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2009-07-01: Transfer CBTL LIQ

CBTL LIQ has been transferred from NCB TUV SUD PSB Pte to NCB TUV SUD PS GmbH

2009-06-29: Medical electrical equipment and software evaluation at the heart of IECEE workshops

Milan, Italy, was the stage of two important IECEE events last April, both hosted by IMQ SpA, the IECEE’s Italian member body. The first one, on 14-15 April 2009, involved the IECEE Medical Electrical Equipment Task Force, and consisted of both a meeting and a workshop. The second event was a workshop on software evaluation which took place on 16-17 April.



Medical electrical equipment

A CAT scan, CT scan, or computerized axial tomography is a way of x-raying a mass in the body that provides three-dimensional views of the mass
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IECEE set up the IECEE Medical Electrical Equipment (MEE) Task Force in September 2007 to consider the implementation of risk management requirements in the third edition of IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. The Task Force consists of 20 members who represent various interests in the field of medical electrical equipment (industry, government agencies, certification bodies, IEC Technical Committee). The group, for which the convenor is Alfred Dolan of the University of Toronto, Canada, is responsible for:

- developing guidelines and working instructions on how to implement the relevant clauses of IEC 60601-1 in helping manufacturers demonstrate compliance with “risk management process” as set down in ISO 14971, Medical devices - Application of risk management to medical devices

- developing a checklist aimed at assisting the medical equipment industry, official authorities and stakeholders around the world in testing in the appropriate manner

- acting as an Advisory Group on the common understanding of ISO 14971 with respect to IEC 60601-1 organizing specific training sessions dealing with risk management issues.

The April meeting of the MEE Task Force was the fifth since its inception in 2007. Throughout these gatherings, the group has developed guidance and finalized Test Report Forms related to risk management. They also organized the introductory training session that took place immediately after the meeting.

About 70 representatives from CBTLs (Certification Body Testing Laboratories) attended the workshop which aimed to promote consistency among test laboratories. First it went through the risk management requirements specified in IEC 60601 and then presented the tools available to all laboratories participating in the IECEE CB Scheme.

As a result of the meeting and the workshop, a series of recommendations and proposals was laid out for approval by the IECEE CMC (Certification Management Committee) at its next meeting in June 2009. These recommendations include ongoing development of guidance for implementing the risk management process particularly as regards the content of the Risk Management File prepared by the manufacturer; the assessment of the Risk Management File; and the reporting of the assessment outcome into the relevant part of the Test Report Form.

A further outcome of the meeting and workshop was the need for additional specific training for laboratory staff, manufacturer testing laboratories, and technical assessors. The Task Force requested a specific workshop early in 2010.

The question of how to deal with collateral standards to IEC 60601-1 was also raised. In the 60601 series of publications, collateral standards specify general requirements for safety applicable to either a group of medical electrical equipment (e.g. radiological equipment) or a characteristic specific to all medical electrical equipment (e.g. electromagnetic compatibility) not fully addressed in the general standard, IEC 60601-1.

The Task Force proposed to develop guidance documents for these collaterals and made a recommendation to the CMC defining a consistent approach for the handling of assessments to collaterals.



Software evaluation

The next two days, 16-17 April, were devoted to the “Software Evaluation” workshop, a premiere for the IECEE.

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Household appliances and multimedia equipment for the home, for example, are two categories of products that rely more and more on software that may be a critical element of the product itself or may play an essential role in its safety. This trend is developing rapidly, as is the need for expertise in evaluating such products.

In its report to the CMC at the IECEE annual meetings in Jeju, Korea in 2008 (see the July 2008 e-tech), the IECEE ACAG (Assessment & Certification Advisory Group) drew attention to this issue, recognizing that IECEE technical assessors, and by extension, CBTL staff, have limited experience and skills in software evaluation. To remedy the situation, the ACAG made some recommendations to the CMC, notably to prepare guidelines and organize a workshop to help interested parties – NCBs (National Certification Bodies), CBTLs, technical assessors – acquire the skills essential to software assessment. To that end, the ACAG proposed to seek and recruit experts in that field, who could contribute and impart their knowledge by giving lectures at the workshop. The CMC approved the ACAG recommendation and a workshop was planned for April 2009.

