FAQ / Information

Hong Kong Accreditation Service (HKAS) is part of Innovation and Technology Commission of the Hong Kong Special Administrative 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 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 MRA are nationally recognized accreditation bodies and are usually owned or endorsed by government.

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 of Singapore.

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.

On 1 January 2019, the Asia Pacific Laboratory Accreditation Cooperation (APLAC) and the Pacific Accreditation Cooperation (PAC) combine to form a new single regional accreditation body cooperation called the Asia Pacific Accreditation Cooperation (APAC).

Previous members of APLAC or PAC, including HKAS, have been transferred to the relevant membership category of APAC, and previous mutual recognition status within APLAC and PAC has been transferred to the APAC Mutual Recognition Arrangement (MRA).

HKAS was 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 https://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.

The APAC MRA was recognised by the International Accreditation Forum (IAF) and the International Laboratory Accreditation Cooperation (ILAC). This means conformity assessment bodies (for example certification bodies, inspection bodies and laboratories) accredited by HKAS or other accreditation bodies that were signatories to the APLAC MRA or PAC MLA, have retained their international recognition through the APAC MRA from 2019 onwards without interruption and change.

Further information about APAC is available on the website: https://www.apac-accreditation.org

 

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

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.

 

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.

 

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 will 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 the Hong Kong Accreditation Service (HKAS) and is NOT a testing laboratory. You may contact our accredited laboratories to conduct the test / calibration.

 

From year 2003 onwards, HKAS no longer publishes printed HOKLAS / HKCAS / HKIAS directory. Instead, the directory is available for download from our webpages for HOKLAS, HKCAS, HKIAS. The internet directory contains up-to-date scopes of HKAS accredited organisations.

 

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 Executive. Alternatively, you may lodge a complaint against the organisation directly to HKAS Executive.

 

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.

 

The information about the related bodies of HKAS, such as Standards and Calibration Laboratory (SCL) and Hong Kong Council for Testing and Certification (HKCTC), is available at the following websites, https://www.itc.gov.hk/en/quality/scl/index.html (SCL) and https://www.hkctc.gov.hk/en/home/index.html (HKCTC).

 

The composition of the current Accreditation Advisory Board, including the names and affiliations of the Chairman and members, is 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 HOKLAS 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 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 HOKLAS 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 consult the laboratory for clarification. You may also contact HKAS for further information regarding the scope of accreditation of a laboratory.

For more information on accredited services and HOKLAS endorsed test report, please visit our 'Frequently Asked Questions': https://www.itc.gov.hk/en/quality/hkas/faq.html.

 

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. 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 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.

 

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 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 for searching accredited organisations for a specific activity. The downloading process may take some time because of 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 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.

 

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.

 

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 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 Clause 5 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 all over the world.

 

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

 

See clause 5 'Determining whether to complain to HKAS Executive' and clause 6 'Procedure for complaining to HKAS Executive against an accredited organisation' of HKAS IN004

 

Procuring management system certification service (e.g. certification to ISO 9001) together with consultancy service will seriously compromise the value and credibility of the certification so obtained.

To protect the credibility of certification, the international accepted practice forbids certification bodies from providing its service as being linked with the service of a management system consultant firm. However, for convenience or other reasons, some organisations are still trying to obtain both consultancy service and certification service through a single contract concluded with a consultant firm. Such an arrangement will raise a doubt that the certification body may be colluding with the consultant firm and will therefore undermine the acceptability of any certification granted under it.

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

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

While any organisation has complete freedom in the way they procure certification service, procuring management system consultancy service and certification services together under a single contract should be avoided.

Note 1:
The following is an example where the relationship between the consultancy organization 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 forbids Certification Body X from certifying the quality management system of Company A.

 

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

You can refer to the procedures for 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.

 

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.

 

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

 

For laboratory personnel, general requirements are given in Section 6.2 of ISO / IEC 17025 (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 7 of ISO / IEC 17021. Specific requirements for specific technical disciplines are given in the relevant supplementary criteria.

 

Laboratories shall meet the requirements stipulated in Section 6.5 of ISO / IEC 17025 and Section 5.3 of HOKLAS 015 for non-medical and medical laboratories respectively. 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.

