ISO 9001 Revision Scheduled for Year 2015


 Sustaining Edge Solutions, Inc. Newsletter

Performance Improvement Solutions for Your Business                              August 2012


This Month
* ISO 9001 Revision for Year 2015
* SES and The Hawaii Gas Company
* Improving Internal Audit Effectiveness
* In the News
* Training Courses


Dates have changed to February 6-9, 2013 Denver, Colorado.  We are a sponsor of this conference!  

Baldrige Regional Conference

September 28, 2012 Scottsdale, Arizona  


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Our newsletters provide information on business management systems.  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, 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 the content or have a subject of interest for a future newsletter, please let us know. 


ISO 9001 Revision Scheduled for Year 2015    

A workshop we attended at the 2012 American Society for Quality (ASQ) World Conference on Quality and Improvement discussed the future ISO 9001 standard revision coming in 2015.


The workshop was titled “Changes to International Standards Quality Management Principles and Management Systems” presented by Jack West.  Jack Chaired the US TAG to ISO TC 176 and is lead delegate for the United States to the International Standards Organization committee responsible for the ISO 9000 family of quality management standards. He continues to serve on these committees.


He stated that ISO 9001:2015 would result in a more extensive revision, addressing global and technological changes in the marketplace. He also shared some insights into these areas and the future of ISO 19011:2011 Guidelines for Auditing Management System.  The following is what we captured in this workshop.


The proposed structure of the ISO 9001: 2015 revision would be as follows:

1. Scope
2. Normative references
3. Terms and definitions 

Clauses 4-10 are distinctly different (two more than current)

4. Context of the organization – Scope and expectations for the management system. 
5. Leadership-Management commitment, policy, roles, responsibilities, and authorities. 
6. Planning-Risks and opportunities, and objectives and plans. 
7. Support-Resources, competence, awareness, communication, and documented information. 
8. Operation-Operational planning and control. 
9. Performance Evaluation-Monitoring, measurement, analysis, evaluation, internal audits, and management review. 
10. Improvement-Nonconformities, corrective action, and continual improvement.


Further items discussed:   

  • A new revision to the 8 Quality Management Principles (QMPs) will take place this year.
  • Sixty countries voted that the current ISO 9001:2008 Standard needs to be revised.  This was the most votes achieved based on prior revision requests.
  • Voice-of-the Customer (VOC) and Risk Management were the largest new entries voted upon to incorporate into the future 2015 version (very glad to see these being incorporated.  Risk management, identfication and mitigation is highly lacking in many company quality systems).
  • ISO 19011:2011 Guidelines to Internal Auditing will become an ANSI Standard this summer.  Internal Auditing and Supply Chain Auditing will be added to the standard. Drafts were submitted for review NLT July 2012.
  • The ISO 19011 website identified in the current revision is still not operative as of this posting.  An added “Guidance” section to ISO 19011 will be included in the spring of 2013.


The ISO Technical Management Board has also adopted a standardized format and common-core text for use in all new and revised ISO management system standards. This promotes greater ease of use for organizations that want to integrate the requirements of standards such as ISO 9001, ISO 14001 and ISO 50001 into a single, coherent system.


To find out more about the future ISO 9001 revision, see Jack West May 2012 Quality Progress Article.  


Sustaining Edge Solutions and The Hawaii Gas Company  

We are very proud to announce our new client:  The Hawaii Gas Company. 

Article excerpt from  Pittman, D. (2012, July 27). Sustaining Edge Solutions lands big kahuna. Inside Tucson Business, p. 4.  


The Hawaii Gas Company has hired Sustaining Edge Solutions, Inc. to design, develop and implement a process leading to ISO 9001 certification for the company. It is an international quality management standard that has been set by the International Organization Standardization in Geneva, Switzerland. The standards encourage efficiency, save operating costs and increase profits. 

The company which serves about 70,000 residential and commercial customers on the six major Hawaiian Islands, literally goes by the name The Gas Company (TGC) in Hawaii. In business since 1904, it has more than 300 employees.  

Mike Futrell, executive vice president of TGC, said the company embarked on the ISO 9001 process to improve quality, customer service, employee relations and overall production – and to sustain those improvements for decades to come. Doing so, he said, would result in long-term improvement to TGC’s bottom-line profitability.

Sustaining Edge Solutions was selected to lead the effort because it has “the right balance of technical expertise, experience and personal customer service,” Futrell said.  

Lance Lam, division manager of Quality Assurance & Compliance (pictured above left with Walter Tighe, president and owner of SES at company headquarters in Honolulu ) for TGC, was also impressed with Tighe and his company. “Walter and Sustaining Edge Solutions provided through website, newsletters and direct contact an in-depth look on how companies can benefit from an ISO 9001 certification,” he said.  

