The Shifting Landscape of Accreditation
By Dr Llewellyn Richards, Chief Executive, IANZ

Applications for accreditation from laboratories have dwindled to a trickle in recent years as most laboratories are already registered. The norm these days is for existing laboratories to extend the scope of their accreditation to meet new market or regulatory requirements. The emphasis for new accreditations is now with inspection bodies, where we are experiencing significant growth and which we expect will continue over the next five years or so. This is well illustrated by the 80 Building Consent Authorities that are being assessed for the Department of Building and Housing. A similar number of local body and private inspection bodies are expected to apply to become accredited as verifiers under new regulations for Food Safety Plans in the near future. Additional assessment and administration staff have been employed and trained in readiness for this growth.

By comparison, the number of accredited laboratories in New Zealand is not growing. It is a strongly competitive market and we are seeing mergers and consolidations rather than new laboratories being established. While the number of companies operating laboratories may decrease, the number of sites is expected to remain at present levels for the foreseeable future and their scopes of accreditation increased

We are working with a number of other regulators in the development of new accreditation requirements. These new activities will require additional accreditation assessment staff to be appointed and trained over the coming years.

Rationalisation of medical testing providers, driven by new District Health Boards requirements, will have an impact on the IANZ laboratory accreditation process. Since 2006, there has been a spate of amalgamations of public (hospitals) and private medical testing laboratories, and this is continuing. Fewer laboratories do not mean fewer assessments by IANZ. Laboratories are becoming larger and more complex in structure and are undertaking a greater volume of tests. For IANZ, this will require considerable more time than previously on and off site to complete the assessment process. Staff numbers in this programme have been increased in the last two years to cope with this change.

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Accreditation - Delivering Trust in the Global Economy June 9 has been designated International Accreditation Day June 9 2008 has been designated as the first International Accreditation Day by the International Laboratory Accreditation Cooperation (ILAC) and the International Accreditation Forum (IAF).

The value of accreditation has been widely recognised and adopted by economies and societies worldwide. Trust, the theme for this year’s International Accreditation Day, has been chosen to highlight the way in which accreditation rules and procedures are harmonised at a worldwide level to underpin free global trade of products and services, and to legal requirements regarding health and safety and protection of consumers and the general public.

In competitive and open markets, both government and business rely on trust to ensure a fair exchange of safe goods and services. The essential aspect of accreditation is that it underpins this confidence because it is a valid means of verifying claims about quality, performance and reliability.

It is through accreditation of laboratories, inspection bodies and medical imaging services that society can have confidence that when something is measured, calibrated, inspected or tested, the job has been done competently. The ability to select a service that has been accredited is an informed and trusted choice and not a gamble.

The use of internationally-recognised standards as the reference criteria for accreditation and the development of Mutual Recognition Arrangements are key to building trust across borders and promoting best practices in conformity assessment worldwide. The MRA now operates throughout 48 economies and in all of these there is greater recognition of accreditation, in particular from policy agencies and regulators, who are adopting accreditation as a mechanism to deliver a multi-discipline solution that can support or act as an alternative to legislation.

A structure has been put into place to support the development of accreditation and related conformity assessment infrastructure in developing economies. Since 2003, the number of newly established Accreditation Bodies has grown by almost 40%.

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New Emphasis for Council

The Testing Laboratory Registration Council, the parent body for IANZ, has responded to Government initiatives and aligned its activities with Government Priorities for economic transformation, supporting families and growing a national identity. Within these priorities, Council has identified these sub-themes as being areas it is making a worthwhile contribution:

Globally competitive firms
With its established Mutual Recognition Arrangements with 68 accreditation bodies worldwide, the Council is assisting New Zealand exports to gain market access across a broad spectrum of products. Meat, dairy, sea foods, wool, manufactured goods, etc, tested in accredited laboratories or inspected by accredited bodies, are effectively competing on the global market through recognition of IANZ accreditation.

World class infrastructure
The Council’s role in the New Zealand conformity assessment infrastructure and the quality of its activities are recognised globally as meeting international requirements. For over 30 years Council staff has been fully involved with the development of international and national standards and conformity assessment guidelines that have ensured goods from New Zealand meet increasingly strict compliance measures.

Innovative and productive workplaces
Assisting businesses to achieve the high standards necessary is an essential role of the Council. Through its New Zealand Quality College, Council is able to train accredited laboratories and inspection bodies in implementation of good management practices to required standards and regulations.

Environmental sustainability
The growing Government emphasis on and assistance with environmental sustainability and ensuring a safe environment, means growing recognition for accredited laboratories testing air emissions, water discharges and greenhouse gas emissions.