 

Laboratories shall meet the requirements stipulated in Section 6.5 of ISO / IEC 17025 and Section 5.3 of HOKLAS 015 for non-medical and medical laboratories respectively. Inspection bodies shall refer to Chapter 9 of HKIAS 003 for the metrological traceability requirements.

 

Laboratories shall meet the requirements stipulated in Section 7.6 of ISO / IEC 17025 and Section 5.5.1 of HOKLAS 015 for non-medical and medical laboratories respectively. Commentary on the HKAS requirements on measurement uncertainty for non-medical laboratories is given 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 shall meet the requirements stipulated in Section 7.2.2 of ISO / IEC 17025 and Section 5.5.1 of HOKLAS 015 for non-medical and medical laboratories respectively. Commentary on the HKAS requirements on method validation requirements for non-medical laboratories is given in Section 7.2 of HKAS Policy Document No. 1.

 

The requirements are stated in Clauses 3.6 to 3.9 of HOKLAS Supplementary Criteria No. 33. These clauses are reproduced below:

An applicant laboratory shall have taken part in appropriate proficiency testing activity(ies), representative of each test area of the laboratory's scope of accreditation to demonstrate its competence in each test area, and obtain satisfactory result before initial accreditation or accreditation extended to a new test area will be granted.

The laboratory shall establish a 1-year PT participation plan. The coverage of the plan shall be representative and adequate to demonstrate the laboratory's competence in performing tests under its scope of accreditation. Where suitable PT programme does not exist or is not practical, suitable alternative means aiming to demonstrate the laboratory's competence shall be included in the plan. The plan shall be regularly reviewed and updated where necessary (for example, in response to changes of the scope of accreditation, staffing, methodology, instrumentation, and other factors that may affect the quality of the laboratory's test or calibration results). Any change to the plan shall be documented and justified. When the laboratory updates its PT plan, it shall ensure its continual suitability in relation to its scope of accreditation.

Records of PT participation for the past four years shall be available to show that the laboratory participated in PT activities representative of the accredited tests / calibration activities under each test area of its scope of accreditation. PT activities participated to represent a group of tests in a test area are expected to vary in subsequent cycles. It should be noted that the necessary level of participation in PT for certain technical disciplines may be specifically defined in the relevant HOKLAS Supplementary Criteria. Where defined, the laboratory shall ensure that the planned participation fulfils the respective PT requirements as stated in the relevant supplementary criteria. Where more stringent PT requirements are stipulated in the relevant supplementary criteria, the more stringent requirements shall be followed.

An assessment team shall determine the adequacy of the PT participation plan and the appropriateness of any PT activities and may, at its discretion, require the laboratory to participate in other forms of PT 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 PT activity because it fails to identify a suitable PT programme, it shall demonstrate to the satisfaction of the assessment team that it has taken all reasonable steps to identify such PT programme and any justification to use alternative suitable means shall be documented. In this clause, PT activity includes any international, regional and national interlaboratory comparisons as well as measurement audits and check samples acceptable to 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.

 

You can refer to the procedures for HKAS accreditation.

 

You are welcome to discuss it with HKAS Contact-Us.

 

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 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.

 

HKAS Accreditation Criteria for Medical Laboratories are in accordance with ISO 15189:2012 "Medical laboratories - 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 "General Requirements for the competence of testing and calibration laboratories".

 

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

• The Government of the HKSAR Standards and Calibration Laboratory;
• National metrology institutes as referenced in HOKLAS Supplementary Criteria No. 2;
• Laboratories accredited by HOKLAS for the specific calibration services provided that the calibration results are reported in HOKLAS endorsed calibration certificates;
• Calibration laboratories accredited by MRA Partners of HOKLAS for the relevant calibration, provided that the calibration results are reported in endorsed calibration 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

 

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.

 

The accreditation symbols for HKAS accreditation programmes have been revised. For each programme, an identification code is added to the symbol. Organisations accredited for more than one programme under the same accreditation scheme may also use combined accreditation symbols. Criteria for using the new symbols are given in the revised HKAS Supplementary Criteria No. 1. Existing documents including letterheads or promotional leaflets / brochures of accredited organisations bearing the old designs of HKAS accreditation symbols may continue to be used until 1 November 2012. The new symbols have to be used for all new documents starting from 1 November 2010. Accredited organisations sublicensed to use the ILAC Laboratory Combined MRA Mark and / or the IAF Combined MLA Mark are required to use the new symbols in the combined marks.

