FAQ / Information

HKAS is a section of Innovation and Technology Commission of the Government of the Hong Kong Special Administrative Region. The main role of HKAS is to promote accredited conformity assessment services to underpin technological development and international trade.

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. Please click the links above for details of the services provided under these schemes.

HKAS is active in international accreditation activities. HKAS was one of the first seven signatories to the Asia Pacific Laboratory Accreditation Cooperation (APLAC) Mutual Recognition Arrangement (MRA). APLAC was formed by laboratory and inspection body accreditation bodies in the Asia Pacific region. Signatories to APLAC MRA were nationally recognised accreditation bodies largely owned or endorsed by government.

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

On 1 January 2019, APLAC and PAC combined to form a new regional accreditation body cooperation called the Asia Pacific Accreditation Cooperation (APAC). Previous members of APLAC or PAC, including HKAS, were transferred to the relevant membership category of APAC, and previous mutual recognition status within APLAC and PAC was transferred to the APAC Mutual Recognition Arrangement (MRA). Further information about APAC is available on the website: https://www.apac-accreditation.org.

HKAS was also one of the signatories of the international MRA signed in Washington DC, on 2 November 2000, at the General Assembly of the International Laboratory Accreditation Cooperation (ILAC). For details of this MRA, please follow this link https://www.ilac.org. On 9 October 2004, HKAS became a signatory to the Multilateral Recognition Agreement (MLA) of the International Accreditation Forum, Inc. (IAF). For details of this MLA, please visit https://iaf.nu/.

 

HKAS recognises accreditation granted by its MRA/MLA partners. The list of HKAS MRA/MLA partners is available through this link https://www.itc.gov.hk/en/quality/hkas/information/mra_mla_arrangements.html

HKAS also recognises reports and certificates issued by conformity assessment bodies accredited by its MRA/MLA partners provided that such reports and certificates bear the accreditation symbol of the relevant HKAS MRA/MLA partner.

 

Every effort is made to promote acceptance of results from accredited organisations, both internationally and locally. Through signing the MRA/MLAs of APAC, IAF and ILAC, accreditations granted by HKAS are widely recognised. HKAS’ MRA/MLA partners recognise the reports and certificates issued by organisations accredited by HKAS. To be recognised, the reports and certificates must bear the appropriate HKAS accreditation symbol.

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.

 

Please refer to our website for MRA/MLA Partners

 

HKAS offers accreditation service to organisations located within the Hong Kong Special Administrative Region (HKSAR) of China. For tests included in the Test Category of Construction Materials under HOKLAS, applications from laboratories located within the Pearl River Delta Region of China are also accepted. Other than these, HKAS does not accept initial application for accreditation, application for extension of scope of accreditation to cover new test categories (other than that of 'Construction Materials' if the laboratory is located within the Pearl River Delta Region) nor application for extension of scope to include new location(s) physically located outside the HKSAR.

 

HOKLAS is an accreditation scheme operated by HKAS and it is NEITHER a testing laboratory NOR a certification body. You may contact our accredited organisations to conduct the test / calibration / product certification.

 

To become an assessor of HKAS for a particular technical discipline, the person should have qualifications and experience necessary for examining, evaluating and judging the effectiveness and quality of that discipline. The person will also be requested to undergo appropriate training and pass necessary evaluations before being appointed as an assessor. HKAS Executive reserves the right to appoint and not appoint any person as an assessor. For further details on appointment of HKAS lead assessor, assessors and technical experts, please click here.

 

The composition of the current Accreditation Advisory Board is listed here. Members’ affiliations are available upon request.

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

 

When looking for a laboratory to perform a test of your interest, HKAS recommends you choose a HKAS accredited laboratory and check with it whether:

1. the test is covered in its scope of accreditation;

2. the test matches with your needs, e.g. Can the method be used for testing your sample? Can the method detect the substance at the level you want?

If the laboratory is using an accredited method to conduct the test for you, it should be able to issue a Hong Kong Laboratory Accreditation Scheme (HOKLAS) endorsed test report. It is therefore always advisable to ask for a HOKLAS endorsed test report, i.e. a report bearing the HKAS accreditation symbol.

