Post on 26-Jan-2023
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: hkas@itc.gov.hk
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.
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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 dspcheung@itc.gov.hk.
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.
8
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 hkas@itc.gov.hk.
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)
“Technical Criteria for Laboratory Accreditation”
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)
“Technical Criteria for Laboratory Accreditation”
(Abridged Version)
HOKLAS 003 (8th Edition)
“Technical Criteria for Laboratory Accreditation”
HOKLAS Supplementary Criteria No. 21, Issue No. 2
“Food” - Detection and quantification of Genetically Modified Organisms (GMO) in food
by Polymerase Chain Reaction (PCR)
HOKLAS Supplementary Criteria No. 20, Issue No. 3
“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
HOKLAS Supplementary Criteria No. 24, Issue No. 2 and Checklist for SC 24
“Medical Testing” Test Category - Cytopathology
HOKLAS Supplementary Criteria No. 25, Issue No. 2 and Checklist for SC 25
“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: hkas@itc.gov.hk
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.
HOKLAS Supplementary Criteria No. 26, Issue No. 2 and Checklist for SC 26
“Medical Testing” Test Category - Chemical Pathology
HOKLAS Supplementary Criteria No. 27, Issue No. 2 and Checklist for SC 27
“Medical Testing” Test Category - Clinical Microbiology and Infection
HOKLAS Supplementary Criteria No. 28, Issue No. 2 and Checklist for SC 28
“Medical Testing” Test Category - Haematology
HOKLAS Supplementary Criteria No. 29, Issue No. 2 and Checklist for SC 29
“Medical Testing” Test Category - Immunology
HOKLAS Supplementary Criteria No. 30, Issue No. 2 and Checklist for SC 30
“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
HOKLAS Supplementary Criteria No. 5, Issue No. 3
“Environmental Testing” Test Category - Asbestos Sampling and Testing
HOKLAS Supplementary Criteria No. 8, Issue No. 4
“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