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What to Expect From the ISO 19011 Revision

By Elisabeth Thaller This year…

By Elisabeth Thaller

This year the International Organization for Standardization (ISO) approved a project to revise ISO 19011:2011—Guidelines for auditing management systems. ISO Project Committee PC 302 was established with experts from numerous countries to revise the standard. The first of four plenary meetings was held during the second week of November in Orlando, Florida.

While it is too soon to say exactly what the new revision of ISO 19011 will look like, here is a brief overview of the most relevant topics that were discussed at the first meeting.

Terms and definitions: ISO 19011 isn’t a management system standard, therefore it’s not required to use the same terminology as other standards. However, it was decided that it’s in the interest of users of the standard that the terms and definitions be aligned with the high-level structure in Annex SL of the ISO directives. One example is the use of the term “documented information,” which will be integrated in ISO 19011 whenever possible.

Risk and risk-based thinking: The committee decided that it’s not necessary to include a new section about risk. However, the concepts of risk and opportunities will be included throughout the standard as applicable.

Remote auditing: The main idea and argument to justify the need to include remote auditing in the revision was that some companies only exist virtually, or that some or all information may not be stored in a physical location. The committee decided that an audit is an audit, no matter where it’s completed. Therefore, there are different tools and methods that can be used—remote auditing being one of them.

Small and medium enterprises (SME): It was determined that it’s not necessary to include a specific section regarding SMEs because the language used in the standard should be generic enough to apply to any type of organization and audit. If any specific guidance is needed for SMEs, it may be included within an annex or notes.

Audit team competence: ISO 19011 and ISO 17021 are compatible and will remain this way. There will be some changes to reflect current challenges regarding auditor and audit team competence—in particular in relation to risk, combined audits, and auditing clauses 4.1, 4.2, and 4.3 of the high-level structure, along with remote auditing.

In summary, we can expect the revision of ISO 19011 to be better aligned with the terminology, business practices, and audit needs of current times. The revision will incorporate concepts such as risk-based thinking and remote auditing, and will also include updated terminology and auditor competence requirements. This will provide a contemporary approach to complex organizational structures and audits.

About the author

Elisabeth Thaller has provided management system consulting, auditing, and training for the past 20 years. During this time, Thaller has coached private and government organizations on the implementation of diverse management system and conformity assessment standards, including ISO 17024 and ISO 17021.

As a contracted evaluator with Exemplar Global, Thaller has performed training provider and course certification audits in the US, Europe, Mexico, and South America.

Thaller is a member of the US TAG to ISO/PC 302 Guidelines for auditing management systems and is actively involved in the current review of ISO 19011. Thaller previously participated in the ISO/TC 176 STTG (ISO 9001:2015), ISO/TC 207 STTF (ISO 14001:2015), and ISO/CASCO/STTF (ISO 17021:2015).

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Awards Program to Promote ISO 50001

An awards program has been…

An awards program has been created to recognize organizations that are transforming their businesses through ISO 50001, which applies to energy management systems certification.

The Energy Management Leadership Awards program was established by The Clean Energy Ministerial (CEM)—a global forum consisting of 24 countries and the European Commission.

The awards aim to raise global awareness of the benefits of energy management and accelerate uptake of the management system to support corporate, national, and global climate goals.

Industrial, commercial, and public-sector companies or facilities that hold a valid, third-party-verified ISO 50001 certificate are eligible to enter. To enter, organizations are required to submit a case study that describes their energy management experience and the benefits of doing so. The entries will be evaluated by an independent panel of international experts.

The winning organizations will be recognized in 2017 during the Clean Energy Ministerial meeting in China, which will host energy ministers and corporate leaders from around the world.

Each organization to submit a qualifying entry will receive an Energy Management Insight Award for helping to build global insight on the benefits of energy management systems. The top-ranking submissions from each country will also be shared with the appropriate governments.

Click here to learn more about the CEM Energy Management Leadership Awards. The deadline for submissions is January 24, 2017.

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New ISO Technical Specification to Improve Animal Welfare

New ISO technical specification ISO/TS 34700:2016, Animal welfare…

New ISO technical specification ISO/TS 34700:2016, Animal welfare management – General requirements and guidance for organizations in the food supply chain aims to ensure the welfare of farm animals across the supply chain.

ISO/TS 34700 will help the food and feed industry develop an animal welfare plan that aligns with the principles of the World Organization of Animal Health (OIE) Terrestrial Animal Health Code (TAHC). The standard is the culmination of a joint effort between ISO and the OIE following the signing of a cooperation agreement in 2011.

