January 2003

Issue No.

33H 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

Why We Need a World Accreditation Mark

Now that the ILAC and IAF mult i lateral arrangements have beensuccessfully established and there are 42 signatories in the ILAC MRAand 29 signatories in the IAF MRA, have we achieved our goal of “onetest, one certif ication, one inspection, one accreditation, acceptedeverywhere” ? The answer is “only partly”. Why? Because regulators,buyers or consumers who look to accreditation for assurance of technicalcompetence are neither familiar with overseas accreditation marks nordo they understand the intent and scope of the MRAs. Moreover, asignatory cannot simply tel l specif iers of accreditat ion to acceptcertif icates or reports with the accreditation mark of MRA partnersbecause a signatory’s participation in the MRAs may be restricted tocer ta in techn ica l scopes. We there fore urgent ly need a wor ldaccreditation mark which can be used by accredited organisations fordeclaring to their clients that the conformity assessment provided isrecognised within the MRAs. The question currently hotly debated iswhether we should have separate ILAC and IAF accreditation mark or ajoint ILAC and IAF Mark.

Separate ILAC MRA and IAF MRA marks or a joint mark for the two MRAs?

Pros of separate marks

• The world accreditation mark is for use by accredited organisationsto show that their conformity assessment is recognised under theMRAs and not for accreditation bodies’ use or even ILAC’s or IAF’suse. Hence, even if ILAC and IAF should merge, separate marksshould be maintained if we wish to emphasise the difference betweenthe two types of accreditation. Laboratories, as represented by theILAC Laboratory Committee, and the national measurement instituteshave made known that they strongly wish to have a ILAC mark andnot a joint mark.

• Separate ILAC and IAF marks would facilitate users to recognise thedifference between accreditation of laboratories and accreditation ofcertification bodies.

• A joint mark could be easily used by rogue bodies to deliberatelyblur the dist inct ion between accreditat ion of laborator ies andcertification of laboratories.

• The cost of registering a mark is only a few hundred US$ and hencethe benefits of having two separate marks outweigh the costs.

Why We Need a WorldAccreditation Mark

Government Laboratory Takesthe Lead in Seeking HOKLAS

Accreditation for GM food, TCM,and Pharmaceutical Products

Testing

Measurement Uncertainty - AreYou Sure Your Clients Don’t

Want It

Training Courses onMeasurement Uncertainty in

Chemical Analysis

Environmental Testing - EnsuringInternational Recognition of Data

Accreditation of Medical Testing

First HOKLAS Liaison Meetingwith Accredited Laboratories

Scope of HOKLAS AccreditationExtended to New Test Areas

New and Revised PublishedDocuments

Objectives and Roles of“Accreditation” and

“Certification” of Laboratories

Alignment of ISO/IEC 17025:1999with ISO 9001:2000

Inspection Bodies Accredited forWelding Inspection Under HKIAS

Accreditation Programme onIndoor Air Quality Certification

Seminars on AccreditationProgramme on Construction

Products Certification

ILAC/IAF Conference andGeneral Assembly 2002

The Ninth PAC Plenary Meeting

PAC Peer Evaluator Workshop

New Members Joining theAPLAC MRA

HKCAS Update

Meeting with Certification Bodies

HKAS Evaluated by PacificAccreditation Cooperation (PAC)

Newly Published ISO 19011:2002Available at PSIB

Accreditation Update

Proficiency Testing Update

Upcoming Training Courses

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• There is strong market need to have a worldaccreditation mark. More deliberations onseparate marks versus a joint mark wouldde l ay t he imp lemen ta t i on o f a wo r l daccreditation mark, limit the effectiveness ofthe MRAs and lead to the need for cross-border accreditation.

• A joint mark would need words or symbolswithin the mark to differentiate betweendifferent types of accreditation and wouldcause over-crowding of the mark, defeat thepurpose of having a symbol instead of wordsto indicate the MRAs and cause complexityin implementation of the mark.

Pros of a joint ILAC/IAF Mark

• There are already too many marks in themarket. For promotional purposes, a jointmark would be more effective and efficient.

• Many accreditat ion bodies operate botha c c r e d i t a t i o n o f l a b o r a t o r i e s a n daccreditation of certification bodies and donot want to register two marks.

• Cost of registration is a consideration.

• As ISO/IEC 17011, the common standard foraccrediting laboratories, certification bodiesa n d i n s p e c t i o n b o d i e s w i l l s o o n b epublished, it would be sensible to have acommon mark.

The issue of separate marks versus a joint markwill be voted upon through a postal ballot byILAC Members.

(Dr. L. H. Ng, Executive Adminstrator of HKAS,is the convenor of the ILAC Task Force on theWorld Accreditation Mark)

Government Laboratory Takes the Lead in Seeking Accreditation forGM Food, Chinese Medicine and Pharmaceutical Products Testing

The Government Laboratory is delighted to bethe first laboratory accredited under HOKLASfor testing of genetically modified (GM) food,t r a d i t i o n a l C h i n e s e m e d i c i n e s a n dpharmaceut ical products. I t is hoped thataccreditation of the Government Laboratory inthese three new test areas can stimulate otherlocal laboratories performing similar tests toseek accreditat ion thereby upgrading theirtesting standard.

Genetically Modified Food

GM foods are foods or food products containinggenetic materials that have been modified bygenetic engineering. Genetic modif icat ionsinvo l ve the iden t i f i ca t ion o f the gene (s )responsible for certain traits in an organism andthen t ransfer r ing that gene(s ) to anotherorganism thereby imparting the traits to thereceiving organism. It may also involve themanipulation of genes of an organism so thatundesirable traits are removed. Since the early‘90s when the first genetically modified foodwas marketed, the safety and environmentalimpact of genetically modified organisms andfood have been subject to intense debate.There are now a number of GM crops available

on the market. The most abundant ones aresoya bean and corn. These GM foods havebeen scrut in ised by regulatory author i t iesworld-wide to ensure their safety.

Safety issue aside, consumers also demandedthat food containing GM ingredients be labelledas such so that they could make an informedchoice. In Hong Kong, the regulations withrespect to GM food labell ing are now underreview.

In support of the legislation on labelling of GMfood, the Government Laboratory started theresearch and development of GM food testingin 2000. To obtain latest information on themost recent development and advances in GMfood test ing, professional members of theGovernment Laboratory visited a number ofworld-renowned food testing institutions. TheGM test ing laboratory of the GovernmentLaboratory was established in early 2001.

The detection method for GM food is based onthe amplification of specific DNA sequencesusing a technique called “Polymerase ChainReact ion” (PCR) . Th is is by far the mostsensit ive method current ly avai lable. Food

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samples are examined for the presence of foodingredients containing, for example, geneticallymodified soya and maize, by employing specificprimers pairs. Such a PCR-based detectionmethod developed for GM soya or maize canbe applied reliably to raw materials as well asprocessed food products. Th is detect ionmethod is we l l su i ted for the purpose ofregu la tory cont ro l o f food labe l l i ng . TheGovernment Laboratory has also acquired amore advanced real- t ime PCR system forquant i ta t ive determinat ion of GM food inagricultural products.

To ensure data comparability, the GovernmentLaboratory has participated in a number ofinter-laboratory comparison exercises on GMfood analysis and has obtained very goodr e s u l t s . G o v e r n m e n t L a b o r a t o r y h a ssuccessfully obtained HOKLAS accreditation forGM food t es t i ng i n Oc tobe r 2002 . Theassessment was conducted by an overseasexpert in GM food testing, Dr Rob Lake, fromthe Inst i tu te o f Env i ronmenta l Sc ience &Research Limited (ESR), New Zealand.

Analysis of food for GM products

Chinese Medicine

The Government Laboratory has a long historyin the examination of Chinese medicine forpossible contaminants and adulterat ion ofwestern med ic ine . In 1998, the Ch ineseMedic ines Sect ion of the Laboratory wasestab l ished to cope wi th the increase inworkload. Both Chinese herbal medicines andproprietary Chinese medicines are routinelyexamined to ensure that they are fitted for use.

