One of the key purposes of a qualit

One of the key purposes of a quality management system is to act as a preventive tool. Consequently, this International Standard does not have a separate clause or subclause on preventive action. The concept of preventive action is expressed through the use of risk-based thinking in formulating quality management system requirements.

The risk-based thinking applied in this International Standard has enabled some reduction in prescriptive requirements and their replacement by performance-based requirements. There is greater flexibility than in ISO 9001:2008 in the requirements for processes, documented information and organizational responsibilities.

Although 6.1 specifies that the organization shall plan actions to address risks, there is no requirement for formal methods for risk management or a documented risk management process. Organizations can decide whether or not to develop a more extensive risk management methodology than is required by this International Standard, e.g. through the application of other quidance or standards.

Not all the processes of a quality management system represent the same level of risk in terms of the organization's ability to meet its objectives, and the effects of uncertainty are not the same for all organizations. Under the requirements of 6.1, the organization is responsible for its application of risk-based thinking and the actions it takes to address risk, including whether or not to retain documented information as evidence of its determination of risks.

A.5 Applicability

This International Standard does not refer to “exclusions” in relation to the applicability of its requirements to the organization's quality management system. However, an organization can review the applicability of requirements due to the size or complexity of the organization, the management model it adopts, the range of the organization's activities and the nature of the risks and opportunities it encounters.

The requirements for applicability are addressed in 4.3, which defines conditions under which an organization can decide that a requirement cannot be applied to any of the processes within the scope of its quality management system. The organization can only decide that a requirement is not applicable if its decision will not result in failure to achieve conformity of products and services.

A.6 Documented information

As part of the alignment with other management system standards, a common clause on “documented information” has been adopted without significant change or addition (see 7.5). Where appropriate, text elsewhere in this International Standard has been aligned with its requirements. Consequently, “documented information” is used for all document requirements.

Where ISO 9001:2008 used specific terminology such as “document” or “documented procedures”, “quality manual” or “quality plan”, this edition of this International Standard defines requirements to “maintain documented information”.

Where ISO 9001:2008 used the term “records” to denote documents needed to provide evidence of conformity with requirements, this is now expressed as a requirement to “retain documented information”. The organization is responsible for determining what documented information needs to be retained, the period of time for which it is to be retained and the media to be used for its retention.

A requirement to “maintain” documented information does not exclude the possibility that the organization might also need to “retain” that same documented information for a particular purpose, e.g. to retain previous versions of it.

Where this International Standard refers to “information” rather than “documented information” (e.g. in 4.1:”The organization shall monitor and review the information about these external and internalissues”), there is no requirement that this information is to be documented. In such situations, the organization can decide whether or not it is necessary or appropriate to maintain documented information.

A.7 Organizational knowledge

In 7.1.6, this International Standard addresses the need to determine and manage the knowledge maintained by the organization, to ensure the operation of its processes and that it can achieve conformity of products and services.

Requirements regarding organizational knowledge were introduced for the purpose of:

a) safeguarding the organization from loss of knowledge, e.g.
through staff turnover;
failure to capture and share information;
b) encouraging the organization to acquire knowledge, e.g.
learning from experience;
mentoring
benchmarking

A.8 Control of externally provided processes, products and services

All forms of externally provided processes, products and services are addressed in 8.4, e.g. whether through:

a) purchasing from a supplier;
b) an arrangement with an associated company;
c) outsourcing processes to an external provider.

Outsourcing always has the essential characteristic of a service, since it will have at least one a