The “Software Evaluation” workshop provided the audience with a series of presentations on all types of issues pertaining to software evaluation, and seen from different perspectives: industry, IEC TC experts, conformity assessment.

Presentations and the discussions that followed all emphasized the obvious need to harmonize views and reach a common understanding and a common practice to assist all parties in dealing with software evaluation. The general conclusion was to set up a specialized TP (Technical Panel) that could provide stakeholders with such a global approach, and thus facilitate trade. This TP would be composed of the experts who gave lectures during the workshop, joined by other leading experts in the software evaluation field, who would work closely with the IECEE’s CTL ETF 1 (Committee of Testing Laboratories’ Expert Task Force 1): Household appliances. It was further decided that all documents and guides issued by the Software Evaluation TP would have to be endorsed by the CTL prior to their submission to the CMC.

2009-05-25: IECEE and the future of Conformity Assessment

Global harmonization, health and environmental issues, together with product personalization and user-friendliness, are key concepts in the future of Conformity Assessment
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By Gösta Fredriksson, Chairman of the IECEE Certification Management Committee and President, Conformity Assessment and International Relations, Intertek

Global harmonization, health and environmental issues, together with product personalization and user-friendliness, are key concepts in the future of CA (Conformity Assessment).

Today, countries throughout the world depend on imports and exports. Yet, in spite of this globalisation, there are no worldwide rules for CA. Global harmonization of standards does not exist, and new certification programmes are continually being created for specific areas, such as the European WEEE (Waste Electrical and Electronic Equipment) and RoHS (Restriction on hazardous substances) directives. All of this affects global trade, and there is no sign of any change in the foreseeable future.

Differences in climate and power supply systems
The most practical and cost-effective situation would be if a single set of tests and a single certification allowed access to the global market. There is in fact a trend in that direction, but obstacles exist, which include climatic variations and different power supply systems. Despite this pressure to minimize divergences in standardization, progress is very slow. Different parts of the world have their own views on how standardization should be performed and their own systems of conformity assessment, testing and certification. Some have put in place compulsory systems, others are based on manufacturers’ own declarations. In addition, new standards and regulations are being developed all the time throughout the world, particularly in the fields of environment and health. In its area of activity, the IECEE (IEC’s System of Conformity Assessment Schemes for Electrotechnical Equipment and Components) is the most effective transportation system that exists for conformity assessment between different regulatory requirements.

New Fields of Focus
Health, environment and safety are perceived to be more important as the industrialized world gains in affluence. There is a growing awareness of and interest in these areas, and they will increasingly become a focus of official market surveillance. All of this intensifies demands on manufacturers, who need to differentiate themselves from other manufacturers of similar products, yet at the same time meet customer demands for safe, environmentally friendly products.

There is also a tendency to give more weight to quality certification of operations, particularly with regard to health, environment and safety. Suppliers need to be able to show that they consistently deliver what they are supposed to.

Understanding your products…and your customers
Globalization is obliging companies to think beyond their own geographical area in order to remain competitive, and they must increase their understanding of cultural and market differences. These last go far beyond legislative requirements, and it is not easy to identify them and follow a standard. Not only do customer requirements vary from market to market, but different customer groups have different demands, preferences and behaviours. This has an impact on the final product; for example, a person’s lifestyle and shopping habits influence the size and design of the refrigerator they purchase. Understanding customers’ needs and uses is essential in new product design. Third-party testing through the IECEE certification system can be more cost-effective simply by enabling the company to focus on its core business – designing competitive products.

graph operators

graph cbtcs

These two charts show the steady growth of the IECEE System

2009-04-09: State-backed International Standardization conference to take place in the Gulf

A major international conference involving the IEC, the IECEE, government officials and industry is scheduled to take place 6-8 December 2009 in Manama, Bahrain. The IECEE is the IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and Components.

The GICSE (Gulf IEC – IECEE International Conference for Standardization and Conformity Assessment in Electrotechnology) is being organized by the IEC and the IECEE in collaboration with GSO (the Gulf Cooperation Council Standardization Organization) and the Ministry of Industry and Commerce, Kingdom of Bahrain. It aims to give stakeholders a thorough overview of the role of electrotechnical standards and their application in Conformity Assessment, in protecting domestic markets from non-conforming products and in ensuring a safe environment, while providing a networking platform for representatives from trade, regulatory and government bodies in the Gulf area.

