With the transition to ISO 9001:2015 now fully underway as life science and other regulated industry companies make the switch, a key aspect of the new standard is its shift in focus from preventive action to risk process. ISO 9001, which specifies requirements for a quality management system (QMS), in its latest iteration, incorporates a formalized, phased risk management system that must be completely worked through to complete the quality risk management process.
“In effect, ISO 9001:2015 is asking you to establish an end-to-end process for identifying and addressing risks so that your QMS can deliver upon its objectives and then to execute that process carefully and consistently through your organization,” said Walt Murray, principal consultant with Pinpoint Consulting and a leading ISO subject matter expert.
Murray added that executing the new focus can be challenging for quality managers given the fact that the standard has to be flexible enough to address a variety of situations and that few tangible specifications are provided.
However, one component of ISO 9001:2015 that is fully delineated is the adherence requirements in Annex SL that form the high level structure (HLS) for all ISO systems going forward.
HLS consists of 10 clauses that all ISO management system standards are required to use. In essence, the guidelines help ensure that quality management systems all have the same: (1)
The cumulative effect is that HLS makes the standard more understandable and easier to read by users, a welcomed improvement given all the jargon that is by necessity a part of manufacturing regulated products. Examples of identical definitions include keywords such as organization, interested party and policy. Another benefit of HLS is that it will allow for greater integration and consistency between systems of different disciplines. (2)
More specifically, the 10 HLS clauses include:
Yet Murray says the key to fully maximizing ISO 9001:2015’s HLS to help elevate the performance of your QMS lies in the standard’s upgraded requirements for documentation of management system processes and heightened document control. The standard no longer simply requires documents and records but the actual documentation of all data within your QMS.
“Documented information in HLS includes new explicit requirements for data and analysis,” Murray said. “Planning documentation is also more formidable then the previous implicit language for this element in ISO 9001:2015.”
Just as documents and records are no longer sufficient for compliance under ISO 9001:2015’s HLS, so is a paper-based QMS no longer a reliable or efficient method for keeping your company’s quality processes integrated, organized and accessible. A dynamic, automated QMS provides you with the capabilities to electronically manage your product, quality and all related documents throughout the enterprise and across a product’s life cycle. The result of going paperless is fewer quality events, reduced risk and readily accessible data management capabilities that can result in greater ROI for your company.
“Today, we are challenged with the risk orientation and innovative approach for opportunity as a visible part of how we manage quality,” Murray said. “Where these concepts were implicit in the past, they are now explicit and auditable as components of an improved QMS.”