August 2003

Issue No.

35H 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

Cost of Quality … a PossibleAnswer?

Electronic Records and DigitalSignatures

Scheduling of LaboratoryReassessments

New and Revised PublishedDocuments

Alignment of ISO 17025:1999with ISO 9001:2000

Accreditation Programme onMedical Testing

ISO/TC 212 Meeting

Second HOKLAS Liaison Meetingwith Accredited Laboratories

Basic Metrology Training Course

Accreditation of ConstructionMaterial Product Certification

Seminar on Accreditation ofGemstone Laboratories

New Staff

Accreditation Update

Proficiency Testing Update

Upcoming Training Courses

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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.info.gov.hk/itc/hkas/

Cost of Quality … a Possible Answer?The following article is contributed by Mr. Howie Ng of i-VAC Certification Ltd.

Introduction

Although ISO 9001 system implementation and certification have enjoyedglobal popularity and success for very many years, critics of ISO 9001management systems believe that such systems are costly to build, to runand to achieve certification. The typically paper-based system that is oftencreated does not necessarily add value to the business in any tangiblemanner. The system is just useful for the external auditor to assess forcompliance.

Indeed, the debate on the value of ISO 9001 management systems has notsubsided. The introduction of the year 2000 version, which is based oneight quality management principles, has not apparently created anysignificant change in the perception of some executives and professionalsas to what ISO 9000 is all about. Therefore, it is the objective of this paperto go back to ground zero and examine the nature of management systemsand the business reasons for implementing an effective management system.

What is a Management System

As a matter of fact, any business undertaking will have a management systemof some kind in place, in order to keep the business going, which mayrange from multinational corporations to the restaurant around the corner.Each organization has to satisfy customer requirements in order to stay inbusiness. Management systems are something like a piece of software thathelps to keep a computer system working smoothly and efficiently. Themanagement system of the restaurant is most probably committed in themind of the owner, and may not be documented. There may not be anymanagement system operating records, as such.

ISO 9001:2000

ISO TC176 (the technical committee responsible for the development ofthe ISO 9000 series of standards) spent almost five years researching anddiscussing the set of principles that are most commonly demonstrated withinsuccessful organizations on a global basis. The results include principlessuch as understanding your customers’ needs and expectations; controllingyour processes; involving your people and not least, continually improvingyour processes.

The major difference between the 2000 edition and the 1994 edition is thatthe origin of the 1994 version could be traced back to the US MIL-Q-9858AQuality Program Requirements, which was first released in 1963. It is basedon a quality assurance concept, whereas the 2000 edition is a brand new

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development based on quality managementprinciples. The origins are very different. The newemphasis is on customers, on process controls,on improvement and achieving effective andsatisfactory results. The focus on documentedprocedures and records is now committed tohistory.

A Long Journey

Although quality management principles seem likecommon sense, the implementation of an effectivequality management system is extremely complex.Many executives historically thought it was the jobof the ‘Quality Manager’ function and failed torecognize it as having much more to do with‘management’ than ‘quality’. Indeed, it has takenan evolution over hundreds of years for executivesand quality professionals alike to discover.

It all began with INSPECTION, which was thoughtto be the way to ensure quality. However, thedisadvantages are obvious. Such systems are notonly expensive to operate and to correct, (rework,scrap, waste etc.), they are subject to humanerrors. Defective products may slip through. Forsectors such as those in the service industries,inspection may not be practical. Delivery is themoment of truth.

Next came QUALITY CONTROL, which involvesoperational techniques and activities to fulfillrequirements for qual i ty ( ISO 8402:1994).Activities such as elementary product testing,process performance measurement, and basicplanning are utilised to assess quality. However,the fundamental quality concept remains asDETECTION.

Therefore, ach iev ing Qual i ty through thePREVENTION of error, rather than by thedetection of error, is a logical breakthrough.Correcting mistakes is not an economical way toachieve, nor maintain, desired quality levels.Mistakes, or non-conformi t ies should beprevented from happening in the first place byeliminating the root cause. This gives rise toQUALITY ASSURANCE, where the emphasis isupon upstream ‘management’ activities in the coreprocesses, and not downstream, where theproducts are made.

The advancement of statistics in process controladvocated by Walter Shewhart (1891-1967)established a conceptual foundation. In anattempt to improve purchased hardware quality,the US military published MIL-Q-9858A QualityProgram Requirements in 1963 for suppliers.Later, which NATO adopted as the AQAP seriesin 1969, which then became BS5750 in 1979.

