July 2006

Issue No.

41H 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

HKAS Seminar for Technical Assessorsand Technical Experts

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HKAS Seminar for TechnicalAssessors and Technical Experts

Medical testing accreditation:our experience

Implementation of ISO/IEC 17025:2005 by accredited laboratories

Accreditation of tests carried outin accordance with standards

written in a language other thanEnglish and Chinese

Joint Declaration of the BIPM,OIML and ILAC

Meeting of users of HKASaccredited services liaison group

How accreditation is valued

Government Laboratory:A Proficiency Testing Schemes

Provider

The ISO 9001:2000 Opportunity...Did we miss it

Update on revision of ISO 15189

Twelfth meeting of ISO/EC212

ILAC Arrangement CommitteeMeeting

APLAC MRA Council Meeting

APLAC RM Training Workshopon Accreditation of Reference

Material Producers

PAC 13th Plenary Meeting

New Staff

New office hours

Accreditation Update

Proficiency Testing Update

Upcoming Training Courses

Every year, HKAS organises a seminar for HKAS technical assessors and technicalexperts to refresh and update their knowledge of accreditation. This is an event inwhich members of HKAS Secretariat and Accreditation Advisory Board (AAB) meetface-to-face with technical assessors and technical experts. It is also an event wherefellow assessors and technical experts share their experience in assessments with eachother. It is an ideal forum where discussions on the best practice for laboratoryassessments take place and areas for improvement are identified.

Every care has been taken to check the accuracyof the information included in this newsletter.However, HKAS Executive does not guaranteeits accuracy and readers should note that if theymake use of such information, they do so ontheir own risk. The views and opinions in thearticles provided by third parties do not reflectthose of HKAS Executive

Cont’d on P.2

Medical Testing Accreditation:Our Experience

The following article is contributed by PathLab Medical Laboratories Ltd.

Accreditation is recognition of a laboratory’s quality control standards and overallperformance. Achieving such recognition requires that a laboratory pass a rigorous setof on-site assessments in addition to a series of external quality assurance programmes(EQAP). A laboratory is granted formal accreditation when it has met the required criteria(which are based on ISO 15189 Medical laboratories - Particular requirements for Qualityand Competence.) Once accredited, the laboratory must undergo regular re-assessments to determine whether it continues to comply with the required criteria. Ingeneral, accreditation offers clients assurance that a laboratory is producing high quality,accurate and consistent results on which vital healthcare decisions are made. Withoutaccreditation, it is impossible to know what standards and quality systems a laboratoryemploys, even if that laboratory has an excellent reputation.

In Hong Kong, accreditation was justsomething to dream about because we didn o t h a v e a l o c a l m e d i c a l t e s t i n gaccreditation programme, and the cost ofseek ing overseas accredi tat ion wasprohibitive to most laboratories in both theprivate and public sectors. We put it on theback burner until two years ago when ISO15189 was published. At first this standardwas intimidating, not just to Hong Konglaboratories, but to laboratories worldwide.Today, ISO 15189 is widely recognized asa global benchmark for medical laboratoriesand has been adopted by scores of countries as the accreditation criteria for medicallaboratories. Canada, with a government sponsored healthcare system, has made ISO15189 accreditation a regulatory requirement and hence, a goal for every laboratory;

Dr. Robert Rej from the New York StateDepartment of Health (2nd from the right)and Dr. Anthony Shek of Queen ElizabethHospital (1st from the right) assessing the

Wanchai main laboratory.

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NATA and IANZ, the accreditation bodies of Australia andNew Zealand respectively, now use ISO 15189 as theiraccreditation standard, so are some accreditation bodiesin USA. Hong Kong Accreditation Service also uses ISO15189 as the accreditation criteria for its medical testingprogramme. All laboratories in the medical testing businessnow have an exciting chance make this standard their goalfor the future.

So what has our laboratory gained from this process? Mostof all, we have become more efficient. Our documentsare more organized, everyone is clearer about proceduresand there is a greater sense of team spi r i t andcamaraderie. We are sharper about quality control andeven more thorough in evaluating new instruments andmaking sure inter-instrument results correlate. We are alsomore mindful of safety and are paying closer attention tonew staff as well as existing people. We have clearerwritten procedures for everyone from bench technologists

to cleaners. We are now checking every aspect of thelaboratory’s function on a regular basis in order to preventproblems from occurring in the first place. And, we havecleared away a ton of outdated textbooks and instruments- suddenly we have much more space!

HKAS Seminar for Technical Assessorsand Technical Experts

Cont’d from P.1

HKAS is most delighted to see another record number ofattendees this year. About one hundred and twentyattendees turned up this year at the YMCA Hotel on 28February 2006. We are also very pleased to see somenew faces joining the cadre of capable and responsibleassessors. With the increasingly diverse scope ofaccreditation offered by HKAS, assessors and technicalexperts are one of our key elements of success. Their hardwork and efforts are undeniably indispensable for whatwe have achieved so far. We wish to thank them forsparing their time in performing assessments, and as Prof.S. L. Ho said during his talk in last year’s seminar,

Mr. Louis Tong of the Virology Division,Department of Health (2nd from the left) talking to

Mr. T.L. Wong, the Department Manager on thevirology serology tests (1st from the left).

We know that many other laboratories are also workingon this process. HKAS assesses the whole laboratory,then each department and finally each individual test inthe scope. To get started, we suggest working on thequality system of the whole laboratory, and then to applyfor those tests that are already performing well on EQAP -more tests can always be added later. Don’t be afraid toask HKAS staff and your colleagues questions.

Accreditation does not mean any laboratory is perfect.But it tells clients that we are committed to quality,conscientious about our work and serious about ourbusiness. We will work hard to maintain this accreditation.

“technical assessors and experts have contributed muchin preventing accidents, some of them were fatal, andimproving the safety of the general public throughlaboratory assessments. We hope that the community ofHong Kong could appreciate their contributions to thewell being of our society.”

Mr Terence Chan, Executive Administrator, HKAS,welcomed the attendees and briefed them on the recentdevelopment of HKAS. He started with a summary of theresults of a survey, done in September last year, ofaccredited laboratories on the service provided by HKAS.More than 98 per cent of respondents were satisfied withthe service provided by HKAS and over 60 per cent saidthe degree of rigour of assessments should remainunchanged or slightly increase. He then spoke of the latestnumber of accredited conformity assessment bodies -135 laboratories, 10 certification bodies and 9 inspectionbodies, and reiterated that the assessments were madepossible with the assistance from assessors and technicalexperts, currently numbered 269 and 22 respectively, and

Dr. Robert Rej was discussing the quality control data withMs Marianne Leung, Laboratory Director of PathLab (1st

from the left) and Mr. S.K. Lee, Branch Manager ofCauseway Bay Branch of PathLab (3rd from the left).

Mr. S.S. Chan, Executive Administrator, HKAS,welcomes all attendees and thanks them for their

work as assessors and technical experts.

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with the support of the AAB and its 13 Working Partiesand 8 Task Forces. Assessors and technical experts havespent, since 1985 when HOKLAS was established, animpressive 3500 mandays on assessments.

