Quality/Business Management Standards

Monday, 16 February 2015
ASR Editor
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Revision Updates – Quality/Business Management Standards

It is anticipated that in the next two years many of the quality management system standards will be revised.

As part of that process, users should keep in mind that in most cases there will be a three year implementation phase negating a grand rush to implement new or revised documents.
When revised standards are released, organizations will want to review the standard with all appropriate personnel, fully understand the scope of the changes, develop an action plan, and gradually implement.

ISO 9001 is the first revised standard expected to be released in 2015 perhaps within the next few months. ISO 9001 has gone through a number of drafts with the latest draft or final discussion circulated among the technical committee writers for final input. It is expected that within the next few months the fully revised ISO 9001:2015 standard will be released for use. Once the revision is out, ASR will share with our clients the implementation expectations.

New Features of ISO 9001:2015

First, a reduction in required documentation with the number of written procedures left to the organization to decide. A Quality Manual is no longer necessary. However, the process approach to business is listed in a similar manner as stated in ISO 9001:2008.

Second, a risk plan replaces preventative actions. Risk appears in two standards now - ISO 13485:2003 (medical devices) and the aerospace industry's AS9100 standard. Neither of these standards clearly defines how to address risk, but ISO 9001:2015 will require organizations to develop a risk plan to address the risk to their business.

Here is a quick review of other standards that are being revised:

ISO 14001:2004 Environmental Management is being revised. The word is that ISO 14001 will follow along the ISO 9001:2015 format including 10 sections of information; a numbering system for all newly developed or rewritten documents that follow the 0 to 10 section format. Expect to see the revised ISO 14001 standard released sometime in 2015. A companion vocabulary standard will also be released to address ISO 14001. definitions.
ISO/TS 16949 for automotive suppliers will likely align itself with ISO 9001:2015. Any changes and implementation will occur in 2016 or after.

ISO 13485:2003 for medical device manufacturers.

Again, rumors have it that some drafts have been written. One of the stated purposes of the 2003 release was to harmonize the standard with all regulatory requirements. This harmonization included the development of up to 17 documented procedures. This contrasts with ISO 9001:2015's view of a very few documented procedures. At this juncture, the medical device community should continue using ISO 13485:2003 as is and wait for further word from standard writers.

AS9100 for aerospace and defense contractors.

This standard has followed ISO 9001 closely. AS9100 is a product of SAE (Society of Automotive Engineers). SAE holds regularly scheduled workshops around the U.S. for suppliers and Certification Bodies.

During one 2014 workshop, officials said SAE would evaluate ISO 9001:2015 after its official release making changes as required. Expect any changes to AS9100 to occur 2016 or later.
OHSAS 18001 addressing occupational health and safety is in the committee draft stage and when released sometime in 2016 will be given a new name - ISO 45001.

CQI-9

CQI-9 for the heat treating industry is a popular self assessment requirement controlled by the Automotive Industry Action Group (AIAG). Phil Makula, a retired TRW metallurgist and chairman of the CQI-9 group, explained to me in a January 2015 e-mail that the group is working on a projected June or later 2015 release of a new 4th Edition CQI-9. Improvement of the HSTA CD and the hyper linking of process tables to appropriate questions for easier user documentation are among the group's objectives.

ASR has heard from a number of clients eager to get to work on revising their system based on the new revisions. Since revisions to the respective standards remain fluid, the best course of action may be to think about the known changes that will occur to your organization's QMS such as risk management (ISO 9001) and wait until the standard is officially released for use. There will be adequate implementation time; most likely it will be a three year process as has been the case in the past.

As revised standards are formally released, ASR will keep clients posted on implementation timelines.

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Automotive

  • IATF 16949
  • Intl. Automotive Task Force
  • BS 25999
  • OHSAS 18001

Medical Devices

  • ISO 13485
  • Product Safety
  • Device Recalls
  • Emergency Situations

Aerospace

  • AS9100
  • AS9110
  • AS9120
  • SAE Technical Standards

Environmental

  • ISO 14001
  • EPA Regulations
  • EMS Tools
  • Emergency Preparedness