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ISO 50001 Revision Moves To Committee Draft 3 Stage

The revision of ISO 50001…

The revision of ISO 50001 for Energy Management Systems (EnMS) continues to progress with the latest draft, Committee Draft 3 (CD3), issued on February 3 and circulated by ISO Technical Committee ISO/TC 301.

Established to help organizations improve energy performance and cut energy costs, ISO 50001 offers a systematic approach to improve energy performance over time through the use of an EnMS. Successful implementation of an EnMS in an organization requires a cultural change and commitment from all levels and functions, especially top management.

Since its release six years ago ISO 50001 has become increasingly important. According to ISO, 11,985 ISO 50001 certificates were issued by the end of 2015, and the number of certificates increased by 77 percent during that year according to ISO’s global survey.

Based on discussions during the ISO/TC 301 meeting held in Paris in January, the revised ISO 50001 standard is likely to be published in January 2019. It will incorporate the high level structure and common text from Annex SL.

Based on current information, the expected timeline for the revision of ISO 50001 is as follows:

  • May/June 2017: Working Group 1 to meet in Beijing, China to generate a draft international standard (DIS), taking into account comments from the CD3.
  • July 2017: DIS to be submitted to ISO for launch of enquiry.
  • February 2018: TC 301 secretary to issue DIS ballot result and associated public comments.
  • June 2018: TC 301 WG1 to meet in Mexico to consider DIS comments.
  • July 18, 2018: final draft international standard to be submitted to ISO for launch of eight week FDIS ballot period.
  • January 19, 2019: ISO to publish ISO 50001:2019.

Comments on the ISO 50001 CD3 must be compiled and returned to ISO within the eight week comment window.

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UN Report Examines Credibility of Management Systems Certification

While market surveillance is a…

While market surveillance is a well-known concept in a regulatory context, a similar approach has been shown to be effective when applied to the voluntary certification of quality management systems, according to a recent report by the United Nations Industrial Development Organization.

In a series of articles, The Auditor Online will share highlights from the “Good Practices: Experience in the Market Surveillance of ISO 9001 Quality Management Systems” report, which presents the case for accreditation bodies or stakeholders completing market surveillance visits to certified organizations to ensure the quality of their products or services.

According to the report, user feedback on the performance of ISO 9001-certified suppliers and the accredited certification process reveals ongoing debate around the effectiveness and credibility of accredited certification.

The debate centers on whether organizations are deriving tangible benefits through ISO 9001 certification, if the certification process is being performed effectively, and whether ISO 9001-certified suppliers can be relied upon to provide “consistent, conforming products and services” to customers.

Systematic feedback was gathered between 2009 and 2015 from purchases regarding their perceptions of ISO 9001-certified suppliers, and from ISO 9001-certified organizations about the implementation and certification process. Feedback was gathered through a survey and a market surveillance activity which involved one-day visits to certified organizations. These visits aimed to determine confidence levels related to various aspects of the organization’s quality management system and the overall level of confidence in the certification process.

To reflect their confidence level in organizations being examined, assessors assigned the following grades:

  • Grade One: “Little or no confidence.” Little or no evidence to support the implementation of this topic.
  • Grade Two: “Some evidence presented, but not at all convincing.” Some evidence was presented, but in the professional judgement of the assessor, there would probably be evidence to support a nonconformity if a detailed audit trail were to be followed in a full system audit.
  • Grade Three: “OK—No reason to doubt that this is being addressed correctly.” The “default” grade, where there is no evidence to suggest reasons for concern, based on the assessor’s experience and professional judgement.
  • Grade Four: “Clear evidence that this is being done, and meets the intent of the relevant standard.” Sufficient objective evidence provided a high degree of confidence that the organization meets requirements.
  • Grade Five: “We can be proud to use this organization as a benchmark for this topic.” To be reserved for truly excellent performance.

A key finding was that there were notable differences in the performance and level of confidence in organizations certified by different certification bodies and under accreditation from different accreditation bodies. Other findings included:

  • More than 95 percent of certified organizations surveyed considered the effective implementation and accredited certification of quality management systems to have been a “good” or “very good” investment.
  • Overall perception of the ISO 9001 standard and accredited certification was good, although the role of accreditation wasn’t well understood by purchases or certified organizations.
  • The purchasers surveyed were mainly satisfied with the performance of their ISO 9001-certified suppliers. In general, ISO 9001-certified suppliers performed “better” or “much better” than non-certified suppliers. However, poor responsiveness of certified organizations to customer complaints was one area of concern.