The most up-to-date scope of accreditation of HKAS accredited laboratories and their contact details can be found on our website (https://www.itc.gov.hk/en/quality/hkas/conformity_assessment_bodies/index.html). If you have queries on whether the accredited test method used by a laboratory suits your need, please seek advice from the laboratories. You may also contact HKAS for further information regarding the scope of accreditation of a laboratory.

 

When talking about the 'accreditation' of a laboratory, many people may think that 'if a laboratory is accredited, all tests it performs must be accredited'. However, this is not always the case. Accreditation is test-specific and only refers to the specific tests listed in the scope of accreditation of the laboratory. While an accredited laboratory may offer a wide variety of testing services, it does not necessarily mean that all tests it conducts are accredited.

For those testing services provided by a laboratory that are not listed in its scope of accreditation, HKAS has not assessed them and therefore has no information on whether the laboratory is competent to perform those tests or not. It could be misleading to say that a test is performed by an accredited laboratory if such a test is outside the laboratory's scope of accreditation. You are therefore advised to be cautious when claiming the accreditation status of a laboratory for certain tests. If in doubt, please clarify with the laboratory or HKAS.

 

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

 

You can click the links below to access our internet directory for HOKLAS, Hong Kong Certification Body Accreditation Scheme (HKCAS), Hong Kong Inspection Body Accreditation Scheme (HKIAS) to find the respective up-to-date scopes. You may also download the complete scope of accreditation for HKAS accredited laboratories, HKAS accredited certification bodies and HKAS accredited inspection bodies. The file is in Acrobat format and you can use the search function provided by Acrobat to look for accredited organisations for specific activities. Please note that the downloading process may take some time due to the large file size.

 

You can access our internet directory for HKAS accredited laboratories, HKAS accredited certification bodies, HKAS accredited inspection bodies for their respective scope of accreditation by clicking the links provided above.

 

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

 

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

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

For detailed requirements governing the issue of an endorsed report or certificate, they are depicted in respective clauses of HOKLAS Supplementary Criteria No. 33 and HKIAS Supplementary Criteria No. 5.

 

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 of HKAS all over the world.

 

See clause 7 'What can clients do to secure satisfactory service from an accredited organisation?' of HKAS IN004.

 

HKAS accreditation regulations require an accredited organisation to have a policy and procedure to handle and resolve complaints. You are advised to lodge a complaint to the organisation first if you are not satisfied with the service it provided. If you are not satisfied with how the complaint is handled by the organisation, you may lodge a complaint to HKAS Executive. Alternatively, you may lodge a complaint against the organisation directly to HKAS Executive. Please refer to HKAS IN004 for further details.

 

The information can be found in HKAS IN004. Please refer to Clause 5, 'Determining whether to complain to HKAS Executive' and Clause 6, 'Procedure for complaining to HKAS Executive against an accredited organisation', for details.

 

Procuring management system certification services (e.g. certification to ISO 9001) alongside consultancy services can seriously compromise the value and credibility of the certification obtained.

To protect the credibility of certification, internationally accepted practice forbids certification bodies from linking their services with those of management system consultancy firms. However, for convenience or other reasons, some organisations still attempt to obtain both consultancy and certification services through a single contract with a consulting firm. Such arrangements raise doubts about potential collusion between the certification body and the consulting firm, undermining the credibility of any certification granted.

To safeguard the value of certification, the internationally accepted practice for certification bodies, as documented in the international standard ISO / IEC 17021-1, imposes stringent requirements on the relationship between consultancy and certification services. It requires that:

• The certification body shall not certify a management system for which a client has received management system consultancy or internal audits, if the relationship between the consultancy organisation and the certification body poses an unacceptable threat to the impartiality of the certification body (see example in Note 1), and,
• The certification body's activities shall not be marketed or offered as linked with those of an organisation providing management system consultancy.

While any organisation has complete freedom in procuring certification services, it is advisable to avoid obtaining management system consultancy and certification services together under a single contract.

Note 1:
The following is an example in which the relationship between the consultancy organisation and the certification body poses an unacceptable threat to the impartiality of the certification body.

Company A wants to obtain ISO 9001 certification for its management system. After employing Consultant M to assist it in establishing or implementing the system, it is now looking for a certification body to provide the certification service and Certification Body X is a possible candidate.