The Government is committed to strengtheningthe control of Chinese medicine in Hong Kong.The Chinese Medic ine Ord inance and i tssubsidiary regulations will be fully implemented

soon. In support of the enforcement of theregulations, the Government Laboratory hasdeveloped a number of analytical methods forthe examinat ion of Chinese medic ine. Todemonstrate the competence in performingtesting of Chinese medicine, the Laboratorystarted preparing for accreditation to ISO/IEC17025 for the analys is of tox ic e lements,namely, arsenic, cadmium, mercury and leadin mid-2002. The tests involve microwavedigestion followed by ICP-MS measurement.HOKLAS acc red i t a t i on was ob ta i ned i nSeptember. The scope of accreditation will beprogressively extended to other tests.

Pharmaceutical Analysis

The Government Laboratory provides analyticala n d a d v i s o r y s e r v i c e s t o g o v e r n m e n tdepartments and the Hospital Authority onpharmaceut ical products to safeguard thehealth of the public. Pharmaceutical productsregistered or apply ing for registrat ion areexamined to ensure that they comply with therelevant quality and safety requirements. TheL a b o r a t o r y a l s o p e r f o r m s t e s t s o npha rmaceu t i ca l p roduc t s d i spensed bygovernment cl inics and publ ic hospitals toensure that they are of satisfactory quality.

Analysis of pharmaceutical products

Samples of Chinese herbal medicine

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The pharmaceutical analysis laboratory hasimplemented a qua l i ty assurance systemconforming to ISO/ IEC 17025:1999. TheLaboratory started preparing for accreditationin mid-2002 and HOKLAS accreditation wasobtained in September 2002. The accreditedtests conform to the U.S. Pharmacopoeia(2002) and British Pharmacopoeia (2002). Therange of pharmaceut ica ls tested inc ludesantihistamine, oral solutions, dermatologicaltopical solutions, cough and cold capsules,gastro-intestinal tablets, antibiotic capsules,anti-rheumatic capsules and anaesthetic drugs.Test parameters involve the ident i f icat ion,

a s s a y, n e u t r a l i s i n g c a p a c i t y, r e l a t e dsubstances, uniformity of mass, dissolution anddisintegration, employing analytical techniquesrang ing f rom the convent iona l t i t r imet ry,gravimetry, thin layer chromatography to thei ns t rumen ta l gas ch romatog raphy, h i ghpressure l iqu id chromatography, in f rareds p e c t r o s c o p y a n d u l t r a - v i o l e tspectrophotometry.

Another step ahead for the Laboratory wouldbe to seek accreditation for testing of otherfrequently prescribed pharmaceutical productswith a scope that allows greater flexibility.

Measurement Uncertainty – Are You Sure Your Clients Don’t Want It?

Fol lowing is an art ic le contr ibuted by Dr.Bernard King. Dr. King was the former Directorof LGC (UK) and National Analytical ReferenceMaterials Laboratory (Australia) as well as apast chairman of CITAC. In this article, Dr. Kingtalks about his personal views on measurementuncertainty (MU) in testing and the reasons whyhe thinks MU is important.

It’s sometimes claimed that it’s inappropriateto report the uncerta inty associated wi thmeasurements, as cl ients don’t require orunderstand it. In a customer centred world, it’sconsidered inappropriate to dictate to them.Also, there is sensit iv ity about reveal ing toclients for the first time that the data providedfor many years is in fact somewhat less certainthan previously implied. For many, it would beeasier to let sleeping dogs lie, but that is not asatisfactory medium term, let alone long termstrategy. The fact is, it is now widely acceptedtha t hav ing some know ledge abou t theuncertainty of a measurement is an essentialpart of making and using measurements. So,what’s the answer?

There are three issues that need to be addressed:

• First, measurement scientists themselvesneed to be persuaded that uncertainty is partof measurement and that effective decisionm a k i n g n e e d s t o t a k e m e a s u re m e n t

uncertainty into account.

• Second, measurement laboratories need todevelop the skills needed to evaluate theiruncertainties and to feel comfortable with thefact that measurement, like the rest of life isnot a certain process.

• Th i rd l y, l i ke any o the r p ro fess iona l s ,measurement scientists need to be able toexplain to their clients the value of their work,including its limitations.

Just as uncertainty of measurement defines theregion of uncertainty, it also defines the regionof confidence. For example, if I report the resultof a chemical measurement as 10 ± 2mg/kg, Iam also reporting that I am confident that theresult is not less than 8 mg/kg or greater than12mg/kg.

Let’s start by recognising some facts of l ife.Measurements are made to inform importantdecisions, such as does an imported foodc o m p l y w i t h r e g u l a t i o n s , o r d o e s amanu fac tu red p roduct meet the c l i en t ’sspecification? Particularly where the results areclose to the decision criteria, reliable decisionscan only be made when we have informationabout the rel iabi l i ty (or uncertainty) of theresults. Anything else is a delusion. There isgrowing recognition of the importance of this

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issue and as a result laboratories accredited toISO/IEC 17025 now need to evaluate theiruncertainties. Clearly, the more important thedecision, the more important it is to have ar e l i a b l e e s t i m a t e o f t h e a s s o c i a t e dmeasurement uncertainty (MU). Some examplescenarios are summarised in Figure 1.

Accreditation bodies require laboratories toevaluate their uncertainties, but this requires thetraining of large numbers of laboratory andaccreditation staff and their customers. Therehas, however, been a shortage of suitabletraining material, making it diff icult to moveforward. In response to this need, an interactiveweb-based course has been produced (www.mutraining.com).

As indicated above, in a quality focused worldit is a brave person that tries to dictate to theirclients. None the less professionals need toadvise their clients and even, sometimes, givet h e m b a d n e w s . H o w e v e r , o n l y w h e nlaboratories are themselves convinced of thevalue of evaluating and reporting the uncertaintyof measurement, will they be in a position toconvince their clients. If the way to a man’sheart is through his stomach, then the way to aclient’s appreciation of the value of uncertaintyis through its measurement laboratory. Thee s s e n t i a l m e s s a g e i s - T h e c o s t o fmeasurements wi th MU est imates wi l l besl ightly higher, but the better data wil l helpclients make savings in other areas of their workand improve outcomes in other ways. Theprofessional standing and even legal liability, ofboth the laboratory and its client, will dependon appropriate use of MU.

It is sometimes said that laboratories shouldwait until clients ask for uncertainty information.Others think that laboratories should take thelead. This is like the problem of the ‘chickenand the egg’ - which came first! You can arguethe point for hours, or you can get on with thejob. For sure, uncertainty is here to stay andlike it or not, sooner or later, clients will get thepicture. I don’t think they will thank those thattried to shield them from the realities of life, ortrust them in the future. There’s a job to be doneby accredited laboratories, which if done well,will enhance their competitiveness, businesspotential and profitability.

Figure 1: Some Common Decision Types

When measurement data are compared withlimit values a number of types of situationscan arise.

(a) When the measured value is far from thelimit value and the compliance decision isclear, then only a rough estimate of MU isneeded.

(b) When the measured result is close to thel imit value, a good est imate of MU isrequired and a small MU value will improvedecision making.

(c) Whe re a f a l se pos i t i v e dec i s i on i sundesirable, underestimation of MU, as in(c*), [where the actual MU is as shown in(c)] can lead to inappropriate decisions.

(d) When the measured value is close to thel imit value, in some cases, the r isk ofcompl iance / non-compl iance can beshared between two parties. However,careful consideration would need to begiven to the level of acceptable MU andthe reliability of its estimation.