Overall, the performance of the certified organizations that were visited was good, which demonstrates the effectiveness of the accredited certification process. However, between six and eight percent of organizations returned unsatisfactory results, and one percent raised serious doubts about the validity of their certification—which calls into question the effectiveness of the certification process.

According to the report, market surveillance activities can be used in place of traditional accreditation methodologies such as office assessments and witnessed audits to investigate complaints or concerns.

Market surveillance can also uncover trends, strengths, and weaknesses in the implementation of quality management systems in particular regions or sectors—all of which is useful information for certification bodies to focus their attention on during surveillance and renewal audits.

To give the data context, the report describes independent third-party certification as a common method sought by organizations to demonstrate that they have met all the requirements of ISO 9001. The certification consists of a certificate of conformity and ongoing surveillance to ensure that the system is maintained in accordance with the standard.

To demonstrate competence to administer management system certification, a certification body may become accredited by an accreditation body. This accreditation is based on the requirements defined in ISO/IEC 17021-1 and is supplemented by other discipline-specific or sector-specific requirements in some cases.

Continue to read The Auditor Online in the coming weeks for more findings from the “Good Practices: Experience in the Market Surveillance of ISO 9001 Quality Management Systems” report.

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ASQ Survey: Quality Improvement Methods Could Help to Reduce Waste, Debt

Only eight percent of government…

Only eight percent of government workers believe the U.S. federal government is running efficiently, adding that shifting priorities and fears of job loss pose major obstacles to making improvements, according to a recent ASQ survey.

In January, ASQ surveyed its members and customers who work in a diverse range of government sectors including defence, health care, military, transportation, finance, and agriculture.

Thirty-one percent of survey respondents said shifting strategies, goals, and priorities are the biggest challenge to implementing quality improvement methods in the federal government.

Other survey highlights included:

  • 19 percent said the biggest hurdle is overcoming organizational fears about the impact of cost-cutting on jobs and project funding.
  • 14 percent cited the greatest challenge as a lack of awareness about quality methods like Lean Six Sigma and how they can benefit the organization.
  • 12 percent said the biggest challenge is viewing quality improvement as a temporary trend.

“The federal government has a great opportunity with the application of quality tools reduce waste and, as a direct result, decrease the burden on the taxpayers,” said Mark Abrams, chair of ASQ’s Government Division.

“Quality tools have proven successful in a variety of sectors including manufacturing and health care, and can be used at all levels of government to increase operational efficiencies and improve taxpayer experiences.”

In addition to noting challenges with the federal government’s structure, survey participants ranked quality improvement tools they see as having the biggest potential for reducing federal waste. Seventy-six percent said lean would provide the greatest benefit to increasing efficiency, followed by Lean Six Sigma at 71 percent, and Six Sigma at 48 percent.

Quality tools such as Lean Six Sigma have been highlighted by past U.S. presidential candidates as a tool for reducing waste and improving efficiency in federal government. Of those surveyed, 42 percent have implemented Lean Six Sigma in their organization. Of these 42 percent, more than 86 percent said it’s been somewhat, very, or extremely efficient.

Federal Government Agencies That Need the Most Help

Fifty-eight percent of respondents ranked infrastructure as the area federal government could most benefit from reducing waste and cutting costs. Furthermore, 55 percent of respondents said Health and Human Services and National Defense would best benefit from quality tools, followed by Immigrations and Customs at 54 percent, and Homeland Security at 53 percent.

First Steps in Ensuring Success with Quality Methods

Possible first steps suggested by respondents for government to effectively implement quality tools like lean and Six Sigma, include:

  • Generate a stronger commitment from management/leaders and integrate into performance standards.
  • Present clearly defined goals and use selected quality tools to implement processes.
  • Provide training for key members of the administration and government agency management teams.
  • Educate government officials at various levels on the quality tools available and techniques that can be applied to their specific situations.
  • Mandate the use of selected quality tools and give them time to work instead of quickly switching to the latest “great” thing.

