DQuality & Standards > HKAS
New - About HOKLAS 003 8th Edition

1. About HKAS

1.1 Can you tell me more about HKAS, its background and history?
1.2 Are overseas accreditations recognised by HKAS?
1.3 Is HKAS accreditation recognised in other economies?
1.4 Which accreditation bodies are MRA partners of HKAS?
1.5 What are the geographical areas served by HKAS?
1.6 Can HOKLAS perform a test for my company?
1.7 I want to have a printed copy of HOKLAS directory, where can I obtain a copy?
1.8 What can I do if I am not satisfied with the conformity assessment service provided by a HKAS accredited organisation?
1.9 How can I become a HKAS assessor or technical expert?


2. Questions of interest to users of accredited service

2.1 Where can I find the scope of service HOKLAS currently provides?
2.2 Why should I use accredited service?
2.3 How to find an accredited laboratory, certification body or inspection body to perform a particular activity?
2.4 How can I know whether a laboratory, certification body or inspection body is accredited for a particular activity?
2.5 If there is no laboratory accredited by HOKLAS for the test required by me, what should I do?
2.6 How is "Laboratory Accreditation" different from "Quality System Registration/Certification"?
2.7 What is an endorsed report or certificate?
2.8 Why should I ask for an endorsed report?
2.9 How can customers secure satisfaction with accredited service?
2.10 How to determine whether it is appropriate to complain to HKAS about the service of an accredited organisation and what is the procedure for lodging such a complaint?

3. Questions of interest to laboratories, certification bodies and inspection bodies

3.1 How can my organisation become accredited?
3.2 How long will it take for my organisation to obtain HKAS accreditation?
3.3 My organisation wants to seek HKAS accreditation, how much will it cost?
3.4 Where can I obtain help or advice for obtaining accreditation?
3.5 What are the qualification and experience requirements for personnel working in applicant and accredited organisations?
3.6 What types of reference materials are accepted by various HKAS accreditation schemes?
3.7 What are the measurement traceability requirements for HKAS accreditation schemes?
3.8 What are the HOKLAS requirements on evaluation of measurement uncertainty?
3.9 What are the HOKLAS requirements on method validation?
3.10 Our laboratory intends to seek HOKLAS accreditation, what are the proficiency testing requirements and when should we enroll in these programmes?
3.11 Are there any other proficiency testing programmes apart from those organised by HKAS?
3.12 What are the typical steps in seeking HOKLAS accreditation?
3.13 If I want to seek accreditation for a test, inspection or certification for which HKAS does not offer accreditation, what can I do?
3.14 Are the certificates issued by HOKLAS accredited laboratories acceptable by other countries?
3.15 Our laboratory is a medical laboratory, should we operate in accordance with ISO/IEC 17025 or ISO 15189?
3.16 Which calibration laboratories are acceptable for HOKLAS for providing calibration service to our laboratory equipment where traceability to the International System of Units (SI) is required?
3.17 How to distinguish between preventive and corrective actions?
3.18 How can my laboratory apply for accreditation of tests carried out in accordance with standards written in a language other than English and Chinese?


4. Questions about HOKLAS 003 8th Edition

4.1 "Continually improve the effectiveness of the management system" is stated several times in particularly under Clause 4.10 of HOKLAS 003 (Eighth Edition). Is a laboratory required to improve precision of its tests, e.g., reduce method detection limit of say, 1 ppm to 1 ppb?
4.2 Clause 5.2.2 states that "The effectiveness of the training actions taken shall be evaluated." Is this requirement related to training in testing only?
4.3 Will compliance with applicable regulatory requirements, for example, those related to laboratory safety, be assessed in HOKLAS assessments?
4.4 The word "ensure" is used in many requirements of ISO/IEC 17025: 2005.When assessing conformity with requirements, should we look at the results rather than the process used to achieve them?
4.5 What are the new accreditation requirements under HOKLAS 003 (eighth edition) as compared to HOKLAS 003 (seventh edition)?
4.6 If a laboratory accredited for tests in different test categories is assessed for some of those test categories only in a reassessment or surveillance visit and found to be in conformity with all the requirements of the 8th edition of HOKLAS 003, will accreditation to the new edition be granted for all the other accredited test categories?

