ANSWER FROM THE QMS EXPERTS: 

Previous versions of ISO 9001 defined one, two and even three types of documentation required to be present in the organization’s quality management system:

• Quality Manual
• Documented Procedures
• Work Instructions
• Records

None of the above terminology is used in the 2015 revisions. Instead, new terminology is employed:

• Maintained Information (procedures, etc.)
• Retained Information (records)

The most recent revision has no prescriptive requirements for any specific type of documentation, leaving the choice of what to document up to the organization, with the exception of the need to retain certain information as evidence of implementation.

As with all of the ISO 9001 standard, a single requirement shouldn’t be analyzed in isolation of the others, and, in the case of 4.4 “Quality Management System and its Processes,” it’s also helpful to consider 4.1 “Understanding the Organization and its Context” as a minimum. By understanding the context of the organization, which includes determining the internal and external issues relevant to the organization’s purpose and strategic direction, plus the needs and expectations of so-called “Interested Parties,” an organization may decide (for example):

• To document a quality manual, because customers expect their suppliers to have one, or
• To have work instructions, because that’s a way to capture knowledge of how to do specific activities of a process (for training use, etc.), or
• To document the new product development process to help improve the time to market of new products.

Quality Management Documents have traditionally been considered to fit a hierarchy of “levels,” however ISO 9001:2015 gives any organization the opportunity to re-evaluate the purpose, style and content of any documentation to confirm its inherent value.

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