All posts by Jane Boler

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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Report Reveals Experience of ISO 9001 Market Surveillance

A new report from the…

A new report from the United Nations Industrial Development Organization presents good practices in applying market surveillance methodology to monitor the effectiveness of ISO 9001 certification in manufacturing enterprises and evaluate the performance of respective accredited certification bodies.

“Good practices: Experience in the Market Surveillance of ISO 9001 quality management systems” concludes that the proper use of ISO 9001–based quality management systems assists developing countries in promoting sustainable trade—thereby helping them achieve inclusive and sustainable industrial development and the 2030 development agenda.

The case studies mentioned in the report show that market surveillance methodology can be used or adapted as an effective tool in other regions and contexts—and for other management systems.
Click here to view a full copy of the report.

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ASQ to Recognize Fellows for Their Contribution to Quality

ASQ recently named 18 members…

ASQ recently named 18 members as fellows in recognition of their achievements and contributions to the advancement of quality. Fellow membership status is awarded to ASQ members in good standing and who meet the following criteria:

  • Hold at least 15 years of quality-related experience.
  • Meet requirements across six professional categories.
  • Are sponsored by peers and endorsed by their ASQ section or division.
  • Have been a senior member for five years or longer.

ASQ Chair Eric Hayler said ASQ Fellows are leaders in the quality community, working to improve their organizations and the communities in which they live.

“These are individuals who dedicate their time and expertise to make the world a better place,” Hayler said.

The new fellows will be honored at a ceremony at ASQ’s World Conference on Quality and Improvement to be held May 1 – 3 in Charlotte, N.C., USA. The new ASQ fellows are:

Eric Alden, Xerox Corp., Canandaigua, N.Y. — For outstanding contributions in measurement, design of experiment and reliability modeling techniques; Six Sigma coaching; developing and teaching workforce development courses; developing and sharing data analysis techniques using Pivot Table and statistical software; utilizing multivariate analysis to improve hospital board knowledge, and leadership in the ASQ Rochester Section.

David Dewayne Butler, TI Automotive, Auburn Hills, Mich. — For outstanding leadership in advancing quality tools and methodologies in supplier quality development in the automotive industry facilitated by the Automotive Industry Action Group and direct supplier leadership; and long-term support of ASQ at the divisional level with impact on quality professions through talks, papers, and teaching.

Rajeev Chadha, National Research Council of Canada, Edmonton, Alberta, Canada — For outstanding contributions to the professional quality movement in Canada and meritorious achievements in the application of Lean Six Sigma, quality and continuous improvement technologies in the Canadian mining industry.

Julie Furst-Bowe, Chippewa Valley Technical College, Eau Claire, Wis. — For numerous contributions in the application of quality improvement principles and practices in the higher education sector and numerous contributions to the field of quality improvement in education though presentations, publications and leadership roles in ASQ and other professional organizations dedicated to achieving and maintaining educational excellence.

Vinay Goyal, Abbott Laboratories, Fullerton, Calif. — For exceptional contributions in developing, promoting and inspiring the advancement of quality and safety practices across diverse industries including medical, commercial, aerospace, and defense organizations. For developing innovative applications of quality methods, educating through mentoring and academia, and continuing to support ASQ and external organizations as a contributor and leader.

Michael Hamada, Los Alamos National Lab, Los Alamos, N.M. — For significant research contributions in the design and analysis of experiments, measurement system assessment and reliability; leadership in interdisciplinary collaborations to improve the practice of science for national security; and dedicated service to the practice of quality.

Bart Hamilton, Consultant, Akron, Ohio — For outstanding leadership in quality education within ASQ and academia for more than 50 years, professional competence in quality management in the tire industry, and mentoring the ASQ Akron-Canton Section and industry in education and training of quality principles.

Michael Kent Hart, Consultant, Kanata, Ontario, Canada — For inspirational leadership of his section’s achievements in their journey to excellence, outstanding contributions to process improvement theory and application, and professional competence in quality management and organizational excellence.

James Miller, Roche, Muncie, Ind. — For outstanding leadership in quality education activities at ASQ, at university and in business; devoted section leadership; and professional competence in quality management within the consumer electronics industry and medical diagnostics industry.

Mark Neal, Global Quality Systems, Prosper, Texas — For significant contributions to the quality profession in quality principles, reliability, safety/risk management and process improvement used in high reliability, safety-critical, and embedded systems. For exceptional long-term corporate leadership in the application of quality principles in products to save or improve lives, and contributions to the ASQ Software Division.

Owen Ramsay, Lloyd’s Register Quality Assurance, Laurelton, N.Y. — For outstanding contributions in advancing process understanding and deployment of Lean Six Sigma rapid improvement methodology initiatives; planned and spontaneous talks at ASQ-sponsored events and other technical forums; and promoting and influencing the expansion of diversity within ASQ and non-ASQ leadership communities.

