hkas news 25.pdf

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It is a great pleasure for me to speak at the opening of the second day of this very important seminar. There are two important issues on the agenda of the APEC Standards and Conformance Sub-committee and the corresponding World Trade Organisation (WTO) Committee on Technical Barriers to Trade (TBT). The first is to encourage trading economies to align their standards or to adopt international standards. The publication of the ISO 8124 standard is an achievement for the toy testing industry and a major step towards facilitating free trade in this area. I hope economies around the globe

Transcript of hkas news 25.pdf

It is a great pleasure for me to speak at the opening of

the second day of this very important seminar.

There are two important issues on the agenda of the

APEC Standards and Conformance Sub-committee and

the corresponding World Trade Organisation (WTO)

Committee on Technical Barriers to Trade (TBT). The first

is to encourage trading economies to align their standards

or to adopt international standards. The publication of

the ISO 8124 standard is an achievement for the toy

testing industry and a major step towards facilitating free

trade in this area. I hope economies around the globe

will adopt the standard as a means of demonstrating

compliance to toy safety legislation.

Even when international standards are adopted, goods

may not be accepted at their ports of entry as doubts

about the validity of the test reports or certifications of

compliance may arise.

The second important issue in removing technical barriers

to trade is therefore to promote acceptance of testing

and certification so that goods need not be re-tested or

re-certified when they reach their destinations. However,

before this can be achieved,

regulator y author it ies or

customs officials must have

confidence in the bodies

performing the tests and

certification. To this end, APEC

and WTO are encouraging

economies to set up conformity

assessment systems which are

transparent and for which

competence can be assured.

They are also encouraging economies to establish mutual

recognition agreements for the purpose of declaring

technical equivalence and achieving mutual acceptance of

test results and certifications.

One way of assuring technical competence is through

accreditation. The responsibility of each accreditation body

is to ensure through assessments that the laboratories,

cer tification bodies and inspection bodies operate in

accordance with the relevant ISO/CASCO standards and

that they have the technical capability to conduct the tests

or certification or inspection to specific product or test

standards.

Worldwide harmonization of accreditation practices is

being achieved through regional and international co-

operations such as the Asia-Pacific Laboratory Accreditation

Co-operation (APLAC) and the International Laboratory

Accreditation Co-operation (ILAC). Mutual recognition

agreements forged within such co-operations provide

confidence that conformity assessments conducted in one

economy are equivalent to conformity assessments

conducted in another economy. Regulatory authorities

can then utilize such technical agreements for acceptance

of the testing or certification conducted for the purpose

of demonstrating compliance to legislative requirements.

Incidentally, the Asia-Pacific Laboratory Accreditation

Co-operation is recognised by APEC as a Specialist Regional

Body which will provide the technical suppor t for

facilitating free trade.

The Hong Kong Laboratory Accreditation Scheme was

established by the Industry Department in 1985 to provide

official recognition to competent

testing laboratories. In 1998

the scope of accreditation was

expanded to cover ISO 9000

certification bodies and in 1999

to inspection bodies. The

accreditation body is now called

the Hong Kong Accreditation

Service. HKAS runs three

accreditation schemes, one for

laboratories called HOKLAS,

one for ISO 9000 certification

bodies called HKCAS and one for inspection bodies called

HKIAS. To-date HKAS has accredited ninety laboratories,

twenty-two of which are for toy testing. As you will see

from our Directory of Accredited Laboratories, laboratories

are accredited for a wide range toy safety standards

including those from Australia, Canada, Europe, Japan and

the United States. Accredited laboratories undergo rigorous

on-site assessments by a team comprising laboratory quality

system experts and experts in specific testing fields, and,

to ensure that the overseas testing standards are correctly

interpreted, we regularly invite overseas experts who have

been involved in developing the standards to act as assessors.

To monitor the performance of accredited toy testing

laboratories we have, so far, organized eleven interlaboratory

(round robin) toy testing programmes, six were on physical

and mechanical testing, three on chemical testing, one on

electrical toys and one on flammability. Some of the

programmes were organized on behalf of the Asia-Pacific

Laboratory Accreditation Co-operation and participants

included laboratories from Europe, Australia and other

economies in Asia.

This year's HOKLAS assessor workshop was held on

29 February, a day that only occurs once every 400 years

and a high risk day for the millennium bug. More than 80

assessors and HKAS accreditation officers participated in

this event at the Hong Kong Convention and Exhibition

Centre. Dr. L. H. Ng, Executive Administrator of HKAS,

opened the workshop with a presentation on the latest

development of the international accreditation activities.

