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HOKLAS 007 Annex II

Management System Checklist

The laboratory shall complete the following checklist, which will be used for the assessment of the laboratory’s conformity with HKAS and HOKLAS accreditation requirements.

The checklist consists of questions based on the requirements of HKAS 002, HKAS Supplementary Criteria No. 6, HOKLAS Supplementary Criteria No. 33 and HOKLAS 003. For further information, please refer to the corresponding document and clause as listed in the second column.

The laboratory shall indicate in the ‘QM Clause’ column, for every question, the clause(s) in its quality manual, operation procedures manual or other related document which can demonstrate the laboratory’s conformity with the requirement.

The columns headed ‘*’ and ‘OK’ are for internal use of HKAS Executive.

A softcopy of this completed checklist shall be provided to HKAS Executive by email or other means.

HOKLAS 007 Annex II (Mar 2017) 1 of 55


HOKLAS Requirements Clause * OK QM Clause Remarks / Questions to be asked at laboratory

Management requirements

OrganisationIs your laboratory or the organisation of which it is part an entity that can be held legally responsible?

003 4.1.1

Is it the responsibility of your laboratory to carry out its testing and calibration activities in such a way as to meet the requirements of HOKLAS 003 and to satisfy the needs of the customer, the regulatory authorities or organisations providing recognition?

003 4.1.2

Does your management system cover work carried out in the laboratory’s permanent facilities, at sites away from your permanent facilities, or in associated temporary or mobile facilities?

003 4.1.3

If your laboratory is part of an organisation performing activities other than testing and/or calibration, are the responsibilities of key personnel in the organisation that have an involvement or influence on the testing and/or calibration activities of your laboratory defined in order to identify potential conflicts of interest?

003 4.1.4

Does your laboratory

- have managerial and technical personnel who, irrespective of other responsibilities, have the authority and resources needed to carry out their duties, including the implementation, maintenance and improvement of the management system, and to identify the occurrence of departures from the management system or from the procedures for performing tests and/or calibrations, and to initiate actions to prevent or minimise such departures?

003 4.1.5a

- have arrangements to ensure that its management and personnel are free from any undue internal and external commercial, financial and other pressures and influences that may adversely affect the quality of their work?

003 4.1.5b

- have policies and procedures to ensure the protection of its customers’ confidential information and proprietary rights, including procedures for protecting the electronic storage and transmission of results?

003 4.1.5c

Assessors for technical operation should concentrate on items marked with a ●; other items will be checked by the assessor for management system operation or the assessment team leader.HOKLAS 007 Annex II (Mar 2017) 2 of 55



Management requirements (continued)

Organisation (Cont’d)Does your laboratory

- have policies and procedures to avoid involvement in any activities that would diminish confidence in your competence, impartiality, judgment or operational integrity?

003 4.1.5d

- define your organisation and management structure, your place in any parent organisation, and the relationships between quality management, technical operations and support services?

003 4.1.5e

- specify the responsibility, authority and interrelationships of all personnel who manage, perform or verify work affecting the quality of the tests and/or calibrations?

003 4.1.5f

- provide adequate supervision of testing and calibration staff, including trainees, by persons familiar with methods and procedures, purpose of each test and/or calibration, and with the assessment of the test or calibration results?

003 4.1.5g

- have technical management which has overall responsibility for the technical operations and the provision of the resources needed to ensure the required quality of laboratory operations?

003 4.1.5h

- appoint a member of staff as quality manager (however named) who, irrespective of other duties and responsibilities, has defined responsibility and authority for ensuring that the management system is implemented and followed at all times; and has direct access to the highest level of management at which decisions are made on laboratory policy or resources?

003 4.1.5i

- appoint deputies for key managerial personnel? 003 4.1.5j

- ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the objectives of the management system?

003 4.1.5k





Organisation (Cont’d)

Do the top management ensure that appropriate communication processes are established within the laboratory and that communication takes place regarding the effectiveness of the management system?

003 4.1.6

Management System

Has your laboratory established, implemented and maintained a management system appropriate to the scope of its activities?

003 4.2.1

Has your laboratory documented its policies, systems, programmes, procedures and instructions to the extent necessary to assure the quality of the test and/or calibration results?

