ISO 9001 Documentation Requirements vs Myths

Introduction:

The ISO 9001:2015 standard brought a significant shift in how the terminology around documentation. Unfortunately, misunderstandings and misconceptions have clouded the true requirements. This article aims to clarify ISO 9001 documentation requirements and dispel common myths.

The ISO 9001 documentation requirements:

  1. Minimal Documented Information: The standard mandates very minimal requirements for “maintained documented information” (aka documents). These include the Quality Management System (QMS) scope, Quality policy, and Quality objectives.
  2. Organizational Determination: Organizations must decide what additional “maintained documented information” is necessary to manage their operations. This shift is not revolutionary, as ISO 9001 hasn’t required operational procedural/instructional documentation since the 2000 version. Organizations have been making these operational decisions independently for years.
  3. Retained Documented Information: The requirements for “retained documented information” (aka records) are largely the same as in the 2008 version, with two exceptions: the removal of the preventive action record and the introduction of a new record for production/service delivery process changes.

The ISO 9001 documentation myths: 

Myth 1: More Documentation is Always Better: Some still equate ISO 9001 with excessive documentation, driven by the belief that auditors seek vast amounts of paperwork. While thorough documentation may suit complex organizations, it’s not universally beneficial. ISO 9001:2015 emphasizes customization, empowering organizations to determine their optimal level and complexity of documentation. Organizations have the obligation to make conscious decisions regarding the level, types and complexity of documentation themselves as to what is best for their individual systems. There’s a “sweet spot” in QMS documentation that organizations must discover for themselves; excessive documentation can be as detrimental as too little.

Myth 2: No Quality Manual or Procedures Means No Need for Documentation: Since ISO 9001:2015 no longer requires a Quality Manual or procedures, the standard is implying that there is no need for such documentation.  This isn’t the case. The 9001:2015 change was in the decision-making responsibility.  Also, this responsibility has been established for operational processes since 2000 and, QMS systems with varying degrees of documentation, have been audited all these years.   While it is easier to audit a more heavily documented system, the purpose of documentation is not to make it easier for the auditor, but to make it easier to manage the operations.

Myth 3: “Maintained Documented Information” Equals “Retained Documented Information:” Since the requirements for control of documents and records have been combined, there is an idea that “maintained documented information” (documents) are the same as “retained documented information” (records), and thus, those requirements in ISO 9001 Clause 7.5 apply equally to both.  

The Big Myth: Ownership of the QMS Rests Solely with Quality Managers: The title “Quality Management System” implies that Quality Managers are solely responsible for documentation strategies and maintenance. In reality, Quality Managers serve as internal consultants and supporters. The true owners and stewards of the QMS, including documentation decisions and upkeep, are Operational Managers. Quality Managers offer guidance, but operational leaders drive effectiveness and results.

Conclusion:

ISO 9001:2015’s documentation requirements are more flexible than ever, allowing organizations to tailor their approach. Dispelling these myths is crucial to understanding the standard’s intent: to empower organizations to build efficient QMS documentation structures that align with their unique needs and operational goals. Ultimately, the success of a QMS rests in the hands of operational leaders who navigate its documentation and execution.

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