ISO 9001:2015 – What you Need to Know, Now
May 02, 2014
For those businesses that already have ISO quality management certification—as well as those preparing to take the first steps of their ISO journey—2015 is poised to be an important year.
ISO 9001:2015 – What it is
The International Organization for Standardization (ISO) recognized the need for a common framework to harmonize the many quality certification standards in use—9001; the more common industry-specific variants like 9100, 14001; and others. With so many cross-references and formatting differences having crept into each standard, the organization found it was all too common for Quality Management Systems (QMS) to be incompatible.
ISO reviews its quality standards every five years or so, the most recent taking place in 2008 (the last major revision went into effect in 2000). In order to begin the lengthy process of standardizing the entire standard library, ISO created Annex SL—the overarching structure that will harmonize 9001:2008 with each of the industry-specific and other standards in the future. As industry standards come up for review, they will be compared to—and ultimately revised to encompass—the structural changes set forth in Annex SL.
What it means
The steps required to maintain ISO 9001:2008 certification after the publication of 9001:2015 will vary with the complexity of each company’s processes and quality manual. In many cases, reformatting the QMS will be a necessity. The additional changes required will vary.
Key differences between existing ISO standards and 2015 include:
- The role of context in QMS development;
- The increased role that leadership must play regarding the design and rollout of the QMS;
- Greater emphasis on effective process management;
- Stressed importance on controlling all outsourced activity through efficient risk management;
- Requirement to assign responsible party/ies for key processes;
- The addition of broader language that encompasses “goods and services” as opposed to more product-centric terminology;
- Requirements related to change management and risk mitigation.
Through Annex SL, 9001:2015 also defines a new standard structure, mapping the 10 new “clauses” against the existing eight. Quality managers studying the new standard should be aware that ISO has not simply added two new clauses, but moved some content across the full spectrum.
It is conceivable that an ISO 9001:2008-certified organization with relatively simple processes can get by with the creation of an index to map their existing sections to the new ones, but the jury is out on that topic until the new standard is finalized once and for all. What exists at present is a “Committee Draft.” The next step will be the creation of a “Draft International Standard” (DIS), which will then be voted on by the various ISO organizations. That draft will require 75% approval to become final, with an expected publication timeframe of September, 2015.
Upon publication, businesses with 9001:2008 and other certifications will typically have 2-3 years to come into compliance with the 2015 standard. Those achieving certification for the first time after the publication of 2015, however, will need to be 2015-compliant from day one.
CONNSTEP recommends “continuing with guidance.” For those in the process of obtaining 9001:2008 or other compliance, there is every reason to believe it can be achieved before the 2015 standard update. Writing new QMS documents with an eye on 2015, however, is judicious and will streamline the transition down the road. Likewise, impending changes should not deter companies without existing certification from pursuing the standard.
The bottom line? Engaging an experienced partner who can provide professional guidance is still the best way to make the transition to ISO compliance –or the initial introduction to QMS certification—as painless as possible. To learn more about the ways your organization can move ahead with the appropriate level of caution, contact CONNSTEP today.
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