It was followed by a talk on the new accreditation standard

- ISO/IEC 17025, presented by Mr. W. W. Wong, Senior

Accreditation Officer of HKAS. Questions and answers

session ensued and feedback

from assessors was solicited

and welcomed. Assessors

were then split into six small

groups to facilitate a more

detailed discussion on

technical issues relating to

specific testing areas.

On t he who l e , a l l

par ticipants agreed that

this was an invaluable

opportunity for assessors

and HKAS officers to enhance mutual understanding, share

experience and strengthen a team spirit with an objective

to enhance the testing standard in Hong Kong. Consensus

was reached after detailed and fruitful discussions on many

technical issues as well as issues relating to assessments.

Ambiguities on HKAS policies and requirements were also

clarified. Following is a gist of the discussions.

HKAS is a member of the Asia-Pacific LaboratoryAccreditation Co-operation multilateral agreement andit has also concluded a bilateral agreement with theEuropean Co-operation for Accreditation. Through theseagreements test repor ts endorsed by HOKLAS arerecognised as technically equivalent to reports endorsedby accreditation schemes in twenty-four overseaseconomies.

I have no doubt that seminars such as this, will contribute

towards the harmonization of interpretation and application

of toy testing standards. Among the audience here there

are HOKLAS assessors as well as representatives from

our accredited laboratories. They are here to learn from

overseas exper ts as well as to contribute to the

discussion. To conclude, I would like to convey my best

wishes for a very fruitful discussion and for our overseas

visitors I would like to wish you a very pleasant stay in

Hong Kong.

An assessor indicated that he would like to receive a copy

of the Outcome Letter for the assessment that he was

responsible for. Dr. Ng explained that a copy of the

Outcome Letter would normally be given to the assessor

only upon request. Assessors could indicate his preference

to the HKAS officer concerned. However, in order to

maintain confidentiality, the letter should either be returned

to HKAS or destroyed after the assessment was complete.

Concern was also raised on the new provision in ISO/IEC

17025 for opinions and interpretations. It was clarified

that it is not a requirement that a laboratory should give

opinions and interpretations on test results. The standard

only provides a provision for giving opinions and

interpretations, and if a laboratory wishes to give them,

then they are required to fulfil certain requirements such

as personnel qualifications, records of the basis on which

the opinions are made, etc.

In response to a suggestion that technical assessors might

be asked to act as lead assessors, concern was raised on

the competence of technical assessors for the evaluation

of quality systems of laboratories. Technical assessors were

assured that they would be given sufficient training on

assessing the quality systems of laboratories.

Another assessor suggested that laboratory accreditation

could be carried out by private commercial organisations

whilst HKAS accredits these organisations. Dr. Ng explained

were highlighted and common quality control procedures

for monitoring the validity of tests, in par ticular for

laboratories having a significant por tion of their work

performed by automation were suggested. Examples of

quality control plans, both internal and external, were

also provided. In addition, the criteria for re-calibration

of heating equipment such as drying oven and muffle

furnace after alteration in their temperature settings

were reviewed.

It was noted that laborator y

p r a c t i c e s d e v i a t ed f r om

documented procedures and

improper use and handling of

equipment were two non-

compliances commonly observed

by the par t ic ipants dur ing

laboratory assessments. The need

for laborator ies to fur ther

strengthen their staff supervision and training is apparent.

Although the suggestion from one of the par ticipants

to replace the current courier post service by e-mail for

forwarding HKAS assessment briefing notes to assessors

had received some support, there were doubts as to its

feasibility, not only in view of the additional resources

required in scanning the documents and converting them

into appropriate electronic versions, but also in view of

the confidentiality of these documents and the possible

complications arising from incompatibility in the computer

systems among the parties concerned.

The discussion session for this sub-group, being led by

Dr. K. C. Pang, started with a self-introduction by individual

par ticipants including one AAB member and seven

HOKLAS assessors for test areas of chemical testing,

asbestos testing and chemical analysis of construction

materials, textiles and garments, toys and children's

products, and food. In response to the proposal made

earlier during the seminar on the use of lead assessors

in place of HOKLAS accreditation

officers for on-site laboratory

assessment, the initial discussion

had been focused on the roles,

responsibilities and related duties

of lead assessor s, including

assessment of the quality system

and technical performance of the

laborator y, preparat ion of

outcome letter, evaluation of any

actions taken to fulfil the given mandatory requirements,

and follow-up actions as deemed necessary.

Also included in the group discussion were issues relating

to the general requirements for and the processes generally

involved in validation and verification of test methods.

