December 2004 e-Newsletter

ISO 17050-1:2004 and ISO 17050-2:2004 give added weight to a supplier's declaration of conformity. These new standards define requirements for suppliers to meet when they make formal claims that products, services, systems, processes, or materials conform to relevant standards, regulations, or other specifications.

Claims that meet the requirements of ISO 17050 are expected to inspire greater confidence among governments, regulatory authorities, consumers, and end users than claims without such backing. This is because the standard represents an international consensus on good practice and establishes a benchmark that can be applied in all business sectors and in all countries.

ISO 17050 offers a framework for what is called a "supplier's declaration of conformity", or "SDoC". An SDoC is one of the ways in which a supplier may seek to demonstrate conformity. This might be required, for example, by health, safety, or environmental regulations - or be desirable because conformity would give potential buyers greater confidence.

Conformity assessment options have included inviting the customer to verify conformity, or by engaging a specialized independent body, such as a testing laboratory or inspection service, to issue a certificate of conformity (e.g., product certification). An SDoC is less time-consuming than either of these options, which means that products can be developed and brought to market faster. It is also cheaper and the savings can be passed on to the customer.

The publication of ISO 17050 puts at the disposal of suppliers an SDoC methodology with greater transparency, added rigor, and globally harmonized practice - which is likely to increase the use of this option in world trade. While streamlining the conformity assessment process, it does not remove the obligation of suppliers and manufacturers to conform to relevant regulations and other legal requirements - which is likely to encourage its acceptance by authorities, as well as, increase the confidence of customers.

The new standard is in two parts. Part 1 specifies the general requirements for an SDoC. Its intent is to increase the value of an SDoC by establishing a clearly understandable standard for this conformity assessment option, and also to encourage its use by making the SDoC more acceptable to government and regulatory institutions. The document includes a sample SDoC.

Part 2 is on supporting documentation to substantiate an SDoC, for example, results of tests carried out by the supplier or an independent body in order to meet legal requirements. Again, the intent is to encourage acceptance of an SDoC by customers and authorities.

The two standards can be ordered through ANSI at: <http://webstore.ansi.org/ansidocstore/default.asp>.

ISO 17050-1:2004, Conformity assessment - Supplier's declaration of conformity - Part 1: General requirements, costs $38.
ISO 17050-2:2004, Conformity assessment - Supplier's declaration of conformity - Part 2: Supporting documentation, costs $28.

If you are an RAB certified auditor, the planned merger of the RAB and QSA organizations will affect your continued auditor certification. In the past, certification basically consisted of successfully completing an auditing class, passing its examination, and then collecting sufficient audits on your log for submission to the RAB.

Beginning next year, the auditor certification process will require passing an online psychometric test to determine if you have the desired attributes. Knowledge and skills will still be determined and may be examined in the classroom or via the Internet. In addition, there will be a requirement for a witnessed audit by a specially selected examiner.

These extra requirements are expected to increase the annual auditor certification fees. The good news is that audit logs and CPD details will no longer be required.

Current auditors will be given a two year transition period. The new merged organization, RABQSA, will continue to offer the non-accredited schemes, e.g., QMS and EMS until YE2006, at which time all schemes will transition to the accredited competency-based schemes.

The new auditor certification period for the accredited schemes will be four years. Throughout this period, RABQSA will conduct surveillance "gap" examinations (an e-based knowledge examination as appropriate to each scheme) to ensure that, in terms of knowledge, the certified auditors remain competent.

Merger of RAB and QSA

The merger of the Registrar Accreditation Board (RAB) and the Quality Society of Australasia (QSA) into RABQSA International is to take effect January 1, 2005. The principal offices will be located in Milwaukee and Sydney, with Joint Venture offices located in Tokyo, Taipei, Hanoi, Kuala Lumpur, and Auckland. Expansion into Mexico and Canada is planned for 2005.