Bernard KingAnalytical Measurement Consultante-mail BKingTeddington@aol.com

Training Courses onMeasurement Uncertainty

in Chemical Analysis

Two 2-day training courses on estimation ofmeasurement uncertainty (MU) in chemicalanalysis were organised on 10-11 October and16-17 October 2002. The course presenter is Dr.Bernard King. The contents of these two coursesare similar to previous ones and are based on theCITAC/EURACHEM approach. Ample workedexamples were given to illustrate the procedurefor estimation of MU in chemical analysis.

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A one-day advanced course was also organisedon 18 October 2002 for those who wish to gaina more in-depth knowledge of estimation of MU.This course is the first of its kind organised inHong Kong and is intended to give those whohave already grasped the basic techniques butwish to further his/her knowledge of and skillin estimation of MU. This is necessary when amore r igorous estimation is merited by, forexample, narrow specification limits.

Environmental Testing : Ensuring InternationalRecognition of Data

The following article was written by Mr. AllanMaynard1, Mr. Blair Easton2, and Mr. Yeoh GuanHuah3 of Australian Laboratory Services Pty Ltd

Introduction

Over the past decade or more, most industrialsectors have become increasingly global in theiroperations. With this comes many challengesincluding the need to ensure that environmentalprograms meet both corporate compliancestandards as well as meeting the regulations ofthe various host countries.

provide a general level of comfort from using asystem that the environmental manager alreadyknows. However, this approach may not bepractical or acceptable to the host country’sregulatory agency.

Alternatively, the International Organization forStandardization (ISO) provides an internationallyaccepted standard (ISO/IEC 17025 - “GeneralRequirements for the Competence of Testing andCalibration Laboratories”) for use by national andinternational accreditation bodies that recognizethe competence of test ing and cal ibrat ion

l a b o r a t o r i e s . T h i srecognition is provided bythe awarding of laboratoryaccreditation that in turncan provide environmentalmanagers with a general

comfort level concerning the competency of thelaboratory. However, an accreditation processmust also align with test method requirementssuch that required data qual i ty object ives(sensitivity, specificity, precision, accuracy) aremet.

This paper provides some background on bothISO and the EPA. The paper discusses theaccred i ta t ion o f laborator ies and makesrecommendations for obtaining reliable data forinternational recognition.

International Organization forStandardization (ISO)

The International Organization for Standardization(ISO) established in 1947 is a worldwide non-

Dr. Bernard King presenting the 1-day advanced course onmeasurement uncertainty in chemical analysis

Environmental testing is ahighly critical componento f any env i ronmenta lmanagement programand it is important thatenvironmental managershave a high degree of conf idence in theirdatabase. This can be a unique challenge whenprojects are in i t iated in var ious countr ies,especial ly i f there isn’t a highly developedlaboratory infrastructure in a particular country ofregion. Certainly it’s possible to send somesamples back to their “home base” be it NorthAmerica or Europe, etc. However, for many tests,it is simply not viable to ship samples over longdistances.

So, how do global organizations ensure they areobtaining reliable and recognizable results thatmeet corporate compliance standards, areacceptable to the host country and are generallyrecognized internationally? Some US companiestend to specify adherence to EPA protocols (e.g.the Contract Laboratory Program - CLP). This can

Environmental managers must ensure thatenvironmental programs meet both corporatecompliance standards as well as meeting theregulations of the various host countries.

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governmental federation of national standardsbodies from some 140 countries, one from eachcountry. The mission of ISO is to promote thedevelopment of standardization and relatedactivities in the world with a view to facilitatingthe international exchange of goods and services,and to developing cooperation in the spheres ofintellectual, scientific, technological and economicactiv ity. ISO’s work results in internationalagreements, which are published as internationalstandards.

The ISO/IEC 17025 standard contains all of therequi rements that test ing and ca l ibrat ionlaborator ies have to meet i f they wish todemonstrate that they operate a quality system,are technical ly competent, and are able togenerate technically valid results.

An integra l part of ISO/IEC 17025 is therequirement for laboratories to participate ininterlaboratory comparison or proficiency-testingprograms and it is this requirement that providesstandards (accrediting) bodies a powerful toolwhen assessing a laboratory’s competence.

Most importantly, accreditation to ISO/IEC 17025provides a basis for the acceptance of testing andcalibration results between countries. Acceptanceshould be faci l i tated i flaboratories comply withthis International Standarda n d i f t h e y o b t a i naccreditation from bodieswhich have entered into mutual recognitionagreements with equivalent bodies in othercountries using this International Standard.

U.S. Environmental Protection Agency (EPA)

The EPA is made up of program offices (~15),regional offices (10) and labs (17) across the UnitedStates of America. An Administrator who isappointed by the President of the United Statesleads the EPA. Their mission is to protect humanhealth and to safeguard the natural environment -air, water, and land - upon which life depends.

The EPA is responsible for researching and settingnational standards for a variety of environmentalprograms (e.g. drinking water and ground waterprotection programs, waste water managementand air quality planning and standards). The EPAthen de legates to the ind iv idua l Sta tes ,responsibility for issuing permits, and monitoring

and enforcing compliance in the USA. Wherenational standards are not met, the EPA can issuesanctions and take other steps to assist the statesand tribes in reaching the desired levels ofenvironmental quality. EPA protocols for themeasurement o f contaminants in wate r,wastewater, soil and wasters are well-establishedand cited in many countries.

The EPA does not accredit for certify laboratories;however, it does administer a National DrinkingWater Certification Program, for laboratories, buthas the individual State’s accrediting authoritycarry out the awarding of Certification.

Currently the EPA provides oversight of al lmanagement and quality assurance activitieswithin the Contract Laboratory Program (CLP). TheCLP is a national network of EPA personnel,commercial laboratories, and support contractorswhose fundamenta l m iss ion is prov id ingcustomers with analytical data of known anddocumented quality. The CLP is primarily used inprograms involving determination of contaminationat U.S. “Super Fund” hazardous waste sites priorto, during and after site clean-up.

What is Laboratory Accreditation?

Most countries around the world have adoptedthe international ISO/IEC 17025 standard asthe benchmark for awarding accreditation.

Accredi tat ion : is theprocedure by which anauthoritative body givesformal recognition that alaboratory is competent

to carry out specific tasks.

Specifically laboratory accreditation provides ameans of determining the competence oflaboratories to perform specific types of testing,measurement and calibration.

It is laboratory accreditation that provides formalrecognition to competent laboratories, therebyproviding a ready means for customers to accessreliable testing and calibration services.

Laboratory Accreditation Recognition-Around the World

The Internat ional Laboratory Accreditat ionCooperation (ILAC) was established in 1977. ILACis an international cooperation between thevarious laboratory accreditation bodies operatingthroughout the world. The cooperation wasformalized in 1996 when 44 national bodies signed

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a Memorandum of Understanding (MOU) inAmsterdam. This MOU provided the basis for thefurther development of the Cooperation and theeventual establishment of a multilateral recognitionagreement between ILAC member bodies. Thekey to this Arrangement being that resultsproduced in one country by a laboratory that isaccredited under a signatory to the Arrangement,will be accepted by other signatories.

Many countries around the world have oneorganization (accrediting body) responsible for theaccreditation of their nation’s laboratories andmost o f these bod ies have adopted theinternational ISO/IEC 17025 standard, as thebenchmark for awarding accreditation.

Some examples of authoritative bodies providingaccreditation to ISO/IEC 17025 are :

• Canada : Standards Council of Canada (SCC)• Australia : National Association of Testing

Authorities (NATA)• Hong Kong : Hong Kong Accreditation Service-

Hong Kong Laboratory Accreditation Scheme(HKAS-HOKLAS)

• USA : American Association for LaboratoryAccreditation (A2LA)

• Singapore : Singapore Accreditation Council -Singapore Laboratory Accreditation Scheme(SAC-SINGLAS)

• Indonesia : Badan Standardisasi Nasional-Komite Akreditasi Nasional (BSN-KAN)

Note : All of these bodies are members of ILAC;as wel l as, s ignator ies to the ILACArrangement.