Validation adequacy as well as various method performance

parameters such as precision, limit of quantitation, working

range, etc., which need to be characterized for validation

of test methods were discussed, with given examples to

facilitate better understanding. Differences in the

requirements for standard and non-standard test methods

that in view of the importance of laboratory

testing in the implementation of safety, health

and environmental protection legislation and

the technical nature of laboratory accreditation,

it has generally been agreed internationally that

laborator y accreditation should not be a

commercial, competitive activity as standards

may be compromised. Laboratory accreditation is thus generally provided

by a non-profit authoritative body which is government supported or

which has strong links with government.

The topics for discussion were method validation, method

performance characteristics, quality control practices and

equipment calibration. Twelve technical assessors for

Environmental Testing Test Category participated in this

discussion group. The discussion star ted with a brief

introduction to the requirement of ISO/IEC 17025 and

the major steps for method validation. Method validation

process was discussed in the context of the ISO 9001

model for design.

The concept of fit for the intended use instead of pursuit

of perfection was brought out. That the extent of

validation should be commensurate with the need of the

given application was stressed. Validation was always a

balance between costs, risks and technical possibilities.

An example of method validation was studied and discussed.

A technical assessor raised the question that the sequence

of validation might not start with the identification of the

particular requirements for an intended use. It might start

with determining the performance of the method and

subsequently compared the performance with the

requirements.

Discussion continued on what the common requirements

were and the techniques for determining method

performance. References were made to publications on

the topics of method validation by AOAC International,

EURACHEM and ISO. Detailed procedures for

determining the method performance characteristics

were given in these references.

An assessor pointed out that the requirements for an

intended use might not be obvious and further gave an

example on the recent European ban on azo-dyes. The

directive did not specify the lowest acceptable level of

azo-dyes. In such a case, other information might have

to be obtained such as discussion papers on the directives

or toxicological data on azo-dyes. The requirement should

be based on the additional information. When assessing

the adequacy of method validation, it was then necessary

to ask the laboratory to supply such information to

substantiate their specified requirements. Assessors should

also exercise their professional judgement when deciding

the adequacy of the method validation, for example,

whether the method detection limit and precision were

sufficient for a particular use.

Another assessor pointed out that there might be

inconsistencies amongst different assessors in their

requirement for the extent of method validation. It was

generally agreed that if the inconsistencies were serious,

HOKLAS should issue guidelines on this area. However,

it was also agreed that assessment by itself was subjective

in nature because assessors had their own technical

experience and opinions.

The discussion then went on to quality control practices.

It was generally agreed that in environmental testing, the

quality control plans should include blanks, duplicates,

surrogates, and control samples, where applicable. The

level of quality control samples should be about 20 per

cent. Quality control char ts should be used where

applicable and acceptance criteria for quality control

parameters should be established and implemented.

The performance checks and calibrations recommendations

given in HOKLAS Supplementary Criteria were also

discussed. It was pointed out that the intervals for

performance checks and calibrations should be regarded

as guidelines and the intervals should be determined by

factors such as the design and usage of the instruments.

However, laboratories should demonstrate that the

intervals adopted were appropriate and assessors should

ensure that the intervals were acceptable based on the

evidence given by the laboratories.

Assessors of the microbiological tests enthusiastically

exchanged their experience and expressed their opinions

that supplementar y cr iter ia for accreditation of

microbiological laboratories specific to different test

categories should be prepared.

As regards the scope of accreditation for environmental

testing, assessors indicated a need for revision. The list

of organisms would be expanded to cover commonly

encounter organisms. It was generally agreed that

classification of microbial

indicators and pathogens be

redefined for different test

categories.

The question of qualification

was also addressed. Assessors

pointed out that some

laboratories employed staff

members who were not fully

competent to perform the

tests. The need for setting

minimum qualification and experience requirements for

both supervisors and junior operators was discussed.

Assessors suggested looking into the feasibility of

recognition of non-microbiology graduate such as

participation in examination offered by academic institutes.

Assessors continued the discussion on criteria of laboratory

area. Instead of fixed space requirements, criteria for

effective separation of sterilization, sample preparation

and decontamination processes were suggested. Assessors

measurement behaviour in all foreseeable situations.

Regarding the new HOKLAS requirement that accredited

laboratories shall take par t in at least one appropriate

proficiency testing activity relating to each major sub-

area of major disciplines of their scope of accreditation,

it was agreed that the actual implementation will be a

balance between cost and confidence. The practice of

other mutual recognition agreement par tners will be

Six calibration assessors joined the discussion. It was

agreed that assessors should not request the laboratory

to quantify uncertainty contributions which are known to

be insignificant to the final uncertainty result. However,

as some contributions which are usually insignificant

may become impor tant under cer tain circumstances,

laboratories must be aware of them in order to set up

the measurement correctly and to understand the

also opined that separate chambers should be provided

for storage of reference cultures, samples, serological/

biochemical reagents and dehydrated media. In addition,

the requirement of a safety cabinet (Class I / II) for handling

pathogens was highlighted.

