All posts by Jane Boler

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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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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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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Workshop to Address Medical Device Regulatory Changes

TÜV SÜD will host a…

TÜV SÜD will host a workshop in March to help manufacturers understand the changing medical device regulatory landscape as a result of the upcoming overhaul of the European Union’s Medical Device Regulation and Approval Process (MDR).

The 2017 MDR Workshop will take place on March 13 at the Kimpton Palomar Hotel in San Diego, California. It will be led by Dr. Bassil Akra, TÜV SÜD’s global director of clinical centers of excellence,

Dr. Akra has a distinguished career in research and development, quality management, and regulatory affairs. He is deeply involved with the development of the EU’s guidance and standards in his capacity as a member of the working group on clinical investigation and evaluation.

Other speakers at the workshop will include Dr. Matthias Fink, Dr. Gerold Labek, and Dr. Yuan Li of TÜV SÜD.

The focus of the workshop will be the regulatory requirements surrounding complex Class III medical devices, such as orthopedics, implants, and those used in contact with the spinal column. Devices previously certified on an equivalence basis and without a significant amount of clinical data may not be certified under the new rules.

Overall, the MDR calls for increased standards for clinical evidence, more intensive documentation, an expansion of the scope of covered devices, and the implementation of unique device identification codes for better tracking of potential defects.

Registration for the workshop will open at 1:30 p.m. PST and the workshop will run from 2:00 p.m. to 6:00 p.m. A group reception and networking buffet will follow. Click here for more information on the workshop.

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ISO 45001 Publication On Track

The working group responsible for…

The working group responsible for developing the new ISO 45001 occupational health and safety standard—ISO/PC 283/WG1—met in Vienna in early February to address the changes submitted to the DIS version of the proposed standard.

At the meeting the working group reviewed comments received after it met in Lithuania last November—during which the committee approved the text for the second draft international standard (DIS2) stage for the majority of clauses 4 to 10.

Based on the progress of the working group, the timeline for the publication of ISO 45001 publication is expected to be:

  • February 2017—Editing and preparation of the DIS2 (previously March 2017)
  • March 2017—DIS2 to be released for translation (previously April/May 2017)
  • May 2017—DIS2 ballot to be held (previously June/July 2017)
  • July 2017—Results of the DIS2 vote and comments to be shared
  • September 2017—PC283 and WG1 to meet to review the results of the DIS2 ballot

The next working group meeting will be held September 18–23 in Malacca, Malaysia. At this meeting, the results of the DIS2 ballot and resulting comments will be reviewed to determine the next steps in the development process.

If the DIS2 is approved and a final draft international standard (FDIS) stage is not required, publication could be as early as October or November this year. If an FDIS is required, the publication of ISO 45001 is likely to be March 2018.

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New Standard for LNG-Fueled Ships

As the use of liquefied…

As the use of liquefied natural gas (LNG)-fueled vessels increases globally, a new ISO standard aims to standardize LNG bunkering operations at the international level and ensure these vessels bunker in a safe and sustainable way.

LNG bunkering involves fuel being transferred from a given distribution source to an LNG-fueled ship. The process involves participation from stakeholders including from the ship-side, LNG supplier, ports, safety personnel, and administrations.

In recent years, ships and vessels fuelled by LNG have become larger, transit greater distances, and bunker in a greater number of ports in different countries. As a result, the number of parties involved in LNG bunkering is growing rapidly. Standardizing safety practices has become necessary to ensure that—regardless of where the bunkering takes place—there is a common set of globally understood requirements—from LNG provider to ship personnel.

ISO 20519, Ships and marine technology – Specification for bunkering of liquefied natural gas fueled vessels, will help operators select vessel fuel providers that meet defined safety and fuel quality standards.

ISO 20519:2017 was produced at the request of the International Maritime Organization, the European Commission, and the Baltic and International Maritime Council. The new standard contains requirements not covered by the IGC Code—the prevailing international code for the safe carriage by sea of liquefied gases in bulk. The standard includes the following items:

  • Hardware: liquid and vapor transfer systems
  • Operational procedures
  • Requirement for the LNG provider to provide an LNG bunker delivery note
  • Training and qualifications of personnel involved
  • Requirements for LNG facilities to meet applicable ISO standards and local codes

Steve O’Malley, chair of technical committee ISO/TC 8, Ships and marine technology, subcommittee SC 11, Intermodal and short sea shipping, and convener of the working group that developed the standard said “The requirements of ISO 20519 can be incorporated as a management objective into existing management programs and provide verifiable compliance.”

O’Malley says this is important because “the requirement to comply with ISO standards is often incorporated into business contracts and may also be referenced by local regulations.”

As the use of LNG as a vessel fuel is relatively new, the standard will need to be updated periodically to incorporate lessons learned over time and as technology changes. To facilitate this, a group has been created to track LNG bunkering incidents and help identify when the standard should be updated.

Click here for more information on ISO 20519:2017.

 

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Speakers Announced For ASQ Lean Six Sigma Conference

A Massachusetts Institute of Technology…

A Massachusetts Institute of Technology senior lecturer, a motivational speaker, and a communications consultant are among the confirmed keynote presenters at the ASQ Lean and Six Sigma Conference.