 

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.

 

In view of the outbreak of COVID-19 and travel restrictions all over the world, HKAS could not carry out some planned on-site assessments of its accredited conformity assessment bodies (CABs), especially those outside Hong Kong. Under such circumstances, HKAS may conduct the assessments remotely by using information and communication technology [“remote assessment”]. Since “remote assessment” has its limitations, remote assessment of a CAB should be considered as a temporary measures adopted by HKAS to monitor the performance of its accredited CABs.

 

“Remote assessment” is only applicable to the assessment of an accredited conformity assessment body for the following purposes:

• surveillance,
• reassessment,
• extending the conformity assessment body’s scope of accreditation which does not have significant technical change,
• signatory interview, or
• transition to ISO/IEC 17025: 2017.

 

1. For a conformity assessment body (CAB) which does not have any permanent premises in Hong Kong, the HKAS assessment team should conduct the remote assessment in HKAS office.
2. For a CAB which has an office in Hong Kong, the HKAS assessment team may conduct the remote assessment at such office covering certain conformity assessment activities of the CAB such as testing, calibration, inspection or auditing performed outside Hong Kong. In case such office is not suitable for conducting the remote assessment, for example, no secure or reliable internet connection, (i) should be followed.
3. If a CAB is performing conformity assessment activities at a high-risk location, for example, a hospital during the pandemic situation, (i) should be followed.
4. When it is necessary to include an overseas technical assessor/expert in the HKAS assessment team the overseas assessor should be invited to conduct the remote assessment at his/her location.

For (i), (iii) and (iv), the CAB should acknowledge its understanding of the risks associated with the remote assessment using information and communication technology and also participate in a “trial meeting” with the HKAS assessment team before HKAS confirms the arrangement for the remote assessment.

 

The team leader of the HKAS assessment team should discuss and agree with the conformity assessment bodies the type of Information and Communication Technology (ICT) to be adopted for conducting the remote assessment well before the start of the remote assessment. Examples of ICT include:

• A video conferencing system which facilitates:
  1. discussion between the HKAS assessment team and the CAB, and/or
  2. witnessing of conformity assessment activities carried out by the CAB;
• Remote access of CAB’s documents and records;
• Transmission of information and evidence in the form of photo, video and/or audio records through email or other secure means.

 

If the CAB cannot provide a secure and reliable internet connection for video conferencing, the HKAS assessment team may choose other means (e.g. teleconferencing) to conduct the remote assessment.

 

The assessment fee schedule for a remote assessment is the same as that for an on-site assessment. The conformity assessment body is required to pay an assessment fee in accordance with an appropriate fee schedule (i.e. HOKLAS 006 / HOKLAS 013 / HKIAS 006 / HKCAS 006).

 

The CAB should have appropriate resources to facilitate the HKAS assessment team to conduct the remote assessment. These may include:

1. a secure internet connection with adequate bandwidth;
2. provision for remote access to documents and records kept at the CAB’s data processing and management system, if applicable;
3. computer system together with full HD stream webcam, headphone and microphone, etc.;
4. audio/visual equipment which facilitates witnessing the CAB’s conformity assessment activities, if applicable.

 

CABs are not allowed to record any parts of the remote assessment process, including the related discussions, through the video or teleconferencing system unless prior approval is obtained from HKAS.

 

A remote assessment follows essentially the same process as for an on-site assessment, except that it is conducted remotely. For example, the assessment will include opening meeting, interviewing of conformity assessment bodies (CAB)’s staff, record and document review and other activities for confirming competence of the CAB. As in an on-site assessment, assessment findings will be consolidated in an assessment report and presented to the CAB’s management during the closing meeting. The assessment report will also indicate the extent to which Information and Communication Technology (ICT) has been used in conducting the assessment and the effectiveness of ICT in achieving the assessment objectives. Any outstanding items that cannot be successfully covered in the remote assessment will also be recorded in the assessment report. After completion of the assessment, the team leader will send the signed assessment report to the CAB.