A major event recently was the adjustment of the HKASmanagement system to ISO/IEC 17011 Conformityassessment - General requirements for accreditationbodies accrediting conformity assessment bodies. This isa new standard combining ISO/IEC Guide 58, Guide 61and TR 17010. As with all other signatories to the ILACand IAF multilateral mutual recognition arrangements,HKAS is required to comply with this standard by end of2005. HKAS is pleased to announce that the APLACMutual Recognition Arrangement Council, at its meetingin Singapore in May, confirmed the continuation ofsignatory status of HKAS.

Mr Chan then briefed the attendees on the newly publishedCode of Ethics for Assessment Personnel. In gist, allassessment personnel have to be impartial, objective,positive, open and helpful. They shall avoid conflict ofinterest, accept no bribery and keep all informationconfidential. Finally, Mr Chan talked about the format ofthe new accreditation certif icate which is issued toaccredited laboratories assessed to be meeting thesecond edition of ISO/IEC 17025 published in May 2005.The new certificate states explicitly that “ a laboratory’sfulfilment of the requirements of ISO/IEC 17025:2005means the laboratory meets both the competencerequirements and management system requirements thatare necessary for it to consistently deliver technically validtest results and calibrations. The management systemrequirements in ISO/IEC 17025 (Section 4) are written inlanguage relevant to laboratory operations and meet theprinciples of ISO 9001:2000 Quality Management System- Requirements and are al igned with i ts pert inentrequirements”. This statement is a verbatim reproductionof the ISO-ILAC-IAF Communique issued on 18 June2005. If necessary, accredited laboratories may quote thiscommunique to their customers. This communique isavailable from the ILAC website. To assist laboratories inaccessing it, a linkage to the ILAC website is provided inthe HKAS website at http://www.itc.gov.hk/en/quality/hkas/about.htm.

user of HOKLAS accredited laboratories. Prof. Ching, apartfrom being the chair of AAB, is also a member of theConsumer Council and is the Vice-chair of its Publicityand Community Relations Committee. As such, he is afrequent user of the service of accredited laboratories. Histalk was most enlightening and has led all of us think againfrom the perspective of the laboratory users, and to focusour attention to those areas which add value to laboratoryassessments.

The second speaker was Ms Mabel Li. She is one of ourmost experienced assessors. She talked about her longexperience in chemical testing, initially as a lecturer ofchemical technology in a tertiary education institution, tothe Chief Executive of an accredited commercial laboratoryand finally an assessor of HOKLAS. Her involvement inthis field for more than three decades has undoubtedlyenriched her knowledge of and expertise in laboratorytesting, which is her main asset as a HOKLAS assessor.

Prof. P.C. Ching, Chair of AAB, giving a talkon his experience as a user of HOKLAS

accredited laboratories.

Dr. K.F. Wong, Chair of AAB Working Party onmedical testing, attracts the attention of

attendees by his interesting talk.

The final speaker was Dr K. F. Wong, MD. He is a memberof AAB, Chairman of the AAB Working Party on MedicalTesting, and the Chief of Service, Pathology Department,Queen Elizabeth Hospital. All attendees were attracted byhis most interesting talk, which described the medicalprogramme from inception to fruition. His remark, quotedfrom an old adage on the grades of medical doctors -“the best doctors prevent diseases, medium doctors treatpatients at the onset of diseases whilst the worst doctorscure diseases” and hence, according to this classification,most doctors nowadays, including himself, are the worstones, was most remarkable.

After the presentations, an open discussion forum ensued,which was followed by group discussions.

Ms Mabel Li sharing her experience as aHOKLAS assessor.

This year, we have the pleasure of having Prof. P. C. Ching,Chairman of AAB giving us a talk on his experience as a

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Group for Chemical Testing

Twenty-six assessors and technical experts attended thisgroup. The following topics were discussed - assessorseminar feedback, laboratory feedback, sampling of testsfor assessment, new/revised requirements of the 8th editionof HOKLAS 003, and empirical in-house method. It ispleasing to note that the feedback from last year’sassessor seminar shows that all respondents consideredthe seminar fulfilling their need and expectation. Ninety-six per cent said that the duration was suitable and therest said it was too short. There are 112 comments and24 suggestions received. Most of the feedback relates toorganising more assessor and technical workshops, andlonger discussion. This reflects that the seminar was verywell received by assessors.

A laboratory feedback questionnaire was sent to allaccredited laboratories in September last year to solicittheir views on the service provided by HKAS. One of themost important issues of the survey is the degree of rigourof assessments. About 67 per cent of respondentsregarded the degree of rigour suitable, about 3 percentsaid that it should be slightly tightened whilst about 30per cent said it should be slightly relaxed. None of themconsidered that it should be either substantially tightenedor relaxed. These results indicate that the degree of rigouris generally suitable, but we should consider slightlyrelaxing those requirements which do not affect theaccuracy of test results directly but require substantialresources to implement.

An assessorraising a

question toHKAS.

During assessments, not all tests under the scope ofaccreditation could be assessed and sampling is required.It is imperative to ensure that the assessment teamswitness a representative number of examples to ensureproper evaluation of the competence of the laboratories.Assessors were advised to give priority to those testswhich have not been assessed before and to select atleast a representative test in each test area. To expeditethe assessment, prior arrangement should be made withthe laboratories. Assessors were further advised that non-critical steps could be skipped, and that more than onetest could be assessed at the same time.

The requirement for method validation was discussed. Itwas emphasized that there are differences in requirementfor standard methods and non-standard methods. Whilstlaboratories are not required to validate standard methods,they are required to demonstrate their capabilities (in termsof the requirements given in ISO/IEC 17025) in performingthe methods. Full method validation is required only fornon-standard methods. A l though the means fordemonstration of capabilities (for standard methods) andvalidation of non-standards method may be the similar(l ike participation in proficiency testing programmesuse of CRMs, verif ications of method performancecharacteristics, etc.), their purpose and hence theirinterpretations are quite different. Assessors should beaware of this when examining the validation and verificationdata presented by laboratories. The discussions continuedon in-house empirical methods. It was highlighted thattest results obtained from in-house procedure for empiricalmethods should be comparable with standard procedures,and as such, most often, in-house procedures are slightmodifications of the standard procedures. It is unlikely thatthe in-house procedures differ significantly from thestandard procedures.

Group for Medical Testing

Mr. Chan responding to a questionfrom an assessor.

Dr. Sidney Tam talks about his experience asa technical assessor.

Over 50 professionals from the medical testing field,i nc lud ing pa tho log i s ts , sc ien t i s t s and med ica ltechnologists participated in the discussion group. Theyare the central players in building up the assessment teamfor medical laboratories. The event provided an opportunityto connect HKAS officers with the team players, sharesome of the assessors’ most recent experience, beinspired by open discussions, and learn about the progressof the accreditation of medical laboratories.

The group for chemical testing was attended by26 assessors and technical experts.

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This year, the theme of the discussion group was the roleand responsibility of a technical assessor and how tomaintain consistency in assessments. Combining anexperience sharing session and a brainstorming quiz, theevent had something for everyone.

We had to thank Dr. Sidney Tam who had kindly sharedhis experience gained as a technical assessor from arecent assessment. To him, the role of an assessor is afollower of the ‘bibles’ governing the accreditation ofmedical laboratories, which are HKAS 002 Regulationsfor HKAS Accreditation, and HOKLAS 015 TechnicalC r i t e r i a fo r Labora to ry Acc red i t a t i on (Med ica lLaboratories). The responsibility of an assessor is toobserve in detail and based on these observations to makeconclusions according to the requirements and one’sprofessional knowledge with a no fear and no favourattitude in the assessment.

