Highlights from 2007-2008 Annual Report of the Testing Laboratory Registration Council

Assessments up on last year
The number of laboratories, inspection bodies, and radiology services actively assessed by IANZ grew to 1,750 units during the year (from 1,728). The major contributors to the increase were building consent authorities assessed against the Stage One standards set by the Department of Building and Housing, radiology services, a small number of testing laboratories, and assessments for the Ministry of Health National Screening Unit. As expected, the number of medical testing laboratories accredited fell due to amalgamations of laboratories in that sector.

Financial Performance
In line with the increased assessments and recent acquisitions by Telarc SAI Limited, revenue for the year grew by 38%, from $10m to $13.9m. However, the costs associated with investments in new accreditation and certification programmes resulted in the Council recording a financial deficit for the year.

Programme Developments
During the year, senior IANZ staff continued to work with officials of government agencies to implement accreditation programmes, including working with the New Zealand Food Safety Authority (NZFSA) on the design and technical criteria for the new Domestic Food Plan. The plan requires third party external verifiers to be accredited to ISO/IEC 17020.

New criteria for accrediting radiology services, based on the medical laboratories standard ISO 15189, were prepared this year and a draft is currently being reviewed by the Radiology Professional Advisory Committee and other relevant experts. It is expected that this new Code of Radiology Practise will be published during 2008-2009.

International
Because of the importance of international recognition for test results and inspection reports to New Zealand trade, and to ensure requirements from overseas do not become overly prescriptive for New Zealand laboratories and inspection bodies, senior IANZ staff were again fully involved in both regional and international laboratory accreditation cooperation forums and the OECD Working Group for GLP.
IANZ has maintained a strong relationship with its Australian counterpart body, NATA. There is considerable cooperation at the programme level, with interaction between technical programme managers, and the interchange of technical experts. IANZ and NATA fully recognise each other’s laboratory and inspection body accreditation programmes, as do most regulators in both countries. This provides seamless recognition of test and inspection reports, thus facilitating the single market concept between New Zealand and Australia. In addition, both IANZ and NATA are full signatories for laboratory and inspection body accreditation at the regional level (Asia Pacific and Europe), and are both foundation signatories of the global mutual recognition arrangement for laboratory accreditation.

Regulatory Forum
This was the first year of the Regulatory Forum established by the Ministry of Economic Development, bringing together providers of conformity assessment services and regulators. The IANZ Chief Executive and other senior managers have attended all meetings and it is proving to be a very useful forum for greater awareness and better understanding of the role and activities of all parties. Discussions have been held with Standards New Zealand and JAS-ANZ (Joint Accreditation System of Australia and New Zealand) to establish greater cooperation in advancing conformity assessment for the benefit of New Zealand business and public interests without inhibiting competition in any way.

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Bill updates standards and conformance infrastructure

On September 9, Commerce Minister Lianne Dalziel introduced a Bill making changes that will help cement New Zealand's reputation for a high quality, trustworthy standards and conformance infrastructure.

"A reputable standards and conformance infrastructure is essential to our international trade by allowing overseas markets to rely on our standards and it allows the government to achieve environmental, health and safety objectives without compromising growth. This Bill updates and simplifies the governance arrangements for our standards and conformance infrastructure to bring it into line with international best practice," Lianne Dalziel said.

The Standards and Accreditation Bill replaces the Acts covering the Standards Council and the Testing Laboratory Registration Council, which are both autonomous Crown entities established by legislation.

The Bill’s primary purpose is to update and simplify the governance arrangements of both the entities by separating their governance and technical advisory functions. The Bill provides for a smaller governing board for each entity, directly appointed by the Minister of Commerce, to promote a better focus on governance.

It requires each entity to establish distinct technical advice structures: for the Standards Council, sector advisory boards (SABs), to improve the strategic direction of standardisation in New Zealand; and for the Testing Laboratory Registration Council, professional advisory committees (PACs), to provide expert advice on accreditation programmes.

The Bill also re-names the entities using the trading names by which they are known to their stakeholders: Standards New Zealand (Standards NZ) and International Accreditation New Zealand (IANZ).

The Bill updates the functions of each. It clarifies that Standards NZ can endorse the processes by which standards are developed, in addition to endorsing standards. The Bill also formalises IANZ’s longstanding designation as New Zealand’s Good Laboratory Practice compliance monitoring authority, in line with OECD decisions.

The Bill arose from a Review of New Zealand’s Standards and Conformance Infrastructure, completed in May 2007, which found that the infrastructure was fundamentally sound but could be improved to meet future challenges.

