In order for your organisation to meet its objectives outlined in its quality management system, you need to make sure you can provide the necessary support required to meet these objectives.
The support clause is composed of ﬁve key elements:
- Creation and control of documented information.
You need to make sure your organisation has competent resource in place to ensure the effectiveness of your quality management system.
Resource considerations should now include:
- Internal resources
- External providers
- Monitoring and measuring resources
- Organisational knowledge required to ensure the processes provide conforming products and services
- External communication.
Your organisation must determine the competency levels needed for those people performing work under your control. Once these competency levels have been determined, your organisation must then ensure that those people possess the necessary competencies, either on the basis of their education, training or experience.
All relevant people doing work under your organisation’s control need to be made aware of your quality policy, any quality objectives that are relevant to them, how they are contributing to the effectiveness of your quality management system and the implications for not conforming to the quality management system requirements.
Your organisation must be able to communicate the quality management system requirements to all people doing work under your organisation’s control. You must determine how you wish to communicate, who it will be aimed at and when such communications will be made.
The organisation needs to consider both internal and external communications relevant to the quality management system.
"The way documented information is deﬁned provides more scope for an organisation to determine what is appropriate for its unique set of circumstances, rather than following a prescriptive format. Put simply, documented information should reﬂect the focus of ISO 9001:2015 on the organisational processes and results, rather than conformance with each element of the standard."
Richard Crute Morris, Assessment Services Capability Development Manager
The requirements of documented information are not new, but there is no longer a requirement for a documented quality manual.
Annex SL, and subsequently ISO 9001:2015 does not refer to a quality manual, procedures, instructions or records. All forms of documentation (hard copy and electronic forms) are now referred to as ‘documented information’.
ISO 9001:2015 includes an enhanced requirement for the creation and updating of documented information. When documented information is created or updated, your organisation must ensure that it is appropriately identiﬁed, described, reviewed and approved for suitability and adequacy.
Your organisation is now required to control documented information, which now explicitly includes conﬁdentiality, integrity and access.
Key change from ISO 9001:2008
Much of this clause is similar in intent to the previous standard, although re-arranged and there have been some enhancements. The most signiﬁcant change here is that there is no longer a requirement for a quality manual.
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