Following the experience sharing was a quiz session. Thequiz addressed some of the common issues encounteredduring assessments such as sample storage, qualitycontrol and safety where inconsistent views exist. Therewas a discussion on the issues afterwards. We werepleased that participants made full use of the discussiontime to exchange ideas and came up with consensusanswers in general. We look forward to holding our nextevent in 2007.

Group for Construction Materials Testing

The group was led by Mr. C. K. Cheung and Mr. FrancisC. C. Wong, Senior Accreditation Officers and Ms JuliaLee, Accreditation Officer of HKAS and attended by about20 technical assessors. The f irst topic was on theimplementation of the HOKLAS 003 (8th Edition) and ISO/IEC 17025:2005 to construct ion materials test inglaboratories. As most assessors have attended a seminaron this subject, only a brief discussion on the majordifferences between the old and new editions of thestandard was held. Mr. Cheung then gave an overall reviewof the work of HOKLAS in the construction materials testcategory in the previous year. This includes new accrediteditems such as testing of steel, cast iron, ductile iron, PEand UPVC pipes, pipe fittings, water valves, fire hydrants,

etc. The Water Supplies and Buildings Departments arethe main users of these testing services. Emphasis wasalso given to the development of testing of active firefighting equipment including fire extinguishers, sprinklers,fire alarms and drenchers, etc. It is expected that therewill be a great demand for these testing services fromthe Fire Services Department. Finally, it is anticipated thatfuture developments in the construction industry willmake use of the construction materials testing results tosupport the construction products certification. Rigorousdiscussions on the wide appl icat ions of productcertification were held among the participants. Currentapplications of the HKAS accredited product certificationhave been focused on the ready mix concrete, fire doorand safety glass. It is expected that demands for thesecertification services will expand to cover other productssuch as active fire fighting equipment and drainage pipes,etc.

Group for Calibration Services, Electrical& Electronic Products Testing, Physical &Mechanical Testing, Textiles & GarmentsTest ing and Consumer ProductsInspection

Prof. S.L. Ho and Mr. C.C. Tse, members of the AAB,together with 19 assessors participated in the group whichwas led by Mr. K.W. Chen and Mr. W.L. Shum,Accreditation Officers of HKAS.

Participants were informed that all HOKLAS assessmentsafter 20 October 2005 were based on the 8th edition ofHOKLAS 003. A number of examples of assessmentfindings relating to the 8th edition were presented fordiscussion.

Severa l common non-conformi t ies ident i f i ed inassessments were presented for discussion. Afterenthusiastic discussion, an harmonised approach hasbeen agreed to record assessment f indings. It isnecessary to record the findings in sufficient detail so thatthe assessed organisations could identify the root causesof the non-conformities and take appropriate correctiveactions.

Mr. C.K. Cheung, Senior Accreditation Officer,HKAS, updating assessors and technical experts onthe accreditation in construction materials testing.

Vivid discussions amongst assessors in the group forCalibration Services, Electrical & Electronic Products

Testing, Physical & Mechanical Testing, Textiles &Garments Testing and Consumer Products Inspection

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HKAS is very pleased to report that the implementationof ISO/IEC 17025:2005 by accredited laboratories isprogressing well. Accredited laboratories which have beenassessed and found to meet the requirements of this newedition will be issued with a Certificate of Accreditationstating that they meet the requirements of ISO/IEC 17025:2005. Eighty-seven new Certificates of Accreditationreferring to the 2005 edition have been issued at the timeof writing this report. It is reckoned that by the time whenthis newsletter is publ ished, more than half of thecert i f icates would have been replaced. Since thepublication of the 8th edition of HOKLAS 003 (based on

Implementation of ISO/IEC 17025:2005by accredited laboratories

Recently, HKAS received applications for accreditationfor performing tests in accordance with standards writtenin Spanish and other foreign languages. As most localpeople, including HKAS officers, assessors and staff of thelaboratory do not understand such languages, to conductthe test and the assessment, an English or Chinese versionof the standard obtained through translation must beprovided. The accuracy and reliability of the translatedversion is critical because the test and the assessment willbe based on it. To assure the accuracy of the translatedversion, HKAS Executive has adopted the following interimpolicy after discussing with laboratories. This policy will betried for two years and amended based on the experienceobtained before accepting it as a permanent policy.

For accreditation of a test carried out in accordance with astandard written in a language other than English andChinese, the applicant laboratory shall obtain an accuratelytranslated version of the document written in a languageunderstandable to the laboratory staff and HKAS assessors.

Accreditation of tests carried out in accordancewith standards written in a language other than

English and Chinese

ISO/IEC 17025:2005) last October, a l l laboratoryassessments have been based on this new edition.Accord ing to the imp lementa t ion schedu le , a l lnonconformities relating to the new edition would beraised as additional recommendations until 15 May 2006.After that date, they will be raised as non-conformities.Hence, nonconformities relating the new edition are nowbeing raised as nonconformities. For significant non-conformities, accredited laboratories have until 15 May2007 to complete the remedial actions to the satisfactionof HKAS Executive. Otherwise, their relevant accreditationsmay be suspended.

The preferred method is for the laboratory to ask for anofficial English or Chinese version from the body whichpublished the standard. If this is not possible, the laboratoryshall commission a competent person to translate thedocument and then check the translated version carefullyand sentence by sentence using the service of anothercompetent person.

In the above paragraph, a competent person is one whohas the required technical knowledge and translation skillfor the relevant languages. For example, if the standard isa chemical standard, the person should be a competentchemist; if the standard is a physical standard, the personshould be a physicist or engineer of the relevant fields inaddition to the required language skill. If the standard is astatutory law or regulation, it may be necessary to obtainthe advice from a lawyer or a person accepted as competentto translate legal documents, etc. A competent person maybe a staff member of the laboratory or from an externalorganization.

Attention was then turned to the recommended maximumintervals for calibration/verification of major referencestandards/working equipment specif ied in HOKLASSupplementary Criteria No. 2. It was agreed that whenthe tolerance of a certain parameter of a measuringinstrument is not specif ied in a test standard, thelaboratory has the responsibility for determining whetherthe parameter is critical, and if it is, how critical it is, andit is up to assessors to judge whether the laboratory’sconclusion is reasonable. Participants also shared their

experience in the checking of calibration certificatesduring assessments.

Finally, issues relating to proficiency testing activities werediscussed. It was pointed out that the percentage ofoutlying results in proficiency testing activities is a HKASobjective. The accreditation requirements relating toparticipation in proficiency testing activities and commonindicators of performance, i.e. z-score and En ratio wereexplained.

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The person performing the checking should be different fromthe one performing the translation. If the person carryingout the translation is from an external organisation, theperson performing the checking shall be from anotherorganization, unless there is convincing evidence to showthat carrying out both translation and checking by the sameorganization will not result in conflict of interest and will notcompromise the quality and credibility of the translateddocument. In either case, the laboratory shall obtain thecredentials of the persons who will carry out the work andsatisfy itself that the credentials are acceptable. Using nativespeakers of the relevant foreign language for carrying outboth translation and checking is preferred. When employingexternal organizations for the work, the laboratory shouldobtain evidence that the work has been done personally bythe agreed persons.