Laboratory Accreditation Recognition - inthe USA

There is no nationally recognized environmentallaboratory accreditation program within the U.S.Regu la to r y requ i remen ts fo r l abo ra to r yaccreditation are at the State or industry-specificlevel and each state has their own accreditingAuthorities with their ownstandards and guidelinesf o r t h e b a s i s o f t h eaccreditation they provide.For the envi ronmentalsector, these standards are usually based on thenational standards for the environmental programsset by the EPA. Only a few accreditation bodieshave adopted the ISO/IEC 17025.

Currently to report analytical data for any nationalprogram within a given state requires the formalaccreditation of that state.

In 1990, the EPA’s Environmental MonitoringManagement Council (EMMC) established aninternal work group to consider the feasibility andadvisability of a nationally recognized accreditationprogram. As a result, the National EnvironmentalLaboratory Accreditation Council (NELAC) wasestablished as a standards-setting body tosupport the National Environmental LaboratoryAccreditation Program (NELAP). The NELACstandards are primarily designed around the ISO/IEC 17025 standard.

Currently, eleven (11) states have becomemembers of NELAP, and have reciprocity betweentheir individual accreditation schemes; however,neither NELAC nor NELAP are members of ILAC.

The Nat iona l Cooperat ion for LaboratoryAccreditation (NACLA), another cooperationbetween accreditation bodies, is also workingtowards a nationally recognized accreditationprogram within the U.S., but separately fromNELAP. Currently the laboratory accreditingmembers include A2LA and the National VoluntaryLaboratory Accreditation Program (NVLAP), bothof which are members ILAC and signatories tothe ILAC Trade Agreement.

Selection and Validation of Methods

Environmental testing is an integral part of anyenvironmental program and so is the selection ofthe appropriate testing method(s). The method(s)selected should be chosen on the basis ofachieving the Data Quality Objectives (DQOs) thatwould be required for the program. These willinclude, but not be limited to, accuracy, precision,selectivity and sensitivity requirements. In orderto meet these requ i rements a method’sperformance must be well documented (i.e.validated).

T h e I S O / I E C 1 7 0 2 5standard speci f ies thegeneral requirements forthe competence to carryo u t t e s t a n d / o r

calibrations, which includes the acceptance oftesting and calibration performed by StandardMethods (e.g. EPA, APHA), non-standardmethods and laboratory - developed methods.

Performance-based methods must meetspecified performance criteria for sensitivity,precision, accuracy, etc. Prescriptive methodsmust be followed exactly as they are published.

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Regardless of the method type (standard, non-standard or laboratory developed), ISO/IEC 17025requires that laboratories fully (formally) validatet h e i r m e t h o d s a n d d o c u m e n t m e t h o dperformance (e.g. selectivity, linearity, precision,accuracy, robustness/ruggedness, uncertaintyand detection limit). In this way laboratories areable to report resu l ts accurate ly, c lear ly,unambiguous ly and wi th the in format ionnecessary for their interpretation.

The most important point here is that, under theISO/IEC 17025 a laboratory can improve upon ordevelop methods on the basis of meetingspecified performance criteria. Professionallaboratory managers consistently advocateperformance based methods as it allows them totake advantage of therapidly changing field ofanalytical chemistry.

The US EPA has undoubtedly developed andpublished numerous well-recognized methodsthat have been adopted in a number of countries.Within the US, there is usually (for permit purposesand various drinking water, groundwater andwaste management programs) a requirement tofollow these published methods exactly as theyare written. These methods are known asprescr ipt ive methods. As wel l , the qual i tyassurance procedures must also be exactlyfollowed even though there may be some newcertified reference materials available to determineprecision and accuracy.

The use of prescr ipt ive methods can beadvantageous under certain circumstances but ingeneral i t can tend to be a barr ier againstcontinuous improvement.

It should be noted that, within the EPA SW-846Series of test methods, qualified analysts canserve as “in-house” methods developers to modifyexisting methods to meet regulatory needs.Specifically when analyses for applications arerequired for which no validated methods exist, (e.g. for unusual matrices or when below thequantitation limits of conventional EPA or otherappropriate methods), it is possible to utilize a non-standard or laboratory developed method.However, the applicable EPA guidelines formethod validation (e.g. Guidance for MethodsDevelopment and Methods Validation for theRCRA Program - Development and Validation ofSW-846 Methods Phase 2 : Formal Validation)must be adhered to.

Accreditation of Medical Testing

Since the last issue of HKAS news, the AABWorking Party on Medical Testing has met threet imes. Var ious issues re la t ing to medica llaboratory accreditation were discussed andagreed upon. The progress so far has been onschedu le . Task Fo rces a re d ra f t i ng theaccreditation criteria for various disciplines andit is expected that Supplementary Criteria formedical testing will be published early next year.Potential assessors have been nominated and

training of them has been arranged.

On 17 December 2002, Dr. L. H. Ng, ExecutiveAdministrator of HKAS and Dr. R. J. Collins,P res iden t o f the Hong Kong Co l l ege o fPa tho log i s t s s i gned a Memorandum o fUnderstanding (MoU) on the co-operation of theaccreditation programme on medical testing.Fol lowing is a press re lease issued on 17December 2002 on the signing of the MoU.

Under ISO/IEC 17025 a laboratory canimprove upon or develop methods.

Conclusions

Laboratory accreditation to ISO/IEC 17025 iswidely (internationally) recognized and is theleading benchmark for developing multilateralrecognition agreements between standardsbodies and their respective countries. The ISO/IEC 17025 standard offers a sound, independentlaboratory accreditation scheme for evaluatinglaboratory competence.

Within the ISO model, a laboratory must properlyselect its methods such that they meet clientneeds and adhere to regulatory requirements.

1 All Maynard, Vice President, Vancouver, BC Canada2 Blair Easton, Quality Manager, Vancouver, BC Canada3 Yeoh Guan Huah, Managing Director, Singapore

Dr. L.H. Ng (left) and Dr. R. J. Collins (right) signed a MOUon co-operation in accreditation for medical testing.

Clinical laboratories in Hong Kong will soon beable to apply for official recognition of theirtechnical competence in medical testing as thisarea w i l l be inc luded in the scope o faccreditation of the Hong Kong LaboratoryAccreditation Scheme (HOKLAS).

HOKLAS is an accreditation scheme operatedby the Hong Kong Accreditation Service(HKAS) under the Innovation and TechnologyCommission. It is a voluntary scheme open toany Hong Kong laboratory that performsobjective testing and calibration falling withinthe scope of the scheme and meets theHOKLAS criteria of competence.

The accreditation programme on medicaltesting will be administered by the HKAS withtechnical support provided by the Hong KongCollege of Pathologists (HKCPath).

The Executive Administrator of HKAS, Dr L HNg, signed a Memorandum of Understanding(MOU) with the President of HKCPath, DrRobert Collins, today (December 17) on co-operation in the programme.

Under the MOU, the programme wil l beadministered and conducted by HKAS whilethe HKCPath will provide professional input tothe accreditation process, advice on thetechnical criteria for accreditation, and up-dates on relevant technical advances inmedical laboratory practices.

Speaking at the signing ceremony, Dr Ng saidthe accreditation criteria - which is expectedto be published by February 2003- will bebased on the standards of the InternationalOrganisation for Standardisation for medicallaboratories.

“Laboratories have to undergo rigorous on-siteassessment by technical experts and are

required to participate in proficiency testingprogrammes and achieve satisfactory results.There will also be continued monitoring ofaccredited laboratories,” she said.

Dr Collins is confident about the success ofthe programme as there is an increasing needfor clinical laboratories to demonstrate thatthey are up to international standard andaccreditation is certainly one way of meetingthis need.

HOKLAS was launched in 1985 and currentlyhas 109 laboratories accredited for electricaland electronic products testing, textiles andgarments testing, toys and children’s productstesting, food testing, calibration services,environmental testing, construction materialstesting and chemical testing.