Juran (born 1904) advocated the involvement ofmanagement in the ‘War’ on quality, whereQUALITY MANAGEMENT involves the entireorganization, customers and suppliers. Topmanagement commitment provides the key for acompany wide approach to quality, with customerneeds and expectations as the focus. Quality toolsand techniques have become more sophisticatedover the years, where the use of the Shewhart /Deming PDCA (Plan, Do, Check, Act) cycleconstitutes a core strategy in improvement.

Cost of Quality

Nothing other than a specific financial assessmentwill really facilitate the full understanding from atop management perspective regarding the issuesre lated to qual i ty. Regrettably, t radi t ionalaccounting practices have not been gearedtowards the accurate calculation of the cost ofquality, although the costs of not achieving qualityare more readily assessed.

In all fairness, the cost of quality is a complexissue. The metaphor often used is the iceberg.What management may readily see is the top ofthe iceberg, which is above water. Whatmanagement may have difficulty in gauging is thepart that is hidden below the water. Costs relatedto, for example, complaint handling, rectification,premium freight costs, pricing or billing errors aregenerally not reported in a transparent manner asa cost of quality failure.

Crosby (1926-2001) in his Quality Without Tears(1984), separated the cost of quality into twoareas: Price of non-conformance and Price ofconformance. The price of non-conformancesincludes all expenses involved in doing thingswrong. According to Crosby, the price of non-conformance may represent up to 20% of salesin manufacturing companies (15 to 25% in JADeFeo paper ) . A l ternat ive ly, the pr ice ofconformance includes expenses to make things

Fig. 1: Evolution of quality management systems

DETECTION (Reactive) PREVENTION (Proactive)

Inspection Quality Control Quality Assurance Quality Management

• Procedures

• Process

monitoring

• Product

testing

• Analysis

• Action

• Statistical

process

control

• Quality

assurance

system

• Cost of

quality

• Improvement

• Process

management

• Involve

customers

and suppliers

• Company wide

involvement

• Measuring

• Sorting

• Scrapping

• Reworking

• Waste

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right. This includes the costs of quality function,education / training and other preventive means.For a well run company, Crosby estimated that tobe only 3 to 4 % of sales.

In Asia, it has been reported (1) in Singapore that5 to 10% of project costs were expended in wrongdo ings and rec t i f i ca t ion fo r an ave rageconstruction contractor. In Australia, it has beenreported (2) that a 1% increase in expenditure onprevention reduces costs from failure from 10%down to 2%.

Therefore, investment in the prevention of errorappears to offer an excellent rate of return.

Fig. 2: Reduction of cost of quality through advancement intechnology

In order to appreciate the relationship betweendifferent approaches and costs of quality, anillustration is presented in Figure 2 above. Thesignificance lies in the horizontal axis. It is not onlythe advancement of technology, i t is thecomplexity of the techniques involved. Inspectionmay simply involve one or just a few trained staff,whereas quality management involves the entireorganization in much more complex mathematicaltechniques and tools used in preventive measures.I t takes much more t ime, resources andwholehearted effort to implement. However,history has proven that quality management effortsw i l l no t be ve ry success fu l w i thout topmanagement commitment. Top managementneeds to be a role model, provide resources andbe h igh ly v is ib le in qua l i t y managementendeavours.

However, the reward in quality management termscould be enormous (e.g. Winning a quality award,gaining significant recognition, increased ordersetc.)

What Might Have Gone Wrong

The promise of quality management is a rosegarden. Unluckily, some organizations that haveimplemented a quality management system maynot necessarily have derived the benefits asclaimed. Such systems may even be valuesubtracting. The cost of quality actually increased.

While it is not the objective in this paper to discussin detail the reasons behind such negative results,what is almost certain is that such managementsystems may not have fitted the actual businessneeds and operational business flow. Although theISO 9001 standard is an international standard,each organization should develop the system toaddress their actual needs, i.e. it has to be tailored.An ISO 9001 system should be developed basedon actual business flow, and should have anymissing elements added. The integration shouldbe seamless and harmonious.

An organization with an ISO 9001 system, whichis in addition to the normal business flow, mayexpose itself to the risk of a value subtractingsystem. ISO 9001:2000 has 136 requirements( i .e. SHALL DOs), of which 21 are recordrequirements and only 6 are documentedp r o c e d u r e r e q u i r e m e n t s . A c c u r a t e l yunderstanding the requirements of ISO 9001:2000may help organizations to determine if they wouldlike to keep certain documented procedures orrecords, which are often the most common sourceof complaint and frustration from operating staff.