The GCC (Gulf Cooperation Council) Standardization Organization (GSO) is a financially and administratively independent entity that is concerned with standardization, conformity verification procedures, accreditation and measurements among the GCC Member States:

* The Kingdom of Saudi Arabia
* The United Arab Emirates
* The State of Bahrain
* The Sultanate of Oman
* The State of Qatar, and
* The State of Kuwait

Saudi Arabia has been a longstanding Member of the IEC, while Bahrain and Qatar joined in the past year. Saudi Arabia and the United Arab Emirates have recently joined the IECEE.

It is hoped that the conference will demonstrate some of the benefits that can accrue through endorsing IEC Standards and participating in the IECEE, thus enabling Gulf countries to play a key role in International Standardization and Conformity Assessment and become more deeply involved in health and safety issues.

At the same time, it is hoped that the conference will suggest ways for GCC Member States to search jointly for the mechanisms that conform to the World Trade Organization trade and customs agreements that are already applicable in the Gulf area.

More information on the programme of the conference and the speakers will be available closer to the actual date of the event.

photo bahrain

Bahrain, as a new IEC Member, is a fitting venue for the Gulf conference.

2009-03-17: ACAG meeting reviews IECEE assessment and certification work

The IECEE (IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and Components) ACAG (Assessment and Certification Advisory Group) met in Geneva, Switzerland, on 3 February 2009. ACAG acts as an advisory committee of the IECEE and gives support to the IECEE Executive Secretary to make recommendations to the CMC (Certification Management Committee) in the field of the peer assessment programme and the uniform understanding and application of ISO/IEC Guide 65, General requirements for bodies operating product certification systems and ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories.

The ACAG, among other assignments, is entrusted with the following tasks:

- to advise on issues related to ISO/IEC 17025 and ISO/IEC Guide 65;
- to advise on a common understanding of Operational Documents related to the IECEE Peer Assessment Programme and their revision
- to advise on issues related to cooperation with regional and international organizations operating Peer Assessment Programmes, such as ILAC (International Laboratory Accreditation Cooperation) and IAF (International Accreditation Forum)
- to support the IECEE Executive Secretary in reviewing assessment reports and other relevant information and confirm whether:
* the assessment has been conducted in a consistent and competent manner
* the information is reliable and sufficient with respect to determining the conformity of the National Certification Body/Certification Body Testing Laboratory (NCB/CBTL) with IECEE Rules, Rules of Procedures and Operational Documents
* all non-conformities have been satisfactorily addressed
- to advise on any other issue as assigned by the CMC

The meeting was spent reviewing the current situation and outcome of the various on-site assessments carried out on existing members and new candidate Testing Laboratories and Certification Bodies. The meeting also addressed specific technical issues including items that assessors are facing in their daily work. All the topics discussed by ACAG members resulted in recommendations that will have to be approved by the CMC at its next meeting in Stockholm, Sweden, in June 2009.

One of the items on the agenda dealt with the 2009 appointment of ACAG members and the mechanisms for granting necessary continuity in the specialist expertise and knowledge that builds confidence within the IECEE community and in the outside world. Beside the Officers and the IECEE Executive Secretary — who currently chairs the ACAG meetings — the other 10 are appointed by the CMC for a period of three years and are eligible immediately for a single re-appointment in the same office. The ACAG stressed the point that its members have to be employed by the IECEE member NCBs/CBTLs, be registered as IECEE Lead Assessors and willing to contribute actively and attend all ACAG meetings.

Other issues raised during the meeting included:

- the application of particular IEC International Standards to conformity assessment testing and certification
- the subcontracting of testing authorized only for main CBTLs and not for Associate CB Testing Labs
- the legal responsibility in case of lawsuit when a NCB issues a Test Certificate based on a Test Certificate previously issued by another NCB
- compliance to ISO/IEC Guide 65 and ISO/IEC 17025
- the certification of a product family
- the responsibility for certification decisions
- expenses for assessment teams in extraordinary conditions (strikes, natural disaster, etc.)
- independence of assessment teams and impartiality of Testing Laboratories

IECEE Peer Assessment Programme activities and ACAG recommendations are submitted to the CMC for formal approval/ratification. ACAG recommendations also form the basis for the on-going discussions with ILAC and IAF.