To HKAS Executive, the laboratory shall provide informationto demonstrate the competence of the persons who havecarried out the translation and checking and a sentence bysentence checking record. HKAS Executive will assess theacceptability of the competent person and check therecords carefully. The assessment team will also evaluate

the accuracy and reliability of the translated document basedon knowledge in similar test standards written in English orChinese. HKAS Executive reserves the rights to ask thelaboratory to provide further evidence to demonstrate theaccuracy and credibility of translated standards.

The laboratory shall have the capability for reviewing thetranslated versions of standards periodically and whenchanges to the original documents have been made. Thisapplies irrespective of whether the translation and checkingwere carried out by internal staff or external parties.

All relevant accreditation criteria apply to tests performedin accordance with standards written in a foreign language.For example, the laboratory may be required to demonstratetheir competence in performing the tests through takingpart in proficiency testing activities, if any doubt relating tothe accuracy of the translated version arises, the laboratoryshall implement corrective actions and where the standardstipulates that the product being tested must be labeledwith statements written in a foreign language, the laboratorymust have adequate provision for checking the acceptabilityof such labels.

Earlier this year, the International Bureau of Weightsand Measures (BIPM), the International Organisation forLegal Metrology (OIML) and the International LaboratoryAccreditation Cooperation (ILAC) has produced a jointdeclaration on the relevance of various internationalagreements on metrology to trade, legislat ion andstandardisation. The declaration invites Governments toendorse, and declare their commitment to use and referto organisations which are signatories to the CIPM MRA,the OIML MAA and the ILAC Arrangement, wherevermeasurements are required as evidence of compliance withlegislation, regulation or the pursuit of human well-beingat a national and international level. The three organisationsfurther invite standardisation organisations, regulatory and

Joint Declaration of the BIPM, OIML and ILAC

trade bodies to note the existence and value of theArrangements, and to col laborate with the threeorganisations so as to develop ways and means of referringto, promoting, and using the Arrangements in their work.The aim of international measurement system is to provideusers with measurement results which can be acceptedeverywhere without the need for further measurements.An important feature of this system is that its use can helpreduce the effects of technical barriers to trade and providea secure base for scientific and other measurementsthroughout society. The Joint Declarat ion and anintroductory covering letter can be downloaded from theILAC webs i te at www.compad.com.au/cms/ i lac/sitearticles/447.

Meeting of Users of HKAS AccreditedServices Liaison Group

The second meeting of the HKAS accredited servicesliaison group was held on 3 May 2006. HKAS staff officerspresented at the meeting clarified issues raised by the liaisongroup members. The liaison group was also briefed on theacceptance of HKAS accreditation in other economies andwas informed that an updated list of mutual recognitionarrangement partners is available from the HKAS website.The meeting was also informed that the directory ofaccredited laboratories has been uploaded to HKAS website

in PDF format and users could now download the file anduse the “search” function with the Acrobat reader to findthe accredited services they need. To ensure the views ofusers of accredited services are fully represented, membersof the liaison group were encouraged to participate in thework of various working parties under the AccreditationAdvisory Board. If any reader wishes to join the liaison group,please contact Ms Donna Cheung on 2829 4837. The liaisongroup usually holds meetings on a half-yearly basis.

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Following is a summary of an article published inthe UKAS newsletter Update earlier this year. It showshow accreditation is valued by accredited laboratoriesand certif ication bodies in the UK. The University ofLeicester carr ied out the research in early 2005 tode te rm ine the bene f i t s o f acc red i t a t i on to UKstakeholders (in particular the Government, certificationand inspect ion bodies, and laborator ies and theircustomers). The aim of this research is to identify thebusiness benefits of accreditation, as well as determinethe preference for accreditation or direct regulation.Preliminary results are now available. The following aresome key points identified by the research.

• 89% of laboratories considered that accreditation addedinterna l va lue to the i r operat ions through theimplementation and use of procedures, processes and

How accreditation is valued

Proficiency testing (PT) is a valuable tool in establishinglaboratory per formance through in ter- laboratorycomparison. Normally, a PT programme is organized insuch a way that a number of participating laboratoriesanalyze the same (or statistically homogeneous) testmaterial distributed by the PT provider. The performanceof any individual participating laboratory would then beevaluated by the deviation of its reported results from theassigned reference values, for example the z-scores. Ingeneral, PT disseminates the teacher-policeman dual roleof (i) demonstrating technical competence and (ii) identifyingproblems for self-improvement for the participatinglaboratories. If a participating laboratory has consistentlydemonstrated good performance in proficiency testing, itsreputation and clients’ confidence should be enhanced.Other specific functions of such interlaboratory comparisonalso include standardization/validation of test methods,establishing comparability for new test methods andassigning values to reference materials. These versatilecharacter ist ics of PT are achieved by the uniquemechanism of monitoring one’s internal system throughan external assessment procedure. Therefore PT is animportant tool in qual i ty assurance part icular ly incircumstances where the PT programmes have intentionallybeen designed to meet specific analytical purposes suchas laboratory accreditation.

In recent years with the introduction of internationallyaccepted requirements for demonstrating the competence

Government Laboratory:A Proficiency Testing Schemes Provider

management techniques.• 40% of laborator ies s tated that accred i ta t ion

contributed to the profitability of their business.• Only 5% of laboratories considered that their customers

did not benefit from the use of accredited services.• 34% of laboratories considered that they gained

business benefits from the international and multilateralaccreditation agreements.

• No certification body stated that accreditation was notimportant to their business.

• 26 out of 30 cert i f icat ion bodies thought thataccreditation added value to their business.

• 28 out of 30 certification bodies prefer accreditation todirect regulation.

• 80% of accredited certification bodies considered thatallowing non-accredited certification negatively affectedtheir business.

of calibration and testing laboratories like ISO/IEC17025,there is a tremendous demand, in terms of quantity andvariety, for good qual i ty PT programmes. Being adesignated metrology institute [1] and the largest publiclaboratory in Hong Kong [2] providing a comprehensiverange of analytical, investigatory and advisory services,the Government l abora to ry (GL ) o f the HKSARGover nment , i n co l l abo ra t i on w i th Hong KongAccreditat ion Services (HKAS) and other regional/international organizations, has been providing a numberof successful PT programmes to laboratories worldwide.The prime objective of the Laboratory’s commitments isto realize its vision as a laboratory providing world-classscientific services and to foster the technical developmentof GL and other laboratories in our economy throughestablishment of traceabil ity and comparabil ity. PTprogrammes organised by GL are all in areas that are indire need of and yet to be provided by the market. Theprogrammes have all along received very good responseand feedback from participating accreditation bodies andlaboratories internationally. Besides the local laboratories,participants from the Asia-Pacific, Middle East, Europe,Americas and even Africa have been involved. As illustratedin Table 1, GL has experience in providing PT programmesunder the testing scope of food, environment, commodityand products, pharmaceuticals and Chinese medicine.Many of these programmes were organized by GL andHKAS under the auspices of Asia-Pacific LaboratoryAccreditation Cooperation (APLAC).