References

(1) ISO 9000 and the Construction Industry(1998) by Low Sui Pheng, ChandosPublishing

(2) Quality does not cost – Its pays (1991) byRoberts R., Australian Construction LawReport, Vol. 10 No. 4

(3) Quality Without Tears (1984) by Phil ipCrosby, McGraw Hill

(4) What is total quality control? (1985) byKaoru Ishikawa,, Prentice

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More and more conformity assessment bodies(CABs) are finding it more efficient and economicalto store and process documents and informationelectronically. We have been asked in manyoccasions whether records stored in electronicmedium are acceptable. Electronic records andelectronic signatures are acceptable to HKAS ifthey meet the requirements of the ElectronicTransactions Ordinance (Cap. 553). CABs shouldstudy this Ordinance carefully to determine theacceptability of their electronic record systems.Following are some salient points of the Ordinancewhich CABs may be interested in.

Electronic Records

Sections 5, 7 and 8 of the Ordinance establishthe acceptability of electronic records under a lawfor giving information in writing, retention ofin format ion, re tent ion or presentat ion ofinformation in its original form, provided that theelectronic records satisfy the specified conditions.Section 9 further states that an electronic recordshall not be denied admissibility in evidence in anylegal proceeding on the sole ground that it is anelectronic record. The conditions for acceptancespecified in Sections 5, 7 and 8 are related to theaccessibility and quality of electronic records.HKAS does not have any additional qualityrequirement for electronic records.

During assessments, HKAS will pay attention tothe following factors: accessibility and display foruse of the records; safety and integrity of therecords, including data backup and recovery;evidence that the records are in their originalformat or can represent accurately the originali n f o r ma t i on , i n c l ud i ng p reven t i on f romunauthorised alterations, and traceability of theelectronic records to the original information. It is

also necessary to ensure that information on theorigin and destination of a record, as well asinformation on the date and time when the recordwas sent or received, is retained. The purpose isto establish that the electronic record system ofthe CAB can meet all accreditation criteria, e.g.,the electronic records for a test or calibration mustinclude, among other information, sufficientevidence to demonstrate that all the quality controlprocedures, including checking of data have beencompleted by appropriate persons before a resultis approved and issued and that such evidencecannot be altered. Proper amendment historymust also be kept and the person making theamendment must be identifiable.

Digital Signatures

Clauses 9.4.5 and 11.4.5 of HKAS 002 allow aHOKLAS or HKIAS endorsed certificate or reportto be digitally signed provided that the digitalsignature is acceptable under the Ordinance.Section 6 of the Ordinance provides that if a ruleor law requires the signature of a person, a digitalsignature of the person satisfies the requirementif the digital signature is supported by a recognisedcertificate. A certificate issued by the PostmasterGenera l or other cer t i f icat ion author i t iesrecognised by the Director of InformationTechnology Services of the Hong Kong SARGovernment is a recognised certificate. There mayalso be other recognised certification authoritiesas allowed in Part IV of the Ordinance.

It should also be pointed out that there areexceptions to Sections 5, 6, 7 and 8 of theOrdinance as explained in Sections 11 to 17.CABs intending to use electronic records orsignatures are urged to study the Ordinancecarefully and seek legal advice, if necessary.

T h e a s s e s s m e n t r e g i m e o f H O K L A Saccreditation consists of a reassessment one yearafter initial granting of accreditation and every twoyears thereafter. Although, in principle, thisassessment regime applies to all tests coveredunder individual assessments, it is the policy ofHKAS to combine reassessments that are duewithin a six-month period. This policy has been inplace for almost ten years. Feedback fromlaboratories indicates that, although combiningreassessments minimises disruption to laboratoryoperation, large assessment teams and long

assessment period cause difficulties in respondingto requests of the assessment teams. A balancebetween the size of the assessment team and thefrequency of assessment visits is desirable. In viewof this, HKAS will make the following arrangement.

1. An assessment / reassessment may spreadover different days within a two-week window.For example, the first assessment day is onMonday and it covers microbiology tests withone assessor and one officer. The second daymay be on Friday of the same week and it

Electronic Records and Digital Signatures

Scheduling of Laboratory Reassessments

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covers chemical tests with another assessorand another officer. The third day may be onFriday of the following week and it coversenvironmental tests with a third assessor andthe officer present on Monday of the first week.This means a laboratory wil l not have toentertain a large team of assessors on anysingle day and efficiency will be enhanced asthere is only a single assessment to arrangeand to reply to.