2009-02-24: Korean Member Body KATS has a new Director, Mr. Youn, Jong Ouk.

Korean Member Body KATS has a new Director, Mr. Youn, Jong Ouk.


Mr. Youn, Jong Ouk

2009-02-23: South African MB Change & South African NCB Name change

The South African Member Body has been changed from SABS to South African National Committee of the IEC
NCB SABS changed name into Accreditation Management, SABS Commercial (Pty) Ltd.

2009-02-18: Brazilian MB Change

The Brazilian Member Body has been changed from TUV RH do Brazil Ltda to COBEI - Comite Brasileiro de Electricidade, Electronica, Iluminaçao e Telecomunicaçoes

2009-02-17: MB & NCB Certif Name Change

MB & NCB CERTIF changed name into CERTIF – Associação para a Certificação

2009-01-21: Annual training for IECEE Lead Assessors

IECEE, the IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and Components, held its annual Lead Assessor training course at the Geneva International Conference Centre on 11-12 December 2008. More than 50 people from around the world took part in the two-day event.

LA Training
Over 50 people attended the Lead Assessor training course

The objective of the training course is for participants to learn about the IECEE Peer Assessment techniques and procedures, based mainly on a common understanding of ISO/IEC Guide 65, ISO/IEC 17025 as well as on Peer Assessment-specific guidelines. It also offers an opportunity to update the Lead Assessors on current issues in IECEE assessment procedures, with a view to promoting more effective and consistent assessments.

The IECEE System is a Multi Recognition Agreement of test results, within which Peer Assessment is an essential tool for building confidence among member NCBs (National Certification Bodies) and Testing Laboratories that participate in the IECEE CB Scheme (IECEE Certification Body Scheme for product test certificates) and FCS (Full Certification Scheme).

The IECEE uses Peer Assessment specifically to guarantee that all Certification Bodies and Testing Laboratories operating within the IECEE CB and FCS Schemes have an optimal knowledge of IEC International Standards and an equal level of competence to carry out testing with the agreed technique and methodology.

This year's training saw representatives from IAF (International Accreditation Forum) and ILAC (International Laboratory Accreditation Cooperation) join the list of distinguished speakers, all of whom had substantial experience in the overall conformity assessment programmes and dedicated expertise in quality management systems and product certification.

Chaired by IECEE Executive Secretary Pierre de Ruvo, the event featured the following speakers:

photo Merih Malmqvist Nilsson
Merih Malmqvist Nilsson, Chairman of ILAC AIC (Accreditation Committee) speaking on the first day of the event

- Merih Malmqvist Nilsson, Chairman of ILAC AIC (Accreditation Committee)
- Lorenzo Thione, Head of IAF delegation
- Norbert Mueller, Head of ILAC delegation
- Wolfgang Kreinberg, Chairman, IECEE Factory Inspection Committee of the IECEE
- Don Mader, Chairman, Board of Appeal of the IECEE
- Jola Wroblewska, UL (Underwriters Laboratories) - IECEE Lead Assessor
- Alberto Pederneschi, IMQ, IECEE Lead Assessor
- Ted Gaertner, KEMA, IECEE Lead Assessor
- Masahiro Sato, JET, IECEE Lead Assessor
- Joe Gryn, ULC, Chairman, CTL
- Craig Diack-Evans, Intertek, IECEE Lead Assessor
- Wolfgang Martin, OVE, IECEE Lead Assessor

photo Wolfgang Martin
IECEE Lead Assessor Wolfgang Martin OVE) during his presentation

The course also allowed technical assessors to share techniques for assessing, for example:

- application of CTL (Committee of Testing Laboratories) list of testing equipment
- concept of specialized testing facilities
- CTL proficiency testing programme, product consultancy, independence & impartiality
- code of conduct for Lead Assessors and Technical Assessors
- independence of certification decisions
- degree of focus on general QMS (Quality Management Systems) standards for accredited entities as opposed to those not accredited.

