hkas news 40.pdf

January 2006

Issue No.

40H o n g K o n g A c c r e d i t a t i o n S e r v i c e

news

36/F., Immigration Tower,7 Gloucester Road, Wan Chai, Hong Kong.

Tel: 2829 4840 Fax: 2824 1302E-mail: [email protected]

Website: http://www.itc.gov.hk/hkas

Transition plan for ISO/IEC 17025:2005and New Certificate of Accreditation

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On 15 May 2005, the International Organisation for Standardisation (ISO) published

the second edition of ISO/IEC 17025 General requirements for the competence of testing

and calibration laboratories replacing the 1999 edition. Apart from medical laboratories,

the technical criteria of HOKLAS are based on this International Standard. As a matter

of fact, Sections 2 to 5 of HOKLAS 003 Technical Criteria for Laboratory Accreditation

is a verbatim reproduction of corresponding clauses of this standard. The eighth edition

of HOKLAS 003, which is based on the second edition of ISO/IEC 17025, was published

in October 2005. A copy of this new edition of HOKLAS has been sent to accredited

laboratories, laboratories that have shown interest in seeking accreditation, laboratory

assessors, and members of Accreditation Advisory Board and its Working Parties and

Task Forces.

The International Laboratory Accreditation Cooperation (ILAC) resolved that, by 1 June

2007, all accreditation certificates of testing and calibration laboratories shall refer to

the 2005 edition of ISO/IEC 17025. Such accreditation certificates shall be issued after

proper assessment of the added and amended clauses of the International Standard.

This assessment can be done during normal surveillance or reassessment activities or

as a separate activity. Since HKAS is a signatory to the ILAC mutual recognition

arrangement, HKAS is obliged to follow this transition plan.

A letter informing all accredited laboratories of the implementation schedule for the 8th

edition of HOKLAS 003 was issued on 12 October 2005. The implementation schedule

is reproduced below. In short, all accredited laboratories need to demonstrate conformity

with the new edition by 15 May 2007. Otherwise, their accreditation may be suspended.

A briefing session on the implementation of schedule for ISO/IEC 17025:2005 was held

on 20 October 2005 at the Hong Kong Central Library. It was attended by 219

representatives from accredited and applicant laboratories and assessors. Participants

were briefed on the changes to the standard and the implementation schedule.

Presentation materials of the briefing session are available from our website at http://

www.itc.gov.hk/en/quality/hkas/about.htm. Questions and answers raised during the

briefing session were also posted on our website.

Upon successfully updating its operation to ISO/IEC 17025:2005, a Certificate of

Accreditation stating that the laboratory meets the requirements of this new edition will

be issued. The following statement will also be included in the certificate:

"This laboratory is accredited in accordance with the recognised International Standard

ISO/IEC 17025:2005. This accreditation demonstrates technical competence for a

defined scope and the operation of a laboratory quality management system (refer joint

ISO-ILAC-IAF Communique dated 18 June 2005)."

1. Transition plan for ISO/IEC 17025:2005 and New Certificate of

Accreditation

2. New and amended requirements ofISO/IEC 17025:2005

3. HKAS Code of Ethics forAssessment Personnel

4. The first HKCAS accreditedProduct Certification Body

5. An update on the progress of themedical programme

6. Experience sharing session onmedical laboratory accreditation

organised by Department of Health

7. 3-day courses on MeasurementUncertainty for medical laboratories

8. Training courses on chemicalanalysis

9. Liaison meeting with users ofHKAS accredited services

10. HKAS Liaison meeting

11. Meeting with Certification Bodies

12. Experience in getting theHOKLAS Accreditation to ISO 15189

via bridging scheme

13. HKAS Assessors

14. APLAC General Assembly andMeetings

15. ILAC and IAF General Assembliesand meetings

16. New staff

17. Accreditation Update

18. Proficiency Testing Update

19. New and revised HKAS publisheddocuments

20. Upcoming Training Courses

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The inclusion of this statement was proposed by ILAC.

The need for this statement arose from difficulties that

accredited laboratories experienced when explaining to

their customers that they should ask laboratories to be

accredited to ISO/IEC 17025 rather than be certified to

ISO 9001. The situation became more acute with the

publication of ISO 9001:2000, as some customers

continued to ask laboratories to be certified, when they

really meant accredited. The confusion is caused by the

perception that accredited laboratories do not operate a

recognised quality management system. The above

statement could also be used by accredited laboratories

in their calibration certificates and test reports.

The joint ISO-ILAC-IAF Communique on the management

systems requirements of ISO/IEC 17025:2005 is available

on the website of ILAC at www.i lac.org. It is also

reproduced below.

Joint ISO-ILAC-IAF Communique on the Management Systems Requirements of ISO/IEC 17025:2005General Requirements for the competence of testing and calibration laboratories

A laboratory's fulfilment of the requirements of ISO/IEC 17025:2005 means the laboratory meets both the technicalcompetence requirements and management system requirements that are necessary for it to consistently delivertechnically valid test results and calibrations. The management system requirements in ISO/IEC 17025 (Section 4)are written in language relevant to laboratory operations and meet the principles of ISO 9001:2000 Quality ManagementSystems - Requirements and are aligned, with its pertinent requirements.

1. Laboratories applying for initialaccreditation

Application for accreditation

HKAS Execut i ve w i l l accept app l i ca t ions fo r

accreditation based on the 8th edition starting from 21

October 2005. HKAS Executive recommends that all

new applications should be based on this edition.

Applications for accreditation based on the 7th edition

will also be accepted until 15 May 2006.

Assessment and granting of accreditation

Starting from 21 October 2005, all initial assessments,

irrespective of whether the application is based on the

7th or 8th edition, will be based on requirements of the

8th edition.

Applications based on the 7th edition:

Between 21 October 2005 and 15 May 2006, non-

conformities against requirements of the 7th edition

identified during assessments will be raised as "Non-

conformities (NCs)". Non-conformities against the new

requirements of the 8th editions wil l be raised as

"Additional Recommendations". These "Additional

Recommendations" will become NCs on 15 May 2006.

Accreditation will be granted when all significant NCs

have been resolved to the satisfaction of HKAS

Executive.

Once a laboratory has been accredited, the third

paragraph in clause 2 "Accredited laboratories" below

applies.