2. For mu l t i -d isc ip l ine labora tor ies , i .e . ,laboratories accredited for tests in several testcategories, the HKAS officers responsible forthe laboratories will contact the laboratories at

the beginning of each year to agree on areassessment schedule for the year. This willal low sufficient time for the laboratory toprepare for the reassessments and thelaboratory can also schedule their applicationsfor extension of accreditation according to theschedule. Laboratories, of course, can stillapply for extension of accreditation any timethey wish.

It is hoped that this arrangement couldstreamline HOKLAS reassessments andminimise the disruption to the operation oflaboratories.

The ISO/CASCO Working Group 25 (WG 25) onalignment of ISO 17025:1999 with ISO 9001:2000held its fourth meeting on 21 July 2003. A draftamendment document (DAM) has been producedand this document will be circulated for voting byISO/IEC members. If the outcome is positive andthere is no major negative feedback, the documentwill be issued as a new edition of ISO/IEC 17025in July 2004. Otherwise, a FDAM will be producedfor voting in August 2004 and the finaliseddocument is expected to be published in March2005. The Working Group also agreed that theoriginal review of ISO/IEC 17025 scheduled for2005 is no longer needed.

Compared with the ISO/IEC 17025:1999, thefollowing are the more significant amendmentsproposed in the DAM. The changes are mainly onsection 4 although some amendments to section5 have also been made.

1. The fol lowing statement is added to theIntroduction

“Conformity of the quality management systemwithin which the laboratory operates to therequirements of ISO 9001 does not of itselfdemonstrate the competence of the laboratoryto produce technically valid data and results.Nor does demonstrated conformity to thisinternational standard imply conformity of thequality management system within which thelaboratory operates to all the requirements ofISO 9001.”

2. The term “management system” has replaced“quality system”.

3. The term “customer” has replaced “client”.

4. Requirement for management’s commitment tocontinual improvement of the managementsystem related to quality has been added. Anew clause 4.10 on improvement has beenadded. The clause reads

4.10 ImprovementThe laboratory shall continually improve theeffectiveness of its management system

New

The following new or revised technical criteriadocuments have been published recently. Anelectronic copy of these documents has been sentto relevant accredited laboratories and assessors.These new or revised documents have also beenposted on our website. Interested persons canvisit our website to view these documents.

HKCAS Supplementary Criteria No.2Accreditation of Construction ProductCertification

New and Revised Published Documents

Alignment of ISO 17025:1999 with ISO 9001:2000

HOKLAS Supplementary Criteria No. 5“Environmental Testing” Test Category -Asbestos Sampling and Testing

HOKLAS Supplementary Criteria No. 8“Environmental Testing” Test Category -Microbiological Testing

HOKLAS Supplementary Criteria No. 20“Chemical Testing”, “ConstructionMaterials”, “Food”and “Toys andChildren’s Products” - Chemical Testing

Revised

Revised

Revised

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through the use of the quality policy, qualityobjectives, audit results, analysis of data,correct ive and prevent ive act ions andmanagement review.

5. A new clause requiring laboratories to seekfeedback from its direct customers is added.It reads:

4.7.2 The laboratory shall seek feedback, bothpos i t i ve and negat i ve , f rom i ts d i rec tcustomers. The feedback should be used andanalysed to improve the management system,testing and calibration activities and customerservice.

NOTE Examples of the types of feedback mayinclude customer satisfaction surveys andreview of test or calibration reports withcustomers.

6. A new requirement on training has been addedto clause 5.2.2. The new requirement is “Theeffectiveness of the training actions taken shallbe evaluated.”

7. New requirements for assuring the quality oftest and calibration results have been added.The original clause 5.9 has been re-numberedas 5.9.1 and the following requirements havebeen added:

f) regular checking of equipment for stabilityand integrity.

5.9.2 Quality control data shall be analysed andwhere it is found to be outside pre-definedaction criteria, the defined actions shall betaken to correct the problem and to preventincorrect results from being reported.

Drafts of the following documents were sent torelevant professional associations and otherinterested parties for consultation in July.

HOKLAS 015 Technical Criteria for LaboratoryAccreditation (Medical Laboratories)

HOKLAS 016 Assessment/ReassessmentQuestionnaire (Medical Laboratories)

HOKLAS Supplementary Criteria No 23 “MedicalTesting” Test Category – Autopsy

HOKLAS Supplementary Criteria No 24 “MedicalTesting” Test Category – Cytopathology

HOKLAS Supplementary Criteria No 25 “MedicalTesting” Test Category – Histopathology

HOKLAS Supplementary Criteria No 26 “MedicalTesting” Test Category – Chemical Pathology

HOKLAS Supplementary Criteria No 27 “MedicalTesting” Test Category – Clinical Microbiology andInfection

HOKLAS Supplementary Criteria No 28 “MedicalTesting” Test Category – Haematology

HOKLAS Supplementary Criteria No 29 “MedicalTesting” Test Category – Immunology

HOKLAS Supplementary Criteria No 30 “MedicalTesting” Test Category – Molecular Pathology

The AAB Working Party on Medical Testing willreview all comments received.