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New legislation covering toys imported in the USA

On September 4, the U.S. Consumer Product Safety Commission (CPSC) presented its plan for implementation of the “Consumer Product Safety Improvement Act (CPSIA) of 2008”. The CPSIA should be of interest to any manufacturer, retailer, importer/exporter, or testing laboratory associated with children’s products. This new legislation mandates that testing laboratories, in order to receive recognition by the CPSC, shall receive their accreditation from an accreditation body who is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA). As IANZ is a signatory to the ILAC MRA, we feel that it is important to bring our laboratories up to speed with this new American legislative requirement.

Starting with lead paint, and progressing forward to cribs, pacifiers, small parts, children’s metal jewellery, baby bouncers, walkers, jumpers, and eventually to all children’s products, the CPSC intends to identify testing requirements for each individual children’s product. According to the new law, all products must be tested by a laboratory accredited to ISO/IEC 17025 by an accreditation body who is a signatory to the ILAC MRA.

The new Act sets very ambitious deadlines for enactment of these testing requirements. The first of these is lead paint, which will be a mandatory test for children’s products, starting 90 days after the commission posts their requirement in the Federal Registry (FR). This posting is expected to take place no later than September 19, 2008. Thus, any children’s product manufactured after December 19, 2008 would be subject to the lead paint testing requirements. The legislation also lays out a time table for implementation of the remaining products over the course of the upcoming year.

More detailed testing requirements for the other products listed above can be found on the CPSC website, www.cpsc.gov. There is a tab at the top of the homepage which links to “Information on the Consumer Product Safety Improvement Act (CPSIA)”. This link will allow you to read the actual CPSIA legislation as enacted by Congress on August 14, 2008. Requirements for testing deadlines of several different children’s products can be found in Section 102. The CPSC also has formatted an automated email system that will provide updates of the CPSIA to any individual who signs up.

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IANZ part of international evaluation team in Dubai

IANZ Assistant General Manager, Mr. Alan Glover (seated far right), was part of the ILAC Peer Evaluation Team that recently visited the Dubai Accreditation Centre (DAC). DAC is now set to become a full member of the International Laboratory Accreditation Cooperation (ILAC) as result of this evaluation.

Other members of the evaluation team were Mr Ralf Egner, Deputy Head of the German Accreditation Body DaTech as team leader, and Mr. Kukuh S Achmad Director of Indonesian Accreditation (KAN).

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Greater involvement with regulators

Geoff Hallam

Adrienne Woollard

In recognition of the important role that IANZ accreditation plays in regulations, IANZ Chief Executive, Dr Llew Richards has announced the appointment of Geoff Hallam to a new position of Technical Development and Regulatory Affairs Manager. Geoff will work with Dr Richards and with Barry Ashcroft, IANZ General Manager – Accreditation Services, in developing new accreditation programmes with regulators and other industry groups.

Dr Richards said that this appointment was a natural progression for IANZ and for Geoff, who has, for some years now, worked closely with the Department of Building and Housing in developing and implementing the Building Consent Authority (BCA) accreditation programme and with the NZFSA on developing food safety related accreditation programmes. An important part of this role will be working with Territorial Authorities, which are responsible for implementing both food safety and building consent regulations. Geoff will be involved in training, regulator workshops and liason with TA personnel to assist in the efficient transition to accredited systems.

Geoff, who was previously Programme Manager – Inspection Body Accreditation Programme, begins his new role on 1 October 2008. Taking on the challenge of Inspection Body Accreditation Programme Manager is Adrienne Woollard who has been an Accreditation Assessor since August 2007.

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Kevin Lysaght

It is with sadness that we learned of the passing of Kevin Lysaght on 4 August in Tauranga. Kevin was a stalwart of quality assurance in New Zealand. He was a member of the steering committee that led to the formation of the New Zealand Organisation for Quality Assurance and was elected deputy president at the NZOQA inaugural conference in May 1977. From that conference Kevin and his associates were charged with the responsibility for improving the knowledge of quality assurance within New Zealand industry.

For many years Kevin was the manager of the UEB Technical Centre which provided quality assurance and testing services for the UEB group of companies. He ensured that his laboratory gained IANZ accreditation for those services and in March 1987 he and his colleagues earned the distinction of achieving New Zealand’s first certification to a quality system standard.

In 1994, Kevin was appointed by the government to the Testing Laboratory Registration Council, which he served on for ten years before retiring in 2004.