After 15 May 2006, all such applications will be treated

as applications based on the 8th edition.

Applications based on the 8th edition:

All non-conformities against requirements of the 8th

edition identified during assessments will be raised as

Implementation Schedule for HOLKAS 003, 8th Edition

219 representatives attended the briefingsession on the transition plan

on 20 October 2005

Mr. W. W. Wong, Senior AccreditationOfficer, HKAS, responding to a question from

a representative of a laboratory

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NCs. Accreditation will be granted when all significant

NCs have been resolved to the satisfaction of HKAS

Executive.

An assessed laboratory shall provide a plan for resolving

all NCs identified in the assessment and the non-

conformities against the new requirements of the 8th

edition raised as "Additional Recommendations" to

HKAS Executive within one month of the assessment

visit.

2. Accredited laboratories

Starting from 21 October 2005, all reassessments,

assessments for extension of accreditat ion and

surveillance visits will be based on requirements of the

8th edition. Before 15 May 2006, non-conformities

against the new requirements of the 8th editions will

be raised as "Additional Recommendations". The

assessed laboratories shall provide a corrective action

plan for all NCs and all non-conformities against the

new requirements of the 8th edi t ion ra ised as

"Additional Recommendations" to HKAS Executive

within one month of the assessment. Same as the

existing policy, all significant NCs must be resolved

within 3 months and all minor NCs must be resolved

before the next reassessment. Accreditation will be

reaffirmed or extended when all the relevant significant

NCs have been resolved to the satisfaction of HKAS

Executive.

Starting from 15 May 2006, all non-conformities against

a l l requirements of the 8th edi t ion ident i f ied in

assessments will be raised as NCs. The outstanding

n o n - c o n f o r m i t i e s r a i s e d a s " A d d i t i o n a l

Recommendations" descr ibed in the preceding

paragraph will also become NCs on 15 May 2006.

All significant NCs against the new requirements of the

8th edition shall be resolved to the satisfaction of HKAS

Executive by 15 May 2007. To allow time for HKAS

Executive to evaluate the act ions taken by the

laboratories, accredited laboratories are required to

confirm to HKAS Executive by 15 April 2007 in writing

with evidence that such NCs have been resolved. If

HKAS Executive cannot confirm that all such significant

NCs have been resolved, it will suspend the relevant

accreditation. NCs other than significant NCs against

the new requirements of the 8th edition will be dealt

with in accordance with the existing policy.

3. Issue of Certificate of Accreditationreferring to the 2005 edition of ISO/IEC17025

Certificates of Accreditation referring to the 2005 edition

of ISO/IEC 17025 will be issued free of charge to

accredited laboratories when conformity with the 8th

edition for the relevant test categories have been

demonstrated to the satisfaction of HKAS Executive.

If an accredited laboratory decides to obtain a new

certificate of accreditation referring to ISO/IEC 17025 :

2005 earlier than the time allowable by the normal

reassessment / surveillance schedule, it may request

HKAS Executive to carry out a specially arranged

surveillance visit but shall have to bear the cost of such

a visit.

When it was decided to revise ISO/IEC Guide 25:1990,

one of the main purposes was to harmonise it with ISO

9001: 1994. The outcome of this revision was ISO/IEC

17025 published in 1999. All those requirements of ISO

9001:1994 and ISO9002:1994 that were relevant to the

scope of testing and calibration services with respect to

the laboratory’s quality system were incorporated in this

ISO standard. In 2000, the third edition of ISO 9001 was

published making the requirements of quality system

relating to ISO 9001 and ISO 9002 obsolete. A revision of

ISO/IEC 17025:1999 was thus started to align its quality

system requirements with ISO 9001:2000. This exercise

has resulted in the publication of the second edition of

ISO/IEC 17025 in May 2005.

New and amended requirements ofISO/IEC 17025:2005

Some of the more important changes are summarised in

the fol lowing table. In addit ion, there is a generic

terminology change. Throughout the second edition of

ISO/IEC 17025, references to “quality system”, “client”,

and “conformance” have been replaced by “management

system”, “customer”, and “conformity” respectively. As can

be seen from this table, there are no major changes in the

requirements other than those related to the alignment of

the management system requirements with those of ISO

9001:2000.

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New/revised requirements of ISO/IEC 17025:2005

Clause New/Revised Requirement

4.1.5a) The laboratory shall have managerial and technical personnel who, irrespective of other responsibilities, have

the authority and resources needed to carry out their duties, including the implementation, maintenance and

improvement of the management system, and to identify the occurrence of departures from the management

system or from the procedures for performing test and/or calibrations, and to initiate actions to prevent or minimize

such departures (see also 5.2)

4.1.5 k) The laboratory shall ensure that its personnel are aware of the relevance and importance of their activities

and how they contribute to the achievement of the objectives of the management system.

4.1.6 Top management shall ensure that appropriate communication processes are established within the

laboratory and that communication takes place regarding the effectiveness of the management system.

4.2.2 The overall objectives shall be established, and reviewed during management review....

4.2.2 c) the purpose of the management system related to quality;

4.2.2 e) The laboratory management’s commitment to comply with this International Standard and to continually improve

the effectiveness of management system.

4.2.3 Top management shall provide evidence of commitment to the development and implementation of the

management system and to continually improving its effectiveness.

4.2.4 Top management shall communicate to the organisation the importance of meeting customer requirements

as well as statutory and regulatory requirements.

4.2.7 Top management shall ensure that the integrity of the management system is maintained when changes

to the management system are planned and implemented.

4.7.1 The laboratory shall be willing to cooperate with customers or their representatives in clarifying the customer’s

request and in monitoring the laboratory’s performance in relation to the work performed, provided that the

laboratory ensures confidentiality to other customers.

4.7.2 The laboratory shall seek feedback, both positive and negative, from its customers. The feedback shall be

used and analysed to improve the management system, testing and calibration activities and customer

service.

4.9.1c) The policy and procedures shall ensure that:

c) correction is taken immediately, together with any deviation about the acceptability of the nonconforming

work;

4.10 The laboratory shall continually improve the effectiveness of its management system through the use of

the quality policy, quality objectives, audit results, analysis of data, corrective and preventive action and

management review.

