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While ISO 9001 specifies the use of documented information in a number of its requirements, there can be a need for your organization to have additional documented information (such as documented procedures, websites, work instructions, manuals, regulations, standards, forms, guides, computer software, telephone “ apps ”) to control the operation of its processes.
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Some of the documented information will need to be reviewed periodically and be revised to be kept up to date. ISO 9001 uses the phrase “ maintain documented information ” in reference to this type of documented information.
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Other documented information needs to be retained unchanged (unless a correction is authorized) to demonstrate conformity and to have confidence that processes are being carried out as planned, or to demonstrate whether or not requirements are being fulfilled (this type of documented information is frequently referred to as a “ record ”). ISO 9001 uses the phrase “ retain documented information ” in reference to this type of documented information. This type of documented information is frequently related to customer requirements, statutory and regulatory requirements, or an organization’s own requirements, for retaining documented information.
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For organizations wishing to demonstrate conformity with the requirements of ISO 9001:2015, for the purposes of certification/registration, contractual, or other reasons, it is important to remember the need to provide evidence of the effective implementation of the QMS.
Where the organization has no specific documented information for a particular activity, and this is not required by the standard, it is acceptable for this activity to be conducted using as a basis the relevant clause of ISO 9001:2015. In these situations, both internal and external audits may use the text of ISO 9001:2015 for conformity assessment purposes.
Clause 5.1.2 Customer focus.
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Terms and definitions.
ISO 9001 Scope - Clause 1 of ISO 9001 describes its scope, the subject of the standard, the quality management system, and the intended results of its application by organizations.
Guidance/Typical evidence.
QMS Scope - ISO 9001 Clause 4.3 states that “The organization shall determine the boundaries and applicability of the QMS to establish its scope… The scope shall state the types of products and services covered”.
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Certification Scope - The scope of certification is derived from the scope of the QMS and is dependent on what the organization decides to have certified. This scope is used to communicate the certification status of the organization’s QMS to relevant interested parties. Sometimes the scope of certification can be smaller than the scope of the QMS and special attention needs to be given to these cases.
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Capture the certification scope within a simple and concise manual.
Note: Any manual should be designed in accordance with ISO 10013:2021 Quality management systems — Guidance for documented information.
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Clause 4.4 - Quality management system and its processes.
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Terms and definitions.
Set of interrelated or interacting activities that use inputs to deliver an intended result.
Guidance/​Typical evidence.
In consideration of your value chain/chains and or the voice of the customer, develop the Plan Do Check Act (PDCA) model.
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Clause 5.2 Policy.
Terms and definitions.
Intentions and direction of an organization as formally expressed by its top management.
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Guidance/​Typical evidence.
Usually a one page document, structured bye elements: background, intent and governance/assurnace.
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Clause 6.2 Quality objectives and planning to achieve them.
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Terms and definitions.
Result to be achieved
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Guidance/​Typical evidence.
Objectives should be established at relevant functions, levels and processes, as appropriate, to ensure the effective deployment of the organisations strategic direction and its Policy.
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Note: Templates made available are indicative training aids and are not guaranteed to meet all management systems stanadrsd requirments; you should advice advise from a qualified professional.