If (i) Certification Body X and Management Consultant M are the same organisation, (ii) they use the same or closely related people to provide the service to Company A, or (iii) the certification decision of Certification Body X can be influenced by Management Consultant M, such relationship may be considered as posing an unacceptable threat to the impartiality of Certification Body X. Under such circumstances, Company A should not seek certification from Certification Body X for its own benefit as the credibility of the certification will be compromised. Indeed, ISO / IEC 17021-1 forbids Certification Body X from certifying the quality management system of Company A.

 

HKAS will issue a certificate of accreditation to an organisation accredited by HKAS. A copy of all valid certificates of accreditation will be uploaded to HKAS' website for public viewing. For further inquiries regarding the validity of the certificate of accreditation of an organisation, please contact HKAS directly.

You can refer to the procedures for Hong Kong Accreditation Service (HKAS) accreditation and relevant application packages.

 

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 activities covered in the scope of accreditation applied, and the effectiveness and efficiency of the organisation in addressing any nonconformities identified during the assessment.

 

The fee schedules of HKAS are available from our website. 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 Hong Kong Laboratory Accreditation Scheme (HOKLAS), Hong Kong Certification Body Accreditation Scheme (HKCAS) and Hong Kong Inspection Body Accreditation Scheme (HKIAS) are given in HOKLAS 006 (local laboratories) and HOKLAS 013 (laboratories outside Hong Kong SAR), 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 man-day(s) required to conduct the assessment and is calculated at the rate given in the fee schedules. The number of days required for a visit will depend on the extent and complexity of the activities to be assessed. Sometimes follow-up visits or another full assessment may have to be conducted. The fees for such visits will also be calculated based on the man-day(s) required.

To maintain the accreditation, the organisation has to pay an annual subscription fee. The organisation also needs to undergo reassessments and surveillance visits regularly, and assessment fees are charged for these visits. The amount and calculation method are detailed in the fee schedules mentioned above.

There may be other fees for additional services. Details are given in the relevant schedules.

 

HKAS publications provide information on the requirements for obtaining accreditation. Further information may also be obtained from HKAS Contact US. After receiving an application for accreditation, a HKAS accreditation officer will contact the organisation to arrange for a preliminary visit to discuss matters related to HKAS accreditation.

 

For laboratory personnel, general requirements for non-medical laboratories are outlined in Section 6.2 of ISO / IEC 17025:2017, while those for medical laboratories are found in Section 6.2 of ISO 15189:2022 and HKAS Policy Document No. 2. For inspection bodies, the general personnel requirements are specified in Section 6.1 of HKIAS 003. For certification bodies, the general personnel requirements are detailed in Section 7 of ISO / IEC 17021-1:2015. Requirements for specific technical disciplines are also given in the relevant supplementary criteria.

 

Laboratories must meet the requirements detailed in Section 6.5 of ISO/IEC 17025:2017 and Section 6.5.3 of ISO 15189:2022 for non-medical and medical laboratories, respectively. For medical laboratories, the requirements are further elaborated in HKAS Policy Document No. 2. Inspection bodies should refer to Section 6.2.10 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.

 

Laboratories must meet the requirements outlined in Section 6.5 of ISO/IEC 17025:2017 and Section 6.5.3 of ISO 15189:2022 for non-medical and medical laboratories, respectively. Inspection bodies shall refer to Section 6.2 of HKIAS 003 for the metrological traceability requirements.

 

Laboratories must meet the requirements specified in Section 7.6 of ISO/IEC 17025:2017 and Section 7.3.4 of ISO 15189:2022 for non-medical and medical laboratories, respectively. Commentary on the HKAS requirements on measurement uncertainty for non-medical laboratories is detailed in Section 7.6 of HKAS Policy Document No. 1. Calibration laboratories shall also refer to HOKLAS Supplementary Criteria No. 13 for additional requirements.

 

Laboratories must meet the requirements stipulated in Section 7.2.2 of ISO / IEC 17025:2017 and Section 7.3.3 of ISO 15189:2022 for non-medical and medical laboratories respectively. Commentary on the HKAS requirements on method validation requirements for non-medical laboratories is detailed in Section 7.2 of HKAS Policy Document No. 1. Requirements for specific technical disciplines are given in the relevant supplementary criteria.