003 4.2.1

Is the system’s documentation communicated to, understood by, available to, and implemented by the appropriate personnel?

003 4.2.1

Are your laboratory’s management system policies related to quality, including a quality policy statement defined in a quality manual (however named)?

003 4.2.2

Are the overall objectives established and reviewed during management review? 003 4.2.2

Is the quality policy statement issued under the authority of the top management? 003 4.2.2

Does the quality policy statement include at least the following:

- the laboratory management’s commitment to good professional practice and to the quality of its testing and calibration in servicing its customers?

003 4.2.2a

- the management’s statement of the laboratory’s standard of service? 003 4.2.2b

- the purposes of the management system related to quality? 003 4.2.2c





Management System (Cont’d)

Does the quality policy statement include at least the following: (cont’d)

- a requirement that all personnel concerned with testing and calibration activities within the laboratory familiarise themselves with the quality documentation and implement the policies and procedures in their work?

003 4.2.2d

- the laboratory management’s commitment to comply with HOKLAS 003 and to continually improve the effectiveness of the management system?

003 4.2.2e

Does the quality manual include or make reference to the supporting procedures including technical procedures?

003 4.2.3

Do the top management provide evidence of commitment to the development and implementation of the management system and to continually improving its effectiveness?

003 4.2.3

Do the top management communicate to the organisation the importance of meeting customer requirements as well as statutory and regulatory requirements?

003 4.2.4

Does the quality manual outline the structure of the documentation used in the management system?

003 4.2.5

Are the roles and responsibilities of technical management and the quality manager, including their responsibility for ensuring compliance with HOKLAS 003, defined in the quality manual?

003 4.2.6

Do the top management ensure that the integrity of the management system is maintained when changes to the management system are planned and implemented?

003 4.2.7





Document Control

General

Has your laboratory established and maintained procedures to control all documents that form part of its management system (internally generated and from external sources), such as regulations, standards, other normative documents, test and/or calibration methods, as well as drawings, software, specifications, instructions and manuals?

003 4.3.1

Document approval and issue

Are all documents issued to personnel in the laboratory as part of the management system reviewed and approved for use by authorised personnel prior to issue?

003 4.3.2.1

Is a master list or an equivalent document control procedure identifying the current revision status and distribution of documents in the management system established and readily available to preclude the use of invalid and/or obsolete documents?

003 4.3.2.1

Does the procedure adopted ensure that:

- authorised editions of appropriate documents are available at all locations where operations essential to the effective functioning of the laboratory are performed?

0034.3.2.2a

- documents are periodically reviewed and, where necessary, revised to ensure continuing suitability and compliance with applicable requirements?

0034.3.2.2b

Does the procedure adopted ensure that:

- invalid or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use?

0034.3.2.2c

- obsolete documents retained for either legal or knowledge preservation purposes are suitably marked?

0034.3.2.2d





Document approval and issue (Cont’d)

Are management system documents generated by the laboratory uniquely identified?

003 4.3.2.3

Does such identification include the date of issue and/or revision identification, page numbering, the total number of pages or a mark to signify the end of the document, and the issuing authority(ies)?

003 4.3.2.3

Document changes

Are changes to documents reviewed and approved by the same function that performed the original review unless specifically designated otherwise?

003 4.3.3.1

Do the designated personnel have access to pertinent background information upon which to base their review and approval?

003 4.3.3.1

Where practicable, are the altered or new text identified in the document or the appropriate attachments?

003 4.3.2.2

If your laboratory’s documentation control system allows for the amendment of documents by hand pending the re-issue of the documents, are the procedures and authorities for such amendments defined?

003 4.3.2.3

Is a revised document formally re-issued as soon as practicable? 003 4.3.2.3

Have procedures been established to describe how changes in documents maintained in computerised systems are made and controlled?

003 4.3.2.4

Review of requests, tenders and contracts

Has your laboratory established and maintained procedures for the review of requests, tenders or contracts?

003 4.4.1





Review of requests, tenders and contracts (Cont’d)

Do the policies and procedures for these reviews leading to a contract for testing and/or calibration ensure that:

- the requirements, including the methods to be used, are adequately defined, documented and understood (see 5.4.2 of HOKLAS 003)?