On the subject of reference cultures, assessors indicated

that the procedures for sub-culturing reference strains

for most laboratories were inappropriate. Most laboratories

adopted a vertical line rather than horizontal line of sub-

culturing. It was suggested

that guidance with reference

to national/international

and up-to-date practice be

prepared.

Assessors generally agreed

that the verification practice

as defined in HOKLAS

Supplementary Criteria No. 8

for environmental samples

was adequate. However,

schedules such as bimonthly or quar terly basis should

be established for infrequently performed tests to ensure

the continuing competence of laboratories. Assessors

further expressed their views on the need and frequency

of participation in proficiency testing programmes.

Assessors were invited to give fur ther inputs for

drafting criteria for accreditation of microbiological

laboratories. Assessors would be informed of the

progress of this issue.

feasibility of adopting personnel certification was discussed.

It was generally agreed that it was difficult and expensive

for laboratories to keep competent testing staff.

The pros and cons of

"flexibility in the scope of

accreditation" were explored.

This means that specific

laboratories may be given the

f l e x i b i l i t y t o i n c l ude

modifications to accredited

test methods in endorsed

test reports prior to formal

notification from HKAS,

provided that there are no

new measurement principles

or techniques introduced.

It was generally agreed this

type of accreditation would encourage accredited

laboratories to use up-to-date amendments to test

standards.

Assessors were concerned that what was actually

happening in the laboratory might be different from

what they observed during assessment visits. There was

concern that laboratories

might sacrifice quality for

gaining business. It was

suggested that unannounced

surveillance visits be made

regular ly to monitor the

performance of accredited

laboratories.

Assessors expressed their

gener a l impress ion on

technical competence of

laboratory testing personnel.

Assessors for electrical tests

s u g g e s t e d t h a t t h e

qualification requirements for laboratory technicians be

raised. It was further suggested that HKAS should organise

more training courses on electrical safety testing. The

monitored. In the meantime, judgement will be based

on whether the laboratory quality assurance regime,

which includes proficiency testing activities and other

verification measure, provides adequate assurance for

all the accredited tests.

The calibration recommendation table in Appendix C

of HOKLAS Supplementary Criteria No. 2 was also

discussed. It was agreed that this table is useful for giving

a general guidance to laboratories where no other

information is available. However, laboratories should

understand that it is their responsibility to determine the

appropriate calibration points and the recalibration

inter vals based on the application, stabil ity and

construction of the instrument. Laboratories should not

adopt the recommendations indiscriminately in lieu of

carrying out their own investigation.

The APLAC-EA policy on traceability of measurement

was also discussed. There was consensus that for physical

quantities, Hong Kong will have no difficulties in

complying with the policy.

In summary, the calibration group discussed the need for

quantifying insignificant uncer tainties, the method to

implement the new HOKLAS requirement on proficiency

testing activities, the usefulness of the calibration

recommendation table in Appendix C of HOKLAS

Supplementary Criteria No. 2 and the APLAC-EA policy

on traceability.

The ISO/IEC 17025 was fur ther discussed at the sub-

group meeting. Discussion was focused on the new

requirements that assessors were uncer tain about

regarding their application in practice, such as preventive

action, validation of methods and estimation of

uncer tainty of measurement. Interpretation of these

requirements by reference to practical examples were

attempted. Forming a working committee to enable the

new standard to be introduced in a more interactive

manner was suggested by some assessors. This

proposal was in fact in line with our planning to hold

regular meetings with accredited laboratories with a view

to reaching a consensus on the approach for estimating

testing uncertainty. Such meetings could be extended to

allow assessors to par ticipate and may include other

matters related to the new accreditation standard.

The implementation of HOKLAS Supplementary Criteria

No. 2 was discussed. It was noted that accredited

laboratories in general had followed these requirements

on equipment calibration satisfactorily.

As informed by an assessor from the Standard and

Calibration Laboratory (SCL) of the Government of

HKSAR, calibration service for load columns is available

in the SCL and the scope of service covered the force

ranged from 0.5kN to 3000kN. There was suggestion

from some assessors that SCL should extend its scope

of services to meet the demand in the market, such as

calibration of stability testers or other common force

measuring equipment.