HOKLAS is internationally recognised. It is asignatory of the International LaboratoryAccreditat ion Co-operat ion Mult i latera lArrangement and the Asia Pacific LaboratoryAccreditat ion Co-operat ion Mult i latera lAr rangement . HOKLAS endorsed tes tcertificates are recognised in 34 overseaseconomies.

10

First HOKLAS Liaison Meeting with AccreditedLaboratories

With an aim to enhance the communicationbetween HKAS and accredited laboratories, aninformal liaison group was formed. The groupcomprises 12 representatives from accreditedlaboratories. Six representatives come from theHong Kong Assoc ia t i on o f Ce r t i f i ca t i onLaboratories (HKACL) - two from each testing

area, viz., construction materials, environmentaltest ing and commodi t ies test ing, and s ixrepresentatives come from the other accreditedlaboratories. Mr. S. S. Chan, Mr. C. K. Cheungand Mr. W. W. Wong represented HKAS toattend the meeting.

11

The First HOKLAS Liaison Meeting with AccreditedLaboratories

The first meeting was held at the conferenceroom of HKAS on 11 December 2002. Issuesdiscussed included assessment procedures,accred i ta t ion c r i te r ia (e .g . measurementtraceability, proficiency testing, measurementuncertainty), training courses, extension ofaccreditation services to other test categoriesa n d a re a s , p a r t i c i p a t i o n o f a c c re d i t e dlaborator ies in in ternat iona l and reg iona laccreditation activities, etc.

F ru i t f u l d i s c u s s i o n s w e re h e l d a n d w eappreciate very much the suggestions andfeedback we received at the meeting. We firmlyb e l i e v e t h a t f e e d b a c k f ro m a c c re d i t e dl a b o r a t o r i e s i s v a l u a b l e f o r c o n t i n u a limprovement of our accreditation service. Theinformal liaison group will meet once every sixmonths. Accredited laboratories can send theircomments and feedback di rect ly to us or

through the liaison group representatives. Therepresentatives are Mr. Cyril T. O’Connor, Mr.Martin Mak, Mr. Corey Ho, Mr. So Chak Tong,Ms. Mok Wing Suet, Mr. Chiu Chun Ming, Mr.Dominic Lam, Mr. Benson Lee, Ms. MirandaLee, Mr. Joseph Poon, Mr. Nigel Cheung, andMr. K. L. Tsang.

Scope of HOKLAS Accreditation Extended to New Test Areas

The scope of HOKLAS accreditation has beenextended to cover new test areas. One suchnew test area is Chinese medicine. Subsidiarylegislation on the control of proprietary Chinesemedicines (PCM) will be enacted shortly. Oneof the requirements for registrat ion is thesubmission of a test report indicating that toxicelements, pesticides residues, etc., are withinthe specified limits. To ensure the validity of testresults, applicants are required to submit, withtheir appl icat ions, HOKLAS endorsed testreports on tox ic e lements and pest ic idesresidues in their products. The SingaporeHealth Sciences Authority has also indicatedtheir intention of accepting HOKLAS endorsedt e s t r e p o r t s f o r t h e p u r p o s e o f P C Mregistration.

Another new area is pharmaceutical productstesting. Recently, the Department of Health hasindicated that applicants for registration ofpharmaceutical products can choose to havetheir products tested in a laboratory accreditedfor the tests.

Other new test areas are performance testingof electrical and electronic products, (includingcommun ica t i on equ ipment pe r fo rmancetes t i ng , l amp ene rgy e f f i c i ency tes t i ng ,refrigerator energy efficiency testing, etc.), andfurniture safety tests.

HKAS welcomes applications for accreditationfor these new tests areas.

New and Revised Published Documents

HKCAS Supplementary Criteria No. 1 wasissued on 22 October 2002. This is a newdocument and lists two additional accreditationcriteria for certification bodies. One relates tothe commitment of organisat ions ho ld ingHKCAS endorsed certificate to allowing HKCASassessment team to witness the accreditedcertification bodies’ audits. The other relates

to the interpretation of ISO/IEC Guide 62:1996by the IAF on the application as given in theIAF Guidance document.

HOKLAS Supp lementa r y Cr i te r i a No. 12“Env i ronmenta l Test ing” Test Category -Sampl ing/Test ing of Ambient for Organ icCompounds” Issue number 2 was published on

12

21 October 2002. This is a revis ion of theprevious issue to take into account recentadvances in this area as well as the ISO/IEC17025:1999.

HOKLAS Supplementary Criteria No. 2 All TestCategor ies - Equipment Cal ibrat ion Issuenumber 3 was published in August 2002. Mainrevisions include reference to HKAS website forour MRA partners for cal ibrat ions and the

Objectives and Roles of “Accreditation” and“Certification” of Laboratories

Fo l low ing i s a repr in t o f a commun iqueprepared by the IAF-ILAC-ISO/CASCO JointWork ing Group on Image and Integr i ty ofConformity Assessment to c lar i fy the keydistinctions between the two different types ofr e c o g n i t i o n o f l a b o r a t o r i e s b y e i t h e raccreditation bodies or certification bodies.

1 Background

For laboratories and users of laboratorys e r v i c e s , o c c a s i o n a l l y t h e r e i smisunderstanding and confusion about theobjectives and functions of “accreditation”based on ISO/IEC 17025 : 1999 Generalrequirements for competence of testing andcalibration laboratories, and “certification” oflaborator ies based on ISO 9001 : 2000,Q u a l i t y m a n a g e m e n t s y s t e m s -Requirements.

This communiqué was prepared by the IAF-ILAC-ISO/CASCO Joint Working Group onI m a g e a n d I n t e g r i t y o f C o n f o r m i t yAssessment to clarify the key distinctionsb e t w e e n t h e t w o d i f f e r e n t t y p e s o frecogn i t i on o f l abo ra to r i e s by e i t he raccreditation bodies or certification bodies.

I t i s impor tan t to no te tha t the re a redifferences in both the emphasis of thestandards (ISO/IEC 17025 and ISO 9001)

and in the processes used to determinecompliance with them.

2. What do the Standards Specify?

ISO/IEC 17025 was developed as a specialpurpose standard for laboratories to specifythe general requirements for their technicalcompetence. While the Standard is generic,i t a lso recognises that for accreditat ionpurposes, (i.e. for independent recognitionof a laboratory’s competence to performspecific tests, or calibrations) the Standardmay require development of guidelines toexplain its use in specific areas of testing ormeasurement.

ISO/ IEC 17025 : 1999 has two ma jo rc o m p o n e n t s , n a m e l y m a n a g e m e n trequirements and technical requirements.The management requirements are writtenin language relevant to laboratory operationsbut were developed to meet the systemsrequ i rements o f ISO 9001 : 1994 andISO 9002 : 1994.

For accreditation against ISO/IEC 17025, theemphas is i s to estab l ish the techn ica lcompetence of a laboratory for a defined setof tests, measurements or calibrations. Indoing so, however, compliance with theStandard’s management requirements is also

contacts o f nominated pr imary s tandardi ns t i t u t i ons , upda t i ng o f t he re f e rencecalibration procedure standards, and revisionof frequencies for some calibrations in light ofrecent international trend.

A c c r e d i t e d l a b o r a t o r i e s a r e s t r o n g l yencouraged to read the new and rev isedSupplementary Criteria as they are mandatoryrequirements for accredited laboratories.

13

assessed. However, accreditation againstISO/IEC 17025 should not be interpreted tobe the same as ce r t i f i ca t i on aga ins tISO 9001.

ISO 9001 : 2000 is a generic standard forquality management systems applicable toall organisations irrespective of type, size orproduct or service provided. Therefore, it isalso applicable to laboratories, even thoughits language is generic. Its purpose is tospecify a quality management system thatwill allow an organisation to demonstrate itsab i l i t y to p rov ide p roduct tha t meetsc u s t o m e r a n d a p p l i c a b l e re g u l a t o r yrequi rements. I t a lso a ims to enhancecustomer satisfaction, including processesfor continual improvements and assuranceof conformity.