 

1. About HKAS


1.1 Can you tell me more about HKAS, its background and history?

Hong Kong Accreditation Service (HKAS) is part of Innovation and Technology Commission of the Hong Kong Special Administration Region Government. The main role of HKAS is to promote conformity assessment services to underpin technological development and international trade.

Hong Kong Accreditation Service (HKAS) provides accreditation for laboratories, certification bodies and inspection bodies, through the Hong Kong Laboratory Accreditation Scheme (HOKLAS), Hong Kong Certification Body Accreditation Scheme (HKCAS) and Hong Kong Inspection Body Accreditation Scheme (HKIAS) respectively. HOKLAS was launched in 1985; HKCAS was launched in 1998 while HKIAS was launched in 1999. For details of the services provided by these schemes, please follow the links provided above.

HKAS is active in international accreditation activities. HKAS is one of the first seven signatories to the Asia Pacific Laboratory Accreditation Cooperation (APLAC) Multilateral Recognition Arrangement (MRA). APLAC is formed by laboratory and inspection body accreditation bodies in the Asia Pacific region. Signatories to MRA are nationally recognized accreditation bodies and are usually owned or endorsed by government. The other signatories can be found following this link http://www.aplac.org/members/signatories_mra.htm.

On 12 November 2003, in the APLAC Mutual Recognition Arrangement (MRA) Council Meeting in Seoul, Korea, the APLAC MRA was extended to cover the accreditation of inspection bodies. HKAS is one of the four inaugural signatories for the inspection body MRA.The other inaugural signatories are NATA of Australia, IANZ of New Zealand and SAC-SINGLAS of Singapore.

HKAS has signed a bilateral agreement with the European Co-operation for Accreditation (EA) multilateral agreement group comprising the national accreditation schemes. The Members of EA are the nationally recognised accreditation bodies of the member countries or candidate countries, of the European Union (EU) and European Free Trade Association (EFTA). HKAS is also one of the signatories of the international arrangement signed in Washington DC, on 2 November 2000, at the General Assembly of the International Laboratory Accreditation Cooperation (ILAC). For details of this MLA, please follow this link http://www.ilac.org HKAS is a member of the International Accreditation Forum (IAF). Members of the International Accreditation Forum, Inc. (IAF) include Accreditation Bodies and other bodies interested in accreditation and certification.

HKAS is also a member of the multilateral recognition arrangement (MLA) Pacific Accreditation Cooperation (PAC) for accreditation of management certification. HKAS had signed the corresponding MLA in October 2004 in Cape Town.

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1.2 Are overseas accreditations recognised by HKAS?

HKAS recognises accreditation granted by its MRA partners. The list of HKAS MRA partners is available through this link http://www.info.gov.hk/itc/eng/quality/hkas/hoklas/agreement/agreement.htm

HKAS will also recognise reports and certificates issued by conformity assessment bodies accredited by its MRA partners provided that such reports and certificates bear the accreditation mark of the relevant HKAS MRA partner.

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1.3 Is HKAS accreditation recognised in other economies?

Every effort is made to promote acceptance of test data from accredited laboratories, both internationally and locally. HKAS MRA partners will recognise the accreditations and reports and certificates issued by organisations accredited by HKAS. To be recognised, the reports and certificates must bear the appropriate HKAS accreditation mark. Through such MRAs, HKAS accreditations and endorsed reports and certificates are widely recognised.

It should be noted, however, that any regulator or individual organisation has the prerogative to accept or reject any certificate. Therefore, to confirm whether a report or certificate is acceptable, the relevant regulator or organisation should be consulted.

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1.4 Which accreditation bodies are MRA partners of HKAS?

Please refer to our website for, HOKLAS MRA Partners, HKIAS MRA Partners, HKCAS MLA Partners.

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1.5 What are the geographical areas served by HKAS?

HKAS offers accreditation service to organisations located within the Hong Kong Special Administrative Region of China. For tests included in the Test Category of Construction Materials under HOKLAS, applications from laboratories located within the Pearl Delta Region of China are also accepted.

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1.6 Can HOKLAS perform a test for my company?

HOKLAS is an accreditation scheme operated by the Hong Kong Accreditation Service (HKAS) and is NOT a testing laboratory. You may contact our accredited laboratories to conduct the test / calibration.

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1.7 I want to have a printed copy of HOKLAS directory, where can I obtain a copy?