Since the last issue of HKAS News, the AABWorking Party on Medical Testing has met threetimes. HKAS representatives also attended twoforums of Hong Kong College of Pathologists inApri l and July to discuss the accreditationprogramme on medical testing. The Chairman ofthe Working Party and HKAS representatives alsomet with various interest groups in August to solicittheir views and feedback.

Following is an open letter of Dr. L. H. Ng,Execu t i ve Adm in i s t r a to r , HKAS, to t hestakeholders of the HOKLAS accreditat ionprogramme for medical laboratories.

I am encouraged by the overwhelming interestshown in the accreditat ion programme andwould l ike to thank those of you who haveprovided comments on the draft SupplementaryAccreditation Criteria for taking the time to doso. The comments will be carefully studied bythe Accreditat ion Advisory Board’s WorkingParty on Medical Testing. I am sure you wil lappreciate that the Working Party will not be ableto take all proposals on the accreditation criteriaon board but we will keep you informed of thedecisions made. I hope that the collection ofviews from a wide spectrum of interest groupsand the intense debate we have had over thepast one and a half years wi l l lead to wideracceptance of the criteria. I take this opportunityto thank, most sincerely, al l of you who have

Accreditation Programme on Medical Testing

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c o n t r i b u t e d t o t h e d e v e l o p m e n t o f t h eaccreditation programme.

In the meantime, I note that there may be somemisunderstanding over the role of Governmenti n t h e m e d i c a l l a b o r a t o r y a c c r e d i t a t i o nprogramme and the objectives of the Hong KongAccreditat ion Service (the “HKAS”). I wouldtherefore appreciate if you would allow me toprovide some clarification.

HKAS was launched by Government as a servicefo r l abora to r i es , ce r t i f i ca t ion bod ies andinspection bodies who wish to seek recognitionof their competence by an independent body.The objectives of the laboratory accreditationscheme HOKLAS, are to provide recognition tolaboratories operating to international standards,t o upg rade t he s t anda rd o f t e s t i ng andmanagement of laboratories, and to promoteacceptance of test results issued by accreditedlaboratories hence minimizing the need for re-testing.

P a r t i c i p a t i o n i n a l l H K A S a c c r e d i t a t i o nprogrammes including the medical laboratoryaccredi tat ion programme is vo luntar y. Theobjective of the medical programme is to offerofficial recognition to laboratories which are ableto demonstrate that they comply wi th theinternational standard ISO 15189.

HKAS i s opera ted by the Innova t ion andTechnology Commission (the “Commission”).The Commission is not a regulatory authority,has no responsibility for Government policies onmedical and health issues and has no intentionor authority to use the programme for licensingor regulatory purposes.

Furthermore, I note that the interpretation of theSupplementary Medical Professions OrdinanceCAP. 359 (the “Ordinance”) has been a point ofargument when HOKLAS accreditation criteriafor medical laboratories was discussed. I wishto po int out that the in terpretat ion o f theOrdinance is not relevant to the determinationo f a c c r e d i t a t i o n c r i t e r i a . T h e H O K L A Saccreditation criteria for medical laboratory isfocused on technical competence and is inaccordance with ISO 15189.

It is possible that use of the term “LaboratoryDirector” in ISO 15189 may have misled someo f you to assume tha t t he acc red i t a t i onrequirements for Laboratory Director should beequivalent to the requirements for “director” inthe Ordinance and use of the term “registrationwith MLT Board” in the accreditation criteria mayhave misled some of you to believe that it is thein tent ion to inc lude the prov is ions o f theOrdinance. This is certainly not the case. ISO15189 is independent from the Ordinance andthe term “registration with the MLT Board” wasused in the accreditation criteria as evidence oftechnical competence of personnel performingcertain functions and it was not used for ensuringcompliance with the Ordinance.

The HOKLAS accreditation criteria states “It isthe responsibility of the laboratory to carry outits work in accordance with the relevant Lawsand Regulations of Hong Kong.” It is not ourintent ion to inc lude provis ions of laws andregulations in the accreditation criteria but it isthe laboratory’s duty to ensure compliance.