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Baldrige Foundation to Expand Awards Program

  The Baldrige Foundation is…


The Baldrige Foundation is expanding its leadership awards program with the establishment of the E. David Spong Lifetime Achievement Award.

The first recipient of the award is its namesake: Dr. E. David Spong.

“This new award recognizes an individual who has performed truly extraordinary service and created a lasting legacy which will inspire future generations of leaders” says Al Farber, Foundation president and CEO.

Dr. Spong has been a Baldrige practitioner and advocate throughout his career, and is a two-time recipient of the Baldrige National Quality Award. He led the Boeing Airlift and Tanker Programs to the 1998 award in manufacturing, and in 2003, he led Boeing’s Aerospace Support division to the Baldrige Award in the service sector.

“I am thrilled to lend my name to this award, but the Baldrige Enterprise is the real champion,” says Dr. Spong. “Baldrige recipients serve as role model organizations for everyone else to emulate. Through Baldrige, ‘best practice’ becomes documented, data driven, evidence-based examples of performance excellence. These examples reach every sector of the economy—manufacturing, small business, service, health care, education, the nonprofit sector and government, and beginning last year, cybersecurity. Baldrige is a recipe for first-class performance.”

“David’s career spans over five decades and encompasses many, varied leadership roles,” continues Faber. “At every step David has been a champion of the Baldrige Framework and the Baldrige Enterprise. The Baldrige Foundation is honored to present this award to him, and future leaders who embody his lifetime commitment to quality.”


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Auditor Profile: Inspired to Improve Food Safety

With more than 35 years…

With more than 35 years experience in the food industry in roles such as kitchenhand, caterer, and auditor, Marjorie Harvey is somewhat of a food safety expert. The Auditor speaks to Harvey to learn how she has channeled her passion for the food industry into a successful food safety auditing and consulting career.

Harvey began her career in the food industry peeling potatoes in a local pub and then as a trade cook. She later went on to own a catering business, manage food services in aged care, and teach hospitality.

After witnessing unsanitary food handling practices and seeing reports of food poisoning outbreaks in the media, Harvey was inspired to improve food safety through designing food safety programs. Her interest in auditing soon followed.

“Food sites had no food handling policies, monitoring records, or food safety systems,” Harvey said. “I enrolled in university so I could learn more about the Food Act and food safety standards to become an accredited trainer and auditor.”

Harvey’s university studies included learning about HACCP, ISO standards, food technology, and auditing. Here, she gained the necessary skills to become the first female third-party food safety auditor for the Department of Human Services in Victoria, Australia. Harvey then went on to establish Australian Food Hygiene Services—an accredited company offering consulting, training, and auditing for the hospitality industry.

Working predominantly in the health care sector, Harvey’s role as director involves auditing, training, writing food safety programs, and consulting.

Throughout her career, Harvey has designed and implemented more than 800 food safety programs for hospitals, aged care facilities, child care sites, and Meals on Wheels. She continues to offer her services to restaurants, hotels, cafés, community services, government bodies, and prisons.

Harvey reflects on highlights of her career as including assisting the industry in all aspects of food safety management and compliance.

“It has been a privilege to work in areas that are high risk and to have the opportunity to assist clients with gaining compliance, and offering an opportunity for continual improvement if they request.”

However the job has its challenges—particularly in regards to travel and the demands of report writing. Getting a start in the industry also isn’t easy.

“From the start it was very challenging as no one had experienced an audit,” Harvey said. “But as time goes by it has become less challenging as most understand the requirements expected from an audit.

“It is also challenging to keep up with new equipment, changed food processes, and current trends.”

Harvey believes a lack of mentoring opportunities and incentives for seasoned auditors to assist new auditors are key issues in the profession, and suggests the following solution:

“Attending relevant industry conferences and auditor forums to ensure they keep abreast with the current requirements.”

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e-Auditing: A Matter of Context

by Shauna Wilson In my…

by Shauna Wilson

In my travels, I am learning from others that some third-party registrars are not accepting internal audits that are conducted virtually. This growing concern over auditing methods is the antithesis of modern work environments. Obviously, a virtual audit is conducted for a remote office, in which most of the time, teams are working together online to communicate and resolve issues. Shouldn’t the audit method replicate the actual working environment? In this article, I will examine e-auditing validation criteria, the use of the context of the organization, and conclude by reviewing other opportunities gained using e-auditing methods.