Safe communities
Accredited laboratories and inspection bodies are widely used to ensure communities and workplaces are safe through the testing and inspection of manufactured and agricultural products, food and drinking water, construction and roading materials and assemblies, gas cylinders, fuels, explosives, safe use of plant and equipment, lifts, cranes, pressure vessels, etc.

Better health for all

From left to right: Dr Campbell Kyle, Miriam Dean QC, Dr Richard Janes (deputy Chair), Dr Robin Pratt (Chair),
Sarah Kennedy, Nigel Cann, Dr Llewellyn Richards (CEO), Dr John Hay, Jo Brosnahan, Richard Dimmock.


The Council’s annual Statement of Intent, which is currently being finalised, provides full analyses of the Council’s activities in relation to Government initiatives. Once presented to Parliament in May, the Statement of Intent will be made available on www.ianz.govt.nz.

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Counterfeit Test Reports Surfacing
By Ian Roy, Manager International Affairs and Government Liaison, IANZ

In late 2007, IANZ intercepted a handful of counterfeit test reports issued by overseas laboratories. The reports, if recognised by IANZ, would have allowed the entry to New Zealand of the products they accompanied.

Although IANZ staff were quick to identify the counterfeit reports, the incident does highlight how valuable test reports have become as a necessary prerequisite for attaining market access for internationally traded goods.

There were several clues that gave the test reports away as counterfeit and IANZ immediately notified the accreditation body whose accredited laboratory was being misrepresented. The overseas accreditation body, who is signatory to a mutual recognition arrangement (MRA) that IANZ has also signed, worked very quickly to ensure all authorities in their territory were mindful of the counterfeit activity.

The robustness of the MRA network ensured that further counterfeit reports were blocked and destroyed, and that all parties were quickly informed. It is reassuring to see the MRA system works so quickly and effectively when challenged by counterfeiters, and has reinforced the confidence all protagonists have in the accreditation process and the MRA system.

The products that the counterfeit test reports accompanied were retested in laboratories accredited by IANZ, but pleasingly, the products were not found to be inferior to the standards they were tested against. This is certainly good news as our worst fear, that of dangerous products being sold with counterfeit test reports, proved unfounded. Instead, it appears that test reports are being forged to avoid the cost of commissioning new reports. However, as the evidence of fraud is clear, importers are being recommended not to accept any products accompanied by counterfeit test reports and to send a clear message to those providing such products.

Nevertheless, the incident has increased not only IANZ’s vigilance when checking reports, but also that of the other 63 accreditation bodies (spread over 48 economies) who are also signatory to the mutual recognition arrangement.

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Importance of Conformity Assessment

The importance of a sound standards and conformance infrastructure in supporting Government’s economic transformation was highlighted in the review of New Zealand’s infrastructure completed in 2007 by the Ministry of Economic Development. It identified the infrastructure as being world class and can be used:

Regulators’ Forum established
The establishment of a forum comprising policy agencies, regulators and conformity assessment infrastructure bodies was a key recommendation of the review. The Forum has already met on two occasions this year and it was quickly established that regulators sought more knowledge of the existing conformity assessment infrastructure. Through participation at the forum, Dr Llew Richards and other senior IANZ staff are helping to improve regulators’ awareness and understanding of accreditation. Separate discussions with several government agencies, including the Ministry of Health, Ministry of Labour and the New Zealand Food Safety Authority, have also helped. A specific metrology sub forum is being established within the Regulators’ Forum to focus on measurement issues.

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China Free Trade Agreement (FTA) to Benefit IANZ Accredited Organisations

Mutual Recognition Agreement (MRA) on Electrical and Electronic Equipment and Components

Included in the just-signed FTA between New Zealand and China is a specific agreement on the mutual recognition of conformity assessment for electrical and electronic equipment (MRA). The MRA concerns electrical and electronic products that are subject to the China Compulsory Certification (CCC) system and to the requirements of New Zealand supplier declarations of conformity for such products.

Currently Chinese exports to New Zealand must be tested to New Zealand standards while New Zealand exports to China must be tested, inspected and certified by Chinese conformity assessment bodies. The MRA gives suppliers in both countries an alternative way to demonstrate compliance with electrical safety and electromagnetic compatibility regulatory requirements.

New Zealand exporters will be able to apply the CCC mark to products before the products are exported to China, on the basis of accreditations and conformity assessment procedures carried out by New Zealand agencies which have been formally accepted in China and to have their products recognised as meeting Chinese requirements on importation.

