ISO Lead Auditor-as-a-Service®
LAaaS - International
Tools & techniques
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.
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.
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.
Maintained documentation
Below are the clauses required to be marinated as documented information.
Documented information requirments
Clause 4.3
Scope
The scope of certification is derived from the scope of the QMS and is dependent on what the organization decides to have certified.
Clause 5.2.1
The intent of this subclause is to ensure that a quality policy is established which aligns with the strategic direction of your organization, including its overall understanding of what quality means to itself and for its customers. The quality policy describes the intentions and direction of an organization as formally expressed by its top management.
Clause 4.4
Process interactions
The intent of this subclause is to ensure that you determine the processes needed for your QMS; This includes not only the processes for production and service provision, but also the processes that are needed for the effective implementation of the system, such as internal audit, management review and others (including processes that are performed by external providers).
Clause 6.2
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.
Retained documentation
Scroll through the slides below for to see what clauses require documentation to be retained
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.