003 4.4.1a ●

- the laboratory has the capability and resources to meet the requirements? 003 4.4.1b ●

- the appropriate test and/or calibration method is selected and capable of meeting the customers’ requirements (see 5.4.2 of HOKLAS 003)?

003 4.4.1c ●

Are, if any, differences between the request or tender and the contract resolved before any work commences?

003 4.4.1

Is each contract acceptable both to the laboratory and the customer? 003 4.4.1

Are records of reviews, including any significant changes, maintained? 003 4.4.2

Are records also maintained of pertinent discussions with a customer relating to the customer’s requirements or the results of the work during the period of execution of the contract?

003 4.4.2

Does the review also cover any work that is subcontracted by the laboratory? 003 4.4.3

Is the customer informed of any deviation from the contract? 003 4.4.4

If a contract needs to be amended after work has commenced, is the same contract review process repeated and are, if any, amendments communicated to all affected personnel?

003 4.4.5





Subcontracting of tests and calibrationsWhen your laboratory subcontracts work whether because of unforeseen reasons (e.g. workload, need for further expertise or temporary incapacity) or on a continuing basis (e.g. through permanent subcontracting, agency or franchising arrangements), is this work placed with a competent subcontractor?

003 4.5.1

Does your laboratory advise the customer of the arrangement in writing and, when appropriate, gain the approval of the customer, preferably in writing?

003 4.5.2

Is your laboratory responsible to the customer for the subcontractor’s work, except in the case where the customer or a regulatory authority that specifies which subcontractor is to be used?

003 4.5.3

Does your laboratory maintain a register of all subcontractors that it uses for tests and/or calibrations and a record of the evidence of compliance with HOKLAS 003 for the work in question?

003 4.5.4

Purchasing services and suppliesDoes your laboratory have a policy and procedure(s) for the selection and purchasing of services and supplies it uses that affect the quality of the tests and/or calibrations?

003 4.6.1

Do procedures exist for the purchase, reception and storage of reagents and laboratory consumable materials relevant for the tests and calibrations?

003 4.6.1

Does your laboratory ensure that purchased supplies and reagents and consumable materials that affect the quality of tests and/or calibrations are not used until they have been inspected or otherwise verified as complying with standard specifications or requirements defined in the methods for the tests and/or calibrations concerned?

003 4.6.2 ●

Do these services and supplies used comply with specified requirements? 003 4.6.2

Are records of actions taken to check compliance maintained? 003 4.6.2





Purchasing services and supplies (Cont’d)Do purchasing documents, for items affecting the quality of laboratory output contain data describing the services and supplies ordered?

003 4.6.3

Are purchasing documents reviewed and approved for technical content prior to release?

003 4.6.3

Does your laboratory evaluate suppliers of critical consumables, supplies and services which affect the quality of testing and calibration, and maintain records of these evaluations and list those approved?

003 4.6.4

Service to the customerDoes your laboratory afford customers or their representatives’ cooperation to clarify the customer’s request and to monitor your laboratory’s performance in relation to the work performed and ensure confidentiality to other customers?

003 4.7.1

Does your laboratory seek feedback, both positive and negative, from its customers? Are the feedback used and analysed to improve the management system, testing and calibration activities and customer service?

003 4.7.2

ComplaintsDoes your laboratory have a policy and procedure for the resolution of complaints received from customers or other parties?

003 4.8

Are records maintained of all complaints and of the investigations and corrective actions taken by the laboratory?

003 4.8

Control of nonconforming testing and/or calibration workDoes your laboratory have a policy and procedures that shall be implemented when any aspect of its testing and/or calibration work, or the results of this work, do not conform to your own procedures or the agreed requirements of the customer?

003 4.9





Control of nonconforming testing and/or calibration work (Cont’d)

Do the policy and procedures ensure that - responsibilities and authorities for the management of nonconforming work are

designated and actions (including halting of work and withholding of test reports and calibration certificates, as necessary) are defined and taken when nonconforming work is identified?

003 4.9.1a

- an evaluation of the significance of the nonconforming work is made? 003 4.9.1b ●

- correction is taken immediately, together with any decision about the acceptability of the nonconforming work?

