2020

MY QUALITY STORY

ISO 9001

Keep the Spirit Alive

Has ISO 9001 really changed over the years?

by Pedro Rafael García-Díaz

People often think: “A new version, a new ISO 9001.” But is it, really?

A few years ago, the plant manager at my organization remarked with fear in her eyes, “The 2015 version of ISO 9001 is coming.” The uncertainty of transitioning to a new model, a new approach, new terms and the adding and subtracting of concepts always brings anxiety. Here are some of the ways ISO 9001 has changed over the years:

  • ISO 9001:1987—which included ISO 9001 for design, ISO 9002 for production and ISO 9003 for final inspection and testing—came with tons of documentation, terms that, initially, nobody really understood and exhausting audits performed by strict auditors with varying criteria.
  • ISO 9001:1994 emphasized preventive actions that still relied heavily on documented procedures and a prescriptive version of each dimension of the quality management system (QMS). Many also found issue with its bureaucratic nature.
  • ISO 9001:2000 rolled ISO 9002 and ISO 9003 into ISO 9001. It introduced process thinking and emphasized the importance of using records to prove compliance, revision control and process performance metrics. It also required upper management to bring the QMS into the business system and take responsibility, not delegate to lower ranks.
  • ISO 9001:2008 didn’t introduce too many changes but reaffirmed and clarified ISO 9001:2000.
  • Finally, ISO 9001:2015 eliminated the bureaucracy and erased the mandatory quality manual and management representative involving upper management. It also brought another new approach: risk-based thinking, which allowed organizations to build their QMSs according to their individual needs, avoiding prescriptions.

But more than 30 years and four revisions after my first certification audit, ISO 9001:2015 still has the same spirit and principles it did in 1987:

  • The customer is at the upper core of the system.
  • Quality control is the spine of the system.
  • It is everyone’s responsibility to consistently and continually improve processes.
  • Objective evidence is used to prove system efficiency.
  • Prevention is the main driver of the system—it’s just called “risk” now.
  • Measurements and metrics of processes are necessary for improvement. You can’t improve if you don’t measure.
  • The involvement and role of upper management is crucial.

ISO 9001:2015 may have new tools and different approaches than older versions, but at the end of the day, its goal is still to standardize and deliver value to stakeholders. Every version is slightly different, but the spirit has remained the same since 1987.


Pedro Rafael García-Díaz is a quality manager and engineer at RoMan Manufacturing in Wyoming, MI. He earned an MBA from the University of Texas at El Paso. García-Díaz is a senior member of ASQ and an ASQ-certified quality auditor and certified manager of quality/organizational excellence.



A fine summary, with an excellent emphasis on what has remained constant in ISO 9001.
--Barbara Popel, 08-08-2019

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