The International Organization for Standardization(ISO) Technical Committee 212 (ISO/TC 212)responsible for drafting ISO 15189 Medicallaboratories – Particular requirements for qualityand competence met on 19 to 21 May 2003 inSydney. Ms. Bella Ho, Senior Accreditation Officer,represented HKAS at the meeting of the WorkingGroup 1 (WG1) of TC212. WG1 deals with mattersre lat ing to qual i ty management in c l in icallaboratories.

Apart from drafting ISO 15189, WG1 is alsoresponsible for drafting a number of relateddocuments, including a recently approveddocument ISO 15190 Medical laboratories -Requirements for safety.

There are also a number of other documents inpreparation by WG1 that may be useful to medical

testing laboratories. There will also be a report onguidance for the resource-limited laboratories onhow to implement a quality system that meets thespecific requirements for quality and competenceof ISO 15189.

TC212 also proposed two new working items atthe recent meeting - one on the risk managementfor patients arising from work in laboratory; andthe other on s tandards for ant imicrob ia lsusceptibility testing of microorganisms. The latteris a joint working item with TC140.

HKAS will continue to participate actively in thework of TC212 in order to keep abreast of thelatest international development in medical testing.

ISO/TC 212 Meeting

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The second HOKLAS l ia ison meeting withaccredited laboratories was held on 26 June 2003at the office of HKAS. Representatives from HongKong Association of Certification Laboratories(HKACL) briefed members on their new initiativeswhich include organising proficiency testingprogrammes, strengthening its participation ininternational and regional accreditation activities,arranging experience-shar ing sessions forlaboratories on training, proficiency testing andmeasurement uncertainty estimation, etc. HKASrepresentatives briefed members on the trainingcourses to be organised in the next few months.

Regarding assessment procedures, memberswere briefed on a plan to implement a gradingsystem of non-conformities. The purpose of thissystem is to allow laboratories to focus theirresou rces on the more impor tan t non-conformities. HKAS will allow more time forlaboratories to rectify minor non-conformities.Moreover, members were informed that, in orderto streamline reassessments, starting from 2004,HKAS will liaise with laboratories at the beginningof the year to agree on a reassessment schedule.

Reassessments w i l l be combined whereappropriate, subject to the agreement with thelaboratories. This will reduce the required numberof assessment visits to a laboratory.

The seventh edition of HOKLAS 003 TechnicalCr i ter ia for Laboratory Accredi tat ion waspublished in July. It was clarified that there is nomajor change to the accreditation criteria. Themain revisions relate to updating of informationand clarification of some HOKLAS policies.

The meeting also agreed to a proposal that theliaison group be extended to cover inspectionbodies. Representat ives f rom accred i tedinspection bodies will be invited to join the liaisongroup.

The contact details of representatives fromaccredited organisations are posted on ourwebsite at http://www.info.gov.hk/itc/hkasAccredited organisat ions could send theircomments and feedback on HOKLAS or HKIASto us directly or to the representatives of the liaisongroup.

This course, co-organised by HKAS and theStandards and Calibration Laboratory of theHKSARG, was held the first time in January 2003.The response was overwhelming. Many technicalstaff of accredited laboratories could not attendthe course because places were limited. It washence decided that this course should beorganised again.

HKAS is pleased to announce the launching of anew accreditation programme. This programme,which operates under HKCAS, is on constructionmaterial product certification. The accreditationcriteria are based on ISO/IEC Guide 65: 1996General requirements for bodies operatingproduct certification system and the InternationalAccreditation Forum (IAF) Guidance on theApplication of the Guide 65. This programmecove rs p roduc t ce r t i f i ca t i on o f gene ra lconstruct ion mater ia ls, bui ld ing, highway,

waterworks and firefighting products, etc. Specifictechnical criteria for this programme are given inHKCAS Supplementary Criteria No. 2.

According to international practice, productcertification systems are classified into eight types(Systems 1 to 8). The HKCAS product certificationaccreditation programme focuses on System 5 –the most rigorous system of them all. System 5 ischaracter ised by in i t ia l type test ing, withassessment and approval of the manufacturer’s

The second series of this course was originallyscheduled for Apri l 2003, but due to SARSoutbreak, the course was postponed to June. Two2 -day training courses were held on 9-11 June2003 and 16-18 June 2003. The total number ofattendees was 40. Simi lar courses wi l l beorganised in the future.

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Second HOKLAS Liaison Meeting withAccredited Laboratories

Basic Metrology Training Course

Accreditation ofConstruction Material Product Certification

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quality control arrangements, followed by regularsurveillance through inspection of factory qualitycontrol and audit testing of samples from boththe open market and the factory.