The new organization will be focused on implementing ISO 17024:2003, " General Requirements for Bodies Operating Certification of Persons". At the core of ISO 17024 is the requirement for the accredited personnel certification body (e.g., RABQSA) to determine industry’s requirements and then define, measure, and objectively examine personnel competence.

Determining and examining competence is about the recognition of persons with the required knowledge, skills, personal attributes, and qualifications to satisfy industry’s requirements. According to the RAB, this will have a significant and positive impact on business performance, and the fundamental value and relevance of personnel certification.

Auditor Certification or Recertification

The following new accredited personnel certification schemes (based on ISO 17024) will be introduced on January 1, 2005: Quality, Environment, Occupational Health and Safety, and Food Safety Management System Auditing, as well as, the Training Provider and Examiner Certification Scheme (TPECS).

Applicants seeking certification or recertification next year to one or more of these accredited schemes will be required to achieve the appropriate competency, including the examination of:

1. Knowledge: Applicants will need a Certificate of Attainment from a RABQSA Certified Training Provider. During 2005 and 2006, certificates from RAB accredited training providers will be recognized as meeting the knowledge-based competency, along with the addition of a "gap" examination. All training providers seeking agreement to examine knowledge will be required to transition to TPECS no later than YE2006.

2. Skill: Applicants will need a Certificate of Attainment from an RABQSA Approved Skill Examiner. This witnessed audit will be coordinated by RABQSA.

3. Attributes: Applicants will need to successfully complete a psychometric assessment (Personal Attribute Assessment System) specific to the appropriate scheme. The assessment tool, referred to as PAAS Master®, will be accessed via the RABQSA web site and should involve no more than 35 minutes of an applicant's time.

In addition, applicants will be required to provide evidence of recognized qualifications reflecting the additional competencies required for the scheme and scope of certification. Applicants must also agree to the RABQSA Code of Conduct and related administrative requirements.

The certification period for the accredited schemes will be four years. Throughout this period, RABQSA will conduct surveillance examinations (an e-based knowledge examination as appropriate to each scheme) to ensure that, in terms of knowledge, the certified persons remain competent.

Skill Examination

Examining skills is about witnessing the performance of the person under realistic operational conditions. Defining the required competency in measurable terms is relatively easy. The difficult task is the examination of the applicant against each competency under defined auditing conditions, i.e., onsite. The traditional approach has been to rely on experience, number of audits, analysis of audit reports, and reference/auditee verification, compared to the prescribed criteria. According to the RAB, this methodology is at best subjective, and at worst, does not truly examine skill and the application of acquired knowledge, which by definition requires onsite examination of the auditor demonstrating specific competence.

Of the formal and informal complaints RAB and QSA receive each year, they report that 90% relate not to the auditor’s knowledge and skill, but to his or her conduct onsite. RABQSA will engage the services of competent skill examiners to provide the examination of the applicant’s performance against defined RABQSA competency standards.

Personal Attribute Assessment System

QSA has been examining personal attributes since the release of ISO 19011:2002. This auditing guidelines document details those attributes; open-minded, perceptive, etc., that effective and efficient auditors should be capable of demonstrating. Late 2003, QSA reviewed a number of international psychometric HR models to determine a simple e-based product that could be shaped to satisfy the examination requirement. Culture Map Limited New Zealand was selected as the preferred supplier and worked with QSA in designing an appropriate examination. The result was the Personal Attribute Assessment System (PAAS Master®).

PAAS Master® is a simple e-based online examination consisting of 85 psychometric questions, which examine 12 personal attributes. The attributes were determined following extensive national and international research and interview with the aim of determining what, in terms of personal attributes, separates the more effective and efficient auditors. Software matrix-analysis of each answer determines whether the applicant has the potential to demonstrate the required attributes.

Essentially, the first six attributes are ‘shall haves’, with attributes 7 - 12 the ‘should haves’. The latter attributes are generally accepted as an indication of the applicant’s potential to add value to his or her performance in terms of their approach, conduct, and application to a given situation. The 'ethical' attribute will remain subject to the new RABQSA Code of Conduct.