4.12.1 Needed improvements and potential sources of nonconformities, either technical or concerning the management

system, shall be identified. When improvement opportunities are identified or if preventive action is required,

action plans shall be developed, implemented and monitored and to reduce the likelihood of the occurrence of

such nonconformities and to take advantage of the opportunities for improvement.

4.15.1 The review shall take account of:

- recommendations for improvement;..

5.2.2 The effectiveness of the training actions taken shall be evaluated.

5.9.2 Quality control data shall be analysed and, where they are found to be outside pre-defined criteria, planned

action shall be taken to correct the problem and to prevent incorrect results from being reported.

5

On 31 August 2005, Castco Certification Service Ltd. was

granted accreditation for production and supply of ready

mix concrete, standard sands for cement testing and

replacement sands for soil testing. This is the first product

certif ication body accredited under the Hong Kong

Certification Body Accreditation Scheme (HKCAS). Two

other applications are being processed.

Hong Kong Accred i ta t ion Serv ice launched the

accreditation service for product certification systems for

construct ion products in August 2003 whi le the

accreditation service for consumer products certification

system was launched in July 2005. The accreditation

criteria are requirements stated in ISO/IEC Guide 65: 1996.

The IAF Application Guide 65 and other application guides

and standards are also applied. With the help of the

Accreditation Advisory Board Working Party on certification

and its task force on consumer product certification, two

Supplementary Criteria documents, HKCAS Supplementary

Criteria 002 and 003, for construction products certification

and consumer product certification respectively have been

published.

The First HKCAS accredited Product Certification Body

In addition to ensuring that a reliable quality system is

effectively implemented, the accreditation criteria emphasize

the technical capability of the certification body, including

the acceptability of its certification scheme, the technical

competence of its staff, and the competence of its testing

laboratory, if any. Such emphasis is necessary to assure

that products certified under accredited certification system

indeed meet the certification requirements.

The accreditation service also promotes transparency in

product certification operation. For construction products,

if a certification mark appears on a product, the relevant

product standards applied must be traceable through this

mark. For consumer products, it is further required that the

certification body shall keep an up-to-date list of products

which it has certified in its website. This list shall be freely

accessible to the public and include links to details of the

certification schemes under which a product is certified. It is

hoped that such transparency will enable users of the certified

products to understand exactly what assurance the product

certification provides. The information also allows users

of products to evaluate whether the certification system

HKAS Code of Ethics for Assessment Personnel

Assessment is the tool used by accreditation bodies to

assess the competence of applicant laboratories, certification

bodies and inspection bodies. Whether the accreditation

will satisfy the requirements and expectation of the

organization being assessed, the users of accredited service

and other stakeholders depends to a large extent on the

performance of the assessment team. However, an

assessment is usually a complex task in which many

judgements have to be made based on a myriad of facts as

well as the perceived relationship between the assessment

team and the organization being assessed. The nature of

the relationship may affect the assessment conclusion. To

help organizations being assessed and assessors conducting

the assessment in establishing a correct moral ground for

their relationship, HKAS issued a Code of Ethics for

assessment personnel in October 2005. This Code

incorporates the prevailing international understanding and

practice and feedback and suggestions from all stakeholders.

All assessment personnel abide by this Code. The essence

of the Code require assessment personnel to:

• Be impartial, objective, positive, open and helpful.

• Avoid any situation that may give rise to real or perceived

conflict of interest or compromise of impartiality.

• Not accept bribery of any form.

• Not discuss with or disclose to any third party any findings

or confidential information relating to any assessment

activity unless required by law or with written consent of

both HKAS Executive and the assessed organisation.

• Not act in any way that may prejudice the reputation and

interests of HKAS and the organisation being assessed.

• Only undertake assessments in which one is competent,

be prepared to admit one’s limitation but ready to exercise

judgement within one’s area of expertise.

• Prepare adequately, assess diligently, focus on significant

issues and report findings truthfully and fairly.

• Treat all persons tactfully and with respect.

• Consider seriously the views of the assessed organisation.

• Cooperate fully with other members of the assessment

team.

The Code may also be used by organizations being assessed

to understand the activities and decisions of the assessment

team. This Code is designed to be self-explanatory. Further

information on the basis of the Code may be obtained from

the HKAS Executive.

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On 7 November 2005, an experience sharing session on

medical laboratory accreditation was organised by the

Department of Health as a part of the Cervical Screening

Programme launched in March 2005. The objective was to

encourage laboratories in both public and private sector

cervical screening laboratories to seek accreditation.

Ms. Bella Ho, Senior Accreditation Officer of HKAS introduced

the features of the HOKLAS medical laboratory accreditation

programme and its application procedures and accreditation

criteria. Ms. Christ ina Leung, Quality Manager of

Histopathology and Cytology Division, Public Health

Laboratory Services Branch, shared with the audiences her

experience at various stages of preparing for accreditation

and the obstacles she had faced. The Histopathology and

Experience Sharing Session on Medical LaboratoryAccreditation Organised by Department of Health

Cytology Division of PHLSB is the first public laboratory

accredited for providing histopathology and cytology testing

service under the HOKLAS

Dr. Chan Keeng Wai, Laboratory Director of Diagnostix

Pathology Laboratories Ltd. also shared his experience in

accreditation. Dr Chan’s laboratory is the first private medical

laboratory accredited by HKAS through the Bridging Scheme.

This scheme is open to laboratories already accredited by

other overseas accreditation bodies to other international

standards. Dr. Chan concluded his experience by saying

that “the public in general and the patients in particular will

be better served if more labs are accredited - this is the reward

and it opens up more opportunities.”

3-day Courses on MeasurementUncertainty for Medical Laboratories

Since the launching of the accreditation programme for

medical laboratories in February 2004, three medical

laboratories, including two public and one private

laboratories, have successfully been accredited to ISO

15189:2003. To denote that these laboratories are providing

medical testing services, the HOKLAS laboratory registration

number given to these laboratories starts with the numeral

of “8”. A suffix of “P” or “S” is also appended to the

registration number to indicate whether the Laboratory

Director is a Pathologist or a Biomedical Scientist.

