ISO 9001:2015 Update - Committee Draft Issued
On 3rd June 2013 a first committee draft of the proposed ISO 9001 revision was issued by the International Organization for Standardization (ISO). It is a dicussion document that only describes the potential requirements of ISO 9001: 2015. Therefore it is not certain that there will not be further changes before the first formal draft (DIS) is issued - currently scheduled for July 2014. But the document does give an indication on what might be included in the revised ISO-standard. SGS gives you a short summary.
Listed below are some of the key points identified in the Committee Draft where new or revised Quality Management System (QMS) requirements have been introduced. Please note, however, that at this stage it is not possible to give any detailed information in relation to interpretation of the requirements. Neither has any guidance been issued. These requirements would need to be complied with only if they will be incorporated into the final published version of the revised ISO 9001:2015.
The organization implementing a QMS would have to identify the "competence" necessary for personnel doing work that affects its quality performance, as well as ensuring that those personnel are competent to do so. Competence would be defined as the "ability to apply knowledge and skills to achieve intended results".
The terms "document" and "record" used in ISO 9001: 2008 would both be replaced throughout the new requirements by the phrase "documented information".
External Provision of Goods and Services
An organisation would be required to take a risk based approach to determine the type and extent of controls appropriate to all types of external provider (whether it is by purchasing from a supplier, for example, or through the outsourcing of processes and functions, etc.) and all external provision of goods and services.
There would no longer be any requirement to identify any QMS requirements that could not be applied due to the nature of the organisations business (clause 1.2 in ISO 9001: 2008). This is because a different approach has been taken to the way in which the requirements of the revised version of ISO 9001 have been stated, so there would no longer be any reasons for an organization’s QMS not to be able to meet all the requirements of the future standard.
Goods & Services
Reference to "product" (as in ISO 9001:2008) would be replaced by the phrase "goods and services".
The term "continual improvement" would be changed to just "improvement".
An organization seeking to implement a QMS would have to determine who are the "interested parties" relevant to its QMS, as well as identifying what the requirements of those interested parties are. An interested party (also referred to as a "stakeholder") would be defined as any person or organization that can affect, be affected by, or perceive themselves to be affected by a decision or activity of the organization implementing the QMS.
There would no longer be a specific requirement for "preventive action". This main reason given for this is that one of the key purposes of a QMS is to act as a preventive tool anyway.
There would be a specific requirement for organizations to apply a process approach to their QMS as well as a list of requirements identifying the essential elements of such an approach.
Risks and Opportunities
When planning for its QMS the organization would have to identify the risks and opportunities that need to be addressed to ensure that the QMS can achieve its intended outcome(s). Having done this, the organization would have to plan actions to address these risks and opportunities, integrate and implement them into its QMS processes and evaluate the effectiveness of these actions.
ISO 9001:2008 Transition
The current intention is that the transition period for users of ISO 9001:2008 to transfer to the new version of this Standard would be three years, though this has still to be formally ratified.
For further information, feel free to contact SGS Germany:
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