003 4.9.1c ●

- where necessary, the customers are notified and work is recalled? 003 4.9.1d -

- the responsibility for authorising the resumption of work is defined ? 003 4.9.1e

Where the evaluation indicates that the nonconforming work could recur or that there is doubt about the compliance of the laboratory’s operations with its own policies and procedures, are the corrective action procedures given in 4.11 of HOKLAS 003 promptly followed?

003 4.9.2

ImprovementDoes your laboratory continually improve the effectiveness of its management system through the use of quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review?

003 4.10

Corrective actionHas your laboratory established a policy and procedure and designated appropriate authorities for implementing corrective action when nonconforming work or departures from the policies and procedures in the management system or technical operations have been identified?

003 4.11.1 ●




Management requirements (continued)Corrective action (Cont’d)

Does the procedure for corrective action start with an investigation to determine the root cause(s) of the problem?

003 4.11.2 ●

Where corrective action is needed, does your laboratory identify potential corrective actions?

003 4.11.3 ●

Does your laboratory select and implement the action(s) most likely to eliminate the problem and to prevent recurrence?

003 4.11.3 ●

Are corrective actions to a degree appropriate to the magnitude and the risk of the problem?

003 4.11.3 ●

Does your laboratory document and implement any required changes resulting from corrective action investigations?

003 4.11.3 ●

Does your laboratory monitor the results to ensure that the corrective actions taken have been effective?

003 4.11.4 ●

Where the identification of nonconformities or departures casts doubts on your laboratory’s compliance with its own policies and procedures, or on its compliance with this document, does your laboratory ensure that the appropriate areas of activity are audited in accordance with 4.14 of HOKLAS 003 as soon as possible?

003 4.11.5

Preventive actionAre needed improvement and potential sources of nonconformities, either technical or concerning the management system, identified?

003 4.12.1 ●

When improvement opportunities are identified or if preventive action is required, are action plans developed, implemented and monitored to reduce the likelihood of the occurrence of such nonconformities and to take advantage of the opportunities for improvement?

003 4.12.1

Do procedures for preventive actions include the initiation of such actions and application of controls to ensure that they are effective?

003 4.12.2





Control of recordsHas your laboratory established and maintained procedures for identification, collection, indexing, access, filing, storage, maintenance and disposal of quality and technical records?

003 4.13.1

Do quality records include reports from internal audits and management reviews as well as records of corrective and preventive actions?

0034.13.1.1

Are all records legible and stored and retained in such a way that they are readily retrievable in facilities that provide a suitable environment to prevent damage or deterioration and to prevent loss?

0034.13.1.2

Have retention times of records been established? 0034.13.1.2

Are all records held secure and in confidence? 0034.13.1.3

Does your laboratory have procedures to protect and back-up records stored electronically and to prevent unauthorised access to or amendment of these records?

0034.13.1.4

Does your laboratory retain records of original observations, derived data and sufficient information to establish an audit trail, calibration records, staff records and a copy of each test report or calibration certificate issued, for a defined period?

0034.13.2.1

●

Do the records for each test or calibration contain sufficient information to facilitate, if possible, identification of factors affecting the uncertainty and to enable the test or calibration to be repeated under conditions as close as possible to the original?

0034.13.2.1

●

Do the records include the identity of personnel responsible for the sampling, performance of each test and/or calibration and checking of results?

0034.13.2.1

Are observations, data and calculations recorded at the time they are made and identifiable to the specific task?

0034.13.2.2





Control of records (Cont’d)When mistakes occur in records, is each mistake crossed out, not erased, made illegible or deleted, and the correct value entered alongside?

0034.13.2.3

Are all such alterations to records signed or initialled by the person making the correction?

0034.13.2.3

In the case of records stored electronically, are equivalent measures taken to avoid loss or change of original data?

0034.13.2.3

Internal auditsDoes your laboratory periodically, and in accordance with a predetermined schedule and procedure, conduct internal audits of its activities to verify that its operations continue to comply with the requirements of the management system and HOKLAS 003?

003 4.14.1

Does the internal audit programme address all elements of the management system, including the testing and/or calibration activities?