An update on the progress of the medical programme

So far, all the three accredited medical laboratories are

directed by pathologists. A further four applications are being

processed, including some biomedical scientist directed

laboratories. A number of others are known to be at the last

stage of their preparation and planned to submit their

applications in the first quarter of 2006. It is envisaged that

by the end of next year, the number of accredited medical

laboratories will have substantially increased. Internationally,

ISO 15189 is also gaining wider acceptance and more and

more medical laboratories are accredited to this standard.

In view of the “uncertainty” experienced and expressed by

many medical laboratory practitioners on the accreditation

requirement relating to measurement uncertainty, HKAS

arranged a course on “Measurement Uncertainty in

Laboratory Medicine”. The course was held twice in the

second half of November.

Dr. Kallner, senior consultant at the Karolinska University

Hospital in Stockholm, Sweden, was invited to deliver the

courses. Dr. Kallner is very experienced in this area. He is a

member of the relevant technical committee of the

International Organization for Standardization (ISO) and

Comite Europeen de Normalisation (CEN) responsible for

meets their needs so that they may have more confidence

in buying the certified products.

More details of the accreditation service and relevant

documents are available from the HKAS website of www.

itc.gov.hk/hkas. Certification bodies interested in obtaining

accreditation for their product certification systems may

contact our officers, Mr C K Cheung (Tel. 2829 4870) for

construction materials and Mr K W Chen (Tel.2829 4826)

for consumer product certification. Parties interested in

knowing how accredited certification systems can help in

assuring the quality of products may also contact them.

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The first meeting with the users of HKAS accredited service

was held on 11 November 2005. It was attended by

representatives from users of accredited services and senior

staff members of the HKAS Executive. The terms of reference

of this liaison group are:

1. A forum for discussion of accreditation issues relevant to

users of accredited services

• The desirable standard of accreditation

• User experience and feedback

• Areas for improvement

2. Enhancement of communication between users of

accredited services and HKAS.

The overall feedback was that the accredited service is

generally satisfactory and the rigor of HKAS assessments

Liaison Meeting with Users ofHKAS Accredited Services

was appropriate. As to the differences between endorsed

and non-endorsed reports, it was clarified that it was not

mandatory for accredited organisations to issue HKAS

endorsed reports. To ensure that the service has been

accredited, users of accredited services should request the

test or inspection results be given on HKAS endorsed reports,

i.e. a report bearing the HKAS accreditation mark.

Nevertheless, according to HKAS regulat ions for

accreditation, the same standard of service should be

provided no matter whether or not an endorsed report is

used. Members were invited to nominate other users of

accredited service to join meeting which will be held on a

half-yearly basis. Members’ comments and feedback are

most welcome and will be the basis for improving the services

of HKAS and its accredited organisations. Readers interested

in joining this group are most welcome. Please contact our

Ms Donna Cheung via email at [email protected].

The HOKLAS-HKIAS liaison group was expanded to cover

certification bodies in June 2005 and renamed the HKAS

Liaison Group. The group has its 7th meeting on 8 December

2005. HKAS is thankful to the representatives for their

valuable feedback which is very important for improving our

services. Following are some of the issues discussed at the

meeting.

HKAS Liaison Meeting

1. HKAS informed the meeting that the APLAC MRA has

been expanded and three new signatories have been

admitted. They are CAEAL of Canada (testing only),

BSPLAS of the Philippines (testing and calibration) and

ema of Mexico (testing, calibration and inspection). The

scope of recognition of TAF of Chinese Taipei has been

extended to inspection. Representatives from laboratories

A series of training courses on chemical analysis were

organised in November 2005. They are “Preparing for

Accreditation”, “Evaluating Measurement Uncertainty in

Chemical Analysis”, “Further Techniques in Measurement

Uncertainty” and “Selecting and Validating Chemical

Training courses on chemical analysis

Methods”. The presenter of these courses was Dr Bernard

King. The courses attracted a total of 56 attendees. HKAS

will continue to organise such courses if there are continuing

demand for them.

drafting standards in metrology and laboratory medicine.

The course was designed to help laboratory personnel to

grasp the concept of measurement uncertainty and let the

participants have hands-on experience in the calculation of

measurement uncertainty using examples in a clinical setting.

The course started with an introduction on measurement

uncertainty and related basic statistics. It went on to the more

practical issues including internal qual i ty control,

interlaboratory comparisons, method evaluation and

validation, and calculation of measurement uncertainty. A

lots of examples from a clinical setting were given.

As limited places were available, priority was given to

participants working in chemical pathology and haematology

areas. Over 60 participants from 25 public and private

hospital laboratories and private laboratories attended the

course. Feedback from the participants indicated that this

sort of course is useful and they welcomed HKAS to organize

similar courses in the future.

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and inspection bodies expressed that the APLAC MRA

was very important for gaining acceptance of their

calibration certificates and inspection and test reports

globally. HKAS will continue to participate actively in

international activities to promote the acceptance of

HOKLAS endorsed reports and certificates by both the

regulatory authorities and other users of conformity

assessment services worldwide.

2. Laboratory representatives found the initiative of HKAS

of combining assessments for similar tests beneficial as

fewer assessments means less disturbances to their

operation. They like HKAS to continue with this practice.

HKAS will continue with this practice and to agree with

the laboratories on the assessment plan at the end of

each year. However, it was agreed that the plans may

be amended to accommodate urgent requests for

accreditation arising from requests of laboratory

customers.

3. HKAS asked the meeting for feedback on the new

arrangement for preparing “br ief ing notes” for

assessments. Representatives from laboratories found

no problem with this arrangement but enquired if it was

possible not to submit those documents that had already

been submitted recently. HKAS explained that, if a full

set of documents were not provided, it would be difficult

to keep them up-to-date. However, laboratories are

encouraged to discuss with the officers-in-charge on the

information to be provided and sometimes a full set of

documents may not be required. HKAS further explained

that, if electronic documents were provided, a content

page with “hyperlinks” to appropriate documents should

be provided to facilitate assessors in finding the required

documents.

4. HKAS briefed the meeting the key issues discussed at

the liaison meeting with users of accredited services held

on 11 November 2005. Representatives of accredited

organisations were asked to nominate their major

customers to join that meeting in order to increase its

representativeness.

