looking for?  This is the third of a three part series by Jim Lee, President of simpleQuE

Clause 6 of ISO 9001:2015 – Planning for Risk and Change
In parts one and two of this series of articles, Context of the Organization and Leadership were covered. Next is the topic of Planning for Risk, which brings risk-based thinking to the forefront. Once the organization has identified the risks and opportunities in Clause 4, it needs to stipulate how to address these.  The planning phase examines who, what, how and when risks must be addressed.  It’s a proactive approach that replaces preventative action and hopefully reduces the need for corrective actions later on.

Particular focus is also placed on the objectives of the management system.  These should be consistent with the quality policy and be measurable, monitored, communicated and updated when needed.  Changes to the QMS should also be planned and consequences understood to assess risk and minimize potential negative impact.

Third party auditors may use the following for evidence of risk based thinking and integration into the quality management system:

Not that all of the elements listed above will be needed, but organizations may experience potential issues if:

Also, read more about Context of the Organization in Part 1 and Leadership in Part 2.

Source:  NQA’s Teaming Conference – August 2017 Congratulations to the entire Barrett team for achieving ISO 9001:2015 certification from global registrar NQA!

Headquartered in Murfreesboro, Tennessee, Barrett Firearms Manufacturing is a world leader in large-caliber rifle design and manufacturing. It was founded in 1982 by Ronnie Barrett, who invented the first shoulder-fired .50 caliber rifle. 