PAAS Master® is not a ‘go/no-go’ evaluation. Simply, it will indicate to RABQSA where an applicant may experience difficulty in terms of demonstrating specific attributes and will be considered in relation to the other competencies of skill, knowledge, and qualification. Where RABQSA may have a concern, the applicant will be required to attend an interview with a RABQSA scheme examiner. The examiner will validate the PAAS Master® result and recommend appropriate professional development. It may be a simple case of the applicant misreading the examination. In the most extreme case, RABQSA may decline certification.

Note: The new application, criteria, and related administrative requirements, should be available at the RAB and QSA web sites in December 2004.

ISO/TR 14969:2004 is available with guidance for the application of the medical device requirements contained in ISO 13485:2003. It does not add to, or change, the requirements of ISO 13485. The guidance can be used to better understand the requirements of ISO 13485 and to illustrate some of the variety of methods and approaches available for meeting its requirements.

This new standard can be ordered through ANSI for $137 at: <http://webstore.ansi.org/ansidocstore/default.asp>.

This article describes the following new Conformity Assessment standards:

ISO 17000:2004, Conformity assessment - Vocabulary and general principles
ISO Guide 60:2004, Conformity assessment - Code of good practice
ISO Guide 67:2004, Conformity assessment - Fundamentals of products certification
ISO Guide 28:2004, Conformity assessment - Guidance on third-party certification system for products
ISO 17011:2004, Conformity assessment - General requirements for accreditation bodies accrediting conformity assessment bodies

ISO 17000:2004 and ISO Guide 60:2004 - Standards to Harmonize Conformity Assessment and Facilitate World Trade

One of the main challenges facing the international trading system is the diverse conformity assessment practices and approaches that persist in different countries and contexts. ISO is contributing to a solution in the form of two essential reference documents for conformity assessment designed to reduce technical barriers to trade and to prevent the emergence of new ones.

These two documents are intended to be used in conjunction with, or when preparing, ISO International Standards or Guides relating to conformity assessment, and also to support the implementation of the World Trade Organization's Technical Barriers to Trade Agreement.

Conformity assessment has become an important component of world trade. At its simplest, "conformity assessment" means checking that products, materials, services, systems, or people measure up to specified requirements (regulations, standards, specifications, etc.). Unless trading partners adhere to identical (or equivalent) conformity assessment procedures and requirements, or recognize each other's conformity assessment results, then the costly problem of discriminatory, non-transparent, and unnecessary obstacles to trade will persist.

The first "solution document" is a new standard, ISO 17000:2004, Conformity assessment - Vocabulary and general principles, that collects and compiles into one glossary-type document all terms and definitions applicable to conformity assessment in English, French, and Russian. It facilitates a coherent approach to the description of conformity assessment activities and the use of harmonized conformity assessment terminology, as well as, contributing to a common understanding of conformity assessment terms.

The second document, ISO Guide 60:2004, Conformity assessment - Code of good practice, recommends good practices for all elements of conformity assessment, including conformity assessment normative documents, bodies, systems, schemes, and results. It is for use by individuals and bodies who wish to provide, promote, or use ethical and reliable conformity assessment services that are characterized by WTO principles like openness, transparency, impartiality, coherence, and consensus.

ISO Guide 67:2004 and ISO Guide 28 :2004 - Guides to the Principles and "How-To" of Product Certification

From checking the safety, health, or environmental protection of products to improving their acceptance by the market, these two new guides aim to improve understanding of the diverse functions and types of "product certification" designed to deliver confidence within supply chains, and to consumers in the global market.