5. HKAS informed the meeting that the second edition of

ISO/IEC 17025 was published in May 2005 and,

according to ILAC, all accreditation certificates need to

refer to this edition by 1 June 2007. A transition plan has

been published. Since there are no substantial changes,

HKAS does not expect any major problem for accredited

laboratories to upgrade their operation. However, before

a Certificate of Accreditation stating conformity with this

edition is issued, a laboratory has to demonstrate full

compliance with it. Laboratory representatives presented

indicated that they did not find any major problem in the

transition so far.

A meet ing with representat ives f rom the HKCAS

accredited certification bodies (CBs) was held on 26

September 2005. The main purpose of this meeting is to

keep CBs informed of the latest developments in the

practice of accreditation at international level and other

issues related to certification. Opportunities were also

taken to brief CBs on the developments in HKAS. A

summary of the main issues is given below.

Temporary sites

For construction sites and other similar cases, CBs were

reminded of the necessity to obtain the project list prior to

each visit. The purpose of this is to determine the

adequacy of auditor man-day. The man-days should be

adjusted according to the number of sites to be visited.

Coverage of entire management system standard for

trainee auditors

CBs were informed of the need to provide evidence that a

trainee auditor had been adequately trained for the entire

management system standard before he/she is qualified

as an auditor.

Meeting with Certification Bodies

Justification for auditor manday

CBs were reminded of the requirement that, in cases where

adjustments have been made to the time listed in the

Auditor Time table, sufficient justifications should be

provided and records of such variations should be

maintained.

Number of auditors in an audit team

It has been observed that some organisations have

difficulties in receiving audit teams with many auditors

because there was insufficient number of staff members

who were responsible for and familiar with quality system

of the organisations. Moreover, as all auditors need to

attend the opening and closing meetings, team meetings,

etc., the time available for auditing will be correspondingly

reduced. This would obviously affect the progress and

efficiency of the audit. CBs should discuss with the

organisation on the appropriate size of the audit team that

it could comfortably receive. Moreover, the duration of

audit may need to be extended, if necessary. While there

is no requirement governing the maximum number of

auditors in a team, audits need to be effective. When a

9

Experience in getting the HOKLAS Accreditation toISO 15189 via the Bridging SchemeBy Dr Chan Keeng Wai, Director, Diagnostix Pathology Laboratories Ltd

I left my position as the Consultant Pathologist at Princess

Margaret Hospital in 1985 to embark on a new career in

private practice. My missions were to provide a good

quality and ethical pathology service of high professional

standard, efficient and profitable, in that order. It is difficult

to evaluate what is ethical but it is easier to assess quality

that is ultimately linked to accreditation.

What is quality? It is defined in ISO 9000:2005 as ‘degree

to which a set of inherent character is t ics fu l f i l s

requirements’. Not to be mistaken for “degree of excellent”

or “fitness for use” which meet only part of the definition’.

It is therefore clear that quality has to be measured

objectively and assessed by an external and independent

source. As a first step, we subscribed to the relevant

External Quality Assurance Programs organised by Royal

College of Pathologists in 1996. Later, we also joined

similar programs organised by the Hong Kong College of

Pathologists. In 2000, we believed that we were ready to

apply for accreditation by NATA (National Association of

Testing Authorities, Australia) based on ISO 17025:1999.

As we were starting from scratch, we had to engage a

private consultancy firm to help us in preparing various

Quality and Operation Manuals. Meanwhile, we held

regular meetings with all the staff to get their understanding

and participation. We also invited our professional

colleagues to visit our laboratory and to conduct unofficial

audits. As a result, we had to make appropriate corrective

and remedia l measures in many areas, inc luding

management, profess ional , technica l , laboratory

environment, safety and accommodation.

In December 2002, our laboratory was formally assessed

by a team of assessors from NATA and they made some

comments and requirements in their report sent to us in

February 2003. Accordingly, we took the necessary follow

up actions and our laboratory was formally accredited by

NATA in May 2003. Re-assessment by NATA was carried

out on 6 October 2004 and a few minor problems were

identified. We went through similar process of responding

to the re-assessment report and accreditation was

renewed and extended for three years.

Soon after getting our reaffirmation of accreditation from

NATA, we attended a briefing session by HKAS (Hong

Kong Accreditation Service) on 3 December 2004,

introducing their Bridging Scheme for medical laboratories

holding other accreditat ions. Ms Bel la Ho, Senior

Accreditation Officer of HKAS, explained in detail how this

Bridging Scheme works, its purpose, who are eligible to

apply and how to apply.

It appeared that the main additional requirements for ISO

15189:2003 as compared with ISO 17025:1999 are certain

specific requirements for medical laboratories such as

continual improvement (in Management Requirement 4.

12) including operational procedure, implementation of

quality indicators and other activities leading to better

pat ient care and further educat ional and tra in ing

opportunities for staff. Since this is in l ine with our

objectives and also to show our support for the local

scheme, we decided to take up this one-off challenge and

submitted our application for accreditation in February

2005. The local scheme has the added advantage of being

a signatory to the International Laboratory Accreditation

Cooperation (ILAC) Mutual Recognition Arrangement

team is large, CBs should obtain information from the

organization as to whom would be the auditees together

with their functions/duties. CBs should be able to match

the number of auditors with that of auditees. HKAS

Executive expects CBs to show evidence in such planning.

Auditor manday for Integrated Management System

(IMS) audit

It was noted that some CBs reduced the auditor manday

by around 30% for individual certification systems and

another further 30% for IMS audit resulting in a more than

50% reduction in auditor mandays. In many such cases,

the justification recorded was simply IMS audit. Experience

showed that, if the reduction was solely due to IMS audit,

saving in auditor time could not be to such an extent. Other

justifications are needed to justify the reduction.

