The ISO 9001: 2015 Change Train is Gathering Steam

Big changes are coming to ISO 9001.  
Prepare to jump on this change train!
ISO change is coming your way in the form of an ISO 9001 update.  This is a major revision to the standard and pharma companies need to prepare to jump on this train. 

Once the standard is published, companies will have a three-year transition period within which to comply.  Managers and other professionals involved in implementing, maintaining and auditing quality management systems are encouraged to be proactive and think about what they can begin doing now to achieve compliance with the revised standard.

Why is This ISO Update Occurring?

Standards are created to provide guidance to companies dealing with specific issues in their marketplace.  As Paula Oddy says in a recent article, “In the case of ISO 9001, the issue is whether the registered organization has a QMS in place that allows it to create products and services that meet customer requirements. Yet even as simple and basic as that statement may be, standards must evolve. The realities of the fast-changing marketplace mean that even a standard that is written nearly perfectly at a specific moment in time can’t anticipate changes that might occur in the future.”(1)

This article is related to the Video:
How IS0 9001:2015 Affects Life Sciences and Manufacturing

“The standard reflects an international orientation to the standard because companies are selling products all around the world,” said ISO expert Walt Murray in a recent video.  “Technology has made work more virtual and this is affecting the way we do business.”
The update has been explicitly designed to emphasize risk-based thinking, according to Murray.

“Preventive action orientation is being replaced with a risk/opportunity orientation,” Murray said.  There is emphasis on customer focus and a de-emphasis on prescriptive requirements and documented [information] procedures, leaving organizations with the effort to figure out what to do.”

The following chart illustrates some of the key differences between ISO 9001:2015 and the current ISO 9001:2008 (2). Similarities are in boldface:

Structure Comparison Chart
ISO/DIS 9001:2015
ISO 9001:2008
Nominative References
Nominative References
Terms and definitions
Terms and definitions
Context of the organization
Quality management system
Management responsibility
Resource management
Product realization
Measurement, analysis and improvement
Performance evaluation
According to ISO expert Peter Knauer, there are seven objectives for the update:
  • To remain relevant
  • To integrate with existing management systems
  • To provide organizational management
  • To provide a foundation for the next 10 years
  • To reflect the increasingly complex organizational environment
  • To reflect the needs of potential users
  • To enhance an organization’s ability to satisfy its customers

A significant change from the current version of ISO 9001 is that there will be no requirement for a quality manual and traditionally documented procedures.
“This is why process orientation will be so important for working within the standard,” Murray said.  “Where companies once followed the steps outlined in a quality manual, now they’ll need to establish [integrated] processes for their work.”

Boarding the Train
Knauer and Murray recognize that companies may look at these changes and feel uneasy. 
“Don’t panic,” Murray advised.  “Take the changes a bit at a time and start working on them now.”

Knauer gave the following recommendations to quality professionals bracing for the new standard:

  • Stay calm and improve upon your processes.
  • Seize the opportunities where you have them.  If you are establishing new processes now, consider how they will integrate with the processes needed to meet the new requirements.
  • Understand key concepts and intents within the new standard. Think about ISO 31000.
  • Practice risk analysis and use critical thinking about what will fit best in the future.
  • Conduct a situation review. Make sure the company context and interested parties are mutually in play. 
  • Plan now for the high-level standards.  Don’t wait until the train has left the station!

For more information about the approaching ISO changes, watch Walt Murray and Peter Knauer in this free 18-minute video. No form is necessary – just click the link to watch!

(1) Getting Ready for ISO 9001:2015 (accessed April 27, 2015)

(2) ISO 9001:2015: Preparing for the Change. (accessed April 20, 2015)
Robyn Barnes, a public relations specialist at MasterControl Inc., writes about the life sciences industry and other regulated environments. Her three decades of marketing and public relations experience include work with USAA, Morrison Knudsen Corp., and KBHome Inc. She holds a bachelor’s degree in journalism and a master’s degree in business from New Mexico State University.