I n a p p l y i n g I S O 9 0 0 1 : 2 0 0 0 t o alaboratory’s operations, the emphasis forc e r t i f i c a t i o n b o d i e s i s t o e s t a b l i s hcomp l iance w i th qua l i t y managements y s t e m s r e q u i r e m e n t s . U n l i k e I S O /IEC 17025, it does not contain technicalrequirements for laboratory personnel andoperations and, as such, certification againstISO 9001 : 2000 should not be interpretedto mean that it demonstrates the technicalcompetence of a laboratory to produce validdata and results.

3. What are the Differences between theProcesses used for LaboratoryAccreditation and Certification?

Apart from the different emphasis of the twoStandards, there are some fundamentald i f fe rences in the processes used byaccreditation bodies and certification bodiest o e s t a b l i s h c o m p l i a n c e w i t h I S O /IEC 17025 : 1999 and ISO 9001 : 2000respectively.

Because laboratory accreditation aims torecognise specific technical competence,t he assessmen ts o f l abo ra to r i e s a reconducted by teams comprising relevant

technical experts and assessors able toevaluate compliance with the managementsystems requirements of ISO/IEC 17025.While the management system requirementsare an important component of a laboratory’sassessment for accreditat ion, the majoremphasis is on determining the specif ictechnical competence of personnel and theavai labi l i ty of al l the technical resourcesneeded to produce reliable data and resultsf o r spec i f i c t es t me thods . O f t en t heaccreditation process will also use objectivedata from proficiency testing programs toassist accreditation decisions. (Proficiencytesting programs are described in detail inISO/IEC Guide 43 : Parts 1 and 2 : 1997).

For cert i f icat ion of a laboratory againstISO 9001 : 2000, the assessment team willconsist of auditors with detailed experiencein assessment o f qua l i t y managementsystems. They may have the technica lexpert ise (or be supported by technicalexperts) to enable them to apply the genericrequirements of Standard to the operationsof laboratory services, but the emphasis ison determining compliance with the qualitymanagement system requirements.

4. Accreditation or Certification of aLaboratory or Both?

Some laboratories are not stand-alonefacilities. They may form part of a largerorganisation, which may have a need tobe certified against ISO 9001 : 2000, whilethe laboratory’s test ing or cal ibrat ionfunctions may also need to be accreditedagainst ISO/IEC 17025.

The decis ion to seek accreditat ion orcertification of a laboratory (or both) willdepend on the overa l l needs of eachlaboratory and the expectat ions of i tscustomers, regulators or other interestedparties for their reassurance about thespec i f i c techn ica l competence o f alaboratory or about its compliance withquality management systems only.

14

Inspection Bodies Accredited for WeldingInspection under HKIAS

HKIAS has expanded to cover constructionproducts inspection and two inspection bodies,A.E S. Destructive and Nondestructive TestingLtd. and Foundation Techniques Ltd., haverecently been accredited for welding inspection.The scope of accreditation covers inspection/approval of welding procedures to BS 4870 :Part 1 : 1981 and BS EN 288 : Part 3 : 1992 aswell as inspection/approval of welder tests toBS 4871 : Part 1 : 1982, BS 4872 : Part 1 :1982 and BS EN 287 : Part 1 : 1992. Regulatoryau tho r i t i e s and o the r use r s o f we ld i nginspect ion serv ice can make use of theseaccredited inspection bodies to assure the

qua l i ty o f the i r we ld ing and enhance thecompetence of qualified welders.

Accreditation Programme on Indoor Air Quality Certification

A Task Force (TF) on accreditation of indoorair quality (IAQ) certification was establishedunder the AAB Working Party on Accreditationof Inspection Body. The chairman of the TF isD r. A l a i n L a m f ro m t h e E n v i ro n m e n t a lProtection Department. A diverse group ofs takeho lders was inv i ted to jo in the TF,including representatives from the ArchitecturalServices Department, the Housing Department,IAQ Society as well as other interested groupssuch as the academia, laboratory associations,bui lding services operators and real estatedevelopers associations, etc.

The accreditation of IAQ certification operatesu n d e r t h e H K I A S . T h e re g u l a t i o n s f o ra c c re d i t a t i o n a re g i v e n i n H K I A S 0 0 2Regulations for Inspection Body Accreditationwhilst the criteria for accreditation are given inHKIAS 003 Cr i te r i a fo r Accred i ta t ion o f

Inspection Bodies, which are based on ISO/IEC17020 - General Criteria for the operation ofvarious types of bodies performing inspection.

A HKIAS Supp lementa ry Cr i te r i a w i l l bepublished to address the specific requirementsfor IAQ. A draft of this document is now underrev iew. An IAQ Cert i f icat ion Guide, whichprov ides technica l gu idance, wi l l a lso bepublished by the IAQ Management Group of thegovernment.

Any inspect ion body interested in seekingHKIAS accreditation for IAQ certification shallhave implemented a quality system and shallbe capable of performing on-site measurementsof the IAQ parameters such as temperature,relative humidity, air movement, carbon dioxide,carbon monoxide, ozone, radon, respirablesuspended par t icu lates and tota l vo lat i le

Alignment of ISO/IEC 17025:1999 with ISO 9001:2000

The CASCO working group on alignment ofISO/IEC 17025:1999 with ISO 9001:2000 metat Geneva on 12 December 2002. A workingdraft was being discussed. The working groupagreed that only the quality system part of thestandard needed to be amended and that theamendment should be kept to a minimum. The

technical part will remain basically unchanged.The more important changes suggested includethe introduction of the ISO 9001:2000 concepto f cont inua l improvement to the qua l i t ymanagement system as well as giving moreemphasis on monitoring of client perception.

15

Seminars on Accreditation Programme on ConstructionProducts Certification

Mr. C.K. Cheung presenting the seminar on the accreditationprogramme on construction products certification at the

University of Hong Kong on 4 October 2002.

HKCAS has expanded to cover accreditationof construction products certification bodies.Two seminars were held to int roduce theprogramme to the industry and univers i tystudents respectively. Both seminars werep re s e n t e d b y M r C K C h e u n g , S e n i o rAccred i ta t ion Off icer respons ib le for theprogramme. The first seminar was held at theHKAS seminar room on 26 September 2002.The seminar focused on passive fire productscert i f icat ion and the audiences were fromgovernment departments, the passive f i rep ro d u c t i n d u s t r y, c e r t i f i c a t i o n b o d i e s ,laboratories and regulatory authorities, etc. Theresponse was good. Over 40 part ic ipantsattended the seminar. The second seminar washeld at the Univers i ty of Hong Kong on 4

October 2002. More than 100 un ivers i tystudents attended the seminar.

ILAC/IAF Conference and General Assembly 2002The International Laboratory AccreditationCooperation (ILAC) and International AccreditationForum (IAF) conferences and General Assemblywere held in Berlin, Germany, in September 2002.This is the second occasion where ILAC and IAFmeetings were held back to back and meetingsof common interest were held jointly. About 200delegates from 40 economies attended themeetings and about 300 delegates attended thecon fe rences . Many meet ings were he ldconcurrently. Dr. L. H. Ng and Mr. Tommy Fungof HKAS attended the conferences and meetings.Some points worth noting are:

• Two new signator ies IPQ (Portugal ) andBMWA (Austria) were admitted to the ILACMultilateral Arrangement. This means that allEA MRA signatories except Lithuania arenow in the ILAC MRA;

• ILAC confirms that on publication of ISO15189 Medical Laboratories - Part icularrequirements for quality and competence,medical laboratories may be accredited tothat standard;

• A proposal was put forward to extend ILAC’smembership criteria beyond compliance withISO/CASCO standards, i .e. membershipmay also include accreditation bodies usingo t h e r s t a n d a r d s l i k e O E C D G L Paccreditation bodies;

• A Work ing Group on acc red i ta t ion o fReference Materials producers was formed.