An e-audit is a systematic, independent, and documented process to obtain evidence through electronic means to determine the extent of conformity to the audit criteria.  The use of e-auditing is increasing because so much of the technology we use in our daily lives—connecting with friends on Skype, finding jobs through LinkedIn, or attending online classes—is done over the Internet. These activities become a gateway to enhancing and applying online communication techniques. The more familiar we become with technology, the less anxious we feel about its interactive uses.

Validating an e-audit relies on the technology used and the auditor’s skill to facilitate a virtual meeting while coordinating with the remote location to find nonconforming evidence. This coordination of events is not an easy task without technical grounding in information technology and facilitation skills. Realistically speaking, a fair amount of registration auditors are limited in this area due to their intense travel schedules. At best, they are passive listeners in “all hands” online meetings. This is not a reason to stop conducting internal audits virtually. Note that ISO 9001:2015 itself and its requirement to understand the context of the organization seems to be a tacit endorsement of the e-auditing process.

ISO 9001:2015 provides an illustration of how complex businesses have become to compete in a global market to offer affordable products. For example, products that contain batteries often make headlines. We can no longer carry a Samsung Note 7 on an airplane or fly with a motorized skateboard. Let’s examine a fictional scenario to apply the “context of the organization” requirement with e-auditing methods.

Battery ABC Co. is a research and development laboratory that designs and manufactures lithium batteries in a small but powerful format, enabling longer charges and lighter cell phones, tablets, and watches. Battery ABC Co. relies on external providers to manufacture its batteries.  Based on the following strengths-weaknesses-threats-opportunities (SWOT) analysis, what internal audit plan does the company’s management team need to mitigate both internal and external issues to meet the needs and requirements of all parties?



In this scenario, management should consider a hybrid audit model. This would incorporate multiple verification methods: onsite audits, e-audits, document information reviews, and product testing to understand the supply chain quality management system. An audit plan should include design and development, the release of product at remote locations, and external provider reviews to ensure manufacturing processes are managed appropriately. External provider reviews could include line yields and defect Pareto charts, process e-audits, and product testing by a third-party lab to ensure the battery meets product specifications and regulatory requirements.

A hybrid audit model approach is necessary for organizations of this nature to completely verify internal and external issues and that interested parties’ needs and requirements are met. The following chart shows an example of a hybrid audit management plan.

e-Auditing: A Matter of Context

e-auditing is an efficient and effective method for risk-based thinking, working with external providers to ensure process controls are in place, reviewing product-related issues real time, and enhancing understanding among all interested parties. Companies that invest in e-auditing allow remote locations to learn from one another. They gain a better understanding of remote processes and can leverage and standardize common processes across distant locations.  Rather than refuse e-auditing methods, training to use technology while facilitating an audit should be a priority of internal and external auditors.

 About the author

Shauna Wilson is president at Amazon Consulting Inc. She is a performance management consultant who designs efficient and effective quality systems. Wilson is an IRCA-certified auditor and leading expert in remote auditing. She holds a Master’s degree in performance management technologies/instructional design.  Wilson wrote InterneTeaming.com: Tools to Create High Performance Remote Teams and co-authored eAuditing Fundamentals: Virtual Communication and Remote Auditing and has been featured in Quality Progress and ASTD’s InfoLine.  Wilson is the education/social responsibility chair at ASQ’s Portland, Oregon Section 607 and currently serves as the U.S. TAG expert for PC/TAG 302 ISO 19011 auditing management systems.

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CEO Blog: We’re Listening!