003 4.14.1

Is it the responsibility of the quality manager to plan and organise audits as required by the schedule and requested by management?

003 4.14.1

Are such audits carried out by trained and qualified personnel who are, wherever resources permit, independent of the activity to be audited?

003 4.14.1

When audit findings cast doubt on the effectiveness of the operations or on the correctness or validity of the laboratory’s test or calibration results, does your laboratory take timely corrective action, and notify customers in writing if investigations show that the laboratory results may have been affected?

003 4.14.2

Are the area of activity audited, the audit findings and corrective actions that arise from them recorded?

003 4.14.3

Do follow-up audit activities verify and record the implementation and effectiveness of the corrective action taken?

003 4.14.4





Management reviewsDoes your laboratory’s top management, in accordance with a predetermined schedule and procedure, periodically conduct a review of your laboratory’s management system and testing and/or calibration activities to ensure their continuing suitability and effectiveness, and to introduce necessary changes or improvements?

003 4.15.1

Does the review take account of:

- the suitability of policies and procedure? 003 4.15.1

- reports from managerial and supervisory personnel? 003 4.15.1

- the outcome of recent internal audits? 003 4.15.1

- corrective and preventive actions? 003 4.15.1

- the results of interlaboratory comparisons or proficiency tests? 003 4.15.1

- changes in the volume and type of the work? 003 4.15.1

- customer’s feedback? 003 4.15.1

- complaints? 003 4.15.1

- recommendations for improvement? 003 4.15.1

- other relevant factors, such as quality control activities, resources and staff training?

003 4.15.1

Are findings from management reviews and the actions that arise from them recorded?

003 4.15.2

Does the management ensure that those actions are carried out within an appropriate and agreed timescale?

003 4.15.2




Technical requirements

GeneralMany factors determine the correctness and reliability of the tests and/or calibrations performed by a laboratory. These factors include contributions from:

- human factors (5.2)- accommodation and environmental conditions (5.3)- test and calibration methods and method validation (5.4)- equipment (5.5),- measurement traceability (5.6)- sampling (5.7),- the handling of test and calibration items (5.8)

003 5.1.1

Does your laboratory take account of these factors in developing test and calibration methods and procedures, in the training and qualification of personnel, and in the selection and calibration of the equipment it uses?

003 5.1.2 ●

PersonnelDoes your laboratory management ensure the competence of all who operate specific equipment, perform tests and/or calibrations, evaluate results and sign test reports and calibration certificates?

003 5.2.1 ●

When using staff who are undergoing training, is appropriate supervision provided?

003 5.2.1 ●

Are personnel performing specific tasks qualified on the basis of appropriate education, training, experience and/or demonstrated skills, as required?

003 5.2.1 ●

Has the management of your laboratory formulated the goals with respect to the education, training and the skills of the laboratory personnel?

003 5.2.2 ●

Does your laboratory have a policy and procedures for identifying training needs and providing training of personnel?

003 5.2.2 ●




Technical requirements (continued)

Personnel (Cont’d)Is the training programme relevant to present and anticipated tasks of the laboratory?

003 5.2.2 ●

Is the effectiveness of the training actions taken evaluated? 003 5.2.2 ●

Does your laboratory use only personnel who are employed by, or under contract to, your laboratory?

003 5.2.3

Where contracted and additional technical and key support personnel are used, does your laboratory ensure that such personnel are supervised and competent and that they work in accordance with your laboratory’s management system?

003 5.2.3 ●

Does your laboratory maintain current job descriptions for managerial, technical and key support personnel involved in tests and/or calibrations?

003 5.2.4

Does your laboratory management authorise specific personnel to perform particular types of sampling, test and/or calibration, to issue test reports and calibration certificates, to give opinions and interpretations and to operate particular types of equipment?

003 5.2.5

Does your laboratory maintain records of the relevant authorisation(s), competence, educational and professional qualifications, training, skills and experience of all technical personnel, including contracted personnel?

003 5.2.5

Is this information readily available and does it include the date on which authorisation and/or competence is confirmed?