Some examples encountered during assessments were

brought up for discussion and the non-conformances that

needed to be treated in a consistent manner were drawn

to the attention of the assessors. Different views were

expressed during discussion on the +0.5 C̊ accuracy

requirement for thermometer used in concrete curing as

well as on the requirement for checking of hardness and

surface texture of platens and spacer blocks. Use of

reference cement in the Rigden method for determination

of cement fineness, and use of standard calibration ash

for determination of PFA fineness were the areas where

consistency needed to be maintained. The latest

development in testing requirements in respect of steel

testing, foundation pile and soil testing were highlighted

for the assessors' information.

Progress on the accreditation of NDT on welding was

made known to the assessor s. The HOKLAS

Supplementary Criteria No. 15 for this test area had been

issued and a proficiency testing programme had been

organised. Ten laboratories participated in this programme.

The first on-site assessment is likely to be performed in

March this year. There was also a discussion on the

new tests soon to be covered by HOKLAS - the hardness

test and Charpy 'V' - notch impact test before the

meeting adjourned.

In 1990, the contract to design, build and operate the

first Chemical Waste Treatment Centre (CWTC) in Hong

Kong was awarded to Enviropace Limited by the Hong

Kong Government Environmental Protection Department.

Enviropace is a joint venture company specifically set up

for the project. Its par tners comprise Pacific Waste

Management Ltd., which is a wholly-owned subsidiary of

Waste Management Inc. headquartered in Houston of

the U.S., CITIC Pacific Limited and Bilfinger + Berger Hong

Kong Ltd.

The CWTC operates different treatment systems that

include oil/water separation, high temperature incineration,

inorganic waste treatment and recovery, wastewater

treatment, physical and chemical stabilization. Like other

chemical companies, operation of the CWTC relies heavily

on the analytical services provided by its in-house

laboratory. The CWTC laboratory takes on the following

important functions and conducts an average of 2,900

tests a month.

1. To characterize the nature of chemical waste and

recommend the appropriate handling, storage and

treatment methodology;

2. To supply the Production Department with information

on chemical composition for in-process monitoring and

control;

3. To assist in environmental monitoring by testing and

analyzing effluents, stack gas emissions, stabilized

residues and ground water samples.

The CWTC is subject to some of the world's most

stringent environmental protection requirements. At the

time when the Centre was designed and built, a number

of testing, monitoring standards and requirements were

included in the CWTC contract. Amongst them, the TCLP

(Toxicity Characteristic Leaching Procedures) extraction

and analysis for stabilized residues going to the landfill,

the use of TO9 and TO14 to analyze organic pollutants

in the ambient air, and the monitoring of dioxin in stabilized

residues and stack gas emission from the incinerator of

the Centre. These testing were not required at other

facilities in Hong Kong.

Back in 1990 and before the CWTC started operation,

representatives from Enviropace and Waste Management

Inc. initiated contact with HOKLAS in an effort to compare

the quality system laid down by HOKLAS in Hong Kong

and GLP in the U.S.. Enviropace then decided to pursue

accreditation by HOKLAS although such was not required

by the contract. The road to being accredited however,

was no easy one. Some of the major problems encountered

in the process included the following.

1. A number of testing is new to Hong Kong and no

suitable assessors were available locally to conduct the

assessment. The high cost of inviting an assessor from

overseas has made it quite impossible to accredit these

tests.

2. It is very difficult to obtain the appropriate Certified

Reference Materials (CRMs) for the validation of the

testing methods.

3. Proficiency testing programmes on the appropriate

matrices are not available.

It was only in 1995 - almost two years after Enviropace

started servicing Hong Kong's industries, that Enviropace

made a major step in obtaining HOKLAS accreditation.

Certain testing such as the TCLP extraction technique and

testing for dioxins, however, are yet to be accredited.

In 1999, HOKLAS invited Dr. Eric J. Reiner, Manager, Dioxin

and Toxic Organics Section Laboratory Services Branch,

Ministry of the Environment, Canada, to come to Hong

Kong to assess the laboratory for dioxins testing. Dr.

Reiner provided some valuable ideas and information on

trace organics testing requirements and standards in

The Environmental Testing Division of CLP Power's

Generation Central Laboratories was granted the HOKLAS

accreditation in November 1999. The Environmental

Testing Division provides laboratory testing services to

monitor the effluent discharged from the power stations

in a bid to ensure that the effluent comply with the limits

of the regulatory licence. CLP Power is committed to

achieving high standards of environmental, health and safety

performance and took the initiative to apply for

accreditation for the Environmental Testing Division.