From year 2003 onwards, HKAS no longer publishes printed HOKLAS directory. Instead, a CD version of the directory is available on request and may be collected from our office at 36/F., Immigration Tower, 7 Gloucester Road, Hong Kong. Alternatively, you can access our internet directory for HOKLAS, HKCAS, HKIAS. The internet directory contains up-to-date scopes of HKAS accredited organisations.

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1.8 What can I do if I am not satisfied with the conformity assessment service provided by a HKAS accredited organisation?

The accreditation regulation requires the organisation to have a policy and procedure to handle and resolve complaints. If you are not satisfied with how the complaint is handled by the organisation, you may lodge a complaint to HKAS Executives. Alternatively, you may lodge a complaint against the organisation directly to HKAS Executives.

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1.9 How can I become a HKAS lead assessor, assessor or technical expert?

To become an assessor for a particular activity of a laboratory, certification body or inspection body, a person must be assessed to have the qualifications and experience necessary for examining, evaluating and judging the effectiveness and quality of that activity. He must also undergo appropriate training and pass the necessary test for conducting assessments. Before appointment by HKAS Executive, endorsement from Accreditation Advisory Board has to be obtained. HKAS Executive reserves the right to appoint and not appoint any person as an assessor. HKAS Executive may also terminate the appointment of an assessor at any time without giving reasons. Interested person may send their curriculum vitae to HKAS Executive. For further details on appointment of HKAS lead assessor, assessors and technical experts, please click here.

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2. Questions of interest to users of accredited service


2.1 Where can I find the scope of service HOKLAS currently provides?

The scope of service currently offered by HOKLAS is available from our website.

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2.2 Why should I use accredited service?

Using an accredited service ensures that the service provider (laboratory, certification body, inspection body) is competent in providing the service in accordance with international standards of practice as the service to be provided has been rigorously assessed by independent specialist in the area.

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2.3 How to find an accredited laboratory, certification body or inspection body to perform a particular activity?

You can access our internet directory for HOKLAS, HKCAS, HKIAS for their respective up-to-date scopes by clicking the links provided above. You may also download the complete scope of accreditation for HOKLAS accredited laboratories, HKCAS accredited certification bodies and HKIAS accredited inspection bodies by clicking here. The file is in Acrobat format and you can use the search function provided by Acrobat for searching accredited organisations for a specific activity. The downloading process may take some time because of the large file size.


2.4 How can I know whether a laboratory, certification body or inspection body is accredited for a particular activity?

You can access our internet directory for HOKLAS accredited laboratories, HKCAS accredited certification bodies, HKIAS accredited inspection bodies for their respective scope by clicking the links provided above.

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2.5 If there is no laboratory accredited by HOKLAS for the test required by me, what should I do?

You may approach our MRA partners to check if they can nominate a laboratory accredited by them for the test you required.

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2.6 How is "Laboratory Accreditation" different from "Quality System Registration/Certification"?

Laboratory accreditation gives assurance on the correctness and reliability of results to specific tests and calibration performed by a laboratory (ie the product of the laboratory). During on-site assessments, emphasis is given to evaluating the competence of the laboratory for the specific activities.

Quality system certification gives assurance that the organisation is operating a compliant quality system. During on-site audits, emphasis is given to checking conformity of the system with the relevant standard. The quality of the products of the organisation is not the focus of the on-site audit.

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2.7 What is an endorsed report or certificate?

A HOKLAS endorsed test report or certificate is a test report or certificate issued by a HOKLAS accredited laboratory for reporting the result of an activity accredited under HOKLAS. A HOKLAS endorsed report or certificate bears the HOKLAS accreditation mark on the right hand top corner of its front page.

A HKIAS endorsed inspection report or certificate is an inspection report or certificate issued by a HKIAS accredited inspection body for reporting the result of an inspection activity accredited under HKIAS and with the HKIAS accreditation mark displayed on the right hand top corner of its front page.

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2.8 Why should I ask for an endorsed report?

An endorsed report signifies that the service provided is in accordance with the conditions of accreditation. To fully realise the benefit of using an accredited service, always ask for an endorsed report. Also, since not all of the services provided by an accredited organisation may fall into its scope of accreditation and an organisation is allowed to issue endorsed report only for the activities that it has been accredited, to ensure that the service you require from the organisation does fall within its scope of accreditation, always ask for an endorsed report.

