ISO 9001:2015 clause 6: a primer
In a previous post, we examined ISO 31000 – a group of standards relating to risk management codified by the International Organization for Standardization (ISO) to provide principles and general guidelines on risk management.
In this article, we’ll discuss another important ISO standard for risk management – ISO 9001:2015. Specifically, we’ll examine clause 6 of this standard. But first things first, a little background on ISO 9001:2015.
The who, what and why
According to ASQ, ISO 9001 is “the international standard that specifies requirements for a quality management system (QMS).” Many organizations use the standard “to consistently provide products and services that meet customer and regulatory requirements.” It is important to note that ISO 9001 is the most widely recognized standard in the ISO 9000 series. ASQ states that it is also the only one in the series “to which organizations can certify.”
ISO 9001 debuted in 1987 and the current version was released in September 2015, thus the designation “ISO 9001:2015.”
Critical in risk management
ISO is considered by many to be the authority when it comes to risk management guidelines and its standards are widely recognized as the law in our industry. ISO 9001:2015 is certainly no exception.
As its focus is quality management systems, ISO 9001:2015 must not be overlooked by risk managers. A QMS is a key component of an effective risk management system – handling everything from documentation and management review to competency and training.
Clause 6 of ISO 9001:2015 is focused on planning. This section builds on previous clauses, primarily clauses 4 and A.4 Risk-based thinking. Clause 6 advises practitioners that once risks and opportunities have been identified per Clause 4, it is essential that an organization outlines how these will be addressed through planning. According to the clause, planning should clearly define the strategies, tactics and personnel involved in addressing risks. Clause 6 also emphasizes a proactive approach in order to minimize issues.
Clause 6 focuses on the QMS and its “quality objectives,” which ISO says must be: