Extracted from Quality Progress / 2016 March
STANDARDS OUTLOOK
Prevention emphasized through risk-based thinking
by John E. "Jack" West and Charles A. Cianfrani
Clause 6.1 of ISO 9001:2015 contains new requirements that direct the organization to consider risks when planning its quality management system (QMS). It also requires that the actions taken to address risks shall be proportionate to the potential impact on the conformity of products and services. In addition, the organization is required to consider how to evaluate the effectiveness of the actions it plans to take to address risks.
Previous versions of ISO 9001 included requirements for correction, corrective action and preventive action. These requirements still exist in ISO 9001:2015, but there is no mention of a requirement for preventive action in clauses 4 to 10. And, while ISO 9001:2008 didn’t mention risk, the 2015 version mentions risk in various forms and contexts about 16 times in clauses 4 to 10.
What does this change in emphasis, wording and direction mean? It depends on your QMS’s content and how it was deployed. For some organizations, QMS changes won’t be required, but others will need changes or new processes.
STANDARDS OUTLOOK
Prevention emphasized through risk-based thinking
by John E. "Jack" West and Charles A. Cianfrani
Clause 6.1 of ISO 9001:2015 contains new requirements that direct the organization to consider risks when planning its quality management system (QMS). It also requires that the actions taken to address risks shall be proportionate to the potential impact on the conformity of products and services. In addition, the organization is required to consider how to evaluate the effectiveness of the actions it plans to take to address risks.
Previous versions of ISO 9001 included requirements for correction, corrective action and preventive action. These requirements still exist in ISO 9001:2015, but there is no mention of a requirement for preventive action in clauses 4 to 10. And, while ISO 9001:2008 didn’t mention risk, the 2015 version mentions risk in various forms and contexts about 16 times in clauses 4 to 10.
What does this change in emphasis, wording and direction mean? It depends on your QMS’s content and how it was deployed. For some organizations, QMS changes won’t be required, but others will need changes or new processes.
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