Abbas Saghaei, Azad University, Tehran, Iran — For effective training of students at universities and professionals across multiple industries, implementing quality practices across organizations that deliver quantifiable financial benefits, outstanding contributions to the quality movement in Iran, and significant research and publications at a national and international level.

Donald Singer, GlaxoSmithKline Pharmaceuticals, Phoenixville, Pa. — For sharing expertise and knowledge in speeches, articles and books for the betterment of society with respect to pharmaceuticals, serving ASQ Quality Press as a committee chair for 35 years, and willingness to help others when needed.

Nicholas Skovran, Quality Horizons LLC, Pittsburgh, Pa. — For outstanding contributions advancing quality practices in health care and other industries, leadership in organizing and delivering quality education and improvement programs from introductory to highly advanced levels, and devoted leadership and support of the ASQ Pittsburgh Section.

Jennifer Joy Stepniowski, Pro QC International, Tampa, Fla. — For drive and passion in raising the voice of quality, in addition to the ongoing dedication to developing and instructing quality education accessible to all, and continuous support of local section activities and management excellence via a demonstration of professional competence in quality across industries and global cultures.

Sandra Storli, Zimmer Biomet, Gurnee, Ill. — In recognition of 30 years of quality-related experience supporting highly regulated organizations with quality systems, clinical trials and regulatory affairs compliance; and activities within the quality community including the ASQ Northeastern Illinois Section, ASQ Food, Drug and Cosmetic Division, ASQ Audit Division, and ASQ Learning Offerings.

William Taraszewski, Meda Pharmaceuticals, Decatur, Ill. — For outstanding leadership in quality management in the pharmaceutical industry, devoted section leadership, and career-long professional development in pharmaceutical analysis.

Rajesh Kumar Tyagi, Telfer School of Management, University of Ottawa, Kirkland, Quebec, Canada — In recognition of continuing leadership in advancing and promoting quality principles in academia and the service industry, tireless efforts to teach and promote the development and benefits of process improvements and service scorecards to an international audience, and participation in national and local conferences.

 

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ISO/IEC 27004 to Measure Information Security Effectiveness

Newly updated ISO/IEC 27004:2016, Information technology – Security…

Newly updated ISO/IEC 27004:2016, Information technology – Security techniques – Information security management – Monitoring, measurement, analysis and evaluation, provides guidance on how to assess the performance of information security management system standard ISO/IEC 27001.

ISO/IEC 27004:2016 explains how to develop and operate measurement processes, while also assessing and reporting the results of a set of information security metrics.

Replacing the 2009 edition of the standard, ISO/IEC 27004:2016 has been updated and extended to align with the revised version of ISO/IEC 27001 to provide organizations increased value and confidence.

Edward Humphreys, convenor of the working group that developed the standard,  said cyber attacks are among the greatest risks an organization can face.

“This is why the much improved version of ISO/IEC 27004 provides essential and practical support to the many organizations that are implementing ISO/IEC 27001 to protect themselves from the growing diversity of security attacks that business is facing today,” Humphreys said.

ISO/IEC 27004:2016 details how to construct an information security measurement program, select what to measure, and operate the necessary measurement processes. The standard also includes examples of different types of measures, and how to assess their effectiveness.

Benefits of implementing ISO/IEC 27004 include:

  • Increased accountability
  • Improved information security performance and ISMS processes
  • Evidence of meeting the requirements of ISO/IEC 27001, applicable laws, rules, and regulations

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Feedback Sought on International Consumer Product Information Guide

The American National Standards Institute (ANSI) is…

The American National Standards Institute (ANSI) is seeking feedback on the latest revision of ISO/IEC Guide 14, Product Information for Consumers.

ISO/IEC Guide 14 provides general principles intended to make it easier for consumers to effectively compare products or services before buying them. The primary purpose of the guide is to advise those responsible for drafting national or international standards what information prospective purchasers require and expect. Additionally, the guide may assist those who write purchase information, such as suppliers, as well as enforcement authorities.

Although the draft guide doesn’t address conformity assessment, it does include the following changes from the second edition:

  • An improved scope and introduction
  • Inclusion of new purchase information labeling tools
  • Relationship with ISO/IEC Guide 37, Instructions for use of consumer products and ISO/IEC Guide 41, Consumer needs in packaging
  • Consideration of vulnerable persons’ product information needs
  • Addition of information on recycling and used goods
  • Improved treatment of risk, sustainability, and privacy issues
  • Addition of new clauses on performance and conditions of use and dependability considerations
  • Deletion of purchase information bodies and purchase information systems

Click here to view the draft of ISO/IEC Guide 14 on Product Information for Consumers. 

Relevant stakeholders are invited to send comments on the draft by close of business January 6 to ANSI Senior Director of International Policy Steven Cornish at scornish@ansi.org.

Based on the input received, the ANSI ISO Council will be asked to approve an ANSI position and submit its comments to ISO before its April 7 deadline.

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