A snap shot of the new version of the ISO Standard context, Changes & Structure
ISO 9001 standard, is the world’s most popular standard for quality management, is now under review, with an updated version due to be available by the end of 2015. The draft is what’s called a Committee Draft one of the formal stages in the process of revising a Standard.
Over 1.2 million organisations are certified to ISO 9001 and while it continues to be as relevant as ever, the revision will take into consideration a number of issues to ensure it enhances an organisation’s ability to consistently provide products that meet customer requirements.
What is Changing in ISO 9001:2015 So Far
â€¢ The Process approach is now embedded in requirements
Clause 4.4 specifies requirements considered essential to the adoption of the process approach. Mostly, these consist of requirements that were already in ISO 9001, but which have now been brought together. But the explicit requirement of the process
approach I think an excellent development.
â€¢ Risk Management is in and the Preventive action out
Risk management is a requirement. Preventive action has been removed which I think a good thing as it was so complicated. It’s believed to be replaced by planning, risk management and the having of a management system in the first place.
â€¢ Different Structure for ISO 9001
There will now be 10 sections (instead of 8) in the Standard; the requirements themselves are set out in Clauses 4-10
The new structure for ISO 9001: 2015
When the new version is released, it will have these 10 sections:
Clause 1 Â Scope
Clause 2 Â Normative references
Clause 3 Â Terms and definitions
Clause 4 Â Context of the organisation
Clause 5 Â Leadership
Clause 6 Â Planning
Clause 7 Â Support
Clause 8 Â Operation
Clause 9 Â Performance evaluation
Clause 10 Improvement
â€¢ Context of the Organisation
The standard’s structure has changed and now condenses to 10 general divisions as shown above.
Realistic changes will greatly improve its ability to provide a framework for quality management to listed users. For example, there are three new clauses that users will likely see in ISO 9001:2015:
Clause 4.1 Understanding the organisation and its context. The purpose of this new section is that the registered organisation shall determine external and internal issues that are relevant to its purpose and that affect its ability to achieve the intended outcomes of its quality management system.
Clause 4.2 Understanding the needs and expectations of interested parties. Typical examples of relevant interested parties could be direct customers, end users, suppliers, distributors, retailers, and partners.
Clause 4.4.2 Process approach. These requirements are more explicit. Specifically, the QMS will be built around processes where products or services are the output. A primary objective of meeting customer requirements is the key.
The process approach in the ISO9001:2008Â version left many businesses unclear about the importance of this concept; 2015 will provide the exact requirements.
â€¢ Nil Mandatory procedures
Interchange from Documents and records (ISO 9001: 2008 Clause 4.2.3 & 4.2.4) to Document information (Clause 9.2 of ISO 9001:2015 Committee draft) which seems to be more acknowledging of electronic documents & document control approaches.
However, the new clause language which more generally requires organisations to retain documented information as evidence of the implementation of the internal audit program and the audit results, it’s been in discussion about not mandating procedures as in the past.
â€¢ Terminology changes
The term product has been replaced with goods and services. This is to make it more generic and applicable to service fields, and remove the inbuilt manufacturing bias.
Continual has been dropped from the phrase continual improvement in favour of just improvement.
Our ISO Consultants will support you through the transition process. A transition period will be set and we will provide you with guidelines and training to help you make this transition as smooth as possible. We will keep posting more information about transitioning to the new standard over the coming months, keep yourself informed by visiting our ISO 9001 certificationsÂ consultant blog page regularly.