At each stage along their life cycle, products - designed, produced, distributed, used, and ultimately disposed of - may give rise to societal concerns such as health, safety, or environmental impacts, durability, compatibility, and suitability. One method of providing reassurance to users to allay their concerns is through product certification. For example, retailers of consumer goods rely on certification as evidence that aspects such as the safety of food and drugs have been verified by a third party, thus giving confidence that products they place on their shelves for sale to the public are not likely to bring harm to their customers.

ISO Guide 67:2004, Conformity assessment - Fundamentals of products certification, is intended to foster understanding of the wide range of possibilities that fall within the context of product certification, and thereby assist those wishing to develop product certification for a particular purpose, and those with responsibility for evaluating such systems. It describes some of the activities of product certification, identifies basic elements and types of product certification, and shows some of the ways of combining these elements to design a product certification scheme. <>

ISO Guide 28:2004, Conformity assessment - Guidance on third-party certification system for products, provides guidelines for those verifications undertaken independently of the supplier and the end user, carried out by a third party and known as "third-party conformity assessment", including sampling, testing, evaluation, surveillance, and responsibility for the certification decision. It also addresses conditions for use of a mark of conformity - which may result from this type of verification - and the conditions for granting a certification of conformity. This second edition, which replaces ISO Guide 28:1982, has been updated to be in alignment with ISO 9001:2000, and with new documents such as ISO 17000:2004, Conformity assessment - Vocabulary and general principles, and ISO 17030:2003, Conformity assessment - General requirements for third-party marks of conformity, as well as, to reflect modern certification practices.

ISO 17011:2004 (One-Stop Accreditation to Boost Cross Border Trade)

This new standard aims to harmonize requirements worldwide for organizations that assess the competence of "conformity assessment" bodies. It will provide a global benchmark for "accreditation bodies" to ensure that they operate in a consistent, comparable, and reliable manner worldwide, thereby providing confidence to purchasers and regulators and facilitating cross-border trade.

Conformity assessment bodies (CABs) check that products, materials, services, systems, or people measure up to the specifications laid out in a relevant standard. A lack of confidence in their competence to perform these tasks may result in redundant, costly, and time-consuming assessments by different accreditation bodies in different countries. Such costs could be drastically reduced if a CAB could be assessed once and the results accepted globally. This process is known as a "one-stop accreditation".

ISO 17011:2004, Conformity assessment - General requirements for accreditation bodies accrediting conformity assessment bodies, sets out a uniform set of requirements for bodies that verify the activities of conformity assessment bodies - from testing, inspection, and management system certification to personnel certification, product certification, and calibration. It will also prove useful in the peer evaluation process for mutual recognition arrangements between accreditation bodies which will allow the contracting parties to recognize the results of each other's inspections, testing, certification, or accreditation for goods and services traded internationally.

The standard's potential for facilitating cross-border trade was witnessed by its recent adoption by the International Laboratory Accreditation Cooperation (ILAC) and the International Accreditation Forum (IAF) as the base set of requirements for their national and regional members. ISO 17011:2004 replaces three sets of overlapping requirements for the same attributes: ISO Guide 58:1993 (laboratories), ISO Guide 61:1996 (certification bodies) and ISO/TR 17010:1998 (inspection bodies).

In collaboration with ISO, a transition period has been agreed by IAF and ILAC members for accreditation bodies to meet the requirements of the new ISO 17011:2004 by 1 January 2006.

6. ISO 14001:2004 and ISO 14004:2004 Are Published

ISO has published revised, improved versions of ISO 14001 and ISO 14004. These standards are expected to put the benefits of implementing an environmental management system (EMS) within the reach of an even greater number and variety of organizations.

"These standards represent the state of the art in environmental management practice," affirmed ISO Secretary-General Alan Bryden, "and are at the leading edge of ISO's comprehensive offering to help organizations address all three dimensions of sustainable development - social, economic, and environmental."

ISO 14001:2004 specifies the requirements for an EMS which provides a framework for an organization to control the environmental impact of its activities, products, and services, and to continually improve its environmental performance. ISO 14004:2004 provides guidelines on the elements of an EMS, its implementation, and the principal issues involved.

