Certification Transition Deadline


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Our newsletters provide information on business management systems and process improvement methods. These systems, our services 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. Further subjects include methods of performance improvement such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.


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Certification Transition Deadline
Close up on a file tab with the word ISO 9001 focus on the main text and blur effect. Concept image for illustration of Quality Standards

September 2018- the deadline for transition to ISO 9001:2015 and other QMS Standards – is here now!

Most of us are willing to claim we experienced some angst with the transition and time period over the last three years. This also included the transition certification body process of wondering do we have it right, and am I going to lose our certification?  Relax, we are not aware of any company that has not been successful with transitioning to various standards. However, common nonconformance threads do exist and have been communicated throughout our industry.


Let’s dive into what are the common nonconformity issues written by certification body auditors based on our investigation, and other feedback we have received.


Section 4 – Not addressing the new requirement to identify and define internal and external interested parties. Also, not looking comprehensively and beyond the common repeatable parties of interest such as customers, management, suppliers and employees.


Section 6 – One of the sub-sections is defining change management. Auditors found that this is not effectively implemented. Another problem is the evaluation of risk. ISO 9001:2015 requires an organizational risk and opportunities evaluation. Internal and external issues missing from the evaluation. This included lack of specific actions to address, and lack of evidence on how the actions were evaluated.


Section 7 – Infrastructure and work environment needs, and the method of determining those needs has been a recurring issue for many years. Not taking the proper time to conduct a comprehensive analysis based on your company product and service needs can result in missed requirements. New to ISO 9001 is the organization’s need to improve their organizational knowledge. This can be through the capture of best practices and lessons learned. Auditors have cited organizations with quality systems that did not effectively capture knowledge.
On-going findings include document control and records retention not effective. An example is training records not effectively addressed and retained.

Section 8 – Receiving inspection was cited as not always effective and the process for approving vendors and disqualifying vendors not defined. Additional common findings included non-conforming material areas not clearly defined or material not identified. Also, formal production change control, and the authorization of change, including necessary actions. Nonconforming outputs – much more than just nonconforming product issues now.

Section 9 – Auditors found lack of training records for ISO 9001:2015 internal auditor training. Management review records that did not address the mitigation of risk or actions taken. Findings also included management reviews that used the prior standard agenda, missing new input requirements. Under AS9100D – risks identified as a new management review meeting output was found missing.


Section 10 – This new section pulls together two subjects – non-conforming material and corrective action. Nothing different – organizations have had to address non-conforming material and corrective action for years. A new issue in the new standard is the addition here of customer complaint language. Auditors found customer complaint logs maintained, but decisions regarding disposition or corrective action not defined or documented. Additionally, corrective action follow-ups were not documented all the time.

Hopefully this information has given you insight into processes you may want to investigate for further improvement. Remember, your CB Auditor will be back.

Have examples beyond these you would like to share with us for communicating to our readers? As always, all responses will remain anonymous.  Let us know!


Quality Plans Guidance Updated

In order to effectively transform business ideas into actions, you need a plan. A quality plan. Guidance on how to create one has just been updated, providing a powerful tool to complement any operational and quality management system, including ISO 9001 and others.


Producing something – whether it be a product, service, process or project – always involves a series of interconnected or complementary processes and tasks that have to be performed, and planning them effectively in advance often leads to better results. A quality plan helps organizations do just that, as it includes a specification of the actions, responsibilities and associated resources that are needed to achieve the desired outcomes.


It is useful as it describes how an organization will actually go about producing the product or service and how these actions can have an impact on other processes or parts of the business.  It is a particularly useful tool for validating new products, services or processes before the work begins and for demonstrating to stakeholders how their requirements are going to be met.


ISO 10005:2018, Quality management – Guidelines for Quality  Plans, gives guidelines for establishing and applying quality plans, and it has just been updated to provide more guidance and more examples to be relevant to organizations of all shapes and sizes.  Roy Ackema, Leader of the working group that updated the standard, said that while it is not essential to have in place ISO 9001, ISO’s flagship standard for quality management systems, in order to benefit from the guidance of ISO 10005, the two standards are based on many of the same concepts and principles, making them highly complementary to each other.

