ISO 9001:2015 & Annex SL The Real Common Core That Has Companies Worried

Sometime in late 2015 the next version of ISO will be released in it's final form. Drafts have been circulating for nearly a year as people attempt to get a sneak peak at the coming changes. These changes are more significant than in 2000.

What is Annex SL? This is the new Common Core adopted by the ISO leadership for all of it's management system standards. First appearing with ISO 9001:2015 it will be the basis of coming upgrades to all the other ISO system standards such as Environmental, Occupational Safety & Health.

First, who is affected? Every company registered to ISO 9001:2008 will be immediately impacted, but no fears you have three years (December 2018) from release before you must upgrade. However, next up will be those with other ISO management system certifications: 14001, 18001, etc. Word on the street is that AS9001 will not be changed, at least in the immediate future and since this standard is not managed by ISO they will not be required to upgrade. Automotive suppliers using TS16949 will not be immediately impacted and this may be the final straw to push it out of the ISO fold to a fully industry managed model like aerospace. Medical companies certified to 13485 are not immediately impacted and strong efforts will be made by the industry to avoid incorporating Annex SL, however as a fully ISO-based standard, they may be forced to upgrade, only time will tell. Such a revision, if required, will be at least five years away.

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The greatest overall impact will be to companies with multiple certifications as they are now faced with managing wholly divergent requirements (anyone still remember the 1980s?). This will be easiest with companies that can effectively isolate lines or divisions. For the rest, focus on the new 9001 criteria and you will find that the rest will be able to fit as well.

Revised elements of ISO 9001 based on Annex SL:

  1. Scope
  2. Normative References
  3. Terms and Definitions
  4. Context of the organization
  5. Leadership
  6. Planning
  7. Support
  8. Operation
  9. Performance Evaluation
  10. Improvement

As you can see, the numbering is changed with the auditable elements increased from five (4-8) to seven (4-10). The criteria have been realigned with the biggest impact being the incorporation of risk management throughout the document. Every major clause includes requirements to identify potential risks in that area and take appropriate action to mitigate those risks. Therefore, Preventive Action has been dropped as a stand-alone requirement and corrective action more aligned with product failures and complaint investigations. Those changes should be easily adopted as it reflects the realities of most certified companies who always struggle demonstrating Corrective and Preventive Action (CAPA) compliance.

Also of significant note is the context of the organization. Past relationships have only described the company, it's customers, and it's suppliers. Now stakeholder requirements must be addressed including, for example, employees, stockholders, and the greater community. In addressing such criteria keep in mind the objective is to keep it appropriate. If you are a large, multinational corporation you will have a large impact with many stakeholders. For a small, family-owned business, you will have few stakeholders. Context also means your position relative to your competition.

This version is much more process driven than it's predecessor all elements interweave within each process in the same way that each process interweaves into your companys management system. Each process must be measured, monitored, and appropriate actions taken when performance is below target. The controls on process measuring are the same as for product measuring. Suitable evidence is required to prove the validity of the measurements made, similar to calibrating gages.

Purchasing, outsourcing, equipment maintenance, IT, and support processes are all lumped into a large section called Resources (element 7). Another element (Improvement number 10) is based upon the current element 8, but focuses more on real improvement and specifically references additional tools such as Lean, Six Sigma, and Innovation.

The 4-P (Prepare, Perform, Perfect and Progress) model for process management as developed by former Chicago Section member, Praveen Gupta is a highly useful tool for managing the change process to implement this version of ISO 9001. The 4-P model helps fulfill the intent of ISO 9001 by focusing on the results (achieving perfection by solid preparation). Implementation of the 4-P model helps reduce the cost of poor quality as the appraisal costs come down by being on target and failure costs come down by better focus on the process inputs.

This model and more will be presented in an ISO 9001:2015 workshop on Friday, March 14. This will be followed by another workshop on Saturday, March 15 dedicated to Risk Management for ISO Compliance. These will provide the opportunity to dig deeper, not just into the content of the revision, but to actively plan an implementation strategy for your company.

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Sources

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Posted in Business Other Post Date 03/23/2015


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