Stakeholder Feedback: ISO 9001:2015 Draft Released

 Sustaining Edge Solutions, Inc. Newsletter

Performance Improvement Solutions for Your Business                                     July 2013


This Month
* ISO 9001:2015 Draft Released
* Product Safety and Recall
* Quality Objectives and Business Performance
* In the News
* Training Courses


ASQ Audit and Quality Management Division Conference  Oct 10-11, 2013 Tucson, AZ.  We are a Conference Sponsor and Exhibitor.



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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.  

Stakeholder Feedback: ISO 9001:2015 Draft Released

The next revision to ISO 9001, currently planned for late 2015, has reached the committee draft stage in the international standards development process     


The United States Technical Advisory Group to ISO TC176, the group responsible for developing consensus positions on ISO 9001, is currently collecting additional feedback from stakeholders as it continues its work on a national view. Please note that the committee draft is still an early stage in the development process, not a mature stage for public enquiry. Therefore, all comments will be collected, evaluated, and submitted under Technical Advisory Group 176. 


What to submit to submit to TAG 176. 


In order for your feedback to be considered, please use the ISO Comment Template (download at ASQ website knowledge center). Reference the line of text on which you are commenting and offer solutions.


General comments are sought on the following issues:

  • After reviewing ISO/CD 9001 (document SC2/N1147), do you agree that the concept of “Exclusions” (e.g., see ISO 9001:2008, clause 1.2) is now redundant, and that requirements for this no longer need to be maintained in the next edition of ISO 9001?
  • After reviewing ISO/CD 9001 (document SC2/N1147), do you agree that the next edition of ISO 9001 should use the term “goods and services” instead of the term “product”?
  • After reviewing ISO/CD 9001 (document SC2/N1147), do you agree that the next edition of ISO 9001 should use the term “improvement” instead of the term “continual improvement”?

How to submit comments.

Please include the following information in your submission: name, company name, industry type, size of business. 

Provide your comments on the ISO Comment Template and send them to no later than July 21, 2013.


ISO has released the Committee Draft (CD) of ISO 9001:2015 for voting and comments from its member nations.  The Draft Document can be downloaded here.  Keep in mind this is just a Draft Document, not the approved standard.

What is the Committee Draft stage?

The Committee Draft stage is the first consultation in the development (or revision) of an ISO standard. During this stage, the countries (ISO members) that have chosen to participate in the development of the standard have between two and four months to form a national position on the draft and comment on it. Some members may decide to get input from the public to help form this national position, but this is not the official public comment stage.

What happens next?

Once the national positions have been submitted, the standard revision process follows its course. Experts (nominated by the ISO member in the participating countries) continue to meet to discuss any problems or questions highlighted, until a Draft International Standard is published. The draft then goes out for public comment. Anyone who is interested can contact their national member body with feedback on the draft standard. This is likely to take place during the first half of 2014.

Once the draft has been finalized and accepted, it is published and the date following the standard’s number is updated (for example ISO 9001:2015).


I am using ISO 9001:2008. What does this means for me?


The goal is to publish the new version of ISO 9001:2008 by the end of 2015.  At that point there will be a transition period (usually two years) before ISO 9001:2008 officially becomes out of date.


Product Safety and Recall         


Two new International Standards for product safety and recall will help reduce the risk of a consumer being injured by unsafe or dangerous products.

ISO 10377:2013, Consumer product safety — Guidelines for suppliers

ISO 10377 provides practical guidance to suppliers on assessing and managing the safety of consumer products, including effective documentation of risk assessment and risk management to meet applicable requirements.

ISO 10377:2013 describes how to:

  • identify, assess, reduce or eliminate hazards
  • manage risks by reducing them to tolerable levels
  • provide consumers with hazard warnings or instructions essential to the safe use or disposal of consumer products


ISO 10377 can be purchased from the ANSI webstore.

ISO 10393:2013, Consumer product recall — Guidelines for suppliers

ISO 10393 provides practical guidance to suppliers on consumer product recalls and other corrective actions after the product has left the manufacturing facility. Other corrective actions include, but are not limited to, refunds, retrofit, repair, replacement, disposal, and public notification.

ISO 10393 will help organizations plan and execute timely and cost-effective recall programs, minimize legal risks, protect consumers from unsafe or dangerous products, and build customer satisfaction and loyalty.

