ISO 9001:2015 & Determining External & Internal Issues

From: Adolpho P., April, 21, 2017 –
My question is regarding ISO 9001:2015 requirements for reporting external and internal issues as a part of the management review process.  Which subjects should be analyzed as the inputs, subclause 9.3.2.b?  I don’t think the standard is clear enough.  As a comment, I think subclause 9.3.2.c5. is redundant.  Your feedback will be appreciated.

From: ATCS, Ask the Experts, April 24, 2017

Hello Adolpho,

Thanks for submitting your comment and question. As you know, ISO 9001:2015 is a generic standard that defines quality management system requirements used by a large variety of industries, organizations, and institutions worldwide.  For this reason, ISO 9001:2015, subclause 9.3.2b, does not prescribe specific external or internal issues, to be addressed during a management review.

ISO 9001:2015, subclause 4.1, more appropriately requires each organization to determine those external and internal issues that may affect their quality management system, as well as to monitor and review these issues.  Subclause 4.1, Notes 1, 2 and 3, provide examples of external and internal issues for general guidance.

Regarding ISO 9001:2015, subclause 9.3.2c5, “monitoring and measurement results”; the possibility for redundancy depends on the results of the organization’s risk based thinking and activities identified to be monitored and measured.  Monitoring and measurement results are not limited to the input items listed in subclause 9.3.2.  Subclause 9.1.1, a through d, requires the organization to determine what must be monitored and measured, methods to be used to monitor and measure, when to measure and when to analyze/evaluate the results.

Dependent on product criticality, process complexity, and identified risk, monitoring and measurement results could include performance indicators (KPIs) as mentioned in subclause 4.4.1c as well as monitoring information connected with the requirements and expectations of relevant interested parties, as referenced in subclause 4.2.

The December 2016 issue of QP Magazine included an article that discusses subclause 4.1 “Understanding an Organization and Its Context,” which highlights the requirement to determine external and internal issues.  This article also discussed subclause 4.2, “Understanding the Needs and Expectations of Interested Parties” and the mandate to monitor and review the requirements and expectations of relevant stakeholders.  Although not identified by ISO 9001:2015, subclause 9.3.2, as an input item, in my opinion, the results of monitoring as mentioned in subclause 4.2, should be included in management reviews since it could provide top management with information to support the organization’s continued ability to meet customer and industry requirements.

I hope this helps.

Best regards,
Bill Aston, Managing Director
Aston Technical Consulting Services

This entry was posted in ISO 9001:2015, QMS Basics, QMS Requirements, Risk Management and tagged , , . Bookmark the permalink.

Comments are closed.