To increase awareness of construction productcertification and its benefit to the industry, HKAS,in collaboration with the Materials Division of HongKong Institution of Engineers (HKIE), organised aseminar on product certification. This seminar washeld in the New World Renaissance Hotel on 22August 2003. More than 150 attended theseminar. The speakers of the seminar comprisedexperienced personnel from various certificationbodies and others, including BSI-UK, ChinaClassification Society, CSIRO Australia, Green Council,HKQAA, PSB Corporation Singapore, UK-CARES andWarrington Fire Research. Mr. C. K. Cheung, Senior

Attendees for the Seminar on Product Certification.

Accreditation Officer of HKAS, was one of thespeakers. Mr. Cheung spoke about “Accreditationof Construction Product Certification”.

HKAS, in collaboration with the GemologicalAssociation of Hong Kong (GAHK) and Hong KongProductivity Council (HKPC), organised a seminaron “Accreditation of Gemstone Laboratories”. Thisseminar was held in the HKAS Seminar Room on5 July 2003. The speakers included Mr. C. K.Cheung, Senior Accreditation Officer of HKAS andMr. K. K. Lee, Principal Consultant of HKPC.About 38 participants attended the seminar. Theyrepresented various sectors in the local gem tradeand included Hong Kong Jewellery & JadeManufacturers Association, Jadeware TradersIndustry & Commerce Association, DiamondFederation of Hong Kong, Gemological Instituteof America, Asian Gemological Institute andLaboratories and some commercial gemstonelaboratories, etc. The seminar focused onintroducing the management and technicalrequirements of ISO/IEC 17025 for the gemstonelaboratories, the benefits of mutual recognitionagreement (MRA) and specific criteria for diamondand jadeite jade testing, etc. The two-hourseminar was followed by another hour of lively andin-depth discussion.

Attendees for the Gemstone Testing Seminar.

Mr. C.K. Cheung, one of the speakers in the seminar.

HKAS will create a test area “GemstoneTest ing” under the test category of“Physical Testing” to provide accreditationof gemstone laboratories. It is expectedthat the accreditation can enhance theconfidence of purchasers on the credibilityand re l iab i l i ty of the test resu l ts ofgemstones. Interested parties can contactMr. C. K. Cheung of HKAS on 2829 4870or ckcheung@itc.gov.hk for further details.

Seminar on Accreditation of Gemstone Laboratories

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Ms. Bella Ho joined the Hong Kong AccreditationService as Senior Accreditation Officer on 28 April2003. She is ma in ly respons ib le fo r theaccreditation programme on medical testing,which will be launched shortly.

Ms. Ho is a microbiologist by training. She is aFellow of the Institute of Biomedical Science (UK),a Chartered Biologist and a member of theInstitute of Biology (UK). Her first degree is inpathobiology, which is the study on the causes ofdiseases. She obtained her Master’s degree inMedical Microbiology from the London School ofHygiene and Tropical Medicine, University ofLondon. She started her career in the Departmentof Microbiology of Queen Mary Hospital, thenmoved on to the Health Science Department ofthe Hong Kong Polytechnic University before

joining the Environmental Protection Department.She has been a HOKLAS assesso r f o rmicrobiology since 1999. Ms. Ho has over 20years of experience in medical and environmentalmicrobiology testing.

New Accreditation Granted

HOKLAS

Shipley Asia Ltd. - Technology and Quality ControlDivision - Customer Service Laboratory(HOKLAS Registration No. 137) was accreditedfor measurement of metallic coating thickness byscann i ng e l ec t ron i c m ic roscopy i n t heMiscellaneous test category. The laboratory is anin-house laboratory and its service is not normallyavailable to the public.

Nutek Systems Ltd. (HOKLAS Registration No.138) was the first laboratory accredited forwatertightness test of tapwares and valves in thetest category of Construction Materials. Thislaboratory offers testing services to the public.

Accreditation was granted to Wilson Curtain WallConsultant (HK) Limited (HOKLAS RegistrationNo. 139) for pull out test for anchor bolts in thetest category of Construction Materials. Thislaboratory provides testing services to the public.

Accreditation Reinstated

The accreditation of the Chit Tat Industrial(Shenzhen) Co., Ltd. - Qual i ty AssuranceLaboratory (HOKLAS Registration No. 114) wasreinstated on 8 August 2003.

Accreditation Suspended

A suspension was imposed on Hong KongInstitute of Vocational Education (Tsing Yi) –Test ing Laboratory of the Depar tment ofConstruction (HOKLAS Registration No. 084) forall tests. The imposed suspension took effect on9 April 2003.

