Management Systems Standard Changes

 Sustaining Edge Solutions, Inc. Newsletter

Performance Improvement Solutions for Your Business                                 May 2014


This Month
* Management Systems Standard Changes
* AS9101 Revision Change
* Steps to Continual Improvement
* In the News
* Training Courses


ASQ Chapter Tucson, AZ General Session June 10, 2014.  Subject: Cost of Poor Quality – Presenter Walter Tighe, SES President     


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Our newsletters provide information on business management systems and process improvement methods.  These systems include ISO 9001 QMS, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, ISO 14001 Environmental Management Standard, and others.  Subjects include performance improvement methods such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

If you have any questions regarding content, or have a subject of interest for a future newsletter, please let us know.   


Management Systems Standard Changes            

The International Organization for Standardization (ISO) requires that standards be reviewed about every five years to determine whether they need to be revised. During the 2012 global user survey for the ISO 9001 standard review, more than 70% of respondents favored including the following concepts in ISO 9001:

  • Resource management
  • Voice of the customer
  • Measurements (performance, satisfaction and return on investment)
  • Knowledge management
  • Risk management
  • Systematic problem solving and learning

Based on the recent release of the committee draft stage document for ISO 9001:2015, it remains to be seen what new requirements will be in the final revision of the standard to be published late next year (do count on risk management being included).  One document that is now and will have an impact on future standard structure is Annex SL. Annex SL is a design specification for the next ISO 9001 revision and will be used to enhance the alignment with other ISO management system standards. ISO/IEC Directives Part 1, 2013 Annex SL, Appendix 2 establishes this high-level structure with identical core text, and common terms and definitions. 

The Annex SL high-level structure consists of 10 elements for all new or revised management system standards going forward:

  1. Scope
  2. Normative references
  3. Terms and definitions
  4. Context of the organization
  5. Leadership
  6. Planning
  7. Support
  8. Operational planning and control
  9. Performance evaluation
  10. Continual improvement

New elements and terms being introduced will most likely determine the need for additional processes and training for currently certified organizations. Annex SL has already meet some resistance being perceived as a return to the “clause approach” even with the requirement in the current draft standard mandating the process approach. Let’s take a look at a couple of other common management system standards we have experience with implementing that Annex SL will impact.


ISO 14001 Environmental


The ISO 14001 EMS standard is also being revised at this time and targeted for release next year. The standard will increase from four to ten clauses mandated by Annex SL. This will likely increase the length from the current revision – CD 2 release from 23 to 44 pages. An addition to 14001 will be increased top management requirements.

ISO 13485 Medical Devices


The ISO 13485 Medical Devices standard currently is from the 2003 revision. It has the common eight clauses and is about 20 pages. To adopt Annex SL, the standard must change to the ten clauses to around 44 pages. ISO 13485 is also being revised, but this revision started before the Annex SL issuance. The committee responsible may not be planning to implement Annex SL in its next revision.

What should we do?


Keep aware of what is going on and be ready to implement any of the new requirements (we of course will keep all our newsletter readers informed of future information changes). A transition period is always communicated on any new standard. In the past, this has been a three year period and we don’t see that changing. Also, be aware that we are seeing consultancies and training companies already advertising ISO 9001:2015 training and workshops. The standard is currently a draft with a late 2015 publish date.  Don’t make the costly mistake of altering your current system on draft standard information sources.

Looking for more information?  Contact Us

 AS9101 Aviation, Space and Defense Changes                   


AS9101 has changed from Revision D  to Revision E.  AS9101E is the standard for Quality Management Systems Audit Requirements for Aviation, Space, and Defense Organizations.

This standard defines requirements for the preparation and execution of the audit process. This document is associated with the method certification body auditors use during AS9100 audits; and can be used effectively for internal audit purposes. Additionally, it defines the content and composition for the audit reporting of conformity and process effectiveness to the 9100-series standards, the organization’s quality management system documentation, and customer/regulatory requirements.

Changes to the standard include:

  • Audit forms have been consolidated.
  • The PEAR (Process Effectiveness Assessment Report) will capture objective evidence of conformity (planned activities) and performance (planned results). It includes both the performance and the conformity assessment results. 
  • CB Auditors will record definitions, targets and values of key performance indicators (KPI’s) related to the audited process on the PEAR.
  • CB Auditors will record detailed objective evidence (e.g., audited procedures, PO’s, work orders, and documents.
  • The principle of recording objective evidence still remains.
  • The Objective Evidence Record (OER) has been replaced.  Objective evidence will now be captured in the super-pear (clause 7 processes).  This includes a QMS Process Evaluation Matrix (for other than clause 7 processes) and an audit report summary.

The rollout date of AS9101E has not been announced by the certification bodies. The certification bodies along with the  auditors will need to be trained on the new forms and provided a date to implement the changes.  You can order AS9101E from the Society of Aerospace Engineers at

Steps to Continual Improvement               


Continual improvement is a type of change that is focused on increasing the effectiveness and/or efficiency of an organization to fulfill its policies and objectives. It is not limited to quality initiatives. Improvement in business strategy, business results, and customer, employee, and supplier business relationships can be subject to continual improvement. Putting it simply, it means getting better all the time.  

What continual improvement is not. Improvement is not about using a set of tools and techniques. Improvement is not going through the motions of organizing improvement teams and training people. Improvement is a result, it can only be claimed after there has been a beneficial change in an organization’s performance.