Moreover, an endorsed report will be accepted by MRA partners all over the world.

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2.9 How can customers secure satisfaction with accredited service?

See the paragraph "What customers can do to secure satisfactory service from an accredited organisation" in this document.


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2.10 How to determine whether it is appropriate to complain to HKAS about the service of an accredited organisation and what is the procedure for lodging such a complaint?

See the paragraphs "Determining whether to complain to HKAS Executive" and "Procedure for complaining to HKAS Executive against an accredited organisation" in this document.

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Questions of interest to laboratories, certification bodies and inspection bodies


3.1 How can my organisation become accredited?

You can refer to the procedures for HKAS accreditation.

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3.2 How long will it take for my organisation to obtain HKAS accreditation?

The actual time required between the submission of an application and the granting of accreditation will depend very much on the applicant's conformity with the HKAS requirements, the range of tests/inspection fields/NACE code covered in the scope of accreditation and the effectiveness and efficiency of the organisation in addressing any non-conformities identified during the assessment. HKAS will try every effort to fulfil our performance pledge. For a well prepared organisation, 6 months is a reasonable estimate.

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3.3 My organisation wants to seek HKAS accreditation, how much will it cost?

The current fee schedule for HKAS is available from our published document. The two major fees that an applicant has to pay are the application fee and the assessment fee. The application fee has to be paid when tendering an application. The amount for HOKLAS, HKCAS and HKIAS are given in HOKLAS 006 (local laboratories) and HOKLAS 013 (overseas laboratories), HKCAS 006 and HKIAS 006 respectively. The assessment fee has to be paid prior to the on-site assessment. The amount depends on the number of assessment unit required to conduct the assessment and may be calculated from the unit rate given in HOKLAS 006, HOKLAS 013, HKCAS 006 and HKIAS 006. The actual assessment units charged for each assessment are a measure of the assessment effort required to service a laboratory / certification body / inspection body. An assessment unit is usually the work carried out by an assessor in half a day. The number of days required for a visit will depend on the extent of the activities. Depending on the finding of the assessment, follow-up visits or another complete assessment may have to be conducted. The fees for such visits will also be calculated based on the assessment units required.
To maintain the accreditation, the organisation has to pay annual subscription fee, reassessment fee and fees for surveillance visits. The amount and calculation method are detailed in the price schedule mentioned above.
There may be other fees for additional services. Details are given in the relevant schedules.

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3.4 Where can I obtain help or advice for obtaining accreditation?

HKAS publications provide information on the requirements for obtaining accreditation. Further information may also be obtained from the HKAS Executive. After receiving an application for accreditation from an organisation, a HKAS accreditation officer will contact the organisation and arrange for an advisory visit to discuss issues relating to HKAS accreditation.

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3.5 What are the qualification and experience requirements for personnel working in applicant and accredited organisations?

For laboratory personnel, general requirements are given in Section 5.2 of HOKLAS 003 (non-medical laboratory) and Section 5.1 of HOKLAS 015 (medical laboratory). For inspection bodies the general personnel requirements are given in Chapter 8 of HKIAS 003. For certification bodies, the general personnel requirements are given in Section 2.2 of ISO/IEC Guide 62 for QMS and Section 4.2 of ISO/IEC Guide 66 for EMS. Specific requirements for specific technical disciplines are given in the relevant supplementary criteria.

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3.6 What types of reference materials are accepted by various HKAS accreditation schemes?

Laboratories shall meet the requirements stipulated in Section 5.6.3 of HOKLAS 003 and Section 5.6 of HOKLAS 015 for non-medical and medical laboratories respectively. Commentary on the HKAS requirements on reference materials is given in Section 5.6 of HOKLAS 003 and HOKLAS 015. Inspection bodies shall refer to Chapter 9 of HKIAS 003 for the reference materials requirements. Laboratories shall also refer to HOKLAS Supplementary Criteria No. 1 for acceptability of chemical reference materials and commercial standard solutions used for the calibration of equipment.

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3.7 What are the measurement traceability requirements for HKAS accreditation schemes?

Laboratories shall meet the requirements stipulated in Section 5.6 of HOKLAS 003 and HOKLAS 015 for non-medical and medical laboratories respectively. Commentary on the HKAS requirements on measurement traceability is given in Section 5.6 of HOKLAS 003 and HOKLAS 015. Inspection bodies shall refer to Chapter 9 of HKIAS 003 for the measurement traceability requirements.