The technical specification intends to support the implementation of relevant practices to ensure animal welfare in livestock production systems, and will allow business operators in the food supply chain to demonstrate their commitment to animal welfare management.

The working group in charge of developing ISO/TS 34700, ISO/TC 34 WG 16, comprised more than 130 experts representing all regions of the world. The group included strong participation from developing countries and a range of stakeholders including private sectors, competent authorities, and nongovernmental organizations.

Dr. François Gary, convenor of ISO/TC 34 WG 16,  said the first beneficiaries of ISO/TS 34700 will be business operators in the animal production food chain including farmers, livestock transport companies, and slaughterhouses.

“By creating a common vocabulary and a common approach to animal welfare management, this ISO technical specification will improve the needed dialogue between suppliers and customers within the food supply chain, especially between primary production and processing operators,” Gary said. “This will be a business-to-business tool.”

ISO/TS 34700 will serve as a helpful tool for the private sector and competent authorities alike to clear up discrepancies in the regulatory framework. Retailers, consumers, and NGOs with an interest in animal welfare protection will be indirect beneficiaries of ISO/TS 34700 as business operators demonstrate their animal welfare commitment.

OIE Director General Dr. Monique Eloit said ISO/TS 34700 will provide an important framework to support the implementation of the OIE’s international standards for animal welfare around the world.

“Consistent implementation of humane and ethical rearing conditions for animals provides certainty for farmers and producers, and confidence for consumers,” Eloit said.

ISO/TS 34700 will undergo systematic review in three years.

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Revision of Core Aerospace Standards Complete

The International Aerospace Quality Group…

The International Aerospace Quality Group (IAQG) has published AS9110:2016 and AS9120:2016, completing the revision of the core aerospace standards.

AS9110 Aerospace Management System for Maintenance, Repair and Overhaul Stations outlines specific requirements that are significant for the maintenance of commercial, private, and military aircraft. AS9110 certification provides an additional layer of control, but does not replace regulatory oversight or customer monitoring.

AS9120 Aerospace Management Systems for Stockist Distributors addresses the chain of custody, traceability, control, and availability of records. AS9120 is applicable to organizations that resell, distribute, and warehouse aircraft parts and other aerospace components.

To drive effective operations in increasingly complex environments, the revision of these standards incorporates the essential changes made to ISO 9001:2015 and additional aerospace, space, and defense stakeholder requirements.

Updates to the AS9100 standards are designed to:

  • Link to the latest version of ISO 9001.
  • Adapt to a changing world.
  • Enhance the ability of an organization to satisfy its customers.
  • Create a consistent foundation for the future.
  • Reflect the increasingly complex environments in which organizations operate.
  • Ensure the standards reflect the needs of all interested parties.
  • Integrate with other management systems.

Organizations currently certified to AS9100, AS9110, or AS9120 will need to successfully transition to the relevant 2016 revision by September 2018.

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2016 Baldrige Winners Announced

The winners of the 2016…

The winners of the 2016 Malcom Baldrige National Quality Award comprise two small businesses and two health care organizations.
The award—which is the United States’ highest presidential honor for sustainable excellence through visionary leadership, organizational alignment, systemic improvement, and innovation—represents four states. This includes the first award recipient from Idaho and four distinctly different operations, including the first winner from the long-term care and rehabilitation field, and the first award recipient from the textile industry since 1989.
The 2016 Baldrige Award recipients—listed with their category—are:

  • Momentum Group of Irvine, California (small business)
  • Kindred Nursing and Rehabilitation Center- Mountain Valley, of Kellogg, Idaho (health care)
  • Memorial Hermann Sugar Land Hospital of Sugar Land, Texas (health care)
  • Don Chalmers Ford of Rio Rancho, New Mexico (small business)

“This year’s honorees are trailblazers in innovation, small business, health care, and sustainable textiles,” says Penny Pritzker, U.S. Commerce Secretary. “Their visionary leadership is helping to power the economy and increase our ability to compete globally. The Commerce Department proudly supports these four outstanding organizations for their unwavering commitment to performance excellence and their dedication to always reaching higher.”
The Commerce Department’s National Institute of Standards and Technology (NIST) manages the Baldrige Award in cooperation with the private sector. An independent board of examiners recommended this year’s Baldrige Award recipients from a field of 34 applicants after evaluating them in the Baldrige Excellence Framework: leadership; strategy; customers; measurement, analysis, and knowledge management, work force, operations; and results. There are six categories for the award: manufacturing, service, small business, health care, education, and nonprofit (including government agencies).
Achievements by the 2016 Baldrige Award winners include:

  • New employees at Don Chalmers Ford (DCF) are mentored by senior leaders and work with the general manager using the firm’s “How I Connect” guide that aligns each individual’s role to the company’s core values and to delivering the “DCF Experience.” This has helped increase the retention rate of sales consultants from 56.3 percent in 2011 to 71.4 percent in 2015, and increase gross profit by 13 percent for 2012-2015. Both marks are significantly higher than the national averages of 26 percent and 8.4 percent, respectively.
  • In support of its core value of “bettering the world around us,” Momentum Group was the first in its industry to offer a full textile product line of reduced environmental impact fabrics. In just over two decades, Momentum Group’s sales have grown more than 400 percent and have outperformed the industry for 19 years out of the 22 that the firm has been in business.
  • For seven consecutive years, Kindred Nursing and Rehabilitation Center—Mountain Valley has achieved a five-star quality rating—the highest possible—from the Centers for Medicare and Medicaid, a ranking designed to help potential residents, families, and caregivers compare nursing homes. Less than one percent of 15,600 skilled nursing facilities nationwide received the five-star rating over that period of time.
  • Memorial Hermann Sugar Land Hospital ranks among the top 10 percent nationally for a number of performance metrics, including emergency center arrival-to-discharge time, compliance with regulations to reduce medication errors, bed turnaround times, radiology and laboratory result turnaround times, and the use of computerized physician order entry.




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ISO 14034 to Expand the Reach of Green Technology

Newly published ISO 14034:2016, Environmental management – Environmental…

Newly published ISO 14034:2016, Environmental management – Environmental technology verification (ETV) aims to help companies developing innovative environmental technologies reach new markets.

ISO 14034 provides independent verification of the performance of new environmental technologies to help manufacturers prove that their performance claims are reliable. The standard also aims to help technology purchasers identify innovations that suit their needs.

ISO 14034 features specific sections on verification principles, accepted testing practices, and reporting requirements.

Benefits of ISO 14034 include:

  • Creating a level playing field for technological innovators.
  • Promoting harmony in the ETV process across international boundaries.
  • Providing a credible, independent assessment of environmental technologies.
  • Enabling informed decision making when identifying and selecting suitable technologies.
  • Achieving sustainable environmental targets.

Benoit Desforges, convenor of the working group responsible for the development of ISO 14034, shared insight into the new standard in an interview with ISO.

“New environmental technologies can make a significant difference in terms of resource and cost savings, but often face serious market obstacles because they are innovations which, by definition, are not yet able to demonstrate a successful track record,” Desforges told ISO. “ETV aims to change this by providing verified evidence to confirm the performance claim of the environmental technology and differentiate the innovation from other competing technologies.”

Desforges said ISO 14034 will first and foremost be used to inform independent verifiers on how to conduct quality-assured verification of an environmental technology.

“ETV helps technology vendors provide objective and trustful data on the performance of an innovative environmental technology,” Desforges told ISO. “For technology buyers and investors, ETV is a reliable source of information on which to base purchasing decisions and better manage technology and investment risks. Finally, ETV provides policy makers, regulators and other stakeholders with clear information on the performance achievable by new environmental technologies.”

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Anti-Bribery Standard Aims to Reduce Business Risk and Liability

Newly published ISO 37001:2016, Anti-Bribery Management…

Newly published ISO 37001:2016, Anti-Bribery Management Systems—Requirements with guidance for use, intends to help organizations of all sizes combat bribery risk within their own operations and global value chains.

Designed by global businesses and stakeholders to emphasize operations and a risk-based approach, ISO 37001 specifies the requirements and provides guidance on how to establish, implement, maintain, review, and improve an anti-bribery management system. The system can either be stand-alone or integrated into an overall management system.

ISO 37001 addresses the following in relation to an organization’s activities:

  • Bribery in the public, private, and nonprofit sectors
  • Bribery by the organization
  • Bribery by the organization’s personnel acting on the organization’s behalf or for its benefit
  • Bribery by the organization’s business associates acting on the organization’s behalf or for its benefit
  • Bribery of the organization
  • Bribery of the organization’s personnel in relation to the organization’s activities
  • Bribery of the organization’s business associates in relation to the organization’s activities
  • Direct and indirect bribery (e.g., a bribe offered or accepted through or by a third party)

While ISO 37001 has the potential to reduce corporate risk, it does not specifically address fraud, cartels, anti-trust/competition offenses, money laundering, or other activities related to corrupt practices. However, organizations can choose to extend the scope of the management system to include these activities.

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ISO and SAE International to Develop Technical Standards for Road Vehicles and Intelligent Vehicle Systems

ISO and SAE International have…

ISO and SAE International have announced a pilot agreement to jointly develop new technical standards and harmonize existing standards. The new Partnership Standards Development Organization cooperation agreement will apply in two areas — Road Vehicles (ISO TC 22) and Intelligent Transportation Systems (ISO TC 204).