Gradual, incremental or breakthrough. Continuous improvement is gradual never-ending change, whereas continual improvement is incremental change. Types of improvements called Kaizen, Lean and Six Sigma are common place methods.  


When should continual improvement be started? All managerial activity is directed either at control or at improvement. Managers are either devoting their efforts at maintaining performance, preventing change, or creating change, breakthrough, or improvement. If businesses stand still, they will lose their competitive edge, so improvements must be made to keep pace and stay in business. Every system, program, or project should provide for an improvement cycle. Therefore, when an objective has been achieved, work should commence on identifying what is meeting the requirements of the process, and what better ways of doing it.

There is No improvement without measurement. An organization must establish current performance before embarking on any improvement. If it does not, it will have no baseline from which to determine efforts.

There are ten common steps to undertaking continual improvement:

  1. Determine current performance.
  2. Establish a need to improve.
  3. Obtain commitment and define the improvement objective.
  4. Organize the necessary resources.
  5. Carry out research and analysis to discover the cause of current performance.
  6. Define and test solutions that will accomplish the improvement objective.
  7. Produce improvement plans which specify how and by whom the changes will be implemented.
  8. Identify and overcome any resistance to the change.
  9. Implement the change.
  10. Put in place controls to hold new levels of performance, and repeat step one.

Continual improvement is far more than a set of techniques. For many,  it involves a radical change in attitudes. The defense of the status quo, and resistance to innovation, cannot be treated as normal management behavior. A fear of reprisals for reporting problems has to be replaced by congratulating people for identifying an opportunity to improve. Keeping of good ideas within departmental walls must be a thing of the past as people share their knowledge and experience in the search for greater organizational success.


Interested in implementing measurable improvement methods in your organization?   Contact Us.


In the News      

2014 Manufacturing Outlook Survey 

Sixty-five percent of manufacturers experienced revenue growth in 2013 but nearly half still consider the economy the biggest challenge, according to results of the ASQ 2014 Manufacturing Outlook Survey.

And while 64 percent of respondents worldwide expect increased revenue in 2014, that percentage is down from years past, albeit slightly. In last year’s Manufacturing Outlook Survey, 65 percent anticipated growth in 2013, and 66 percent of respondents to the 2012 outlook survey anticipated growth in 2013.

Despite the percentage of manufacturers expecting increased revenues in 2014, 46 percent of the respondents say the economy continues to be the biggest hurdle to operations, while 18 percent said the shortage of skilled workers is the biggest challenge they foresee in 2014.

Other hurdles identified include “global competition,” “lack of new products,” “government sequestration” and “lack of leadership.”

Smart manufacturing drives efficiencies

In addition to questions about manufacturers’ financial outlook for 2014, the survey asked about manufacturers’ use of smart manufacturing – which the Smart Manufacturing Leadership Coalition defines as the integration of network-based data and information that provides real-time understanding, reasoning, planning, management and related decision making of all aspects of a manufacturing and supply chain enterprise.

According to the results, only 13 percent of those surveyed said they use smart manufacturing within their organization. Of those organizations that claim to have implemented smart manufacturing, 82 percent say they have experienced increased efficiency, 49 percent experienced fewer product defects and 45 percent experienced increased customer satisfaction.

Of the manufacturers that have not implemented smart manufacturing, interest, cost and resistance from management continue to stifle deployment, according to the survey.

The results show that 37 percent of those surveyed have no interest in smart manufacturing, while 29 percent say cost is the biggest challenge. In addition, 14 percent said resistance from management is the biggest hurdle when considering a smart manufacturing system.

“While many indicators point to an improved economy, it’s clear that it’s a topic that continues to be a concern of manufacturers,” said ASQ Chair John Timmerman. “Quality tools that increase customer satisfaction, increase efficiencies and reduce errors can help quell the anxiety of manufacturers and stabilize their businesses by boosting market share and revenues.”

For more survey information visit the ASQ Website.

Training Courses

To see the course description, schedule, and on-line registration click on the course title below. We deliver onsite training for all these courses and customized training to fit your specific needs.  We offer group discounts.  


View all our Courses

View Our Web Based E-Training Courses   

ISO 9001 Quality Management

Understanding and Implementing ISO9001:2008

ISO 9001:2008 Process Based Internal Auditor 

Documenting Your Management System

AS9100 Aviation, Space and Defense

Understanding and Implementing AS9100C (9110 &9120) Aviation, Space and Defense

AS9100C:2009 Process Based Internal Auditor

Documenting Your Management System 

ISO/TS 16949 Automotive

Understanding and Implementing ISO/TS16949:2009 Automotive

ISO/TS16949:2009 Process Based Internal Auditor
Documenting Your Management System 

ISO 14001 Environmental

Understanding and Implementing ISO14001:2004 Environmental
ISO14001:2004 Process Based Internal Auditor

Lean Enterprise and CI 

5S Five Pillars of a Lean Workplace Organization
Continuous Process Improvement
Lean Six Sigma
8 Disciplines (8D) of Problem Solving

ISO 13485 Medical Devices

Understanding and Implementing ISO 13485:2003 Medical Devices
ISO 13485 Process Based Internal Auditor 

ISO 27001 Information Security

Understanding and Implementing ISO 27001:2005 Information Security
ISO 27001 Process Based Internal Auditor 

All courses can be delivered at your company. Don’t see a course, location, or date that fits your needs?

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