The MRA will make it easier for New Zealand regulators to monitor and enforce the electrical safety and electromagnetic compatibility of imported products, including through providing for cooperation with Chinese regulators in surveillance and enforcement actions.

Other benefits include reduced language barriers; better compliance of Chinese imports by making it easier for Chinese manufacturers to demonstrate compliance; and improved quality assurance through requirements for factory inspections and certification.

The MRA is a first for China. It is the first agreement under which its authorities accept the results of testing, factory inspection and certification by Conformity Assessment Bodies accredited in another jurisdiction.

The MRA preserves the sovereign right of each country to set and apply mandatory requirements in relation to the covered products; and to take any measures deemed necessary in relation to non-compliant products.

Source: http://chinafta.govt.nz/index.php

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Proficiency Testing - An Important Part of Accreditation

Confidence that a testing or calibration laboratory consistently obtains reliable results is of major importance to users of laboratory services. Users seeking such an assurance can have greater reliance on laboratories that participate in proficiency testing schemes.

Proficiency testing is the use of inter-laboratory comparisons to assess laboratories’ abilities to perform tests competently. This may include assessments by laboratories themselves, by their clients, or by other parties such as regulatory bodies or IANZ. These external capability measures supplement the laboratory’s own internal quality control procedures and complement the on-site laboratory assessment by technical specialists, as required for IANZ accreditation.

Proficiency testing has gained international acceptance as an essential monitoring activity. It is particularly important in sensitive areas of trade (e.g. food), health and safety (e.g. medical services, patient care and sports-drug testing) and the environment (e.g. monitoring greenhouse gases in various matrices and temperature measurements).

Often, proficiency testing schemes also provide information for other purposes, including:

A specialised form of proficiency testing is key comparisons that allow for the verification of calibration and measurement capabilities. This covers a specified range of measurement values accompanied by reliable estimates of measurement uncertainty, which are essential in the dissemination of metrological traceability of measurement results from National Measurement Institutes to field laboratories.

A proficiency testing standard, ISO/IEC 17043, is being mooted by the International Organisation for Standardisation (ISO). The new standard is intended to combine the two parts of the current guiding document, ISO/IEC Guide 43, primarily directed at best practice general requirements for proficiency testing providers themselves. In addition, the standard is expected to include procedures for an annex for the use of proficiency testing results by interested parties such as regulators.

Participation in Proficiency Testing Schemes
IANZ accredited laboratories are encouraged to participate in as many proficiency testing programmes as possible to enhance their external quality assurance. Laboratories are expected to participate in one such programme prior to gaining accreditation and, subsequently, in sufficient programmes to cover the scope of accreditation.

The following directories provide information on available proficiency testing programmes:
APLAC: http://www.aplac.org/documents/pt/aplac_pt_003_issue_10.pdf
EPTIS: http://www.eptis.bam.de/

APLAC proficiency testing programmes
The Asia Pacific Laboratory Accreditation Cooperation arranges for proficiency testing programmes to be run and expects accredited laboratories in all economies that are members of the MRA (which includes IANZ) to participate. These programmes are as much a measure of the IANZ performance in accrediting laboratories as it is a measure of participating laboratories’ performances. The cooperation of participating laboratories is appreciated.

Details of the APLAC proficiency testing programme can be found on: http://www.aplac.org/aplac_pt_programs.html

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Changes to Advisory Committees

There have been numerous changes to members of the various accreditation Professional Advisory Committees, and a new PAC has been established for Building Consent Authority accreditation. These committees provide IANZ with technical advice and with a link to industries and relevant professional bodies. Members are experienced technologists, scientists, radiologists, engineers and other technical professional experts and are highly regarded in their fields of expertise.

A full list of committee members is maintained on http://www.ianz.govt.nz/about2/pacs.htm

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New Accreditations

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That's iso, not I-S-O

The next time you're talking about standards or the International Organisation for Standardisation, be sure to pronounce it as "iso" and not "I-S-O." This is because ISO does not, in fact, stand for the International Organisation for Standardisation (or the International Standardisation Organisation, which doesn't even exist).

Turns out that ISO is simply the universal short form that the founders of the International Organisation for Standardisation bestowed on their organisation. If the International Organisation for Standardisation were to be abbreviated, it would come out as IOS, not ISO, anyway. But the three letters are the same so, naturally, confusion has ensued among many trade publications. Even dictionaries get this wrong.

This was explained at a recent conference in Boston by Ken Holman, who was at the time the international secretary of the ISO subcommittee responsible for the Standard Generalised Markup Language (SGML). He noted that the name actually comes from "iso," the Greek prefix for equal. For instance, isometric refers to the equality of measurement.