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Since May 2005, the Government Laboratory hasincorporated the requirements as stipulated in internationalstandards such as ISO Guide 43-1:1997 and relevantelements of ISO/IEC 17025:2005, ISO 9000:1994 andISO13528 into its quality system to reflect the complianceof its practice as a PT scheme provider. Efforts have alsobeen spent in setting up dedicated facilities for organizationof PT programmes. This summer, the Laboratory is goingto seek accreditation to ILAC G13:2000 Guidelines for theRequirements for Competence of Providers of ProficiencyTesting Schemes.

Looking ahead, the Government Laboratory will continueits commitment for sustainable development as alaboratory serving in the best interest of Hong Kong andproviding world-class scientific services.

Table 1: A selection of PT programmes conducted by the Government Laboratory

Reference:[1] BIPM website (CIPM MRA - Appendix A): www.bipm.org[2] Government Laboratory website: www.govtlab.gov.hk

The ISO 9001:2000 Opportunity ... Did we miss it?

The following article is contributed by Mr Howie Ng ofi-VAC Certification Limited. This is an abridged version ofhis article originally published in the Chinese ConformityMagazine, Beijing in September 2005. The full text ineither Chinese or English is available for download at www.i-vac.com\index5.htm

Introduction

On the 15th of December 2000, the Internat ionalOrganization for Standardization published the ISO 9001:2000 standard.The fundamental difference between the old and the newversion of ISO 9001 is that the old version is a ‘Model forQuality Assurance’ whereas the new standard looks at‘Quality Management System Requirements’. While qualityassurance is focused on products, quality management isfocused on the organization and its customers. In orderto enhance customer satisfaction, an organization mustgo beyond compliance to product specifications and toimplement measures that are in l ine wi th qual i tymanagement principles.

Management system

Some believe that a management system is analogous todocuments and records. Paperwork may be one of theperceived changes in the organization if it had implementedan ISO 9001 system. Some form of management systemexists in practically all organizations (e.g. an ice-creamvendor). Every going concern would have certainprocesses to keep the organization running. There maybe order-taking, production, del ivery, and accountreceivable processes, to name a few. A managementsystem is like an operating system inside a computer. Itinstructs the hardware how to operate.ISO 9000:2000 (the vocabulary standard) defines amanagement system as a set of interrelating or interactingelements to establish policy and objectives and to achievethose objectives. A management system may exist in theminds of management (e.g. owner) without beingdocumented. An effective management system is onewhere planned results are achieved. The measurement ofeffectiveness is neither the volume of documents andrecords created nor the number of nonconformities

Scope of the Programme No. of Participants Completion Date

Heavy Metals in Paints 24 July 1990Heavy Metals in Water 10 Dec 1993Good Assay 25 Oct 1995Asbestos Counting 5 Jan 1996Benzoic Acid in Food (APLAC T004) 134 Jun 1997Heavy Metals in Paints (APLAC T013) 47 Mar 1999Flammability Test (APLAC T016) 52 Jun 2000Drugs in Cough Syrup (APLAC T038) 32 Aug 2004GM Food 6 Mar 2005Heavy Metals in Herbal Medicine (APLAC T043) 38 Jan 2006Heavy Metals in Paints (APLAC T039) 71 Feb 2006Organochlorine Pesticides in Herbal Medicine (APLAC T049) 70 July 2006 (tentatively)

10

identified during an audit.In order to effectively implement an ISO 9001 system, itshould seamlessly integrate with the daily activities of anorganization. ‘Substance’ is more important than ‘Form’.As long as the organization has satisfied the intent of thestandard, certification body auditors should not prepare anonconformity report. Say there is a process within theorganization to adequately review and discuss the seveninput requirements of a management review. From thatprocess, there are sensible conclusions on the three outputrequirements (with record). The organization is deemedto satisfy the requirements of management review (clause5.6). The process could be a face to face meeting orconducted through other communication means. It couldeven be held over dinner!

Customer requirements and product

During the interview with top management, it is commonfor the external auditor to ask ‘What is your product?’ TheCEO or General Manager may feel that this is a too obviousquestion. ‘Did you read our product leaflet or surf ourweb site?’ Deming in his renowned 4-day training for topmanagement quoted one example . Carbure tormanufacturers missed the opportunity. If they hadpositioned the product as ‘air fuel mixer’ they may havenoticed the changes in the market and preventedthemselves from bankruptcy with the advent of fuelinjection. The hidden questions of the auditor include‘What does your product cover?’ and possibly ‘What arethe characteristics of your product?’ In the establishmentand implementation of an effective management system,the organization should consider (a) the purpose of theorganization (b) the needs and expectations of thecustomers they are hoping to satisfy.

Policy and objectives

One of the f irst steps in implementing an effectivemanagement system is to formulate a quality policy. ISO9001 specifically requires the policy to be ‘appropriate tothe purpose of the organization’. The organization shallthoughtfully consider what business they are in and whatproducts they are providing. It shall be thoroughlydiscussed within the organization so as to ensure buy in.

The policy shall be short and to the point. From an internal

Update on Revision of ISO 15189

The second edition of ISO 15189, which contains onlyminor amendments to the current edition, has beenforwarded to the ISO Central Secretariat. It will likely beissued as an amendment to the current edition. Theamendments are corrections of minor typographical errors,

communication point of view, a lengthy policy may not bethe best. Staff shall not be required to remember or recitethe policy however they should have a solid understandingof what it is all about. The standard also requires the policyto provide a framework for the establishment and reviewof objectives. That is, the policy shall be supported byobjectives and shall not become an empty slogan. If theorganization determined that safety shall be included inthe policy, it will formulate safety related objectives andhave it supported by a series of action programs.

Based on a high level objective, the standard also requireslower level objectives to be established at relevantfunctions and levels. For example, if customer satisfactionis 95%, objectives for other functions may include,• Telephone pick up time < 5 sec• Reply to customers with errors < 1/ 10,000• Written reply lead time < 2 days• Customer service training > 16 hours per

staff per year• Customer information system downtime < 10 minutes/

month(numbers suggested for reference only)

The way forward

Many organizations started off their ISO 9001 systemjourney based on customer certification requirements.With hands on experience, both top management as wellas the staff involved came to realize the potential of theISO 9001 system: how it may be posit ioned as amanagement control platform to support and improvevarious organization initiatives. Gradually the so-called ISOsystem disappeared. It has integrated seamlessly into thedaily activities.

Often complaints about the ISO 9001, particularly thosefrom front line staff, concern the extra (and perceived asmeaningless) workload that is deemed necessary aftersystem implementation. It is the responsibi l i ty ofmanagement staff to ensure a high level buy in. In orderto effectively implement a management system and toeliminate non value-adding processes and documentation,it is fundamental for the management system architect andimplementation personnel (including internal auditors) toacquire an accurate understanding of the intent andrequirements of the standard.

changes in the quoted references and re-numbering. Astatement will also be added to the “Introduction” sectionto specify that ISO 15189 is not intended to be used forcertification. A definition for accreditation will be addedto the “Terms and Definitions” section. There will be a

11

new subc lause added to requ i re the laboratorymanagement to ensure that appropriate communicationprocesses are established within the laboratory and thatcommunication takes place regarding the effectiveness ofthe quality management system.