A photo of the laboratory staff, a reflection of theimportance of team work leading

to HOKLAS accreditation

10

HKAS Accreditations are based on findings in on-site

assessments conducted by our assessors. Assessors are

our most important resource and the quality of our

accreditation is dependent on the competence and

professionalism of our assessors. As HKAS provides

accreditation in many technical fields, HKAS needs

competent professionals, including pathologists, scientists

and engineers of various disciplines, chemists, physicists,

microbiologists, biomedical scientists etc., to act as lead

assessors, technical assessors and technical experts for

conducting assessments for laboratories, certification bodies

and inspection bodies. All professionals working in Hong

Kong, irrespective of their full time employment are welcome

to become HKAS assessors. Acting as an assessor is a

worthwhile community service contributing to improving the

HKAS Assessors

standard of local laboratories, certification bodies and

inspection bodies and thereby improving the overall

competitiveness of Hong Kong SAR. Training for conducting

assessments will be provided by HKAS. To thank for the

service provided by lead assessors, technical assessors and

technical experts, an honorarium of HK$1,800 to HK$2,500

is payable for each on-site assessment day. More information

is given in a document in the HKAS website under the heading

of “Become a HKAS Assessor” or following this link: http://

w w w . i t c . g o v . h k / e n / d o c / q u a l i t y / h k a s / a s s e s s o r

appointment%20of%20assessors%20details%20content.

doc. Professionals interested in providing this meaningful

community service may contact Ms Donna Cheung at

telephone 2829 4802 or [email protected].

The APLAC General Assembly and meetings were held on

13-18 November 2005 in Chiangmai, Thailand. This was an

annual event consisting of a series of meetings organised

for discussing and resolving technical and non-technical

issues relating to accreditation of laboratories and inspection

bodies, and the mutual recognition arrangement (MRA) of

their accreditation. Mr. S. S. Chan, Executive Administrator,

HKAS and Mr. W. W. Wong, Senior Accreditation Officer,

HKAS attended the meetings.

Some salient points of the meetings are:

APLAC General Assembly and Meetings

(MRA) (53 accredi tat ion bodies in 42 economies

worldwide) and the cost is much lower than other overseas

schemes. The HKAS sent their team to assess us on 27

April 2005. After a full day’s gril l ing, we received 19

o b s e r v a t i o n s ( m i n o r n o n - c o n f o r m i t i e s a n d

recommendations) from the assessors. Without delay, we

addressed these issues and duly reported to HKAS within

a short time. We were accredited by HKAS on 23 May

2005 in Histopathology and Cytopathology with a

pathologist as the Laboratory Director. Thus, we are the

first private pathology laboratory in Hong Kong to be

accredited by both NATA and HOKLAS for medical testing

The impacts of being an accredited laboratory are several:

1 For the staff: better working environment, educational

and training opportunities.

2 For the laboratory : probably bet ter bus iness

opportunities.

3 For the referring doctors and other laboratories:

assured quality service.

4 For the patients: assured credibility and confidence in

our test reports.

By being a pioneer in obtaining laboratory accreditation,

we have set an example for other laboratories in Hong

Kong to go for the accreditation under HOKLAS. The

public in general and the clinicians and patients in particular

will be better served if more laboratories are accredited.

That will help raising the standard of medical testing in

Hong Kong to an internationally recognised level that we

will be proud of. Thus, in this respect, the pivotal role

played by HOKLAS cannot be underestimated.

APLAC welcomes three new signatories to the MRA.

11

1. There are three new signatories to the APLAC MRA. They

are CAEAL of Canada (testing only), BPSLAS of the

Philippines (testing and calibration) and ema of Mexico

(testing, calibration and inspection). The signatory status

of TAF of Taiwan was reaffirmed and its scope of

recognition was extended to inspection. The continuation

of three other accreditation bodies’ signatory status, viz.,

SCC of Canada (calibration and testing), VLAC of Japan

(testing) and TLAS of Thailand (testing and calibration)

was confirmed. JAS-ANZ was admitted to APLAC as a

full member. It is a trans-national organisation covering

both Australia and New Zealand.

2. The MRA Council resolved that all accredited laboratories

needed to meet the 2005 edition of ISO/IEC 17025 by 1

June 2007. This is in line with the corresponding ILAC

resolution.

3. The MRA Council resolved that medical testing would

be listed as a separate entry to the scope of recognition

under the MRA. Detailed procedure for this will be worked

out and discussed at the next MRA Council meeting.

4. It has been decided that APLAC will be incorporated in

New Zealand. The General Assembly endorsed the

proposed Constitution of APLAC.

5. The Technical Committee discussed the issue of CMCs

and BMCs. BMCs are used by accreditation bodies to

indicate the calibration capabilities of their accredited

laboratories. CMCs are used by BIPM to indicate

calibration capabilities of national measurement institutes

under its MRA. There was a discussion between BIPM

and ILAC as well as other regional laboratory accreditation

cooperations with a view to harmonised the description

of the capability of calibration laboratories. A task group

under the Technical Committee was set up to further

discuss this issue and Tony Russell, APLAC Chair, was

appointed as the coordinator of this task group. A

discussion paper will be prepared.

The general assemblies of the International Accreditation

Forum (IAF) and International Laboratory Accreditation

Cooperation (ILAC) and related meetings of 2005 were held

in Auckland, New Zealand in September. The following is a

summary of the more important resolutions made:

ILAC

1. OAA of Argentina for calibration and testing, NLAB of

Egypt for calibration and testing, PCA, Poland for

calibration and testing, IAS of USA for extension of

signatory status to include calibration, ONARC of Cuba

for calibration and testing were accepted into the ILAC

MRA.

2. To proceed with a global multilateral mutual recognition

arrangement for inspection jointly with the International

Accreditation Forum (IAF). It is expected that the

remaining issues relating to the evaluation of critical

locations can be resolved at the 2006 ILAC General

Assembly meeting to be held in Cancun of Mexico.

3. To include accreditat ion of medical reference

measurement laborator ies using ISO 15195 in

combination with ISO/IEC 17025 under the current ILAC

MRA arrangement.

4. To include accreditation of reference material producers

using ISO Guide 34 in combination with ISO/IEC 17025

under the current ILAC MRA arrangement when

appropriate procedures for this activity have been

developed and agreed by ILAC.

5. Approval of ILAC P9, policy for participation in national

and international proficiency testing activities. P9 will

become effective from 1 January 2006.

6. That all ILAC members shall have a cross-frontier

accreditation policy in harmony with ILAC G 21.

7. To endorse the use of ILAC G13 together with ISO Guide

43 as the base criteria for accreditation of proficiency

ILAC and IAF General Assemblies andmeetings in 2005

Photo taken at the opening ceremony of the 2005 APLACGeneral Assembly in Chiangmai, Thailand

HOKLASRegistration

No.Name of Laboratory

Accredited Test Categoriesand

Test Areas / DisciplinesClientele

156

157

Yang Mulia Gems Limited - Hong Kong GemsLaboratory

HILTI (Hong Kong) Ltd. - Testing Laboratory

12

After working in HKAS for about six years, Dr. Eddie Pang

was posted back to the Government Laboratory in August

2005. HKAS Executive would like to thank Dr. Pang for his

contribution in the work of HKAS and also wish him every

success in his future endeavours.

