Insights on Environmental Health & Safety (EHS), Operational Risk and Product Stewardship

ISO 9001 Changes Are Rolling In; Are You Ready?

March 15th, 2017
Banoo Behboodi
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Major differences in terminology between ISO 9001:2008 and ISO 9001:2015 include:

  1. “Products” has been broadened in scope to include “Products as well as Services” that must meet ISO 9001:2015 standards.
  2. There are no longer any “Exclusions” as there were in the previous ISO 9001:2008 revision, so “nonapplicable” is no longer an acceptable answer.
  3. Companies are no longer required to assign a designated “Management Representative.” Similar responsibilities and authorities are instead assigned to department managers that are responsible for the operations and associated documentation needed to comply with the latest ISO 9001 standards.
  4. The focus has been switched from having standard “Documentation, Quality Policies and Procedure Manuals and Records” to the single term “Documented Information,” which encapsulates all documents in any form.
  5. “Work Environment” has been broadened in scope to include all aspects of the environment that can positively or negatively affect the operation of processes.
  6. “Monitoring and Measuring equipment” has been broadened in scope to include monitoring and measuring resources.This would include for instance the use of external providers of services such as third-party gague and test facilities.
  7. “Purchased products” has been broadened in scope to include “externally provided products and services” that may be acquired through “external providers” or what used to be termed suppliers.

Without a doubt, the International Standards Organization is the standard bearer in the world of standards, but maintaining those standards is your standard burden to bear.

That’s why staying on top of ISO changes is so critical, and there are none more significant than when the organization makes changes to its 9001 quality management standards roughly every six to eight years. We’re nearing that tipping point as ISO 9001:2015 slowly rolls out with companies needing to be in full compliance by September 2018.

And it’s important to note that with those ISO 9001 changes comes a series of revisions to related standards in more specialized fields. For example, the automotive industry is being asked to switch gears and move from the ISO/TS 16949 standards to IATF 16949:2016 while new standards are also being launched specifically for the aerospace industry, AS9100:2016, and going under the knife in the medical device industry with the implementation of ISO 13485:2016.

To maintain a competitive advantage in the marketplace, it behooves companies to plan accordingly.

Keeping in mind that ISO doesn’t actually audit companies to see if they’re maintaining the standards, Sphera recommends that you book your audit time as early as possible with whichever third-party auditor you use because of the number of organizations that are currently undergoing a re-audit to the new standard. The new ISO 9001 standards are in many ways leaving the old version in the dust. What the International Standards Organization is trying to do is encourage companies to have continuous improvement more so than what we’ve seen in the past.

Checking Under the Hood

With the customer expectations being that your company is complying with the ISO standards and specific documentation created to describe how your operations are run, how you track the performance of those products and services is essential to make sure they’re effective and efficient.

You need to be able to say how you performed the processes in your company, do it that way and then prove that you actually did it. This requires records that enable your company to track your progress against performance goals that your management team reviews typically on a monthly and quarterly basis. Where performance is less than acceptable, you need to have an action plan in place that demonstrates continuous improvement is a part of your company culture.

In older versions of the standard, companies could assign a “management representative” who was in charge of overseeing the quality control of the complete product life cycle. Not anymore. That’s out the window. Companies will now have to train department managers to ensure ISO standards are maintained with documented evidence of ongoing performance. That means department heads won’t be able to sit back, relax and let the management representative do the driving when it comes to complying with ISO standards.

The new standard focuses on “documented information,” which gives companies more options for keeping track of the information than the old standard that required a quality manual. Computerized solutions have become critical in being able to coordinate company activities as involved as ISO 9001 demands, and that is why Sphera’s Operational Risk solution is such an important product to help companies ensure compliance.

Sphera can also offer a Gap Analysis template for companies that wish to check if they’re a well-oiled machine in terms of ISO compliance.


Banoo Behboodi

Banoo Behboodi is Sphera’s director of industry solutions. Behboodi has extensive experience in implementation of EH&S solutions with emphasis on Operational Risk Management including Risk Assessment, Management of Change, Incident Management, Audits, Occupational Safety, etc. She has led many successful global solution implementations in the Oil & Gas, Chemical, Pharma/Bio-Pharma, Medical Devices and Discrete Manufacturing industries.

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