003 5.2.5

Accommodation and environmental conditionsDo your laboratory facilities for testing and/or calibration, including but not limited to energy sources, lighting and environmental conditions, facilitate correct performance of tests and/or calibrations?

003 5.3.1 ●





Accommodation and environmental conditions (Cont’d)Does your laboratory ensure that the environmental conditions do not invalidate the results or adversely affect the required quality of any measurement?

003 5.3.1 ●

Is particular care taken when sampling and tests and/or calibrations are undertaken at sites other than a permanent laboratory facility?

003 5.3.1 ●

Are the technical requirements for accommodation and environmental conditions that can affect the results of tests and calibrations documented?

003 5.3.1 ●

Does your laboratory monitor, control and record environmental conditions as required by relevant specifications, methods and procedures or where they influence the quality of the results?

003 5.3.2 ●

Is due attention paid, for example, to biological sterility, dust, electromagnetic disturbances, radiation, humidity, electrical supply, temperature, and sound and vibration levels, as appropriate to the technical activities concerned?

003 5.3.2 ●

Are tests and calibrations stopped when the environmental conditions jeopardise the results of the tests and/or calibrations?

003 5.3.2 ●

Are there effective separations between neighbouring areas in which there are incompatible activities?

003 5.3.3 ●

Are measures taken to prevent cross-contamination? 003 5.3.3 ●

Are access to and use of areas affecting the quality of the tests and/or calibrations controlled?

003 5.3.4 ●

Does your laboratory determine the extent of control based on its particular circumstances?

003 5.3.4 ●

Are measures taken to ensure good housekeeping in the laboratory? 003 5.3.5 ●

Are special procedures prepared where necessary? 003 5.3.5 ●





Test and calibration methods and method validation

GeneralDoes your laboratory use appropriate methods and procedures for all tests and/or calibrations within its scope, including sampling, handling, transport, storage and preparation of items to be tested and/or calibrated, and, where appropriate, an estimation of the measurement uncertainty as well as statistical techniques for analysis of test and/or calibration data?

003 5.4.1 ●

Does your laboratory have instructions on the use and operation of all relevant equipment, and on the handling and preparation of items for testing and/or calibration, or both, where the absence of such instructions could jeopardise the results of tests and/or calibrations?

003 5.4.1 ●

Are all instructions, standards, manuals and reference data relevant to the work of the laboratory kept up to date and made readily available to personnel (see 4.3 of HOKLAS 003)?

003 5.4.1 ●

Does deviation from test and calibration methods occur only if the deviation has been documented, technically justified, authorised, and accepted by the customer?

003 5.4.1 ●

Selection of methodsDoes your laboratory use test and/or calibration methods, including methods for sampling, which meet the needs of the customer and which are appropriate for the tests and/or calibrations it undertakes?

003 5.4.2 ●

Are methods published in international, regional or national standards preferably used?

003 5.4.2 ●

Does your laboratory ensure that it uses the latest valid edition of a standard unless it is not appropriate or possible to do so?

003 5.4.2 ●

When necessary, is the standard supplemented with additional details to ensure consistent application?

003 5.4.2 ●





Selection of methods (Cont’d)When the customer does not specify the method to be used, does your laboratory select appropriate methods that have been published either in international, regional or national standards, or by reputable technical organisations, or in relevant scientific texts or journals, or as specified by the manufacturer of the equipment?

003 5.4.2 ●

Are laboratory-developed methods or methods adopted by the laboratory used only if they are appropriate for the intended use and only if they are validated?

003 5.4.2 ●

Is the customer informed as to the method chosen? 003 5.4.2

Does your laboratory confirm that it can properly operate standard methods before introducing the tests or calibrations?

003 5.4.2 ●

If the standard method changes, is the confirmation repeated? 003 5.4.2 ●

Does your laboratory inform the customer when the method proposed by the customer is considered to be inappropriate or out of date?

003 5.4.2

Laboratory-developed methodsIs the introduction of test and calibration methods developed by the laboratory for its own use a planned activity and assigned to qualified personnel equipped with adequate resources?

003 5.4.3 ●

Are plans updated as development proceeds and effective communication amongst all personnel involved ensured?