The third edition of ISO 15189 is expected to be a majorrevision to be published in 2008. The 2008 edition is nowin its third draft and some of the proposed changes arehighlighted below:• Quality objectives established “shall be measurable” and

consistent with the quality policy. Being measurablecould be on ordinal or nominal scale, e.g. terms suchas “effective”, “efficient” and “timely” are considered asmeasurable while “world class” or “leading edge” is not.

• The term “Laboratory Director(s)” in the current ISO15189 was intended to refer to a single person or a groupof persons managing the laboratory. In the revisededition, “(s)” would be deleted and the term “LaboratoryDirector” will refer to a single person having overallresponsibility. The “Laboratory Director” and the othermanagement personnel would be collectively termed“Laboratory management”. This is consistent withHKAS’s current use of the term “Laboratory Director”.

• A copy of the report from referral laboratory is currentlyrequired to be kept in both the laboratory’s file and the

patient’s file. The second part of the requirement wouldbe deleted as the patient’s file might be kept by thehospital administration and outside the control of thelaboratory.

• The definition of referral laboratories would be slightlyamended to include laboratories consulted for secondopinions for histopathology, cytology and relateddisciplines.

• In situations where a laboratory does not have a freechoice of referral laboratories, and hence can not selectthem based on evaluation results, the laboratory is stillexpected to evaluate the performance of the referrallaboratories, to review the arrangement with them andto provide feedback to them.

• The requirement for “Advisory Services” would beamended to require laboratory staff to have systematiccommunications with clinical staff instead of regularmeetings; and that the laboratory staff would be requiredto interact with cl inicians on effectiveness of thelaboratory service instead of participating in clinicalrounds.

• A new clause 5.9 on information system would beinserted. Materials would be taken from the currentAnnex B, which is “informative” at present. This impliesthat there would be new requirements on the laboratoryinformation system security, backup, checking, etc.

The twelfth meeting of the ISO/TC 212

The ISO Technical Committee 212 (TC212) responsiblefor the drafting of medically related standards had its 12thmeeting in Berlin, Germany from 31 May to 2 June 2006.Ms. Bella Ho, Senior Accreditation Officer, representedHong Kong Accreditation Service at this meeting. Threeworking groups under this technical committee heldsimultaneous meetings during this period. The major itemsfor discussion by WG1 at this meeting were the draft ofthe 2008 edition of ISO 15189 and the revision of ISO15190, a standard on safety for medical laboratories. Moredetails of the development of the ISO 15189 are given inanother article in this issue of HKAS News.

ISO 15189:2003 stakeholder survey

A draft report on the ISO 15189 stakeholder survey heldearlier in 2005/6 was presented by Ms. Regina Robertsonof NATA. The views of stakeholders from Hong Konghad been included. The finalized report will be providedto all survey respondents and will also be posted for freeuse on ILAC and ISO websites. As guidance onimplementat ion of ISO 15189 and measurementuncertainty and traceability were the key areas raised bythe stakeholders, this report will include a list of currentlyavailable guidance documents prepared by differentcountries on implementation of ISO 15189. Specific

comments received on clauses of ISO 15189 will bereviewed and considered in the course of revising thestandard. The next stakeholder survey will likely takeplace 1-2 years after the publication of the 2008 editionof ISO 15189.

Revision of ISO 15190

ISO 15190 is a standard on safety for medical laboratoriespublished at the end of 2003. As it is the intention ofWG1 to include this standard as a normative reference inthe 2008 edition of ISO 15189, there is a need to revise itscurrent “guidelines” format to “requirements” format. Aproject group led by John James of UK and comprisingmembers from Canada (Michael Noble), New Zealand (PhilBarnes), and China (Zhai Pei Jun) has been formed torevise ISO 15190.

ISO 22870 on Point-of-Care Testing

A separate standard, ISO 22870, for Point-of-Care Testing(POCT) was published in January 2006. This standard isintended to be used in conjunction with ISO 15189 foraccrediting point-of-care testing in a hospital setting.Patient self-testing in a home or community setting isexcluded. The original plan was to incorporate it into the

12

next revision of ISO15189. WG1 reviewed the way forwardwith this standard but did not make a decision.

If this standard becomes part of ISO 15189, hospitals

ILAC Arrangement Committee Meeting

The ILAC Arrangement Committee (ARC) met in Tel Aviv,Israel in February 2006. The fol lowing issues werediscussed.

1. Discussions were held on the procedures for handlingcomplaints by accreditation bodies (ABs). Examples werediscussed but it was recognised that regulatoryrequirements with respect to confidentiality varied fromeconomy to economy, and for some governmental ABs,they were also abided by their governmental policies onhandling of complaints and disclosure of information. Itwas thus concluded that ILAC guidance might not beappropriate but ABs could make reference to theprinciples given in ISO 10002 Quality management -Customer satisfaction - Guidelines for complaintshandling in organizations when establishing theirprocedures for handling complaints.

2. A report on the economic impact on the ILAC MRA waspresented by Dr Seta of International Accreditation Japan(IAJapan). According to his study, the reduction ofconformity assessment cost due to the ILAC MRA isestimated to be around USD49.4 billion based on theWTO published figure of the total amount of productsexported in 2002. A more detailed report will be expectedto be ready at the next meeting.

3. The meeting deliberated the proposed procedures forexpanding the scope of ILAC MRA to cover other fields.An ILAC document wil l be drafted based on thecomments received at the meeting.

4. Proposed texts of the ILAC MRA that included inspectionbody and Reference Material Producer accreditationrespectively were discussed. Since there were somesignificant points that needed to be amended, theconvenor of this working group was asked to proposerevised texts at the next meeting for further deliberation.These issues include the inclusion of other ISO standards

for medical testing, e.g. ISO 15195, etc., in the MRA.

5. Mr W. W. Wong, Senior Accreditation Officer of HKAS, isthe convenor of the working group on the use ofaccreditation symbols and claims of accreditation status.A draft policy document on this topic was submitted toall ILAC members for comment in October 2005. A totalof 162 comments have been received and responses tothe comments were discussed. The meeting approvedto submit the revised document for formal balloting afterthe necessary amendments. It was unanimouslyapproved on 15 May 2006 by ILAC members. Thisdocument sets requirements for signatories to the ILACMRA on this topic.

6. A representative from International Organisation for LegalMetrology (OIML) was invited to give a presentation ontheir Mutual Acceptance Arrangement (MAA). OIML is agovernment-to-government organisation established in1955 and has 60 member states and 53 correspondingmembers. A Memorandum of Understanding (MoU)between ILAC and OIML was proposed whereby the twoorganisations agreed to cooperate in areas of testing andcalibration. OIML agreed to support the use of andrecognise test reports and calibration certificates issuedby laboratories accredited by signatories to the ILAC MRAfor the purpose of demonstrat ion of measuringinstruments meeting its specifications. HKAS accreditedlaboratories will benefit from this MoU.

7. The Joint Committee on Traceability in LaboratoryMedicine (JCTLM) and ILAC are currently conducting asurvey on reference measurement laboratories forcharacterisation of medical reference materials. Only afew laborator ies have been ident i f ied. As morelaborator ies are requi red, ILAC members wi thaccreditation programme on medical laboratories wererequested to assist in the identification of referencemeasurement laboratories.

