The 5th Incarnation: Proposed Changes to ISO 9001

The 5th Incarnation: Proposed Changes to ISO 9001

Konyika Nealy, Vice President of Quality Assurance & Validation, Pilgrim Quality Solutions 

Are radical changes coming? Is this fifth incarnation of ISO 9001 a drastic departure from its predecessor? Will it reshape the world of manufacturing as we know it? Word around the water cooler is “No.”

The bulk of the changes are stylistic to harmonize the format and language of several management system standards. Adhering to the Annex SL there are now 10 main clauses as opposed to eight. Preventive action has been replaced by risk management, which is in essence the same activity just brought upstream to the QMS planning stage.

The number of quality principles has been reduced from eight to seven only because explicit statement of a systems approach to management was deemed unnecessary as it was already implied. Product, which is more applicable to a physical item, has been expanded to goods and services to better reflect the current business community.

There is also new emphasis on outsourcing as a part of the greater ecosystem. None of these changes are earth shattering.

Still, there are some updates to terms and definitions that are sparking lively debate among quality managers and auditors.

Overall, ISO 9001:2015, still in draft form (and thus still vulnerable to further edits based on feedback from the over 120 countries participating in its authorship), takes a more descriptive approach to quality than ISO 9001:2008. The standard, while providing an answer to the question of what is expected, relies upon the user to make appropriate choices within that context.

As a result, required procedures are conspicuously missing from the text. So while the emphasis on process control remains, the mandate for a governing document is gone. The job just got a little harder for quality managers who took comfort in pointing to the text and shouting “because it says so right here!” Auditors are scratching their heads pondering how to write nonconformities against these less obvious requirements.

But let’s get down to brass tacks. In a nutshell, what documented information will be required by ISO 9001:2015?

  • Scope of the QMS including exclusions (limited to “monitoring and measuring devices” and “operation”) and their associated justifications
  • Quality Policy
  • Quality Objectives
  • Calibration/verification of monitoring and measuring devices
  • Training records
  • Evidence of execution to plan (extent determined by the company)
  • Contract reviews
  • Supplier evaluations and performance monitoring
  • Traceability – Unique ID (i.e. batch records)
  • Customer or supplier property deemed lost, damaged or unacceptable
  • Change reviews
  • Evidence of conformity
  • Release authorizations
  • Nonconformities and associated actions
  • Performance indicator results
  • Internal audits
  • Management reviews
  • Corrective actions
  • And that familiar catch all of any other information determined by the organization as being necessary

So while ISO 9001:2015 appears to be a completely reasonable revision that retains the focus of the globally respected standard, there will thankfully be a three year transition period to hash out the details with your auditors.

The ISO standards for quality management systems serve as the basis for Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP) required by most government regulatory bodies. SmartSolve enterprise quality management software (EQMS) helps you automate these processes and makes it easier to deploy them across your value chain. Learn more about SmartSolve.


Konyika Nealy

Vice President of Quality Assurance & Validation, Pilgrim Quality Solutions

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