What Documentation ISO 9001:2015 Really Requires?

While the ISO 9001:2008 version was explicit about documentation, ISO 9001:2015 allows more freedom in how, what and when to document a quality management process element (such as specific procedures).

It appears this evolution is not only to accommodate more modern forms of communication such as video, audio and other electronic records, but to allow an organization the flexibility to re-use appropriate information, maintain current versions easier, provide broader access/distribution and reduce costs associated with documentation. (Note: This change does not require changing mediums and allows an organization to also reuse existing quality management system documentation, as long as it conforms See explanation below.)

The Changed Nature of ISO 9001 Documentation

The new ISO 9001:2015 standard has removed the distinction between documents and records. Both are now called documented information. As per ISO’s definition, the term “documented information” refers to information that must be controlled and maintained. It therefore expects that you also maintain and control the medium as well as the information. This “documented information” is used as evidence of conformance.

Having It Your Way (Sort Of)

ISO 9001 2015 essentially allows the organization to tailor the completeness or complexity of documentation to its own situation, as long as it still achieves its overall objectives. The shift does not, however, lessen the requirement for proper documentation. As noted in the standard, “documented information” can be required:

  • When information needs to be disseminated or shared
  • To prove (and retain that proof) that a quality process has been completed and what the results were
  • To retain organizational knowledge including:
    • Processes
    • Specifications/Revisions
    • Goals/Expectations
    • Monitoring/Measurements
    • Analysis/Reviews/Evaluations/Validations
    • Terminology
    • Decisions Made
    • Negotiations
    • Notifications
    • Authorizations
    • Actions taken
    • Assets/Inventories/Property Management
    • Position Descriptions/Qualifications
    • Etc.

So What Is Required?

According to ISO 9001:2015 clause 4.4, requires an organization to:

“maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confident that the processes are being carried out as planned.”

In ISO’s Guidance on the requirements for Documented Information of ISO 9001:2015 provides these guidelines on what to document:

  1. Documenting critical portions of the quality management system (QMS) such as its scope, key operational processes, policies and objectives
  2. Documenting important, but perhaps less critical information that supports the QMS such as process flow charts, specific quality and operational procedures, schedules, information collection approaches (i.e. forms, surveys), business plans, etc.

Will a Quality Manual be required?

The short answer is that under ISO 9001 2015, a quality manual will not be required. The DIS ISO 9001:2015 standard does not specify requiring a formal quality manual. However, a quality manual can still satisfy the requirement for documented information concerning:

  • Your quality policy
  • The scope of the QMS
  • Information to support quality related processes

In many cases, the information required by the QMS will still be most convenient and accessible if collected, published and maintained through a traditional quality manual format.

Document Maintenance

As noted in section 7.5, the standard still applies traditional rigor in updating, protecting and retaining documents for information that has been deemed a critical part of the QMS (and other related management systems). There are many specific clauses that essentially call for this documentation (see sample section from ISO documented information guidance below) integrity.

Examples Of ISO 9001 2015 Required Documentation

iso 9001:2015 and Annex SL

While ISO 9001 2015 documentation requirements are less restrictive than previous revisions, there are still specific instances where documented information must be recorded and retained by the organizations evidence of achieved results as noted above.

Whether an organization has an existing QMS or is just starting, the key is to let the processes that are used to meet its goals determine documentation requirements. If documentation that exists can be shown to support the QMS’ processes effectively, then it can and should be used for that goal. If not, then the appropriate level of effort to transform or re-purpose that documentation into the proper function should be applied.

This flexibility does not, however, relieve the organization from being able to prove that it is meeting its quality management goals. As noted above, the standard has many instances where it calls for specific evidence of conformity. Documentation must accordingly be accurate, objective and current in this regard, and in practice, must stand up to the scrutiny that a properly executed external audit will demand. So, while ISO 9001:2015 is more accommodating regarding documentation directives, the discipline used in compiling previous revision’s quality management system requirements may still be a viable approach.

 

Please note that certain text from the ISO 9001 standard is only used for instructional purposes. Standard Stores recognizes and respects the International Organization for Standardization (ISO) copyright and intellectual property guidelines.

ISO 9001 All in One Package

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