Oswald A. Dodds, who chairs ISO/TC 207/SC 1, the ISO technical group that developed the two standards, provided an executive summary of the improvements: "These revised versions take account of the considerable body of user experience since the standards were first published in 1996. ISO 14001:2004 is easier to understand and easier to use. The intent of its requirements has been made clearer, which will facilitate its translation and consistent implementation around the world. In addition, its compatibility with the ISO 9001:2000 standard for quality management systems has been increased. In turn, ISO 14004:2004 is more consistent and compatible with ISO 14001:2004, which will encourage their joint use and so enrich understanding of EMS. The language of ISO 14004 has also been made more accessible to small and medium-sized enterprises. As these make up the vast majority of businesses in the world, it is very much in everyone's interest that they too implement the good environmental management practices distilled in ISO 14001:2004 and ISO 14004:2004."

ISO 14001 is the standard against which an organization may have its EMS audited by an independent registrar that then vouches for the conformity of the system to the standard's requirements by issuing an "ISO 14001 certificate". Certification is not a requirement of the standard, but many organizations have chosen this option because of the perceived credibility of an independent verification. At the end of 2003, more than 66,000 certificates to ISO 14001:1996 had been issued in 113 countries and economies, over 34% more than the previous year and the largest annual increase so far recorded by The ISO Survey.

Alan Bryden announced: "Although ISO itself does not carry out certification, we wish to ensure a smooth transition to ISO 14001:2004 for organizations currently certified to ISO 14001:1996. We have therefore been cooperating to develop a joint policy for the transition with the International Accreditation Forum." Note: The IAF is an international association that represents national accreditation bodies set up in many countries to verify the competence of certification bodies.

ISO and the IAF have agreed to set the period for making the transition from ISO 14001:1996 certificates of conformity to the ISO 14001:2004 version at 18 months from the ISO 14001:2004 publication date. Beyond this period, the IAF will recognize only certificates to ISO 14001:2004. The technical details of this 18-month transition policy, including instructions for registrars accredited by IAF members, are currently being balloted by the organization and are expected to be finalized in early December, when they will be announced in a joint ISO-IAF communiqué.

The ISO/TC 207 Chair, Daniel Gagnier, commented: "Forward-looking business organizations need to commit to sustainable development as a strategic objective. That means implementing good environmental management practices, not polluting or depleting the environment, reducing waste and making efficient use of resources, and respecting the environmental concerns of customers, shareholders, employees, local communities, regulators, and society as a whole. ISO 14001:2004 and ISO 14004:2004 provide a road map to this strategic objective."

ISO 14001:2004, Environmental management systems - Specification with guidance for use (Costs $78 at ANSI, or $50 as consensus draft at ASQ)
ISO 14004:2004, Environmental management systems - General guidelines on principles, systems and supporting techniques (Costs $107 at ANSI, or $50 as consensus draft at ASQ)

Note: The "consensus drafts" at ASQ contain the verbatim text of ISO 14001:2004 and ISO 14004:2004. Electronic versions can be ordered at: <http://e-standards.asq.org>.

To enroll in these public classes, go to Class Schedule at our web site, or call us at 800-404-7585. Classes taught by Larry Whittington are shown in yellow.

ISO 9001:2000 Lead Auditor (RAB Accredited) - BSI Management Systems
Initial course version developed by Larry Whittington

Understanding ISO 9001:2000 Requirements (Atlanta Only - $295)
Course developed by Larry Whittington

Quality System Documentation (ISO 9001:2000)
Course developed by Larry Whittington

The above public courses can be offered on-site at your facility. In addition, we offer these on-site courses:

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Whittington & Associates provides training, consulting and auditing services for quality systems based on ISO 9001, ISO/TS16949, TL9000, AS9100, ISO 13485, as well as, ISO 27001, ISO 20000, ISO 22000, and ISO 14001.