The second day of the course was when all participants took the examination that serves to check the capability of the Lead Assessor, summarize the information gathered during the on-site assessment and to highlight non-conformities or lack of compliance with IECEE Rules and ISO/IEC Guides/Standards. It also serves to determine, for a given scenario, whether all Lead Assessors reach the same conclusions. Upon passing the final examination at the end of the course, Lead Assessors receive a Certificate as Registered Lead Assessors.

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Participants taking the examination on the second day of the event

IECEE Lead Assessors are important contributors to the IECEE community in general and to the Peer Assessment programme in particular, essential in building confidence within the community and outside it among the various stakeholders.


2009-01-21: MoU formalizes long-standing collaboration between IEC and IAF

IEC General Secretary and CEO, Ronnie Amit, and IAF (International Accreditation Forum) Chairman, Thomas Facklam, signed a MoU (Memorandum of Understanding) on 27 October 2008 formalizing collaboration between the two organizations.

logo IAF"IAF - Certified once, accepted everywhere"

The CAB (Conformity Assessment Board), which is the IEC’s governing body on conformity assessment activities, and the three IEC Conformity Assessment Systems, IECEE, IECEx and IECQ, have been cooperating with the members of IAF for years on technical and administrative issues.

In making this cooperation official, the MoU recognizes what has been done in the past and encourages the joint IAF/IEC CAB Technical and Policy Panels to develop the possibilities for mutual recognition of each organization's assessments. The MoU formalizes plans for conducting a pilot programme of joint IAF/IECEE certification body assessments and the recognition of IAF certification body accreditations by IECEx and IECQ.

This step should facilitate a coordinated interpretation and application of ISO/IEC Guide 65, General requirements for bodies operating product certification systems (the future ISO/IEC 17065) for assessing product certification bodies operating in the IEC CA Systems. This includes developing and sharing common understanding of the technical issues and duly harmonizing the respective assessment procedures. Common interpretation and guidance is expected to be published and made available to all.

On the IEC side, the joint IAF-IEC/CAB Technical Panel is composed of CAB representatives, including IECEE Executive Secretary Pierre de Ruvo and IECEx and IECQ Executive Secretary Chris Agius.

photo MoU signing
Representatives from the International Accreditation Forum and the IEC seen here in the Lord Kelvin room

The MoU also specifies that joint assessments of common certification body clients should be conducted wherever possible, and that IAF and IEC/CAB should develop a basis for recognition of the roles of each organization’s technical and lead assessors in the conduct of those joint assessments. In addition, and wherever practicable, joint work on the development of harmonized procedures and policies should be undertaken.

The rationale for cooperation between IAF and IEC/CAB and its three CA Systems is that it brings greater efficiency in all conformity assessment activities, helps reduce duplication of effort and maximizes the harmony in technical evaluations conducted by both organizations.

Commenting on this new agreement, Amit said: "Informal cooperation between IEC and IAF has proved to be very successful and has lead to the signing of this MoU. By formalizing our relationship, we hope to give it the impetus to go even further."


The three IEC Conformity Assessment Systems

IECEE is the IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and Components.

IECEx is the IEC System for Certification to Standards Relating to Equipment for Use in Explosive Atmospheres.

IECQ is the IEC Quality Assessment System for Electronic Components

2009-01-16: CBTL KTL UK name change

CBTL KTL UK has changed name to TRaC Telecoms & Radio Limited.

2009-01-16: NCB & CBTL TRL Compliance Ltd. change name

NCB and CBTL TRL Compliance Ltd. have changed name to TraC EMC & Safety Ltd.

2009-01-12: New IECEE Member Body: ICONTEC – Colombia joins the IECEE

ICONTEC joins the IECEE and becomes the Colombian Member Body. The IECEE Community is pleased to welcome the 52nd Member Country and wishes ICONTEC the very best for their future operation in the truly worldwide Conformity Assessment Scheme, IECEE.



Contact:

Executive Director of ICONTEC - Mr. Fabio Tobon,
Tel: (571) 607 88 88 Ext.:1201

E-mail: ftobon@icontec.org

 

tobon

2009-01-05: NCB KTL has a new General Director, Mr. Mr. Jung-Sup Kim and a new Director, Mr. Heun-Chan Park.


NCB KTL has a new General Director, Mr. Mr. Jung-Sup Kim and a new Director, Mr. Heun-Chan Park.


Mr. Heun-Chan PARK and Mr. Jung-Sup KIM