When ISO 9001:2015 is released later this year, organizations will spend a lot of time interpreting new or revised concepts and this bringing with it the risk of misinterpretation. Because the standard’s language is written with a degree of vagueness—to allow its application to any organization—it is essential that transition plans and training for implementers and auditors consider elements beyond the requirements themselves. To properly apply the standard’s requirements to your quality management system (QMS), three items must be considered for an effective approach to transition planning and training: the introduction, the annexes and ISO 9000:2015—Quality Management Systems—Fundamentals and Vocabulary.
The standard’s tone is set by the introduction, and it provides an overview of these key points:
- Its clauses first clarify why the standard exists, and this tells you what purpose it serves and what your organization should expect from it.
- The roles of ISO 9000, ISO 9001 and ISO 9004 are explained. Other guideline standards—in the ISO 10000 range—also are introduced, showing that ISO 9001 alone doesn’t contain everything you must know for effective quality management. It only contains the minimum requirements for a complete QMS.
- A holistic description of the process approach is provided. You can learn what the concept means, including an introduction of plan-do-check-act (PDCA) cycles and what the implementation of the process approach can bring to a QMS.
- A deeper explanation of the PDCA cycle is given, including how it can be applied to either individual processes or the entire QMS.
- Risk-based thinking is clarified. The standard’s position on this concept is quite open-ended, and it’s primarily because ISO 9001 is intended to address all organizations regardless of the volatility of their industries. In other words, risk has different repercussions in different industries. For some organizations, the consequences of a nonconforming product or services can equate to minor inconveniences to the customer or end user, but for other organizations, the results can be calamitous. Risk is, therefore, variable, depending on the industry and the product or service. Formal risk management programs may be essential in some organizations but are not a critical component in others.
- Lastly, the introduction explains the compatibility of ISO 9001 with other management system standards. Here is where the boundaries are set. This section explains that although ISO 9001 follows the same common structure, text and terminology as other
- ISO management system standards, it does not include requirements specific to other management systems. Its focus is specific to the management of quality.
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