Hawaii Gas Company owns and operates the only synthetic natural gas (SNG) manufacturing plant of its kind in the U.S. The plant makes SNG from byproducts of imported petroleum that is refined and distributed to its customers in metropolitan Honolulu through a 1,100-mile pipeline network. The company supplies liquefied petroleum gas, or propane, to commercial, residential utility and non-utility customers statewide.

It is expected it will take 18 to 24 months to complete the ISO 9001 certification project for Hawaii Gas Co. In that time, Tighe expects to make seven to nine trips to Hawaii, with each visit lasting for one or two weeks.  


Improving Internal Audit Effectiveness        


Internal auditing, when effectively implemented, can be considered the most important tool in your quality system tool box. It’s the primary method for continuously monitoring a company’s quality management system (QMS). In fact, the feedback from internal auditing is critical to the growth of the QMS and contributes to the financial payback of certification.   

Through an audit, an organization can identify a system’s ineffectiveness, take corrective action, and ultimately support continuous improvement. Unfortunately, a poorly deployed internal auditing system can lead to increased, nonvalue-added costs, auditor and auditee frustration, many hours of wasted resources, and an eventual QMS breakdown.  


Let’s look at some weaknesses we have observed within companies. 

Not understanding the definition of, and not basing audits on, status and importance. Status can be defined as how a department, process, or discipline is performing against established company policies, objectives or goals. Questions that could be asked considering status include: 

  • What are the performance indicators for an area, group, or department reflecting, and what is the performance history? 
  • Have there been changes in process, equipment, personnel, or management?

If the performance history of a given department, process, or group is meeting established expectations, then its status could be considered healthy.


Importance is different, but linked to status. Therefore, concentrate on the areas that are critical (importance). Increase the internal audit focus on areas that are the root cause or otherwise not performing to expectation (status). This is especially critical when companies implement a new department, processes, training and company initiatives. Also, the relationship of these aligned with “customer touch points” what the customer values, when monitored and measured will drive status identification.


Truly effective audit schedules concentrate on potential, not just obvious, shortcomings or weaknesses. In a manufacturing enterprise, utilizing control plans along with related design or process failure, mode, effect, analysis (FMEA) can also be helpful as a guide to identifying critical areas.


The key is to focus the audit schedule on the areas that are or could potentially be a root cause for nonconforming situations as well as areas critical for maintaining product conformity. The audit schedule is a living document and should be revised as appropriate. The individual responsible for scheduling audits should be fully aware of management review output data; customer, internal, and supplier concerns; and organizational infrastructure changes.


When developing your audit schedule, consider the following:


  • Focus on the “management of change” within the QMS (i.e., customer feedback and complaints, new employees, new equipment or processes, new training, quality initiatives, new departments, root cause areas of constant concern).
  • Try short-duration, and highly-concentrated audits in place of long, extended audits where focus is bound to be lost.
  • Consider scheduling additional activities such as corrective action effectiveness validation, customer complaint resolution effectiveness, and assessing company statutory/regulatory requirements, if applicable.


In the News    

 ISO 9001 in the Supply Chain   

Free brochure explains ways that suppliers can demonstrate ISO 9001:2008 conformity. 


Managers responsible for selecting suppliers or responsible for purchasing decisions now have available an attractive hard copy version of the ISO brochure,ISO 9001 in the Supply Chain,up to now published uniquely as a web document.

The brochure explains the different ways that suppliers can demonstrate ISO 9001:2008 conformity. It also describes what you can do if things go wrong and you are dissatisfied with performance of your supplier. 


National Quality in Education Conference     

Systems thinking helps prepare students for college and careers.


Preparing students with the 21st-century skills they need to ultimately gain access to college and future careers is a challenge facing educators throughout the United States. Implementing best practices and innovative approaches to help student achievement is the goal of the 20th National Quality Education Conference sponsored by the American Society for Quality (ASQ).


The conference focus areas include:

  • Curriculum, instruction, assessment, and 21st-century learning. 
  • Strategic planning and systems thinking.
  • Using quality practices to close the achievement gap, pre-K-12 through college.
  • Baldrige in education for significant continuous improvement.


 Visit the National Quality Education Conference Website.


FDA Proposes Unique Device Identification System for Medical Devices 

In response to requirements in legislation that passed Congress with broad bipartisan support, the U.S. Food and Drug Administration (FDA) proposed that most medical devices distributed in the United States carry a unique device identifier, or UDI.


A UDI system has the potential to improve the quality of information in medical device adverse-events reports, which will help the FDA identify product problems more quickly, better target recalls, and improve patient safety. The FDA has worked closely with industry, the clinical community, and patient and consumer groups, and conducted four pilot studies in the development of this proposed rule. The FDA is seeking comment on the proposal for 120 days.

For more information visit the FDA UDI Webpage.


Training Courses

To see the course description, schedule, and on-line registration click on the course title below. We deliver onsite training for 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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