 

The requirements are stated in Clauses 3.5 to 3.11 of HOKLAS Supplementary Criteria No. 33.

 

To conform to the impartiality requirements in ISO/IEC 17011:2017, accreditation bodies, including HKAS, no longer organise proficiency testing (PT) programmes. You may search for PT providers and programmes offered in the Asia Pacific Region at the APAC PTP Search website. Information on other PT programmes is also available in the database maintained by the European information system on proficiency testing schemes (EPTIS). Please check with the relevant PT providers regarding their accreditation status before participating.

 

You can refer to the procedures for HKAS accreditation.

 

You are welcome to discuss it with HKAS Executive.

 

Every effort is made to promote acceptance of results from accredited laboratories, both internationally and locally. HKAS’ MRA partners 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 symbol. 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.

 

The requirements are stated in Section 2 of HOKLAS Supplementary Criteria No. 2

 

For the 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 in a language understandable to both the laboratory staff and HKAS assessors. The preferred method is for the laboratory to request an official English or Chinese version from the body that published the standard. If this is not possible, the laboratory shall commission a competent person to translate the document and then carefully check the translated version, sentence by sentence, using the service of another competent person.

In this context, a competent person is someone who has the required technical knowledge and translation skills 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 skills. If the standard is a statutory law or regulation, it may be necessary to obtain advice from a lawyer or a person recognised as competent to translate legal documents. A competent person may be a staff member of the laboratory or from an external organisation.

The person performing the checking should be different from the person performing the translation. If the translator is from an external organisation, the checker shall be from another organisation, unless there is convincing evidence doing both translation and checking within the same organisation 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 individuals carrying out the work and ensure that the credentials are acceptable. Using native speakers of the relevant foreign language for both translation and checking is preferred. When employing external organisations for this work, the laboratory should obtain evidence that the work has been done personally by the agreed individuals.

To HKAS Executive, the laboratory shall provide information to demonstrate the competence of the individuals who carried out the translation and checking, along with a sentence-by-sentence checking record. HKAS Executive will assess the acceptability of the competent person and review 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 request further evidence from the laboratory to demonstrate the accuracy and credibility of the translated standards.

The laboratory shall have the capability to review the translated versions of standards periodically and when changes to the original documents occur. This applies irrespective of whether the translation and checking were performed by internal staff or external parties.

All relevant accreditation criteria apply to tests performed in accordance with standards written in a foreign language. If any doubt arises regarding the accuracy of the translated version, the laboratory shall implement corrective actions. Where the standard stipulates that the product being tested must be labeled with statements written in a foreign language, the laboratory must have adequate provisions for checking the acceptability of such labels.

 

Below are some major benefits of obtaining accreditation:

Recognition of competence –

Accreditation provides formal third-party recognition to competent conformity assessment bodies. The accredited organisation is independently assessed against international standards in carrying out specific activities e.g. laboratory testing / calibration, inspection or certification.

Marketing advantage –

Accreditation facilitates acceptance of test and calibration results, inspection reports and certifications by governments, contractors, procurers and consumers who want independently verified service providers. Accreditation in turn promotes corporate images and aids the sustainability of business of competent conformity assessment bodies.

International acceptance –

Through the various multilateral mutual recognition arrangements among accreditation bodies worldwide, overseas markets are more ready to accept HOKLAS endorsed test and calibration results, HKIAS accredited inspection reports and HKCAS accredited certifications. This cross-border recognition mechanism reduces the need for repetition of testing, calibration, certification and inspection in the importing economies and thereby facilitating trade.

 

HKAS information notes are informative documents. Normally, they only provide guidance to applicant or accredited organisations on specific topics. HKAS information notes are neither intended nor appropriate for accreditation purpose.

 

According to ISO/IEC 17011, a remote assessment is defined as an assessment of the physical location or virtual site of a conformity assessment body using electronic means. A virtual site is an online environment allowing persons to execute processes, e.g. in a cloud environment.

HKAS carried out remote assessments as a temporary measure during the outbreak of COVID-19 when travel restrictions and social distancing measures were imposed. Under normal circumstances, HKAS does not conduct remote assessments.