We welcome Ms. Ada Leung to HKAS as Accreditation

Officer. She is mainly responsible for leading assessments

for chemical and microbiological tests in various test

categories. Ms Leung joins us from the Government

Laboratory where she has worked as a chemist for over ten

years. She has extensive analytical chemistry experience that

ranges from environmental testing, pharmaceutical analysis

to examination of Chinese medicines. Ada holds a BSc (Hons)

degree in chemistry and biology from the Hong KongMs Ada Leung, Accreditation Officer, HKAS

Polytechnic and an M.Phil degree in chemistry from the

Chinese University of Hong Kong.

New Staff

Accreditation Update

New Accreditation Granted

A certification body and ten laboratories have obtained

accreditation since the last issue of HKAS news. Fugro

Certification Services Limited (registration number HKCAS

010) was accredited for ISO 9001 and ISO 14001 certification

on 23 September 2005. The names of the accredited

testing providers. The GA also endorsed the review of

G13 and requested ISO to urgently revise ISO Guide 43

Part 1 and 2 and convert them into a standard.

8. That ISO/IEC 17025:2005 be implemented by all

accredited calibration and testing laboratories by 1 June

2007

9. To establish a Joint Working Group with IAF for

communication and marketing issues and to prepare its

terms of reference.

IAF

1. OAA (Argentina) for QMS, EMS and Product and PCA

(Poland) for QMS, EMS and Product were accepted into

the IAF MLA.

2. The principles of the IAF Cross Frontier Accreditation

Policy are to be applied to all fields of accredited

certification offered under IAF membership.

3. To take action to confirm a date by which all foreign critical

locations are assessed on-site with results to be reported

by the MLA Committee at the 2006 general assembly.

4. To proceed with a global Multilateral Mutual Recognition

Arrangement (MLMRA) for inspection jointly with ILAC.

5. To encourage the JWG for Inspection to reach consensus

on the technical issues under debate and looks forward

to a resolution of these matters at the Cancun meeting,

November 2006.

Physical and Mechanical Testing- gemstone testing

Construction Materials- anchor bolt and dowel bar

Public

Public

laboratories and their HOKLAS registration numbers,

accredited test categories and clientele are summarised

below. HKAS wishes to congratulate them on their success

in obtaining accreditation.

13

Construction Materials

An update on the prof iciency test ing programme

Proficiency Testing Update

HKAS would also like to offer our congratulations to Castco

Certification Services Limited (HKCAS Registration No. 009)

on their success in obtaining accreditation for product

certification on 31 August 2005. The scope of accreditation

covers product conformity certification (product certification

system No. 5 as defined in the ISO/IEC Guide 67:2004) for

ready mixed concrete production, standard sand production

and replacement sand production. Castco is the first

certification body accredited for product certification under

HKCAS.

Accreditation Suspended and Reinstated

Foundation Techniques Ltd. (HOKLAS Registration No. 071)

voluntarily suspended all aggregate site tests under the test

category of “Construction Materials” effective 29 June 2005.

The accreditation of The Hong Kong Standards and Testing

Centre Ltd. (HOKLAS Registration No. 003) for EMC tests

under the test category of “Electrical and Electronic Products”

was reinstated on 17 October 2005.

Change of Legal Status

HOKLAS Registration No. 004 was transferred from CMA

158

159

160

161

162

163

164

803P

CTC Asia Limited

Hong Kong Science and Technology ParksCorporation - ProductAnalysis Laboratory (PAL)

API Lab Testing Limited

Mr. CHE Kee Keung Trading As Far EastTechnical Services

MaxLab Cal ibrat ion Centre Limited -Calibration Laboratory

Hong Kong Baptist University - DioxinAnalysis Laboratory

ISPL Consulting Limited - Testing Laboratory

Histopathology and Cytology Division ofPublic Health Laboratory Services Branch,Centre for Health Protection, Department ofHealth

Textiles and Garments- Colour fastness, performance and strength tests forfootwear, glove and leather

Physical and Mechanical Testing- coating thickness for metallic coatings

Toys and Children’s Products- flammability and physical and mechanical tests

Construction Material- Testing for welds

Calibration Services- for electrical measuring instruments

Environmental Testing- Polychlorinated dibenzodioxins and polychlorinateddibenzofurans determination for ambient air, incineratorfly ash and sediment and soil

Construction Materials- anchor bolt

Medical Testing- anatomical Pathology

Public

Public

Public

Public

Public

Public

Public

Public andprivate

hospitals andclinics

Testing and Certification Laboratories to CMA Industrial

Development Foundation Limited with effect from 3 October

2005. The laboratory has been granted accreditation for

the test categories of “Electrical and Electronic Products”,

“Chemical Testing “, “Chinese Medicine”, “Environmental

Testing”, “Food”, “Textiles and Garments” and “Toys and

Children’s Products”. It provides testing service to the public.

Accreditation Terminated

Fugro Geotechnical Services (HK) Limited has voluntarily

terminated its HOKLAS accreditation for all tests with effect

from 27 April 2005.

Stanger Asia Ltd. (HOKLAS Registration No. 021) has

voluntarily terminated its accreditation for all tests for cooking

benches and sink units under the test category of

“Construction Materials” effective 5 May 2005.

The accreditation for all chemical tests under the test category

of “Construction Materials” of the Housing Department

Materials Testing Laboratory was voluntarily terminated with

effect from 29 September 2005.

organsied by HKAS in the year 2005 and 2006 is

14

Toys and Children’s Products

Final report on APLAC T039 - Toy Safety Proficiency

Testing Programme has been issued. A total of 71

laboratories from 26 accreditation bodies participated in

this programme. The performance of the majority of

participating laboratories was satisfactory with more than

90% of the reported coated plate test results achieving

satisfactory z-scores. This programme was joint ly

organised by HKAS and the Government Laboratory.