APLAC MRA Council Meeting

The APLAC Mutual Recognition Arrangement Councilheld its meeting on 22-24 May 2005 in Singapore. Themain issues discussed include the following.

1. ISO/IEC 17011 Conformity assessment - General

offering point-of-care testing service to patients have totake note of this development. The requirements in ISO15189 will also apply to POCT service provided by hospitallaboratories.

requirements for accreditation bodies accreditingconformity assessment bodies was published in 2004.According to a resolution of ILAC, all signatories to theregional MRA are required to meet this standard by theend of 2005. The MRA Council accepted the HKAS self-

13

Bureau of Laboratory Accreditation, Department of ScienceService (BLA-DSS), Thailand was admitted to the APLAC MRA

for testing. From the left are:Mr. S.S. Chan , Chair of APLAC MRA Council,

Mrs. Suchin Srikongsri, Deputy Director General and ActingDirector of BLA-DSS,

Mr. Tony Russell, Chair of APLAC

APLAC MRA Council delegates posting for a group photo

declaration and the review report on the self-declaration,and resolved that the signatory status of HKAS fortesting, calibration and inspection would continue andthe re-evaluation date would remain unchanged. TheCouncil also accepted the follow-up evaluation reporton the medical programme of HKAS, and ISO 15189will be included under the scope of recognition. Theinaugural signing of ISO 15189 will take place at thefirst MRA Council meeting next year.

2. Bureau of Laboratory Accreditation, Department ofScience Service (BLA-DSS), Thailand was admitted tothe MRA for testing. The total number of APLACsignatories is therefore increased to 24. The signatorystatus of the Bureau of Laboratory Quality Standards(BLQS), Department of Medical Sciences (DMSc),Ministry of Public Health, Thailand for testing is reaffirmed.

3. Proposed amendments to APLAC MR-001 Proceduresfor establishing and maintaining the APLAC MutualRecognition Arrangement Amongst AccreditationBodies were discussed. The amendments are mainlyrelated to the re-formatting of the document. There areno substant ia l changes to the procedures andrequirements. This document will be further reviewedagainst IAF/ILAC A2:2006 IAF/ILAC Multilateral MutualRecognition Arrangements: Requirements for Evaluationof a Single Accredi tat ion Body and necessaryamendments will be made.

4. Mr W. W. Wong, Senior Accreditation Officer, HKAS,who is the convener o f the work ing group onreference materials, reported the work of the workinggroup. A document on the assessments of referencematerial producers is being drafted by a task groupo f the APLAC Techn ica l Commi t tee i n c losecollaboration with the RM Working Group. Mr Wong

also reported on the 3-day training workshop onRMP accreditation held in Beijing on 10-12 April 2006,w h i c h w a s a t t e n d e d b y 1 6 p a r t i c i p a n t s . Arepresentative from EA and IAAC also attended theworkshop. There are four accreditation bodies thathave applied to join the MRA for RM. One AB wasevaluated in March and the other three wi l l beevaluated next year. The inaugural signing of the MRAfor RM wil l take place when four ABs have beenevaluated and found to meet the requirements.

APLAC RM Training Workshop on Accreditation ofReference Material Producers

A 3-day training workshop on accreditation of referencematerial producers was held in Beijing on 10-12 April 2006.The China National Accreditation Board for Laboratories(CNAL) hosted this event. The presenters of the course wereMr. W. W. Wong, Senior Accreditation Officer of HKAS,who is the convener of the APLAC Working Group onReference Material Producer Accreditation, Dr Ed de Leer,Director of Science of NMi Van Swinden Laboratorium,Netherlands National Measurement Standards Institute andchair of International Advisory Group on Reference Materials(IAGRM), and Ms Roxanne Robinson, Vice-President ofAmerican Association for Laboratory Accreditation. Sixteenrepresentatives from Asia-Pacific Laboratory AccreditationCooperat ion (APLAC), European Cooperat ion for

Accreditation (EA) and Inter-American AccreditationCooperation (IAAC) attended the workshop. The topicsdiscussed included the accreditation criteria (i.e. ISO Guide34 and ISO/IEC 17025 in combination), planning of andapproach to assessments of reference material producersand setting up of an accreditation programme. The APLACMRA Council has decided to extend the MRA to cover RMPaccreditation and the inaugural signing of the MRA will takeplace when four accreditation bodies have been evaluatedand found to meet the requirements. It is the intention that,with the establishment of this MRA, laboratories couldsource reference materials from accredited producers sothat they could be assured of the quality of referencematerials they use.

14

13th PAC Plenary Meeting

Mr. Tommy Fung of HKAS attended the 13th PAC PlenaryMeeting held in Hanoi, Vietnam during the period 27 Mayto 2 June 2006. Since the last meeting in 2005, two newAssociate Members have joined PAC. They are the AsianAccredited Certification Body Federation (AACBF) andJapan Information Processing Development Corporation(JIPDEC). This brings the total PAC membership to 23(17 Full and 6 Associate members). We would like tocongratulate DSM (Malaysia) on their signing of the EMSMultilateral Mutual Recognition Arrangement (MLA) at thisPlenary Meeting.

New Staff

After working in HKAS for about six years, Mr. S. F. Yipwas posted back to the Civil Engineering and DevelopmentDepartment in April 2006. HKAS Executive wishes tothank Mr. Yip for his hard work in HKAS and wishes himevery success in his future endeavours.

Ms. Julia Lee joined HKAS on 20 February 2006 as anaccreditation officer. Prior to her employment with HKAS,Ms. Lee has worked in an in-house quality control

Julia is looking forward to workingwith accredited laboratories.

laboratory as a Laboratory Superintendent for more thanten years. She has extens ive exper ience in theimplementation and maintenance of quality system to ISO/IEC 17025, ISO9000, ISO14000 and OHAS 18000.Chemical and physical quality control tests for constructionmaterials, and chemical tests for air and wastewatersamples are within her range of expertise. Julia holds abachelor’s degree in Chemical Technology from the HongKong Polytechnic University and a master’s degree inanalyt ical chemistry f rom the Hong Kong Bapt istUniversity. She also possesses a diploma in InformationTechnology and Quality Management from ChineseUniversity of Hong Kong and a postgraduate certificate inOccupational and Environmental Health and SafetyManagement from University of Portsmouth. In HKAS, Ms.Lee’s main areas of responsibility is accreditation of testsin the test category of “Construction Materials”.

The 13th PAC Plenary Meeting27 May - 4 June 2006, Hanoi, Vietnam

In line with the government’s 5-day week policy, startingfrom 1 July 2006, the off ice hours of Hong KongAccreditation Service are as follows:.

Monday to Friday : 8:45 am to 6 pm(lunch break : 12:30 pm to 1:30 pm)Saturdays, Sundays and Public Holidays : closed

The new office hours are also posted at our websitehttp://www.itc.gov.hk/en/5day.htm.

If you require any further information, please contact us at :Tel : 2829 4837Fax : 2824 1302Email : hkas@itc.gov.hk

Accreditation Update

A certification body and eleven laboratories have obtainedaccreditation since the last issue of HKAS news. AccreditedCertification International Limited (registration numberHKCAS 011) was accredited for ISO 9001 (qualitymanagement system) and ISO 14001 (environmental

New Office Hours

management system) certification on 28 April 2006. Thenames of the accredited laboratories and their HOKLASregistration numbers, accredited test categories and clienteleare summarised below. HKAS wishes to congratulate themon their success in obtaining accreditation.