“ISO 10005 was updated to reflect modern business practices,” he said. This includes improvements to the terminology and concepts as described in the 2015 version of ISO 9001, such as those related to addressing the needs and expectations of relevant parties and managing organizational knowledge.”

“It also offers more guidance on how to apply risk-based thinking to decide the processes, resources and methods to be used.”

You can purchase ISO 10005:2018, Quality management – Guidelines for Quality Plans at the TechStreet Store.


Improving Customer Satisfaction

We all know that our customers are the primary reason for our successful companies, including our jobs. We also know that retaining loyal, happy customers is the key to any successful business, but the fickle consumer world is not always easy to please. A series of guidelines has just been published, bringing together international best practice on customer satisfaction.


From handling complaints to service with a smile, taking care of customers is a science in itself and one not to be taken lightly as it can have a dramatic effect on both staff morale and the bottom line. Studies abound that show that those companies that perform well in customer experience have higher revenues and returns on investments. Not to mention that most customers don’t go back to a company if they have a bad experience.


Getting the customer experience right, then, is imperative. A series of international standards dedicated to improving customer satisfaction has just been updated, to ensure the information is most relevant and reflects revisions to ISO’s flagship standard for quality, ISO 9001.
Stan Karapetrovic, Leader of the working group that revised the standards said they guide organizations on implementing effective systems to improve customer satisfaction.
“These guidelines were revised simultaneously, aligning both with ISO 9001 and with each other,” he said. “While each of the standards can be efficiently implemented by themselves, their integrated application is very effective as well.”
These standards are:

ISO 10001, Quality management – Customer satisfaction – Guidelines for codes of conduct for organizations.

ISO 10002, Quality management – Customer satisfaction – Guidelines for complaints handling in organizations.
ISO 10003, Quality management – Customer satisfaction – Guidelines for dispute resolution external to organizations.
ISO 10004, Quality management – Customer satisfaction – Guidelines for monitoring and measuring.
You can purchase these standards at the TechStreet Store.



In the News
Global Employee Confidence in Business Conditions 

The business confidence index, which measures employees’ confidence in near-term business conditions and long-term economic prospects in their industry, registered at the highest levels in five years. In addition, key regions surveyed as part of this report – Asia, North America, Europe, Australia and New Zealand, and Latin America – showed an increase in employee perceptions of job opportunities in their current locations, industries and functions.

For more information, including employee intent to remain in current positions see the Gartner Press Release.


ISO 22000:2018 Food Safety Management System   


Food safety is about the prevention, elimination and control of foodborne hazards, from the site of production to the point of consumption. Since food safety hazards may be introduced at any stage of the process, every company in the food supply chain must exercise adequate hazard controls. In fact, food safety can only be maintained through the combined efforts of all parties: governments, producers, retailers and end consumers.

Aimed at all organizations in the food and feed industries, regardless of size or sector, ISO 22000:2018, Food safety management systems – Requirements for any organization in the food chain, translates food safety management into a continuously improving process. It takes a precautionary approach to food safety by helping to identify, prevent and reduce food borne hazards in the food and feed chains.

For more information view the ISO.org News.

Training Courses
All courses can be delivered at your company or at our training centers. We do provide training beyond our home state of Arizona. Click on the course title for description, schedule, registration and payment. Group discounts are available. We also provide custom designed training to fit your specific needs. All training is fully documented for your training records and certificates of training are awarded.
Don’t see a course or schedule that fits your needs?  Contact us.

We have received some interesting feedback from our clients this year on their transition certification audit to the various standards we support. We are finding a variety of interpretations from certification body auditors in regards to requirements of standards, including the application of how the client company meets the requirement, and specific objective evidence reviewed.

Always be aware that if a nonconformance is written against your documentation and/or objective evidence, do ensure that the content of the language used in the write up by the auditor makes absolute sense to you, and your management team.  If not clear and understandable, bring it up immediately during your certification body auditor out brief, conducted at the very end of your audit process.


Walter Tighe and SES Team
Sustaining Edge Solutions, Inc.
Toll Free 888-572-9642


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