ISO 10393 can be purchased from the ANSI webstore.


Quality Objectives and Business Performance          


Are you having a difficult time identifying quality objectives for your organization? Think about your business.

According to ISO 9000:2009, 3.2.5, a quality objective is something sought or aimed for, related to quality. ISO 9001:2008, 5.4.1, states your quality objectives must be measurable and consistent with the quality policy.   


Clause 5.3 of ISO 9001:2008 says your quality policy is a framework for establishing quality objectives. It also says that the policy must include a commitment to 1) comply with requirements, and 2) continually improve the effectiveness of the quality management system. Using the quality policy as a framework, you would have a quality objective to measure the degree to which requirements are being met, as well as, a quality objective that measures the results of the quality management system.

If your quality policy identifies other important areas, for example, product reliability, you would be expected to have another measurable target for product reliability.  ISO 9001:2008, clause 8.2.1, says a required performance measure is for customer satisfaction. Remember, goals are conditions to be achieved in the future. They should be defined consistent with your vision and mission. Goals are established to guide your decisions and actions. They don’t change as much as objectives. Your objectives must involve measurable results to achieve your goals.


Objectives are focused on critical issues and milestones. They describe the activities and targets to achieve your goals. They even identify the dates for completing the activities. They are measurable in terms of being achieved, or not. For example, a general goal might be to reduce waste. The related, specific objective might be to reduce rework from 10% to 5% by the end of 2013.

Depending on your industry, you might consider quality objectives such as:

  • Scrap Rate = Product Rejects / Products Produced
  • Return Rate = Products Returned / Products Shipped
  • Complaint Rate = Received Complaints /Total Customers
  • Design Stability = Change Requests / Product Releases
  • Service Quality = Defective Transactions / Total Transactions

Be careful how you set these objectives and how you communicate them. You might find people actually manipulating processes to achieve the desired results, especially if the numbers are used to evaluate employee performance. When handled poorly, performance targets can result in internal competition and a lack of cooperation. In fact, a specific process objective can be optimized at the expense of overall system performance.


If a target is perceived as arbitrary, and set beyond the capability of the process, it may lead to employee frustration, reduced morale, and even lower performance. Individuals must feel they have some control over the outcome for an objective to actually promote improvement. The objectives should help monitor and control the processes, not the people.


In the News      
Kirin Manufacturing achieves ISO 9001:2008 Certification
Congratulations to our client, Kirin Manufacturing for achieving ISO 9001 certification. Kirin Manufacturing produces high-quality, affordable, custom metal and machined products for over 15 years. For more information about Kirin Manufacturing and its capabilities visit the company website.  
SME Looks to the Future   


The Society of Manufacturing Engineers one of the manufacturing industry’s most prolific and trusted sources of knowledge and information, has announced several strategic changes to unify the organization and provide greater value to stakeholders across manufacturing. “SME is focused on serving manufacturing enterprises, employees and education. It is our manufacturing engineering roots, experience and expertise that uniquely qualifies us to do this,” stated SME President Dennis Bray, PhD, FSME. 


SME is rolling out its new brand throughout the remainder of the year at its tradeshows, conferences and other events, advertising in trade publications, a new website and marketing materials.


View the new SME website and improved content.

Is Your email Stressing You Out?    



A unique study by Loughborough University has found a direct link between workplace stress and email use.


The findings show a direct link between email and stress and indicate that employees were more prone to increased stress when reading and sending emails, and less susceptible when retrieving and filing email messages. This was indicated not only by raised cortisol levels, but also increased blood pressure and heart rate.


The research also found that employees were glad to receive new email for timely information, in response and in gratification for work complete. However, they were particularly annoyed to receive new email when irrelevant, an immediate response was required or when it interrupted and distracted them from their work tasks. The participants in their diaries also raised a number of adverse effects of email use, such as increased expectations, misinterpretation, alienation and blame culture.

But as Researcher Tom Jackson explains, email is not the enemy. “Over the years email has been the focus of many research studies and is sometimes portrayed as a bad communication medium,” he adds.

“Indeed, this study has shown that email causes stress when compared to having email free time. However, if email is compared to other ways of communicating-which was also observed in this study-email is no worse than any other media. Multitasking email alongside other communication media, such as phone and face-to-face meetings, increases the risk of becoming stressed.


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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