Attendees of the conference to be held on February 27 and 28 at the Pointe Hilton Tapatio Cliffs Resort in Phoenix, Arizona, will learn about topics including doing more with less, lean and Six Sigma fundamentals and implementation, and sustaining results. The conference will offer more than 40 sessions on topics including sustaining results from projects to transformation, implementation of lean and Six Sigma, building a successful lean Six Sigma organization, and selling lean and Six Sigma.

Keynote speakers include:

  • Steven Spear—senior lecturer at Massachusetts Institute of Technology’s management and engineering schools, and author of The High Velocity Edge.
  • Thom Singer—author of 12 books on the power of business development and entrepreneurship. Singer has experience working in sales, marketing, and business development for Fortune 500 companies.
  • Jacob Stoller—author of The Lean CEO, a book that features interviews with CEOs who have implemented lean management organization wide. Stoller specializes in the communication between experts and outsiders in areas including information technology, accounting, and engineering.

Other confirmed presenters include Jim Benson—pioneer in applying lean and kanban to knowledge work, and Tonianne DeMaria Barry­—co-founder of Kaizen Camp and Modus Institute. Benson and Barry will co-present. Together, the pair have helped the United Nations, The World Bank, Starbucks, JPMorgan Chase, and others create cultures of continuous improvement.

Click here to view the full program, session descriptions, and to register for the ASQ Lean and Six Sigma Conference.

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Event Highlights Medical Device Regulations and Standardization Processes

Last month the Standards Alliance…

Last month the Standards Alliance teamed up with the National Institute of Quality and the ASTM Latin America Office for phase two of the Peru Workshop on Medical Devices Regulations and Standards: Policy and Technical Aspects in Lima, Peru.

The Standards Alliance is a public-private partnership between the American National Standards Institute and the U.S. Agency for International Development, and is focused on implementing of the WTO TBT Agreement in developing countries.

The event—held on January 24 and 25—was a follow-up to the first medical devices workshop held in November 2015 and focused on the implementation of medical devices quality management systems, quality control, and technical training on biological test methods.

More than 55 Peruvian participants representing the private and public sector attended the workshop. Representatives who provided the U.S. perspective included Dr. Terry Woods from the U.S. Food and Drug Administration, Dr. Spiro J. Megremis from the American Dental Association, Brian Berg from Boston Scientific, Dawn A. Lissy from Empirical Technologies, Stephen Spiegelberg from Cambridge Polymer Group, and ANSI International Policy Manager Jessica Roop.

The National Institute of Quality, Medicines, Supplies and Drugs, the Ministry of Foreign Trade and Tourism, National Institute of Health, and Peru Compras provided Peruvian viewpoints and feedback.

The workshop addressed key topics including:

  • Medical device regulations, standards, and conformity assessments in the United States and Peru with a focus on eliminating unnecessary barriers to trade.
  • Best practices in forging regulations and the use of standards for medical technology products.
  • Health and safety issues including level of risk classifications for medical devices and the effectiveness of standards in supporting these objectives.
  • Technical standards in public purchases and the challenges of medical device quality control.
  • ASTM International’s standardization processes, technical committees and material test methods for assessing and evaluating the performance of orthopedic and cardiovascular devices and test methods for analytical testing and assessing device cleanliness.
  • Inter-laboratory testing and the evolution of dentistry standards.

Click here to view the presentations from the workshop.

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TÜV SÜD Acquires Advanced Compliance Solutions

Provider of testing, auditing, inspection…

Provider of testing, auditing, inspection and certification, training, and consultancy services, TÜV SÜD, has acquired the assets of Advanced Compliance Solutions Inc. (ACS).

ACS was co-founded in 2001 by brothers Scott and Michael Proffitt and partner Sam Wismer. Together they set out to reduce compliance-testing burdens for manufacturers and streamline the approval process. By providing flexible solutions, ACS maintain a strong focus on customer service, making them an ideal partner for TÜV SÜD.

All five ACS testing facilities in Georgia, Florida, and North Carolina are now part of the TÜV SÜD America organization. The combined organization now serves as a premier provider of testing and certification services for EMC, wireless, product safety, Energy Star, and other quality and performance evaluations.

This union of people, equipment and locations greatly expands the reach and capabilities of TÜV SÜD in the southeast United States.

TÜV SÜD Director of Sales and Business Development Doug Hughes said they are excited to welcome ACS to the TÜV SÜD family.

“They have been one of the most respected and successful service providers in the industry for more than 15 years,” Hughes said. “The integration of ACS into TÜV SÜD demonstrates our continued dedication to growth and excellence in the United States. In addition to anchoring our safety certification and EMC capabilities in the Southeast, it greatly expands our wireless testing and certification portfolio.”

ACS Co-founder and President Scott Proffitt said “if you surround yourself with good people who are the best at what they do, you’ll have a team that is ready to tackle any challenge and overcome any obstacle.

“Our long relationship as a partner lab has strengthened the synergies between our team and the like-minded staff at TÜV SÜD,” Proffitt said.

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