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3.8 What are the HOKLAS requirements on evaluation of measurement uncertainty?

Laboratories shall meet the requirements stipulated in 5.4.6 of HOKLAS 003 and Section 5.6.2 of HOKLAS 015 of HOKLAS 015 for non-medical and medical laboratories respectively. Commentary on the HKAS requirements on measurement uncertainty is given in Section 5.4.6 of HOKLAS 003 and Section 5.6.2 of HOKLAS 015. Calibration laboratories shall also refer to HOKLAS Supplementary Criteria No. 13 for additional requirements.


3.9 What are the HOKLAS requirements on method validation?

Laboratories shall meet the requirements stipulated in Section 5.4.5 of HOKLAS 003 and Section 5.5.2 of HOKLAS 015 for non-medical and medical laboratories respectively. Commentary on the HKAS requirements on method validation requirements is given in Section 5.4.5 of HOKLAS 003 and Section 5.5.2 of HOKLAS 015.

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3.10 Our laboratory intends to seek HOKLAS accreditation, what are the proficiency testing requirements and when should we enroll in these programmes?

The requirements are stated in Clauses 9.2.5 and 9.2.6 of HKAS 002. These clauses are reproduced below:

An accredited laboratory shall take part in proficiency testing programmes which are relevant to its scope of accreditation organised or specified by HKAS Executive unless it can demonstrate to HKAS Executive that it has already participated in alternative programmes which are acceptable to HKAS Executive. The performance of an applicant or an accredited laboratory in any proficiency testing activity relevant to its scope of accreditation shall be acceptable to HKAS Executive. An applicant laboratory shall take part in at least one appropriate proficiency testing activity, where available, before accreditation will be granted. After accreditation has been granted, the laboratory shall take part in at least one appropriate proficiency testing activity, when available, which is related to each major sub-area of major disciplines of the accredited activities as specified in its scope of accreditation, every four years. The assessment team shall determine the appropriateness of any proficiency testing activities and may, at its discretion, require the laboratory to participate in other forms of proficiency testing activity so as to evaluate its competence in performing specific tests, calibrations or other laboratory activities. Where an applicant or an accredited laboratory is unable to participate in any appropriate proficiency testing activity because such activity is not available, it shall demonstrate to the satisfaction of the assessment team that it has taken all reasonable steps to identify such activity. In this clause, proficiency testing activity includes any international, regional and national interlaboratory comparisons as well as measurement audits and check samples acceptable to HKAS.

It should be pointed out that proficiency testing is a means for assuring the quality of test and calibration results. Therefore, the other quality assurance measures taken by the laboratory will be taken into consideration when assessing whether a laboratory has participated in adequate proficiency testing activities.

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3.11 Are there any other proficiency testing programmes apart from those organised by HKAS?

You may select the programme that best suit your laboratory from the APLAC Proficiency Testing Directory. You may also search the database maintained by European information system on proficiency testing schemes (EPTIS) for suitable programmes. You may also contact the HKAS accreditation officer responsible for the relevant technical discipline for assistance. HKAS MRA partners offer accreditation service for Proficiency Testing Providers. You may find proficiency testing programmes accredited by these accreditation bodies through their websites.

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3.12 What are the typical steps in seeking HOKLAS accreditation?

You can refer to the procedures for HOKLAS accreditation.

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3.13 If I want to seek accreditation for a test, inspection or certification for which HKAS does not offer accreditation, what can I do?

You are welcome to discuss it with HKAS Executive.

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3.14 Are the certificates issued by HOKLAS accredited laboratories acceptable by other countries?

Every effort is made to promote acceptance of test data from accredited laboratories, both internationally and locally. HKAS MRA partners will recognise the accreditations and reports and certificates issued by organisations accredited by HKAS. To be recognised, the reports and certificates must bear the appropriate HKAS accreditation mark. Through such MRAs, HKAS accreditations and endorsed reports and certificates are widely recognised.

It should be noted, however, that any regulator or individual organisation has the prerogative to accept or reject any certificate. Therefore, to confirm whether a report or certificate is acceptable, the relevant regulator or organisation should be consulted.

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3.15 Our laboratory is a medical laboratory, should we operate in accordance with ISO/IEC 17025 or ISO 15189?

