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.
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