The Generation Central Laboratories have five divisions,

namely, General Chemistr y, Environmental, Fuel,

Construction Materials, and Metallurgy. The Laboratories

provide a variety of testing services to suppor t the

Company's generation and distribution activities. The

Construction Materials Testing Division of CLP Power's

Generation Central Laboratories was accredited as early

as in 1993 to provide quality control and product testing

for the Company's fuel ash business.

Five departments of CLP Power were awarded ISO 9000

certificates in 1999. The Special Project - Distribution

automation received the ISO 9001 certificate whereas

Generation Maintenance Workshops, Metering Systems

Branch, Electrical Testing Workshop and Instrumentation

Branch received the ISO 9002 cer tificates. The

accreditation and certification are further demonstrations

of the company's effor ts in quality management in

various business operations.

Canada. He has also reconfirmed

that the procedures of our

laboratory were generally in line

with international practices.

In the very near future, Enviropace

would like to see the remaining few

tests accredited by HOKLAS.

Laboratory service is certainly an

integral par t of Enviropace's

commi tmen t to p rov i d i n g

professional and comprehensive

chemical waste collection and

disposal services to the industries

of Hong Kong.

Initiated by the HKAS Executive, a meeting amongst

the 6 accredited certification bodies and HKAS Executive

was held on 11 February 2000 at HKAS. Mr. Adrian

Broadbent of LRQA kindly volunteered to co-ordinate

and to chair the meeting. The discussion focused on the

technical issues regarding certification to ISO 9000 series.

It was agreed that a summary of the discussion would be

published in HKAS News for general information.

The main points discussed were:

Applicability of Design Validation

The Group agreed that all organizations certified to

ISO 9001 must address the Design Validation clause

of the Standard, in par ticular architectural design

organizations. The degree to which the organization

performs validation is dependent upon the contract

and legal/regulatory requirements and the nature of

the project. It would not be acceptable for architectural

design organizations to document that design validation

is not applicable to their business.

Non-Fulfillment of Unrealistic Specification

Requirements

When a certified organization or applicant fails to meet

a requirement in the client's specification, the auditor

should raise a non-conformity. The organization would

need to provide evidence in writing that the client has

approved any relaxation of the specification if it is

considered to be an unrealistic requirement.

Inclusion of Additional Business Activities inCertified Scope

For organizations that have multiple cer tificates for

related companies or divisions, the scope on any

certificate must be based on activities reviewed by the

auditor. Activities not reviewed for that company or

division shall not be included in the scope, even though

the activities may have been reviewed under the scope

of a related company or another division.

Use of Accreditation Logos on Business Cards

Most accreditation bodies specify a minimum size for

their logo (e.g. UKAS and HKAS). The Group considered

that the minimum size may be reduced to allow use

on business cards, provided that the printing remains

legible and no in-filling occurs.

HKAS Executive informed the Group of an EA

document (EA 3/01) was issued in December 1999

regarding the use of accreditation mark. The document

is available on the EA website,

Extent of Regulatory Knowledge by Auditors

Auditors are expected to have appropriate knowledge

of the industry and legal/regulatory requirements of

the economy/country where the organization operates.

This is par ticularly important when an organization

certified in one country commences operations in a

second country with the certification granted in the

first country. For some industries (e.g. construction),

the regulatory requirements can be quite different and

the initial auditors may not be aware of the differences.

Approvals to ISO/DIS 9001 : 2000

The Group noted the requirement of the IAF

(International Accreditation Forum) that accredited

certificates shall not be issued against draft international

standard (DIS) or final draft international standard

(FDIS) of 9001 : 2000. Certification bodies must have

their accreditation scope extended to include the new

standard prior to issuance of accredited cer tificates

to the new Standard.

Not all certification bodies represented have finalized

their policy on the form of recognition for organizations

that are audited to the DIS or FDIS of 9001 before

publication of the Standard. LRQA and HKQAA

confirm that they will only issue a "letter of compliance",

not a certificate.

