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.
The post UN Report Examines Credibility of Management Systems Certification appeared first on The Auditor.
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.”
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.”
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 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.
2017 is ISO’s 70th anniversary! The ISO story began in 1946 when delegates from 25 countries gathered in London to discuss the future of standardization. A year later, on 23 February 1947, ISO officially came into existence. In this post-war era, the founding members saw international standards as a key to the world’s reconstruction efforts.
Back in 1947, the purpose of the fledgling organization was to facilitate the coordination and unification of standards developed by its member bodies, all of which were national standardization entities in their respective countries. The founders decided that the organization would be open to every country wanting to collaborate with equal rights and equal duties.
These founding principles still hold true today and the ISO family has blossomed to include 163* members from almost every country in the world. Standardization has come a long way and ISO International Standards, which now cover almost all aspects of technology and business, will continue to ensure positive change in an evolving world.
The first steps
Following the creation of the organization, 67 groups of experts (called technical committees) were set up in specific technical fields such as screw threads, marine technology, food, textiles, paints and laboratory equipment with a mandate to develop International Standards. This led to the birth, in 1951, of the first ISO standard (called “Recommendations” at the time) –ISO/R 1:1951, Standard reference temperature for industrial length measurements. Since then, the ISO portfolio has expanded to include over 22 000 standards supporting all the important technological, environmental and social changes that have taken place in the world.
“For 70 years, ISO has made standards that have shaped our history and accompanied the world’s greatest innovations. From the standardization of materials, components and equipment for the aerospace or automotive industry to the measurement of environmental pollutants, from establishing a management system to ensure food safety in the supply chain to creating guidelines for human-robot interaction, the need for international standardization has always evolved with the needs of industry and society,” says ISO President Dr. Zhang Xiaogang.
Expanding the community
ISO has worked hard over the years to broaden its circle of stakeholders, bringing different audiences to standardization, such as consumers or developing countries. The 1950s saw a number of new ISO member bodies join the organization from the developing world. To respond to these members’ needs, ISO set up in 1961 the ISO Committee for developing country matters (ISO/DEVCO), which helps them get the most out of standards development work. Today, three-quarters of ISO’s members are from developing countries.
Helping to improve the satisfaction and safety of consumers is another vital role of standards. Integrating their views in standards development is therefore essential because these real-life perspectives help ensure that issues such as safety and quality are adequately addressed. The importance of consumer leverage was endorsed by the creation, in 1978, of a Council Committee on Consumer Policy, now officially known as the ISO Committee on consumer policy (ISO/COPOLCO), to promote and encourage consumer interests in standards.
Effective and wide-reaching stakeholder engagement is essential in maintaining the relevance of International Standards. To ensure a strong relationship between standards and innovation, ISO has built collaborative ties with a network of global and regional organizations, including a partnership with the International Electrotechnical Commission (IEC) and the International Telecommunication Union (ITU), and has forged links with over 700 international organizations working in fields related to standardization. Furthermore, the contribution of large and small businesses, regulatory authorities and governments throughout the world is fundamental to the proper functioning of ISO.
Challenges for the future
“For the past 70 years, ISO has developed standards that drive industrial progress, promote global commerce and improve health, safety and the environment. But this is just the beginning,” says Dr. Zhang.
“Looking to the future, it is clear that our world faces many challenges that cut across national borders. Climate change, water scarcity, cyber security and large-scale migration are just some of the issues we face today that require integrated, international action.”
Many of these challenges have been included in the 17 Sustainable Development Goals (SDGs) adopted by the United Nations as part of their 2030 Agenda for Sustainable Development. Launched in 2015, the SDGs set ambitious targets for the next 15 years and will help concentrate international action to end poverty, protect the planet and ensure prosperity for all.
“The ISO community has many standards that can help organizations and companies address this agenda,” says Dr. Zhang. “We are ready to provide efficient tools to help the different communities worldwide face up to these challenges and shape a better world.”
The future of standardization is promising.
This article has been republished in full with permission from ISO.