Annex SL – Changes for ISO Standards

August 18th, 2015

The final draft international standard (FDIS) of ISO 9001:2015 has been released in July, and the revised standard is slated for publication in September. Based on Annex SL of the “Consolidated ISO Supplement,” some elements of the standard will be restructured to allow for easier integration of multiple management systems.

Integrated management systems generally refers to integrated processes that result in one management system to implement such as ISO 9001, ISO 14001, and OHSAS 18001.

Annex SL consists of 9 clauses and 3 appendices. This annex has been developed primarily with ISO technical committees who develop management system standards.  The impact of Appendix 2 of Annex SL will be felt by all users of management system standards in the future.

Appendix 2 is in three parts:

* high level structure,

* identical core text,

* common terms and core definitions.

Future management system standards will need to have these elements. In addition, there will be less confusion and inconsistency because common terms will all have the same definition and there will be common requirements across all the management system standards, for example the requirement to establish, implement, maintain and continually improve the management system.

High level structure

The major clause numbers and titles of all management system standards will be identical They are:

  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.

All future ISO MSS should be consistent and compatible, and will have the same look and feel. At this time, it is questionable whether ISO 13485 Medical Devices Standard will utilize Annex SL.  We are hoping that this could be the beginning of the end of the conflicts, duplication, and misunderstanding arising from precisely different requirements across the various MSS.

ISO 9001 Moves to Final Draft International Standard (FDIS)

July 14th, 2015

On July 9th 2015, the ISO/FDIS 9001:2015 was issued in 28 pages, the last stage in the ISO 9001 revision process. This is the last formal draft before final publication scheduled on September 23, 2015. ISO member countries have about 2 months to vote on the latest draft of the standard before the September 9, 2015 deadline.

ISO/FDIS 9001:2015 positions the new version of the standard as an integral part of an organization’s efforts with leadership enhancement for development, and promotes it as a tool for improving an organization’s overall performance. It drives more internal and external stakeholder focus as part of the adoption of a risk-based approach to quality management and emphasizes the importance of adopting a quality management system  as a strategic direction for the organization.

In addition to renaming and repositioning some QMS activities, other significant new requirements have been introduced.

Based on our review of the FDIS, and compared to the DIS, changes are relatively minor. The most extensive ones have been to the Introduction and Graphic Figures, which have been simplified, with explanations being moved to an informative Annex. The terms and definitions have now been removed from the standard and added to ISO 9000.

Organizations that are already certified to ISO 9001:2008 will have three years from formal publication of ISO 9001:2015 in September to transfer to the new version of the standard. The  transition period will end in September 2018.

If interested, you can purchase the ISO/FDIS 9001:2015 at the ASQ Website.   FYI:  The ISO 14001:2015 Environmental Management System Standard FDIS has also been released for voting.

The IATF Wants to Hear From You!

June 12th, 2015


The members of the International Automotive Task Force (IATF) are the authors of ISO/TS16949 Automotive Quality Management System. The IATF has announced that they have begun the task of revising the automotive industry’s quality management system (QMS) standard to align with the High Level Structure of FDIS ISO 9001:2015.

The IATF wants a piece of your mind!

The IATF is requesting that each stakeholder organization (whether OEM, supplier of any tier, or CB) provide a single response to this survey. Please complete all parts of Section I and Section II of the survey. In Section III, it is not necessary to provide input on every clause. You are encouraged to provide input on any clause where you have identified opportunities for improvement. For each response in Section III, it is necessary to complete all three columns (restatement of the current requirement, identified issue with the current requirement, and proposal for new wording for the requirement) for the input to be considered in the analysis.

The survey will be open from June 1, 2015 to July 10th, 2015. Only responses received during this period will be included in the analysis. The survey is available at the following link – HERE.

This survey is a very important opportunity to improve the future QMS standard for the automotive industry. The IATF is requesting you promote participation from your company. Your responses to this survey will identify key opportunities for improvement in the ISO/TS16949 requirements and in the ISO/TS audit process to the IATF. 

AS9100:2016 – What’s Ahead?

May 14th, 2015

astronaut-earth.jpg The AS9100 Aviation, Space and Defense Standard is undergoing a major revision aligned with the ISO 9001:2015 expected release of September 2015. 

With a slight lag of a few months, it is expected that the AS9100:2016 (including AS9110 Aviation Maintenance Organization and AS9120 Stocklist Distributor) will be released in the second quarter of 2016.  The gap between the published release of the ISO 9001:2015 and the AS9100:2016 standards will create a shorter time period for AS registered organizations to transition to this new standard.

Because the AS standards are being released approximately eight months after the ISO 9001:2015 standard, the “three year” transition is actually a little over two years for aerospace companies. This all is based on the assumption that the aerospace standards are published in April of 2016.  If that deadline is not met, the transition period will be even shorter.

Currently, the AS9100:2016 standard is in the draft stages and therefore still undergoing change.  But what is known is that it will mirror the new Annex SL ten-clause format of the ISO 9001:2015 standard.  In addition, it is expected that the following areas will be added or enhanced:

  • Product Safety
  • Human Factors
  • Risk
  • Preventive Action
  • Counterfeit Parts
  • Configuration Management
  • Product Realization and Planning
  • Post Delivery Support
  • Project Management
  • Design Development and Supplier Management
  • Quality Manual
  • Management Representative

As these standards work their way through the various groups  and specific stakeholders, it is expected that there will continue to be changes from their current draft forms.  Watch for updates to these standards in our future newsletters.

Have you found the root cause yet?

April 13th, 2015

We frequently ask or hear others ask that question. Root cause analysis (RCA) is an old subject and is familiar to many people. If your company is registered to a major global quality standard, you hear it very often and you most likely have contributed to a corrective action using it.

Many who use it are unaware of the concept’s larger context. Asked what root cause means, some typically respond with:

  • “It is what is really happening.”
  • “It is the one thing that causes everything else.”
  • “It’s the light switch. When you flip it, the lights go on.”

These explanations imply there is one specific thing that is the originator of the considered effects, and the origination is absolute, meaning unconditional and inevitable. This absolute origination is usually referred to as the root cause. The challenge to people is to know when and where to stop drilling down through the infinite layers of cause and effect and conclude they have reached a root cause. The clue resides in the typical business mind-set. It’s similar to selecting something that can yield a high return on investment. That is how most businesses make decisions.

One key to unlock the root cause is called the span-of-control or sphere-of-influence principle.

Span of Control

Many people have not thought much about the deeper meaning of root cause and, therefore, are not clear on when and where to stop searching for root causes. The so-called root causes are what people subjectively choose to serve in the role of origination. The task to pursue the root cause is really the task to decide when and where to terminate the chain of causation to generate high ROI.

Sphere of Influence

Similarly, if a cause is outside the sphere of influence (persuasion only), it’s a good indication you can stop drilling because working beyond that generates no returns. That’s not to say you’ll always give up in this case. The focus then must be shifted to expanding the influence boundaries to enclose the cause currently outside of your influence. In our experience, the sphere of influence is frequently the dominating factor in root cause selection.

Many people have not thought much about the deeper meaning of root cause and, therefore, are not clear on when and where to stop searching for root causes. The so-called root causes are what people subjectively choose to serve in the role of origination. The task to pursue the root cause is really the task to decide when and where to terminate the chain of cause and effect to generate a high return on investment.