• Closer co-operat ion wi th the IEC-CABscheme has been deve loped and jo intassessments were proposed.

organic compounds, etc. For on-site samplingof formaldehyde, nitrogen dioxide and airbornebacteria and testing of these parameters inlaboratories, both sampling and testing needto be performed by laboratories accredited forthese tests.

A pro f ic iency tes t ing programme wi l l beorgan ised to assess the per fo rmance o finspection bodies interested in providing the

IAQ cert i f icat ion serv ice. The prof ic iencyprogramme will include measurements of someo f t h e I A Q p a r a m e t e r s . S e m i n a r s o naccred i ta t ion o f IQA cer t i f i ca t ion wi l l beorganised. The accreditation programme will belaunched in early 2003. Interested persons maycontact Mr. C. K. Cheung, Senior AccreditationOfficer responsible for the programme on 28294870 or via e-mail at ckcheung@itc.gov.hk.

16

The PAC family

The Ninth PAC Plenary MeetingThe Ninth Pacific Accreditation Cooperation(PAC) Plenary Meeting was held in Acapulco,Mexico from 3 to 9 August 2002. The PACPlenary Meeting is an annual event where bothtechnical and administrative issues relating tothe operation of PAC and its Mutual RecognitionArrangements (MRA) are discussed and agreedupon. There were about 40 participants andalmost all PAC members were represented. Themembership of PAC is made up of accreditationbodies from largely APEC member economies.Projects and work items are undertaken bythree committees, namely, the DevelopmentPrograms Committee, the Technical Committeeand the Promot ion Commit tee. Mr C. K.C h e u n g , S e n i o r A c c re d i t a t i o n O f f i c e r,

represented HKAS to a t tend the p lenarymeeting and the other committee meetings.

Mr. C.K. Cheung attended the PAC Peer Evaluator Workshop atAcapulco, Mexico on 14 August 2002.

Photo taken after the signing ceremony of new signatories to the APLAC MRA

PAC Peer Evaluator Workshop

Immediately following the PAC meetings, apeer evaluator workshop was held from 10 to

The As i a -Pac i f i c Labo ra to r yA c c r e d i t a t i o n C o o p e r a t i o nwe lcomed the Depa r tmen t o fM e d i c a l S c i e n c e o f T h a i l a n d( D M S c ) a n d D e p a r t m e n t o fStandards Malaysia (DSM) to itsmutual recognition arrangement fortesting. The signing ceremony washeld on 14 November 2002 as partof the APLAC annual meeting heldin Vancouver on 10-15 November2002.

14 August 2002 in the same venue. Theworkshop was sponsored by APEC for trainingpeer evaluators for establishment of MRA onQ u a l i t y M a n a g e m e n t S y s t e m ( Q M S ) ,Environmental Management System (EMS) andProduct Cert i f icat ion accredi tat ions. Th isw o r k s h o p p ro v i d e d a n o p p o r t u n i t y f o rattendees to harmonise their interpretation ofthe relevant ISO Guides (ISO/IEC Guides 61,62, 65 and 66) and the corresponding IAFGuidance documents. About 20 participantsf ro m t h e PA C m e m b e r s a t t e n d e d t h i sworkshop. Mr C. K. Cheung attended theworkshop after attending the PAC Plenarymeeting.

New Members Joining the APLAC MRA

16

The meeting also decided to accept ISO 15189as a primary criteria document for accreditationof medical laboratories as an alternative to ISO/IEC 17025 upon its publication. To providegu idance fo r APLAC MRA eva luat ion fo r

i n s p e c t i o n b o d i e s , t h e I L A C / I A F d r a f tinterpretation documents for ISO/IEC 17020was also accepted as an interim guide, subjectto approval by postal ballot.

HKCAS UpdateHKAS extended its service to include accreditationof certification bodies operating assessment and

certification of environmental management systems(EMS) on 30 December 2002.

Meeting with Certification BodiesAfter attending the International AccreditationForum (IAF) Technical Committee meeting andthe IAF Plenary Meeting held in September2002, Mr. Tommy Fung held a meeting withHKCAS accredited certification bodies (CBs) on30 September. The meeting was attended by9 representatives from the accredited CBs. Mr.C. K. Cheung of HKAS was also present. CBswere informed of the developments at theinternat iona l leve l and changes of HKASrequirements. Some of the more importantpoints discussed are summarized below.

HKCAS Supplementary Criteria No. 1I n l i n e w i t h t h e I A F G u i d a n c e , t h i sSupp lementa ry Cr i te r i a requ i res HKCASa c c r e d i t e d C B s t o h a v e e n f o r c e a b l ear rangements wi th organ isat ions ho ld ingHKCAS endorsed certificates to allow HKASassessment teams to witness the performanceof the CBs’ audit teams at the organisations’site.

Transfer of CertificationAnnex 4 of the IAF Guidance on the Application

of ISO/IEC Guide 62 provides guidance on thet r ans f e r o f I SO 9001 and 9002 qua l i t ymanagement system certificates between CBs.Mr. Fung drew CBs’ attention to clause 2.2 inthe Annex, which states that “normally, a visitto the prospective client” is required. HKASwould expect a visit to be conducted unlessotherwise justified. An organisation certified bya CB accredited by a signatory to the IAF MLAis not considered as sufficient justification onits own.

Certification of QA Consulting FirmsRegarding certif ication of quality assuranceconsulting forms, Mr. Fung noted with concernthat the activit ies of the consultants on-sitewere not witnessed by audit teams of CBs.Although it is not mandatory to witness on-siteactivities in initial certification audits, witnessingis expected during the certification cycle.

Transition for ISO 9001:2000At the IAF Plenary Meeting, the deadline for transitionto ISO 9001:2000 for accredited certification wasreaffirmed to be 15 December 2003.

Hong Kong Certification Body AccreditationScheme (HKCAS) of HKAS was evaluated by aPAC Peer Evaluation Team on 25-29 November2002. The evaluation was for HKAS applicationfor joining the PAC Multilateral Mutual RecognitionArrangement (MLA). The PAC team was led byMr. Kiyoshi Futagawa of JAB, Japan. Mr. EkanitRomyanon from NAC, Thailand was a teammember and Mr. Suprapto from KAN-BSN,Indonesia was also present as an observer.

Evaluation of HKCAS by PAC Evaluation Team

HKAS Evaluated by Pacific Accreditation Cooperation (PAC)

17

The evaluation team concluded that HKCAS isoperating in accordance with the requirementsof ISO/IEC Guide 61 and the IAF interpretative

18

guidance. It is expected that the team wouldpresent a report to PAC in January 2003.

Newly Published ISO 19011:2002Now Available at Product Standards Information Bureau

A new ISO s t anda rd , I SO 19011 :2002Guidelines for Quality and/or EnvironmentalManagement Systems Audit ing , has beenpublished. It is a joint auditing standard for bothquality and environment management systems,replacing ISO 10011-1, ISO 10011-2, ISO10011-3. It provides guidance on principles ofaudit ing, managing audit programmes, theconduct of audits and on the competence ofauditors. It is particularly relevant to auditors,organisat ions implement ing qual i ty and/orenvironmental management systems, and thoseinvolved in auditor cert i f icat ion or training,cer t i f i ca t ion/ reg is t ra t ion o f managementsystems, and accreditation or standardisationin the area of conformity assessment.

The new standard is available for perusal at theProduct Standards Information Bureau (PSIB)of the Innovation and Technology Commission.The P roduc t S tandards L ib ra ry o f PS IBma in ta ins a co l l ec t ion o f some 120,000international/national standards, including thewho le se ts o f ISO s tanda rds and o the rpublications such as regulations, guides andhandbooks. Computer/Internet facil it ies areprovided to facilitate reading electronic copiesof standards as well as visit ing websites of

standards bodies and regulatory authorities. Afree Technical Enquiry Serv ice on generalin terpretat ion of s tandards and technica lrequirements is also available.