Accreditation Terminated

The accreditat ion of Zhongshan HungwanConcrete Piles Co. Ltd. – Quality DepartmentTesting Laboratory (HOKLAS Registration No.093) has been suspended since March 2003. Animposed termination was applied to the laboratoryby HKAS for all tests on 4 July 2003.

HKCAS

i-VAC Certification Limited (HKCAS RegistrationNo. 7) was accredited for quality managementsystem certification in July this year. This bringsthe number of certification bodies accreditedunder HKCAS to seven.

HKIAS

The Castco Testing Centre Limited (HKIASRegistration No. 7) is accredited for the inspectionservice of precast staircase, precast concretefacade and precast concrete pipes. It provides athird party inspection service to the public.

New Staff

Accreditation Update

11

Construction Materials

The f ina l repor t for the Foundat ion Pi lesProficiency Testing Programme – HCM/2003/01(Sonic Logging Test) was issued in May 2003. Atotal of n ine laborator ies took part in theprogramme. Testing personnel from participatinglaboratories performed the tests on a control panelplaced at the Materials Testing Laboratories of theHousing Department. Some laboratories did not

pick up the known defects in the concrete paneland one laboratory did not measure the full heightof the panel. Laboratories with outlying resultshave been requested to conduct an investigationand report their findings to HKAS. It is apparentfrom this proficiency test that relatively goodagreement among different laboratories can beexpected when laboratories are employing thesame test procedures.

A prof ic iency test ing programme on non-destructive testing of concrete cover of reinforcingbars using covermeters was organised in July2003. Two operators from each of the tenparticipating laboratories were asked to performthe test on the reference blocks at the office ofHKAS. The results are being analysed by HKAS.

Proficiency Testing Update

12

If you wish to contribute to the next newsletteror require further information on any of the

items in this newsletter,please contact the HKAS Executive,

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

Tel: 2829 4840 Fax: 2824 1302Website address: http://www.info.gov.hk/itc/hkas/

E-mail address: hkas@itc.gov.hk

Upcoming TrainingCourses

• The Quality Management in the Laboratory Workshop22-24 September 2003

• The Internal Quality System Audits Workshop25-26 September 2003

• Preparing for Accreditation in Medical and ChemicalLaboratories8 October 2003

• Evaluating Measurement Uncertainty in ChemicalAnalysis9-10 October 2003

• Selecting and Validating Methods for Chemical Analysis13 October 2003

• Advanced Workshop on Measurement Uncertainty forChemical Analysis14 October 2003

• The Quality Management in the Laboratory Workshop1-3 December 2003

• The Internal Quality System Audits Workshop4-5 December 2003

• Metrology Training Course15-17 December 2003

Interested readers should note that latestinformation on training courses is posted onour website at www.info.gov.hk/itc/hkas.Please contact HKAS for enrolment of thecourses.

Chemical Testing

A total of 36 laboratories from 19 economiesparticipated in the APLAC T038 - Pharmaceuticaltesting proficiency testing programme organisedby HKAS in collaboration with the GovernmentLaboratory, Hong Kong. Samples were distributedto overseas accreditation bodies and localpart ic ipants in July 2003. Part ic ipants arerequested to return the test results to HKAS bymid September 2003.

Toys and Children’s Products

A proficiency programme on EN71 Part 3 is beingorganised by HKAS in collaboration with theGovernment Laboratory under the auspices ofAPLAC. Participating laboratories will be providedwith a piece of aluminium plate coated with alkydpaint. They are required to determine the migrationof four toxic elements, viz., barium, cadmium,chromium and lead according to EN 71 Part 3:1994. Local laboratories and those nominated byother accreditation bodies wil l be invited to

participate in the programme. It is expected thatsamples will be delivered to the participants inOctober 2003.

Calibration

The artifact for the interlaboratory comparisonprogramme on force transducer (EA ILC F3) wassent to the participating calibration laboratory inHong Kong in August 2003. The result is expectedto be ready for submission to the organiser byend of August.

The updated Proficiency Testing ProgrammeSchedule organised by HKAS for the ConstructionMaterials test category in 2003 and 2004 is givenbelow:

Test AreaScheduled

Dates

Foundation Piles –Sonic logging

NDT - Covermeter

NDT welding

Aggregate – physicaltest

Bituminous Materials –Air void content

Soil – particle density

Diagnostic test -schemit hammer

Soil – in-situ densitytest by NuclearDensometer

Foundation Piles –Pile dynamic test

January2003

June2003

October2003

November2003

February2003

January2004

February2004

April 2004

Final reportissued

Reportunderpreparation

ProgrammepostponedtoDecember2003

Postponed