Talking with our customers, certified auditors, engineers, and training providers, it is clear that the world we work in is continually changing. When many of us started our careers 20 to 30 years ago, everything seemed straightforward. We needed auditor qualifications to demonstrate that we were qualified and competent. As…

bainesTalking with our customers, certified auditors, engineers, and training providers, it is clear that the world we work in is continually changing. When many of us started our careers 20 to 30 years ago, everything seemed straightforward. We needed auditor qualifications to demonstrate that we were qualified and competent. As we extended to a wider range of audit programs, or schemes, we extended the qualifications. Since then, much has changed. We have people starting their careers, through to those retiring, but recognize that those retirees still want to be involved in some capacity. It is important that we listen to the needs of all of our customers from young people at the start of careers, to those diversifying, to those whose reputation is well established. We need to also be sure we add value to all stages. This is our mission. With this in mind, we have a number of initiatives we are following.

Auditor registration is an attractive career path for many. ASQ Certified Quality Auditors (CQA) have already expressed an aptitude for audit and so we are offering Exemplar Global certification to those already CQA qualified. If this is of interest, please contact us. A similar initiative for Certified Quality Engineers is being developed. Both of these reflect the “whole of career” service that both ASQ and Exemplar Global aim to provide.

Recently, Exemplar Global released an ISO 13485 Medical Devices Auditor scheme. Previously a scope of the quality management system scheme, the launch of this scheme reflects a response to a need from customers who specialize in this important sector.

For many years Exemplar Global has offered a Provisional Auditor scheme for those just starting and maybe do not yet have the experience to become fully qualified auditors. Until now, there has been a limit to the time you could remain “provisional.” However, recognizing that many value the qualification but do not have that experience, we have decided that Provisional Auditor status can be retained. Naturally, we still encourage everyone who can to upgrade to fully registered auditor status to demonstrate their qualification and experience.

Finally, for now, we are updating our iNARTE schemes to ensure we continue to add value to this important group of customers.

At Exemplar Global, we are listening to our customers and wider group of stakeholders. Please let us know your feedback.

Revised ISO 31000 DIS Seeks to Simplify Risk Management

The revision of ISO 31000:2009, Risk management –…

The revision of ISO 31000:2009, Risk management – Principles and guidelines has progressed to Draft International Standard (DIS) stage, with the draft now available for public comment.

ISO 31000 provides guidelines on the benefits and values of effective and efficient risk management and aims to help organizations to better understand and address uncertainties.

The revision seeks to simplify the standard using simple language to make risk management easy to understand. To do so, the terminology of ISO 31000 has been reduced to simple concepts and some terms have been moved to ISO Guide 73, Risk management – Vocabulary, which deals specifically with risk management terminology. This is intended to be read alongside ISO 31000.

Jason Brown, chair of ISO technical committee ISO/TC 262, Risk management, that developed the standard said, “The message our group would like to pass on to the reader of the DIS is to critically assess if the current draft can provide the guidance required while remaining relevant to all organizations in all countries.

“It is important to keep in mind that we are not drafting an American or European standard, a public or financial services standard, but much rather a generic international standard,” Brown said.

The draft also includes improvements such as the importance of human and cultural factors in achieving an organization’s objectives and an emphasis on ingraining risk management in the decision-making process. Despite these changes, the overall message of ISO 31000 of integrating the management of risk into a strategic and operational management system remains the same.

The next step in the process is to finalize the revision work to reach the Final Draft International Standard stage. The finalized version of ISO 31000 is expected to be published by the end of the year or early 2018.

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Revised ISO 44001 Standard to Aid Business Collaboration

A new standard has been…

A new standard has been published to help businesses collaborate with other organizations or individuals.

ISO 44001, Collaborative business relationship management systems  Requirements and framework, aims to assist companies to establish and improve collaborative relationships, both within and between organizations.

The standard provides the overall components of a management system for business relationships as well as operational process requirements.

ISO 44001 follows the common high-level structure, making it easier for anyone using multiple management systems. The standard also features an eight-stage life cycle to ensure sustainable relations, including operational awareness, value creation, knowledge, internal assessment, partner selection, working together, staying together, and exit strategies.

The standard was developed by ISO project committee ISO/PC 286, Collaborative business relationship management – Framework. ISO/PC 286 Secretary Mick Maghar said the standard is applicable to both private and public organizations of all sizes.

“ISO 44001 can be used on many different levels, from a single project or one-to-one partnership to multiple partner alliances across the whole organization,” Maghar said. “It will help businesses to work better together, maximize the benefits of their stakeholder relationships and support their sustainability.”

Click here for more information about ISO 44001:2017.

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