With the start of the voting process on the final draft, management system standard ISO 9001 has reached its final stage of revision. ISO member countries now have 2 months to review the draft and cast their votes before September 9, the standard's expected publication. Following the publication, organizations will be granted a three-year transition period to migrate their quality management systems to the new edition. But what will ISO 9001:2015 bring to organizations and will it be worth the wait? As MANNAGENN, we believe that it will be. Here is an executive summary of the 5 key changes that will be taking effect with the current revision and a list of primary challenges as a result of these changes.
ISO 9001's rigidity with the way it enforced procedures had always been heavily criticized for a number of reasons, including the considerable amount of resources it consumed, the excessive number of paperwork it created and the redundant bureaucracy it generated. A radical shift in the thinking, ISO 9001:2015 requires "zero" procedures. The number of prescribed prerequisites are also less. What it requires instead is a demonstration of the identified areas and controlled outcomes. Leaving how these demonstrations are performed to organizations themselves, the revised standard is flexible to a greater extent. It is also more practicable "in a natural sense" as the system does not tend to interfere synthetically with how organizations do their business as it unintentionally inclined in the past.
The new revision classifies documentation and records (described as documented information) under 3 sub-clauses; 7.5.1. General, 7.5.2. Creating and updating and 7.5.3. Control. Again leaving the decisions to organizations themselves on determining which information to be kept, updated and controlled, the standard is more involved with outputs rather than inputs. Attempting to transform to an operation and performance based philosophy from a document oriented approach,
ISO 9001:2015 is truly attached to "what" is being done inside organizations instead of "how" it is done, unlike its earlier revisions. What can be perceived within the system is a certain determination to increase organizations' ability to offer conformable products and services and improve their customer satisfaction. Activities like planning and updating objectives, increasing awareness about these objectives, measuring and monitoring results and ensuring the quality of both internal and external communications are given a higher priority compared to documentation.
ISO 9001:2015 brings an integrated approach to leadership and organizational management. The final revision does not step in into organization and leadership in case of problems that are subject to corrective and preventive action. It expands its scope by covering any internal or external issue that has significance for the management system in terms of organization and leadership. The standard, for the first time in its history, is more concerned with understanding organizations, their context, environment and operations, and address possible risks and opportunities than it is concerned with itself.
A big flaw in ISO 9001 by design was its close focus to the production industry. It wouldn't be wrong to claim that, in the previous revisions, 9001 was a standard intended to be utilized in the production industry which later was extended and fabricated to a degree to be "also available" for the service sector. The final revision on the other hand has taken service organizations into consideration starting from the proposal phase both in terminology and subject matter.
ISO 9001:2015 is truly attached to "what" is being done inside organizations instead of "how" it is done.
Eventually ISO 9001:2015 has become compatible with other management system standards. By adopting the high level structure as set out in Annex SL of ISO Directives Part 1 which standardizes sub-clause titles, core text, common terms and core definitions, the revision will enhance compatibility and alignment with other ISO management system standards.
With its fundamental differences, ISO 9001:2015 will be exposing new challenges to organizations. Here is a list of the 3 possibly most prominent challenges.
But, what all three of these challenges have in common is the fact that they are “actual”, real-life challenges that are being currently experienced by organizations. ISO 9001:2015's challenges are not artificial, theoretical or conceptual as it was in the earlier revisions. Again, for the first time in its history, the challenges to conform ISO 9001 have aligned with the realities of competition. In this regard, we believe that the final revision has succeeded to go beyond being a marketing material which organizations engage as a certification of their quality to their consumers and become a managerial instrument with the potential to provide competitive advantage to organizations.
In a similar manner with Nigel Croft’s opinions, Chair of the ISO subcommittee revising the standard, we believe that ISO 9001:2015 is an opportunity for organizations to improve their management systems in general rather than being a new set of requirements that have to be met . Our professional opinion is in favor of the final revision from a competitive point of view.
ISO 9001 is ISO’s (International Organization for Standardization) most well-known standard, with more than 1.1 million certificates worldwide. It provides requirements to help companies demonstrate that they can offer their customers consistent, good quality products and services. It also provides a framework to help them streamline their processes and become more efficient at their businesses. ISO 9001 can be used by organizations of all types and sizes. The standard has inspired a series of documents for sector-specific applications including the automotive sector, the medical sector, local governments and more.
ISO 9001 standards generally go through periodic revision every 3 to 5 years to ensure they are relevant and up-to-date. The new edition is expected to be published in September 2015.
We would like to remind that our analysis are based on ISO 9001:2015 Final Draft International Standard (FDIS). Although minor changes are expected on the final stage of the revision, please take notice that the standard has not yet finalized.
 Economist, The, Why Good Strategies Fail, Lessons for the C-Suite, Sponsored by the Project Management Institute (PMI), The Economist Intelligence Unit Limited, 2013.
 Lazarte, Maria, Vote Starts on Final Draft of ISO 9001, News, ISO (The International Organization for Standardization), July 9, 2015.
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Publish Date: July 26, 2015 1:03 PM