HOKLAS Accreditation Criteria for Medical Laboratories are in accordance with ISO 15189:2003(E) "Medical laboratories - Particular requirements for quality and competence". If your laboratory is interested in obtaining HOKLAS accreditation, it should operate to ISO 15189. Non-medical laboratories should operate in accordance with ISO/IEC 17025:2005(E) "General Requirements for the competence of testing and calibration laboratories".

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3.16 Which calibration laboratories are acceptable for HOKLAS for providing calibration service to our laboratory equipment where traceability to the International System of Units (SI) is required?

The HKAS Executive will, for the time being, accept as evidence of traceability to SI units, calibrations which have been performed by :

  • The Government of the HKSAR Standards and Calibration Laboratory;
  • Nominated primary standards institutions as referenced in HOKLAS Supplementary Criteria No. 2;
  • Laboratories accredited by HOKLAS for the specific calibration services provided thatthe calibration results are reported in HOKLAS endorsed calibration reports/certificates;
  • Calibration laboratories accredited by MRA Partners of HOKLAS for the relevantcalibration, provided that the calibration results are documented in endorsedcalibration reports/certificates of the respective accreditation body;
  • Other specified calibration laboratories designated by the HKAS Executive from time to time.

More information is given in HOKLAS Supplementary Criteria No. 2


3.17 How to distingusih between preventive and corrective actions?

Clause 4.12 of HOKLAS 003 is on Preventive action.

NOTE 1 to that clause is:- ¡§Preventive action is pro-active process to identify opportunities for improvement rather than a reaction to the identification of problems or complaints.¡¨

It is not uncommon to find that laboratory personnel consider action for preventing recurrence of a problem is preventive action.

Perhaps the relevant clauses in ISO 9001:2000 might help.

Clause 8.5.2 Corrective action

The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence.

Clause 8.5.3 Preventive action

The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence.

The same action could be a corrective action or preventive action depending on whether the action was taken before or after occurrence of the nonconformity/problem.

For example, a pedestrian footbridge was built for crossing a busy road. If it was built after someone was knocked down by the busy traffic, it would be a corrective action to eliminate recurrence of similar accident. If it was built before any accident, it would be a preventive action to eliminate such potential accident.

It should be noted that action to prevent recurrence of nonconformity found in an internal audit is corrective action not preventive action.

3.18 How can my laboratory apply for accreditation of tests carried out in accordance with standards written in a language other than English and Chinese?

For accreditation of a test carried out in accordance with a standard written in a language other than English and Chinese, the applicant laboratory shall obtain an accurately translated version of the document written in a language understandable to the laboratory staff and HKAS assessors.The preferred method is for the laboratory to ask for an official English or Chinese version from the body which published the standard.If this is not possible, the laboratory shall commission a competent person to translate the document and then check the translated version carefully and sentence by sentence using the service of another competent person.

In the above paragraph, a competent person is a person who has the required technical knowledge and translation skill for the relevant languages.For example, if the standard is a chemical standard, the person should be a competent chemist; if the standard is a physical standard, the person should be a physicist or engineer of the relevant fields in addition to the required language skill.If the standard is a statutory law or regulation, it may be necessary to obtain the advice from a lawyer or a person accepted as competent to translate legal documents, etc.A competent person may be a staff member of the laboratory or from an external organization.

The person performing the checking should be different from the person performing the translation.If the person carrying out the translation is from an external organisation, the person performing the checking shall be from another organization, unless there is convincing evidence to show that carrying out both translation and checking by the same organization will not result in conflict of interest and will not compromise the quality and credibility of the translated document.In either case, the laboratory shall obtain the credentials of the persons who will carry out the work and satisfy itself that the credentials are acceptable.Using native speakers of the relevant foreign language for carrying out both translation and checking is preferred.When employing external organizations for the work, the laboratory should obtain evidence that the work has been done personally by the agreed persons.

To HKAS Executive, the laboratory shall provide information to demonstrate the competence of the persons who have carried out the translation and checking and a sentence by sentence checking record.HKAS Executive will assess the acceptability of the competent person and check the records carefully.The assessment team will also evaluate the accuracy and reliability of the translated document based on knowledge in similar test standards written in English or Chinese.HKAS Executive reserves the rights to ask the laboratory to provide further evidence to demonstrate the accuracy and credibility of translated standards.