15

Change of Legal Status

HOKLAS Registration No. 013 was transferred from LamGeotechnics Limited to Lam Laboratories Limited with effectfrom 1 April 2006. The laboratory has been grantedaccreditation under the test categories of “ConstructionMaterials” and “Environmental Testing”. It provides testingservice to the public.

Accreditation Terminated

Lam Geotechnics Limited (HOKLAS Registration No. 013)voluntarily terminated all physical tests except Atterberg limitsand PSD tests under the test category of “ConstructionMaterials” effective 1 February 2006. With the legal statusbeing transferred to Lam Laboratories Limited (see left), allHOKLAS accredited activities of Lam Geotechnics Limitedwas voluntarily terminated with effect from 1 April 2006.

Proficiency Testing Update

An update on the proficiency testing programme organsied by HKAS in the year 2006 is given below:

HOKLASRegistration No.

Name of LaboratoryAccredited Test Categories and

Test Areas / DisciplinesClientele

165

166

167

168

169

170

171

172

173

804P

805S

Jewellery Trade Laboratory Limited

Department of Health, Centre for HealthProtection, Public Health Laboratory ServicesBranch, Microbiology Division, Food and WaterLaboratory

Excel Building Diagnostic & Inspection ServicesLimited

Shenzhen University - Yantian Port Laboratory

Suntech Testing Limited

Fugro Technical Services (Guangzhou) Limited

Modern Testing Consultants Limited

Castco Testing Centre (Zhongshan) Limited

Acoustic Testing Services Limited

Department of Health, Centre for HealthProtection, Public Health Laboratory ServicesBranch, Microbiology Division

PathLab Medical Laboratories Ltd.

Physical and Mechanical Testing- gemstone testing

Environmental Testing-Water and wastewater testingFood-Testing for general food stuff, diary products,milk and Sterilized/UHT milk

Construction Materials- Testing for adhesives, anchor bolts, coating, concrete,dowel bars, mortar, plaster, render, steel, tile and welds

Construction Materials- Testing for aggregates, blocks & bricks, concrete,soil and PFA

Construction Materials- Testing for anchor bolts and welds

Construction Materials- Testing for aggregates, blocks & bricks, cement,concrete and PFA

Construction Materials- Testing for adhesives and anchor bolts- Core drilling

Construction Materials- Testing for aggregates and concrete

Construction Materials- Acoustic tests

Medical Testing- Clinical Microbiology and Infection- Immunology

Medical Testing- Chemical Pathology- Clinical Microbiology and Infection- Haematology- Immunology

Public

Governmentdepartments

Public

Public

Public

Public

Public

Public

Public

Public and privatehospitals and clinics

Private physicians,medical centres, privateand public hospitals andother medically related

institutions

Construction Materials

StatusScheduled DatesTest Area

Aggregate - physical test

Aggregate - alkaline aggregate reaction

Non destructive testing - pile sonic logging

Soil - in-situ density test by Nuclear Densometer

Non destructive testing - soil nail

Anchor bolts - Proof load test

Reinforcing steel - physical test

-

-

July 2006

July 2006

August 2006

October 2006

November 2006

Final report issued. Laboratories which were identified as outliers arerequested to investigate the cause and report their findings to HKAS.

Samples dispatched to participants for testing in April. Results returned toHKAS for analysis and compilation of final report underway.

Invitations sent to interested participants

This programme was originally scheduled for January 2006

This programme was originally scheduled for January 2006

Programme being planned and interested laboratories will be invited toparticipate in due course.

This programme was originally scheduled for February 2006. Interestedlaboratories will be invited to participate in due course

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Chinese Medicine

Final report on APLAC T-043 - Herbal Medicine ProficiencyTesting Programme has been issued. A total of 46laboratories from 19 accreditation bodies participated in thisprogramme. The performance of the majority of participatinglaboratories was satisfactory with more than 90% of thereported results of cadmium and lead having satisfactory z-scores. This programme was jointly organised by HKAS andthe Government Laboratory.

A proficiency testing programme on organochlorine pesticideresidues in herbal medicine (APLAC T049) was jointlyorganized by the Government Laboratory and HKAS.Samples were sent to nominated participants in February2006 and results received in March and April 2006. Interimreport and draft final report were issued in May 2006. Thepreparation of the final report is now underway and it will beready for publication in July 2006. A total of 70 laboratoriesfrom 26 economies participated in the programme.

Others programmes organised under theauspices of regional accreditation bodycooperation

Final report for APLAC T045 - Fasteners proficiency testingprogramme organised by TAF was issued. The performanceof Hong Kong participants is generally satisfactory. A non-accredited laboratory provided some outlying results.

APLAC APM 017 - interlaboratory comparison programmeon mass calibration is being jointly organised by Hong Kong

Association of Testing, Inspection and Certification (HKTIC),formerly known as Hong Kong Association of CertificationLaboratories (HKACL), HKAS and National AccreditationBody, Indonesia (KAN). The artifacts are being circulated toparticipating laboratories.

Three Hong Kong laboratories have been nominated toparticipate in the APLAC T051 - Analysis of Restrictive HeavyMetal Elements in Plastics organised by TAF of Taiwan, China.

Two Hong Kong laboratories have participated in a wateranalysis programme organised by OAA of Argentina underthe auspices of IAAC. This is one of the activities that APLACand IAAC agreed to cooperate with each other. Sampleswere sent to the participants in May 2006 and results weresubmitted to OAA in June.

Invitations for participation were sent to Hong Konglaboratories to participate in the APLAC T055 - Metals inWater organised by CAEAL of Canada under the auspicesof APLAC.

New edit ion of HKAS DocumentsPublished

Four revised HOKLAS Supplementary Criteria have beenpublished since the last issue of HKAS News. They are shownin the following Table with the dates of implementation. Thesedocuments are mandatory. Accredited laboratories areadvised to study them and adjust their management systemand operation procedures accordingly on or before theimplementation dates. These documents are available at ourwebsite at http://www.itc.gov.hk/hkas.

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

October 2006

• Internal Auditing of Laboratories to ISO/IEC 17025October 2006

• The ISO Guide to the Expression of Uncertainty inMeasurementlate 2006

Interested readers should note that the latestinformation on training courses is posted on our websiteat www.itc.gov.hk/hkas. Please contact HKAS Executivefor enrolment of the courses.

HKAS published documents Publication Date Implementation Date

HOKLAS Supplementary Criteria No. 1 Issue No. 4Acceptability of Chemical Reference Materials and Commercial Standard SolutionsUsed for the Calibration of Equipment

HOKLAS Supplementary Criteria No. 6 Issue No. 4Environmental Testing” Test Category - Chemical Testing

HOKLAS Supplementary Criteria No. 10 Issue No. 4Environmental Testing” Test Category - Accreditation of Site Testing/Sampling(Water, Waste Water and Sediment)

HOKLAS Supplementary Criteria No. 7 Issue No. 4Internal Audits and Management Reviews

19 June 2006

19 June 2006

19 June 2006

23 June 2006

19 December 2006

19 December 2006

19 December 2006

23 August 2006