SAE International is a global association of engineers and technical experts in the aerospace, automotive, and commercial-vehicle industries. SAE International Chief Executive Officer David L. Schutt said the agreement is in response to the transformational changes taking place in many global industries, including mobility engineering.

“Increasing technological complexity must be addressed through collaborative efforts in standardization to avoid duplication and reduce cost across the global network of automotive business partners,” Schutt said. “We look forward to a successful collaboration with ISO.”

Standards highlighted for joint development include those related to wireless charging, vehicle interoperability, automated vehicle level definition, and automotive cybersecurity. The development of these standards will consider both SAE and ISO processes for balloting and approval.

In addition, the resulting standards will benefit from the combined expertise of ISO and SAE, and will optimize stakeholder resources, making the standards more effective and relevant to the market.

ISO Acting Secretary-General Kevin McKinley said ISO aims to bring together experts to share knowledge and develop market relevant international standards to provide solutions to global challenges.

“Collaborating with standards development organizations in specific industries can only help to achieve this aim,” McKinley said.

The agreement was approved by the respective governing bodies of ISO and SAE in consultation with ANSI, the ISO national member body where SAE has its legal seat.


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Toy Safety Standard Updated

One of the world’s most…

One of the world’s most widely used toy safety standards has been revised and published as F963-16: Standard Consumer Safety Specification for Toy Safety.

Leading experts in and advocates for toy safety collaborated for five years to complete the revision.

“We identified existing parts of the 2011 standard that needed clarification, updating, or alignment,” said ASTM member Joan Lawrence, senior vice president, standards and regulatory affairs, Toy Industry Association Inc., and chair of the Subcommittee on Toy Safety F15.22. “We also looked at potential emerging safety issues, new product features and new ways that toys are being used that may pose a risk to children.”

Lawrence said F15.22 recognizes the importance of its role in protecting children and continually looks to ensure that the standard supports safety and reflects the latest information on risk.

The updated standard includes the following changes:

  • New requirements on battery safety
  • Soaking and compression tests for magnets
  • Changes to requirements for toys that involve projectiles
  • New requirements for materials and toys that could expand if accidentally swallowed
  • New requirements and clarifications related to microbiological safety
  • Clarifications to requirements related to heavy elements in the substrate materials of toys and the addition of an optional, alternate test method for total screen testing
  • A new curb impact requirement, clarification of overload and stability requirements, and a strap exemption for ride-on toys
  • Clarification of requirements and supplemental guidance for impact hazards

F963 is used by manufacturers, importers, and retailers to design and sell products that comply with laws such as the U.S. Consumer Product Safety Act and the Consumer Product Safety Improvement Act, which mandates that all toys comply with the standard. The standard is also used by regulatory bodies and testing laboratories.

F963 was created in 1986 by ASTM International Committee on Consumer Products (F15), and is the modern edition of the world’s first comprehensive safety standard, which dates back to 1976.

Click here for further information on F963.

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ANAB and ABFT Enter Strategic Alliance

The ANSI-ASQ National Accreditation Board…

The ANSI-ASQ National Accreditation Board (ANAB) and the American Board of Forensic Toxicology (ABFT) have formed a strategic alliance that will see ANAB administer the ABFT accreditation program on behalf of the ABFT.

The ABFT establishes and enhances voluntary standards for forensic toxicology and the examination and recognition of scientists and laboratories that provide forensic toxicology services.

Although the ABFT laboratory accreditation program will remain unchanged, all forensic toxicology laboratories accredited by the ABFT or seeking ABFT accreditation will now have an avenue to become accredited to ANAB’s forensic testing program based on ISO/IEC 17025, the international standard for testing laboratories. Each laboratory accredited by ANAB and ASCLD/LAB will have the opportunity to add the ABFT Laboratory Accreditation Standard to its scope of accreditation.

Under the new alliance, ABFT laboratory inspectors will continue to conduct inspections for ABFT’s current laboratory accreditation program. ABFT laboratory inspectors and ANAB-ASCLD/LAB toxicology assessors will receive training to conduct ANAB assessments that include the ABFT Laboratory Accreditation Standard.

The ABFT has had an accreditation program for forensic toxicology laboratories involved in postmortem toxicology and human performance testing for 19 years. The board currently accredits 40 laboratories. ANAB-ASCLD/LAB has been accrediting forensic toxicology laboratories for more than 30 years. The ANAB-ABFT alliance will combine the resources of both programs to provide the highest quality accreditation services available in postmortem and human performance forensic toxicology.

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