003 5.4.3 ●

Non-standard methodsWhen it is necessary to employ methods not covered by standard methods, are these subject to agreement with the customer and do they include a clear specification of the customer’s requirements and the purpose of the test and/or calibration?

003 5.4.4





Non-standard methods (Cont’d)Has the method developed been validated appropriately before use? 003 5.4.4 ●

Validation of methodsDoes your laboratory validate non-standard methods, laboratory-designed/ developed methods, standard methods used outside their intended scope, and amplifications and modifications of standard methods to confirm that the methods are fit for the intended use?

003 5.4.5.2 ●

Is the validation as extensive as is necessary to meet the needs of the given application or field of application?

003 5.4.5.2 ●

Does your laboratory record the results obtained, the procedure used for the validation, and a statement as to whether the method is fit for the intended use?

003 5.4.5.2 ●

Are the range and accuracy of the values obtainable from validated methods (e.g. the uncertainty of the results, detection limit, selectivity of the method, linearity, limit of repeatability and/or reproducibility, robustness against external influences and/or cross-sensitivity against interference from the matrix of the sample/test object), as assessed for the intended use, relevant to the customers’ needs?

003 5.4.5.3 ●

Estimation of uncertainty of measurementIf your laboratory is a calibration laboratory, or a testing laboratory performing its own calibrations, does it have and apply a procedure to estimate the uncertainty of measurement for all calibrations and types of calibrations?

003 5.4.6.1 ●

If your laboratory is a testing laboratory, does it have and apply procedures for estimating uncertainty of measurement?

003 5.4.6.2 ●





Estimation of uncertainty of measurement (Cont’d)In cases where the nature of the test method preclude rigorous, metrologically and statistically valid, calculation of uncertainty of measurement, does your laboratory at least attempt to identify all the components of uncertainty and make a reasonable estimation, and ensure that the form of reporting of the result does not give a wrong impression of the uncertainty?

003 5.4.6.2 ●

Is reasonable estimation based on knowledge of the performance of the method and on the measurement scope and make use of, for example, previous experience and validation data?

003 5.4.6.2 ●

When estimating the uncertainty of measurement, are all uncertainty components which are of importance in the given situation, taken into account using appropriate methods of analysis?

003 5.4.6.3 ●

Control of dataAre calculations and data transfers subject to appropriate checks in a systematic manner?

003 5.4.7.1 ●

When computers or automated equipment are used for the acquisition, processing, recording, reporting, storage or retrieval of test or calibration data, does your laboratory ensure that:

- computer software developed by the user is documented in sufficient detail and suitably validated as being adequate for use?

0035.4.7.2a

●

- procedures are established and implemented for protecting the data and include, but not be limited to, integrity and confidentiality of data entry or collection, data storage, data transmission and data processing?

0035.4.7.2b

●

- computers and automated equipment are maintained to ensure proper functioning and are provided with the environmental and operating conditions necessary to maintain the integrity of test and calibration data?

0035.4.7.2c

●





EquipmentIs your laboratory furnished with all items of sampling, measurement and test equipment required for the correct performance of the tests and/or calibrations (including sampling, preparation of test and/or calibration items, processing and analysis of test and/or calibration data)?

003 5.5.1 ●

In those cases where the laboratory needs to use equipment outside its permanent control, does it ensure that the requirements of HOKLAS 003 are met?

003 5.5.1 ●

Are equipment and its software used for testing, calibration and sampling capable of achieving the accuracy required and comply with specifications relevant to the tests and/or calibrations concerned?

003 5.5.2 ●

Are calibration programmes established for key quantities or values of the instruments where these properties have a significant effect on the results?

003 5.5.2 ●

Before being placed into service, is equipment (including that used for sampling)calibrated or checked to establish that it meets the laboratory’s specification requirements and complies with the relevant standard specifications?

003 5.5.2 ●

Is equipment checked and/or calibrated before use (see 5.6 of HOKLAS 003)? 003 5.5.2 ●

Is equipment operated by authorised personnel? 003 5.5.3 ●

Are up-to-date instructions on the use and maintenance of equipment (including any relevant manuals provided by the manufacturer of the equipment) readily available for use by the appropriate laboratory personnel?

003 5.5.3 ●

Are each item of equipment and its software used for testing and calibration and significant to the result, when practicable, uniquely identified?