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New Accreditations
Congratulations to these organisations for achieving IANZ accreditation.

Laboratories
• AgResearch Limited, GenomNZ, Animal Genomics Section
• Gauge Cal North Limited
• New Zealand Laboratory Services Limited, Hastings
• Silver Fern Farms Limited - Finegand Laboratory

Radiology
• Trinity MRI Limited, Auckland

Inspection Bodies
• Fire System Inspections Limited, Auckland
• Quality Auditing Specialists Limited, Morrinsville

Building Consent Authorities
• Central Otago District Council
• CGAF Limited T/A Bay Inspections, Tauranga
• Grey District Council
• Mackenzie District Council
• Manukau City Council
• Opotiki District Council
• South Wairarapa District Council
• Tasman District Council
• Tauranga City Council
• Thames Coromandel District Council
• Upper Hutt City Council
• Waipa District Council
• Waitaki District Council
• Wanganui District Council
• Whangarei District Council

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Reminder: Electronic files available

Accredited bodies are reminded that, in addition to the printed versions, IANZ accreditation and ILAC-MRA logos and endorsement statements are available as electronic files.

Accreditation Logos

Using the accreditation logo will enhance your reputation and the value of accreditation in the marketplace. These logos are being promoted in New Zealand and overseas through counterpart bodies of New Zealand’s major trading partners.

ILAC-MRA Mark

All testing and calibration laboratories accredited by IANZ are eligible to use the ILAC-MRA Mark and may do so under a sub license agreement with IANZ. It is not permitted to be used by other organisations recognised by IANZ, such as accredited inspection bodies, GLP Compliant Laboratories, accredited certification bodies and the like.

Those eligible accredited organisations wishing to use the mark need to contact their IANZ Programme Manager who will forward the sub licence agreement for signing. This agreement, required by ILAC to protect the mark from misuse, automatically renews with each re-accreditation. There is no charge for obtaining or using the mark.

Endorsement labels

Accredited organisations are encouraged to make reference to their accreditation in reports, certificates or other documents. Note that the rules for the endorsement of reports contained in the IANZ Procedures and Conditions of Accreditation must be followed.

These files may be obtained free of charge by contacting the Accreditation Services administration team on (09) 525 6655 or by emailing info@ianz.govt.nz.

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Articles of Interest

10 Auditing rules
Quality Progress July 2008, p45-49
The author lists 10 rules that he claims will significantly improve the effectiveness of audits making the results more useful to management.

Off to a good start
Quality Progress June 2008, p67-69
Looks at seven things to remember when initiating an audit. The seven things to remember are: confirm authority, provide information, communication channels, site safety rules, arranging the audit and observers and guides.

Aspects of auditing in clinical laboratories
Accreditation and Quality Assurance, Online First April 2008

Eight keys to successful ISO 22000 implementation
ISO Management Systems May-June 2008, p 35-39
Outlines eight practical steps to successful ISO 22000:2005 'Food safety management systems - Requirements for any organization in the food chain' implementation.

Photocopies of these articles are available on request from Rosemary Apperley, our IANZ Librarian free of charge. Email library@ianz.govt.nz or phone 09 525 6655 to obtain a copy. Please provide a mailing address as we are prevented by copyright from emailing them to you.

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Training Courses of Interest

Quality Management
ISO 9001 Management Systems
Auckland 2-3 December

Implementing Quality Management Systems
Auckland 24-26 November

Implementing and Auditing Quality Management Systems
Auckland 24-28 November

Laboratory Management
Laboratory Quality Management
Auckland 15-17 October

Traceability and Uncertainty in Measurement
Christchurch 3-4 November

Auditor Training
Internal Auditing
Auckland 4-5 December

Management Systems Auditing
Auckland 6-7 November
27-28 November

Environmental
Implementing Environmental Management Systems
Auckland 3-5 November

Implementing and Auditing Environmental Management Systems
Auckland 3-7 November

Details of all courses and booking forms are available from www.nzqc.co.nz, by phoning 0800 9000 99 or emailing info@nzqc.co.nz.

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Christmas Holiday Office Closure

IANZ office will close at 12.00 noon on Wednesday 24 December 2008, and reopen on Monday 5 January 2009.

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Correction

In the July issue of Focal Points, in the item headed ‘Registrations up in 2008’, the data in the table (for both 2007 and 2008) is actually “active assessment units”, not registrations or accreditations as indicated. “Active” means operative (currently accredited), suspended or applicant assessment units. The actual number of registrations is less than that stated in the table.

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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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