The laboratory shall have the capability for reviewing the translated versions of standards periodically and when changes to the original documents have been made.This applies irrespective of whether the translation and checking were carried out by internal staff or external parties.

All relevant accreditation criteria apply to tests performed in accordance with standards written in a foreign language.For example, the laboratory may be required to demonstrate their competence in performing the tests through taking part in proficiency testing activities, if any doubt relating to the accuracy of the translated version arises, the laboratory shall implement corrective actions and where the standard stipulates that the product being tested must be labeled with statements written in a foreign language, the laboratory must have adequate provision for checking the acceptability of such labels.



4.1 ¡§Continually improve the effectiveness of the management system¡¨ is stated several times particularly under Clause 4.10 of HOKLAS 003 (Eighth Edition). Is a laboratory required to improve precision of its tests, e.g., reduce method detection limit of say, 1 ppm to 1 ppb?

The laboratory shall aim for improvement in the effectiveness of its overall management system.Effectiveness of a management system is the degree it has achieved the intended results.Therefore, what should be improved depends on what are considered the ¡§intended results¡¨.The ¡§intended results¡¨ should be related to the ¡§overall objectives¡¨ stated in 4.2.2 of HOKLAS 003.If one of the objectives is to achieve technical excellence, then increasing the precision of tests may be an appropriate means to achieve the objective.On the other hand, if the objective is to enhance customer satisfaction to the service provided by the laboratory and if increasing the testing precision will increase the testing cost while providing no tangible benefit to the customer, then increasing testing precision may not be an improvement at all. Note 1 under clause 1.4 of ISO/IEC 17025 states ¡§The term ¡¥Management System¡¦ in this International Standard means the quality, administrative and technical systems that govern the operation of a laboratory.¡¨Therefore, improvement in other quality administrative aspects will also satisfy the requirement of Clause 4.10. For example, a laboratory may establish a target for limiting the excessive use of stationery to reduce running cost of accredited testing services. The laboratory may however wish to focus more on the quality and technical systems.

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4.2 Clause 5.2.2 states that ¡§The effectiveness of the training actions taken shall be evaluated.¡¨ Is this requirement related to training in testing only?

No. The requirement is applicable to all types of training, which may or may not be related to testing directly.

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4.3 Will compliance with applicable regulatory requirements, for example, those related to laboratory safety, be assessed in HOKLAS assessments?

No. HKAS is not a regulatory authority and HOKLAS assessments do not cover regulatory requirements, not even those related to safety. ISO/IEC 17025:2005, on which HOKLAS 003 is based, explicitly stated in its Scope that ¡§Compliance with regulatory and safety requirements on the operation of laboratories is not covered by this International Standard¡¨. This statement is reproduced on page 2 of HOKLAS 003. It is a laboratory¡¦s own responsibility to ensure that its operation meets all applicable regulatory requirements. HOKLAS assessors may give general advice on good laboratory practice, including those on laboratory safety, but following the advice should not be regarded as meeting the relevant regulatory requirements.

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4.4 The word ¡§ensure¡¨ is used in many requirements of ISO/IEC 17025: 2005.When assessing conformity with requirements, should we look at the results rather than the process used to achieve them?

In an assessment, the assessor is looking for evidence of conformity. Assessing the end results is one of the means. However, the assessor should be cautious as to whether the end result was achieved by chance or by a managed process. Depending on the situation, the assessor might have to establish what was the intended process / procedure. In some cases, the standards may have explicit requirements on the process / procedure.

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4.5 What are the new accreditation requirements under HOKLAS 003 (eighth edition) as compared to HOKLAS 003 (seventh edition)?

Significant changes of HOKLAS 003 (eighth edition) are summarized in the HKAS presentation slides of the briefing session on 20 October 2005, which are available for download from HKAS website under ¡§Seminar and Training¡¨.

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4.6 If a laboratory accredited for tests in different test categories is assessed for some of those test categories only in a reassessment or surveillance visit and found to be in conformity with all the requirements of the 8th edition of HOKLAS 003, will accreditation to the new edition be granted for all the other accredited test categories?

Accreditation to the 8th edition of HOKLAS 003 will be granted for test categories which have been assessed and found to be in conformity with the requirements of this edition. HKAS will arrange with the laboratory to cover all test categories before 15 May 2007.

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