HKAS Executive have not defined the auditor training

requirements for the new standard. However, before

an accredited cer tificate to ISO 9001 : 2000 can be

issued, it may require that a visit to the organization

is needed after publication of the Standard to confirm

ILAC G1:1994 Guidelines for the Establishmentand Review of Mutual RecognitionAgreements

ILAC G2:1994 Traceability of Measurements

ILAC G3:1994 Guidelines for Training Courses forAssessors

ILAC G4:1994 Guidelines on Scopes of Accreditation

ILAC G5:1994 Calibration and Maintenance of Testand Measuring Equipment

ILAC G6:1994 Guidance under ISO/IEC Guide 25 forLaboratories Performing Sampling

ILAC G7:1994 Accreditation Requirements andOperating Criteria for HorseracingLaboratories

ILAC G8:1996 Gu ide l ines on Assessment andRepor t ing o f Compl iance wi thSpecification

ILAC G9:1996 Guidelines for the Selection and Useof Cer tified Reference Materials

ILAC I1:1994 Legal Liability in Testing

ILAC I2:1994 Testing, Quality Assurance, Certificationand Accreditation

ILAC I3:1996 The Role of Testing and Accreditationin International Trade

ILAC I4:1996 Gu i d an ce Documen t s fo r t hePreparation of Laboratory QualityManuals

International Laboratory Accreditation Co-operation

(ILAC) publishes information documents of interest to

accreditation bodies, laboratories, trade and regulatory

bodies. The documents cover accreditation practices,

measurement traceability, legal liability, trade issues

related to testing and international agreements. Access

to these publications is available through ILAC's website

at www.ilac.org.

The scope of accreditation service under HKCAS has

been expanded to include the following three areas:

NACE Rev. 1 Area No. 32

- financial intermediation, real estate, renting

NACE Rev. 1 Area No. 35

- other services

NACE Rev. 1 Area No. 36

- public administration

compliance. Certification bodies are recommended to

make such provision in their "letter of compliance".

Guidance on Scope Statements for Certification

HKQAA kindly provided a guidance document on

scope statements for comment by others. The intent

is that some agreement can be reached and the policy

could then be applied.

Next Meeting

It was the consensus of the Group that the discussion

had helped to harmonize the practice of certification

bodies and in interpretation of requirements. It was

agreed that such discussion meeting should be

continued. The next meeting is planned for early June

2000, which will allow discussion on the outcome of

the next IAF Working Group 1 meeting scheduled to

be held in May 2000. Training requirements of auditors

for the ISO 9001 : 2000 is one of the agenda items

of the WG 1 meeting. Mr. Howie Ng kindly agreed

that HKQAA will arrange the next meeting.

ILAC-S1:1997 Guidelines for the Preparation, Layoutand Numbering of ILAC Publications

ILAC-S2:1998 Rules

Interested readers could visit ILAC's website to get detailed

information on the above documents.

Since the issue of the Supplementary Criteria No. 15

for NDT, a number of laboratories have applied for the

accreditation for NDT. Initially, accreditation for ultrasonic

tests on welding of plates and pipes, radiographic tests

using X-ray and Gamma ray method, magnetic particle

test for permanent magnets and A.C. yokes, and liquid

penetrant test using the fluorescent and non-fluorescent

methods will be offered. Prior to the assessment

programme, a proficiency testing programme on ultrasonic

tests was organised by HKAS. About ten laboratories

participated in the programme. Two operators from each

laboratory conducted the tests, using their own equipment

(e.g. UT flaw detectors and calibration blocks, etc), at the

HKAS office. Each of the operators performed the tests

twice for three standard test samples of known welding

flaws and defects. The same three standard samples were

used by the laboratories. In this way, precision for within-

laboratory, between-laboratory, single-operator and

multiple-operator could be obtained. The analysis of data

was performed according to APLAC PT002 and ISO/IEC

Guide 43-1. Outliers were identified and asked to conduct

an investigation and take appropriate corrective actions.

A final report on the programme will be published upon

completion.

ILAC G10:1996 Ha r mon i s ed P ro cedu re s fo rSur veillance & Reassessment ofAccredited Laboratories

ILAC G11:1998 Guidelines on Assessor Qualificationand Competence

ILAC G12:2000 Guidelines for the Requirements forthe Competence of ReferenceMaterials Producers

ILAC G13:2000 Guidelines for the Requirementsfor the Competence of Providers ofProficiency Testing Schemes

ILAC G14:2000 G u i d e l i n e s f o r t h e U s e o fAccreditation Body Logos and forClaims of Accreditation Status

The long-awaited ISO/IEC17025 was issued on 15

December last year. This standard, which replaces

ISO/IEC Guide 25, will be adopted by HOKLAS as the

technical criteria for laboratory accreditation. HOKLAS

is now in the process of finalising the policies on the

new standard. HOKLAS 003 will be revised to reflect

the changes. According to the ILAC guidance, all

laborator ies should meet the new standard's

requirements within two years after the issue of the new

standard, that is, before the end of 2001. Laboratories

will be informed of the migration plan shortly. The new

standard is available for perusal at the library of Product

Standards Information Bureau (PSIB) of the Industry

Department at the same address as HKAS. Interested

readers may also order a copy from ISO through

PSIB.