Chinese Medicine

Comments on the draft final report on APLAC T-043 -

Herbal Medicine Proficiency Testing Programme have been

received from the APLAC Proficiency Testing Committee

and the final report is expected to be ready for distribution

in January 2006. This programme was jointly organised

by HKAS and the Government Laboratory.

A new programme (APLAC T049) is being organised by

HKAS in collaboration with the Government Laboratory

under the auspices of APLAC. This programme is on

organochlorine pesticide residue analysis in herbal

medicine. Invitation has been sent to accreditation bodies

for nominations of participants. Samples are scheduled

for dispatch to participating accreditation bodies in January

2006.

Physical and Mechanical Testing

The final report on gemstone (quartz) testing proficiency

testing programme has been issued. Laboratories

identified as outliers have been requested to undertake

an investigation and provide the findings to HKAS.

Textiles and Garments

The final report on APLAC T044 on textile testing jointly

organised by Hong Kong Association of Certification

Laboratories (HKACL) and HKAS has been issued. APLAC

and APEC member economies were invited to participate.

A total of 55 laboratories from 16 accreditation bodies

participated. The performance of the participants is

generally satisfactory. Overall, there are 489 results

returned and 45 results from 22 laboratories have been

identified as outliers.

Others

APLAC APM 017 - interlaboratory comparison programme

on mass calibration is being jointly organised by Hong

Kong Association of Certification Laboratories (HKACL),

HKAS and National Accreditation Body, Indonesia (KAN).

The Hong Kong Standard and Calibration Laboratory and

the reference laboratory of KAN are monitoring stability of

the artifact used for this programme. It is expected that

circulation of the artifact will start in February 2006.

Interim reports on APLAC T020 - chemical testing of

Portland Cement and APLAC T021 - alcoholic beverage

testing organised by Taiwan Accreditation Foundation (TAF)

have been distributed to Hong Kong participants. Their

performance is satisfactory.

Interim report on APLAC T045 - Fasteners organised by

TAF has been distributed to Hong Kong participants. Out

of the 14 results reported by Hong Kong laboratories, 2

results from a laboratory were identified as outliers. This

laboratory is not accredited by HKAS for the test.

Final report on APLAC T048 - Beef veterinary drug residue

organised by China National Accreditation Board For

Laboratories (CNAL) has been distributed to Hong Kong

participants. Their performance is satisfactory.

Test AreaScheduled

Dates Status

Aggregate - physical

test

Aggregate - alkaline

aggregate reaction

Soil - in-situ density

t e s t b y N u c l e a r

Densometer

Non destructive testing

- soil nail

Reinforcing steel -

physical test

May 2005

December 2005

January 2006

January 2006

February 2006

Testing completed and

da ta ana l ys i s i s i n

progress

Sample homogeneity

study underway and

interested laboratories

w i l l b e i n v i t e d f o r

part ic ipat ion in due

course

Interested laboratories

w i l l b e i n v i t e d f o r

participation shortly

Invitation to participate

sent out

P r o g r a m m e b e i n g

planned and interested

laborator ies wi l l be

invited to participate in

due course

summarised below:

New and Revised HKAS Published Documents

Published/RevisedDateHKAS published documents

HOKLAS Supplementary Criteria No. 2, Issue No. 4

“All Test Categories - Equipment Calibration and Verification”

HOKLAS 003 (8th Edition) (Chinese version)

“Technical Criteria for Laboratory Accreditation”

(Abridged Version)

HOKLAS 003 (8th Edition) (Abridged Chinese version)


HOKLAS 007 (October 2005)

“Assessment/Reassessment Questionnaire for Non-medical Laboratories”

HOKLAS 007 Checklist (October 2005)

“Checklist on compliance with HOKLAS requirements”

HOKLAS 003 (8th Edition) (Abridged English version)


(Abridged Version)

HOKLAS 003 (8th Edition)



“Food” - Detection and quantification of Genetically Modified Organisms (GMO) in food

by Polymerase Chain Reaction (PCR)


“Chemical Testing”, “Construction Materials”, “Food” and “Toys and Children’s Products”

- Chemical Testing

HOKLAS Supplementary Criteria No. 23, Issue No. 2 and Checklist for SC 23

“Medical Testing” Test Category - Hospital Autopsy


“Medical Testing” Test Category - Cytopathology


“Medical Testing” Test Category - Histopathology

28/11/2005

28/11/2005

28/11/2005

25/10/2005

25/10/2005

19/10/2005

12/10/2005

23/09/2005

2/8/2005

25/7/2005

25/7/2005

25/7/2005

15

If you wish to contribute to the next newsletter

or require further information on any of the

items in this newsletter,

please contact HKAS Executive,

36/F., Immigration Tower,

7 Gloucester Road, Wan Chai, Hong Kong.

Tel: 2829 4840 Fax: 2824 1302

Website address: http://www.itc.gov.hk/hkas

E-mail address: [email protected]

Upcoming Training Courses• Laboratory Management Based on ISO/IEC 17025

May 2006

• Internal Auditing of Laboratories to ISO/IEC 17025

May 2006

• Basic Metrology Training

June 2006

Interested readers should note that the latestinformation on training courses is posted on ourwebsite at www.itc.gov.hk/hkas. Pleasecontact HKAS Executive for enrolment of thecourses.


“Medical Testing” Test Category - Chemical Pathology


“Medical Testing” Test Category - Clinical Microbiology and Infection


“Medical Testing” Test Category - Haematology


“Medical Testing” Test Category - Immunology


“Medical Testing” Test Category - Molecular Pathology

HKCAS Supplementary Criteria No. 3, Issue No. 1

Accreditation Programme for Consumer Product Certification

HKCAS 013 - Assessment/Reassessment Questionnaire and checklist


“Environmental Testing” Test Category - Asbestos Sampling and Testing


“Chinese Medicine”, “Environmental Testing”, “Food”, “Miscellaneous” and “Toys &

Children’s Products” - Microbiological Testing

HKAS Supplementary Criteria No. 1, Issue No. 5

“Use of HKAS Accreditation Marks and Claims of Accreditation Status”

25/7/2005

25/7/2005

25/7/2005

25/7/2005

25/7/2005

19/7/2005

19/7/2005

11/7/2005

11/7/2005

30/6/2005

16

hkas news 40.pdf

Documents

Transcript of hkas news 40.pdf