If you wish to buy a copy of this new standardand/or other standards published by ISO, IEC,BSI, SAA, or other standards bodies, you coulddo so through PSIB's Standards Sales Service.Both original and photocopies of ISO 19011 areavailable for sale at CHF85.25 (about HKD443)and CHF110 (about HKD572) respectively. Thepurchasing procedures are set out at the PSIBwebsite at http://www.info.gov.hk/itc/eng/quality/psis/salesguide.shtml

Details of PSIB services can be found at http://www.info.gov.hk/itc/eng/qual i ty/psis/psis.shtml. For more information, you are mostwelcome to visit PSIB at 36/F, ImmigrationTower, 7 Gloucester Road, Wan Chai, HongKong or contact us by telephone on 2829 4820,by fax on 2824 1302, or via email at psib@itc.gov.hk. PSIB opens from 8:45am to 12:30pmand from 1:30 to 5:15pm (Monday to Friday),from 9:00am to 12:00noon (Saturday), exceptpublic holidays.

Accreditation UpdateNew Accreditation Granted

HOKLAS

Tw o l a b o r a t o r i e s h a v e b e e n g r a n t e daccreditation for the determination of thicknessof metallic coatings using scanning electronicmicroscopy and scanning auger microcopyunder the Test Category of “Miscellaneous”. TheAdvanced Surface and Mater ia ls Analys isCentre of the Chinese University of Hong Kongwas granted HOKLAS Registration No. 132 andit provides testing services to the public. TheC e n t r e f o r E l e c t r o n i c P a c k a g i n g a n d

Assemblies, Fai lure Analysis and Rel iabi l i tyEngineering (EPA Centre) of the City Universityof Hong Kong also provides testing to the publicand was granted HOKLAS Registration No.135.

HOKLAS Registration No. 133 was granted tothe Materials Engineering & Testing Limitedcover ing Test Categor ies o f “Ca l ib ra t ionServices” and “Construction Materials”. Thelaboratory provides services to the public forca l ibrat ion of force test ing machines andphysical tests for aggregates, cement andconcrete.

Change of Laboratory Name

HOKLASRegistration

No.

Effective

DateFormer Laboratory

NameNew Laboratory Name

006

053

058

8 Nov 2002

8 Oct 2002

1 Dec 2002

PCCW - HKT Limited -

Calibration & Testing

Laboratory

Merchandise Testing

Laboratories (HK) Ltd.

ACTS Testing Labs

(HK) Ltd.

Sun Creation Engineering

Limited -

Calibration & Testing

Laboratory

Bureau Veritas Consumer

Products Services (Hong

Kong) Limited -

Kwai Chung Office

Bureau Veritas Consumer

Products Services (Hong

Kong) Limited -

Kowloon Bay Office

Accred i ta t ion was granted to The Rad ioL a b o r a t o r y o f t h e O f f i c e o f t h eTelecommunicat ion Authority for test ing ofradiocommunicat ion equipment under thecategory of “Electrical and Electronic Products”.T h e l a b o r a t o r y w a s a s s i g n e d H O K L A SRegistration No. 134 and it provides testingservices to the public.

Accreditation Suspended

The Apparel and Textile Testing Laboratory ofHong Kong Polytechnic Univers i ty Text i leM a n u f a c t u r i n g Te c h n o l o g y C e n t re h a svoluntarily suspended all its accredited testswith effect from 13 September 2002.

Accreditation Terminated

Bureau Veritas Consumer Products Services(Hong Kong) Ltd - Kwai Chung Office voluntarilyterminated its accreditation for all physical andmechanical tests under the Test Category of“Toys and Children’s Products” effective 15October 2002.

ACTS Test ing Labs (HK) L td . vo lun ta r i l yterminated its accreditation for all tests underthe Test Category of “Textiles and Garments”with effect from 4 October 2002.

19

Sunnic Research & Testing Laboratory Ltd.voluntarily terminated its accreditation effectivefrom 27 June 2002.

HKIAS

Two inspect ion bodies have been grantedaccreditation for welding inspection under the“Construct ion Mater ia ls Inspect ion” F ie ld.HKIAS Registration Nos. 5 and 6 were grantedto A.E.S. Destruction and Non-DestructionTesting Ltd. and Foundation Techniques Ltd.respectively.

Proficiency Testing Update

Construction Materials

The final report for the steel proficiency testingprogramme - HCM/2002/3 (Tensile Testing -Reinforcing Steel ) has been issued and theperformances of the laboratories were generallysatisfactory. Only one laboratory was identifiedas an outlier and the laboratory was requestedto provide the investigation findings to HKAS.

Tes t resu l t s f o r t he P ro f i c i ency Tes t i ngProgramme - HCM /2002/5 (Detection of thepotential alkali-reactivity of aggregates) hasbeen comple ted and ana lys is o f da ta i sunderway.

Reference cement samples for the cementproficiency testing programme - HCM/2002/4(Density, finness, consistency and setting times

determination) were distributed to participantsin August and a l l tes t resu l ts have beenreceived. The performance of participants isgenera l ly sat is factory. Those laborator iesidentified as outliers were requested to providean investigation report to HKAS.

A proficiency testing programme on Indoor AirQuality measurement is now being planned. Theprogramme involves the determination of fivemajor parameters, viz., temperature, relativehumidity, air movement, carbon dioxide andtotal volatile organic compounds. It is expectedthat the programme will be launched in March2003. Invitations will be sent to participants inFebruary 2003. Interested parties can contactMr. Eric Lee at tel. 2829 4804 for more details.

StatusTest

Category Test Area/Scheduled

Dates

Construction

Materials

Calibration

Services

Soil - Atterberg Limits and

Moisture Content)

Foundation Piles - Sonic

logging

Cement - Fineness Test

Reinforcing steel -

Tensile strength

Concrete - Diagnostic

Tests

Foundation Piles -

Pile dynamic test

Soil - Standard

Compaction

Bituminous Materials -

Air void content

Aggregates -

Potential alkali-reactivity

Calibration of compression

testing machines

February 2002

January 2003

July 2002

July 2002

September

2002

December

2002

February 2003

August 2002

April 2002

Final report

issued

Programme

delayed

Final report

issued

Final report

issued

Programme

cancelled

Postponed until

further notice

Programme

delayed

Programme

delayed

Final report

issued

Final report

issued

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

• Metrology Training Course13 – 15 January 2003

• Seminar on Accreditation of Medical Testing17 February 2003

• Training Course on the ISO Guide to Expressionof Uncertainty in Measurement5 – 7 March 2003

• Laboratory Quality Management Based on ISO/IEC 1702510 – 12 March 2003

• Internal Audit ing of Laborator ies to ISO/IEC1702513 – 14 March 2003

• Metrology Training Course28 - 30 April 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.

Calibration Services

The final report for the Calibration of CompressionTesting Machines Proficiency Testing Programme- HCAL/2002/01 has been issued and theperformance of the laboratory was generallysatisfactory. Laboratories with outlying resultswere requested to submit the investigation findingsto HKAS.

A Schedule of Proficiency Testing Programmeogransied by HKAS for the Construction Materialsand Calibration Services Test Categories in theyear 2002 and 2003 is given below:

Toys and Children’s Products

The final report for the APLAC T022 Toy SafetyP r o f i c i e n c y Te s t i n g P r o g r a m m e -“Determination of emission sound pressurelevel” has been issued to local participants andother accreditation bodies.

Others

Final report for APLAC T032 - Dairy ProficiencyTesting Programme has been distributed toHong Kong participants. The performances oflaborator ies accred i ted for the tests aresatisfactory.

I n t e r im repo r t f o r APLAC T030 - FoodMicrobiological Proficiency Testing Programmehas been distributed to Hong Kong participants.

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