"That is where the ISO comes from. It is not an abbreviation," Holman said.

So when you see the designation ISO 9000, for instance, you'll know to pronounce it “iso” and not I-S-O. And please don't call ISO an abbreviation.

Thanks to Joab Jackson’s Tech Blog for this enlightenment.

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Publications Update

Since last October, a number of IANZ criteria publications have been updated and produced in the new single-column format. Included are:

General Criteria

Specific Criteria

Supplementary Criteria

Technical Guides

Information Guides

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Staff Changes at IANZ

	Graham Walker, Acting Programme Manager – Medical Testing, resigned from IANZ to pursue a range of different initiatives including cultivating his lime and avocado trees, completing community work locally and abroad and assisting medical laboratories and radiology practices with special projects. He will remain on hand for a period to assist with the induction of the new Programme Manager (see below) and to lead some large medical laboratory and radiology assessments over the next few months. Graham has been a stalwart for accreditation in New Zealand during his 16 years with IANZ. He assumed responsibility for the medical testing programme in 1993 and facilitated the rapid expansion of this programme. He represented IANZ in the drafting of the ISO 15189 standard for medical testing and in 1996 established the radiology accreditation programme. This programme, which was the first in the world at that time, was actively promoted by Graham during his years with IANZ and it now extends across most New Zealand radiology practices.
	Replacing Graham as Programme Manager for the medical testing accreditation programme is Shelli Turner, who commenced on 25 March. Shelli has a BSc in Chemistry from Otago University and 21 years experience working in medical laboratories, specialising in Clinical Biochemistry. For the past seven years Shelli was with ESR as Programme Manager Workplace Drug Testing at the Kenepuru Science Centre, Porirua. Previous positions were with Capital Coast Health as Scientific Officer - Toxicology, Medical Laboratory Scientist – Biochemistry, Head of Biochemistry and Laboratory Manager - Kenepuru Hospital and Coordinator Core Laboratory.
	A graduate from University of Salford, UK with BSc (Hons) Diagnostic Radiography 1999, Stephen Ringwood moved to New Zealand in January 2001 and worked in various hospitals around the country. The majority of his time in New Zealand was spent with Northland Health in Whangarei where he held the position of Clinical Tutor. He returned to UK in March 2006 and worked for Interhealth Care Services UK Limited. Here he assisted in the commissioning of a radiology department in a new elective orthopaedic hospital and worked as temporary Imaging Services Manager until returning to New Zealand in September 2007. Stephen held a locum position back at Northland Health until January 2008, when he joined IANZ as an Accreditation Assessor in the Radiology Service programme. His main areas of interest in radiography are Orthopaedics, trauma and CT.
Assisting with the administration of the Inspection Body Programme for nine months is Stephanie Taylor, who has a wide and varied work experience. She ran her own company, Heirloom Industries Limited for a number of years, has been involved in property renovations, farmed goats with her husband in Clevedon where she was also involved in viticulture and wine making, and was food and wine specialist with Delmaine Fine Food and Wines Limited, Auckland.

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Training Courses of Interest

LABORATORY MANAGEMENT
Analytical Method Validation
For chemical and biological testing laboratory personnel to learn about the concepts and conduct of analytical method validation.
4-5 June
Auckland

NZS ISO/IEC 17025
For laboratory managers, signatories and technical assessors to better understand this standard and the assessment process.
19-20 June
Auckland

Laboratory Quality Management
Introduces ISO/IEC 17025 and quality management to staff new to a laboratory environment.
14-16 May
Auckland
NB. This course will be held in Christchurch 13-15 August.

Traceability and Uncertainty in Measurement
For analysts required to estimate the uncertainties of their test results and for those responsible for technical management of testing laboratories.
17-18 June
Auckland

AUDITING
Internal Auditing
Provides knowledge and confidence needed to complete effective internal audits.
22-23 May
31 July-1 August
Auckland
NB. This course will be held in Wellington and Christchurch in September.

INSPECTION BODY MANAGEMENT
Introduction to Inspection Body Accreditation
For those required to develop and implement inspections against standards (e.g. ISO/IEC 17020) or regulations (e.g. Food Control Plans).
26-27 June
Auckland

Full details of all courses and booking forms are available from www.nzqc.co.nz,
by phoning 0800 9000 99 or email to info@nzqc.co.nz.

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To contact IANZ call 09 525 6655 or email info@ianz.govt.nz
Private Bag 28908, Remuera, Auckland 1541
626 Great South Road, Ellerslie 1051

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