The one-hundredth laboratory accreditation was granted

to the Hong Kong Police Force Communications Branch

Calibration Laboratory in October last year. Mr. Jolly Wong,

Head of the Systems Engineering and Research of the

Communications Branch remarked that it took them nearly

two years of preparation and practising to reach this world

class level. During these two years, they had to review

virtually every operational procedure to the point of detail

and bring them up to the HOKLAS requirements. Two

major manuals - Quality and Procedure had to be written

on every single aspect of their work, right down to the

smallest attribute. We offer our congratulations to them

on their success in gaining HOKLAS accreditation.

Our website has been upgraded to include information that may be of interest to the readers. The following forms

and publications are now available at our website and can be downloaded, if required.

HOKLAS 002, HOKLAS 005, HOKLAS 006, HOKLAS 007, HOKLAS 011, HOKLAS 012, HOKLAS 013

HKCAS 002, HKCAS 005, HKCAS 006, HKCAS 007, HKCAS 011

HKIAS 002, HKIAS 005, HKIAS 006, HKIAS 007, HKIAS 011

Furthermore, application forms for HKAS organised seminars, workshops and training courses can also be downloaded.

HKAS News will be posted on the website. Suspensions and/or terminations, of the whole laboratory or for particular

tests, will also be indicated on the scopes of accreditation of the laboratories. We will continuously enhance our website

to include information that is useful to our readers. Comments on and suggestions for our website are most welcome.

Four laboratories have obtained HOKLAS accreditations since the last issue of HKAS News, bringing the total number

of accreditations granted to 107. The newly accredited laboratories are:

A.E.S. Destructive and Non-Destructive Testing Ltd. (HOKLAS 104) for Calibration Services Test Category

Quality Control Laboratory of the Hong Kong Oxygen and Acetylene Co. Ltd. (HOKLAS 105) for Chemical Testing Test

Category

Ground Research Laboratory Ltd. (HOKLAS 106) for Construction Testing Test Category

Racing Laboratory of the Macau Jockey Club (HOKLAS 107) for Chemical Testing Test Category

We offer our congratulations to them on their success in gaining HOKLAS accreditations.

The APLAC T016 Proficiency Testing Programme

on flammability of toys to EN71 Par t 2 : 1993 has

been completed. Interim repor ts with the results

of par ticipating laboratories have been issued to

par ticipating accreditation bodies and laboratories.

Their comments will be incorporated in the final

repor t, which is expected to be published in about

two months' time.

The proficiency testing programmes on aggregate,

pulverised fuel ash and chloride ion penetration in

concrete are completed and final reports have been

distributed to par ticipants. The performance of the

participants is generally satisfactory. Laboratories with

outlying results are requested to investigate the causes

and report the findings to HKAS.

A proficiency testing programme (APLAC T022) on

acoustical testing to EN71 Par t 1 : 1998 has been

organised under the auspices of Asia Pacific Laboratory

Accreditation Co-operation (APLAC). The response

is very encouraging. A total of 30 laboratories from

the Asia Pacific Region and Europe have participated.

Homogeneity testing of the test samples has been

completed. Test samples will be dispatched to

participating laboratories shortly.

A proficiency testing programme on non-destructive

testing (NDT) has been organised for laboratories

interested in seeking accreditation in this testing field.

This programme is first of its kind organised in Hong

Kong. A more detailed description of this programme

is given on page 13.

Amertrack Environmental Testing Ltd. (HOKLAS 038) has voluntarily suspended all tests in the Environmental Testing

Test Category effective 15 February 2000.

The Gold Assaying Laboratory of Tse Sui Luen Jewellery Co. Ltd. (HOKLAS 061) has voluntarily suspended all tests in

the Chemical Testing Test Category effective 22 February 2000.

Readers are encouraged to consult the scopes of accreditations at our website for the most current accreditation status

of laboratories.

This year's Directory

o f A c c r e d i t e d

Laboratories is now

available at our office

at 36/F, Immigration

Tower, 7 Gloucester

Road, Wanchai, Hong

Kong. To facilitate users

in finding the scopes of

accredited laboratories,

a list of laboratories in

alphabetical order of

their names is added to

the Directory. Readers who have access to the internet

can also obtain the scopes of accredited laboratories at

our website at

Three new members joined the APLAC MRA on 3

December 1999. They are CNACL (People's Republic

of China), JCSS (Japan) and ICBO (USA). There are now

13 signatories to the APLAC MRA. In addition, Mexico

has joined the APLAC MoU.