ISO 9001 Quality Management System:
The biggest and most obvious differences that were introduced in 2015 with the latest revision of ISO 9001 this assumes that you have some familiarity with the previous version of ISO 9001 that is 2008,
Enhancing the role and involvement of an organization’s senior management or leadership in the management system is a very significant change. Stories are bounded manages to declare that quality management and the quality management system was the responsibility of the quality department and the Management Representative or MR. This new revision of ISO 9001 Certification effectively buries that concept by getting rid of the role of the MR as a requirement of the standard and reassigning the MR’s accountability for QMS conformance and effectiveness.
Top management as a whole. This does not mean that an organization must shut down its quality department or lay off its quality manager if it has one. It simply means that the back does not stop with that department or manager responsible for quality and conformance to the standard. Now clearly stretches to the top management of the organization as part of this enhanced role and responsibility leadership of the organization is expected to do a regular review of the context in which the organization conducts its business and out of that determine its strategy.
The QMS policy and objectives should then be set to align with that strategy, most healthy businesses, and service organizations will be doing this anyway when they do their annual review and SWOT analysis to revise the business plan or at the three or five-year strategic planning session. The point is that this is now a requirement of the new standard and your third-party auditor will be asking to see evidence that this is being done.
No less significant in innovation is the new emphasis on risk-based thinking, which has acquired the acronym RBT and quality circles. RBT to be applied at various stages in the planning, design, development, and release of products and services. Again, your third-party auditor will be asking to see evidence that this is being done and you will want to be looking for this in your internal audits.
Risks we are talking not only about potential hazards to health and safety but also the risk of damage to property and all financial loss whether for the customer, a third party, or the organization itself, the assumption is that one important purpose of a quality management system is exactly to prevent bad things happening.
That’s risk-based thinking will weigh risks against the benefits of proceeding or not proceeding with the course of action and decide on implementing mitigations or not. By introducing the concept of risk-based thinking into ISO 9001 the technical committee that produced the 2015 revision. Trying to walk the middle road between an insufficient consideration of risks and benefits on the one hand and the more formal risk analysis and management required. Some people welcome RBT this considered uncertain thinking. Perhaps the most rapidly obvious difference in the new revision is how the structure has been changed to align with the common 10 clauses high-level structure developed by ISO.
This is to facilitate greater management among the many different management system standards. For example, the new revision to ISO 14001 also adopts the same structure, which is built around the PDCA plan do check act sequence. The intent was to make it easier for organizations to address the requirements of more than one ISO management system standard within a single integrated system of management processes.
At the same time, they have tried to simplify some of the language and terminology in the standard without requiring organizations to change to these new terms. For example, with the 2008 provision talked about documentation quality manual, documented procedures, or records, the new standard simply talks about documented information to cover all of these terms that you are still welcome to continue using your old terminology.
You simply won’t find these terms in the 2015 revision of the standard. The language has also been modified to make the standard less specific to manufacturing and more inclusive of other organizations especially service organizations. That’s wherever the 2008 revision referred to products, the 2015 standard has products and services.
There are many other changes and you will certainly need to do a formal gap analysis to see where your existing QMS is lacking about the new requirements. I have chosen to bring these changes to your attention because they reflect the spirit and purpose of the new revision and fill all the lower-level strict changes. Grasping and running with these changes should help you avoid getting trapped in the weeds as you implement your transition to ISO 9001 standard.