003 5.5.4 ●

Are records maintained of each item of equipment and its software significant to the tests and/or calibrations performed?

003 5.5.5 ●





Equipment (Cont’d)Do the records include at least the following: 003 5.5.5

- the identity of the item of equipment and its software? 003 5.5.5a

- the manufacturer’s name, type identification, and serial number or other unique identification ?

003 5.5.5b

- checks that equipment complies with the specification (see 5.5.2 of HOKLAS003)?

003 5.5.5c

- the current location, where appropriate? 003 5.5.5d

- the manufacturer’s instructions, if available, or reference to their location ? 003 5.5.5e

- dates, results and copies of reports and certificates of all calibrations, adjustments, acceptance criteria, and the due date of next calibration?

003 5.5.5f

- the maintenance plan, where appropriate, and maintenance carried out to date? 003 5.5.5g

- any damage, malfunction, modification or repair to the equipment? 003 5.5.5h

Does your laboratory have procedures for safe handling, transport, storage, use and planned maintenance of measuring equipment to ensure proper functioning and in order to prevent contamination or deterioration?

003 5.5.6

Is equipment that has been subjected to overloading or mishandling, gives suspect results, or has been shown to be defective or outside specified limits, taken out of service?

003 5.5.7

Is it isolated to prevent its use or clearly labelled or marked as being out of service until it has been repaired and shown by calibration or test to perform correctly?

003 5.5.7

Does your laboratory examine the effect of the defect or departure from specified limits on previous tests and/or calibrations and institute the “Control of nonconforming work” procedure (see 4.9 of HOKLAS 003)?

003 5.5.7





Equipment (Cont’d)Whenever practicable, is all equipment under the control of the laboratory and requiring calibration labelled, coded or otherwise identified to indicate the status of calibration, including the date when last calibrated and the date or expiration criteria when recalibration is due?

003 5.5.8

When, for whatever reason, equipment goes outside the direct control of the laboratory, does your laboratory ensure that the function and calibration status of the equipment are checked and shown to be satisfactory before the equipment is returned to service?

003 5.5.9 ●

When intermediate checks are needed to maintain confidence in the calibration status of the equipment, are these checks carried out according to a defined procedure?

003 5.5.10 ●

Where calibrations give rise to a set of correction factors, does your laboratory have procedures to ensure that copies (e.g. in computer software) are correctly updated?

003 5.5.11

Is test and calibration equipment, including both hardware and software, safeguarded from adjustments which would invalidate the test and/or calibration results?

003 5.5.12 ●

Measurement traceability

GeneralIs all equipment used for tests and/or calibrations, including equipment for subsidiary measurements (e.g. for environmental conditions) having a significant effect on the accuracy or validity of the result of the test, calibration or sampling calibrated before being put into service?

003 5.6.1 ●

Does your laboratory have an established programme and procedure for the calibration of its equipment?

003 5.6.1 ●





Measurement traceability (Cont’d)

Specific requirements 003 5.6.2

Calibration 003 5.6.2.1

If your laboratory is a calibration laboratory, is the programme for calibration of equipment designed and operated so as to ensure that calibrations and measurements made by the laboratory are traceable to the International System of Units (SI) (Système International d’unitè )?

0035.6.2.1.1

●

A calibration laboratory establishes traceability of its own measurement standards and measuring instruments to the SI by means of an unbroken chain of calibrations or comparisons linking them to relevant primary standards of the SI units of measurement. The link to SI units may be achieved by reference to national measurement standards. National measurement standards may be primary standards, which are primary realisations of the SI units or agreed representations of SI units based on fundamental physical constants, or they may be secondary standards which are standards calibrated by another national metrology institute.

0035.6.2.1.1

●

When using external calibration services, is traceability of measurement assured by the use of calibration services from laboratories that can demonstrate competence, measurement capability and traceability?

0035.6.2.1.1

●

Do the calibration certificates issued by these laboratories contain the measurement results, including the measurement uncertainty and/or a statement of compliance with an identified metrological specification (see 5.10.4.2 of HOKLAS 003)?

0035.6.2.1.1

●

Do calibrations that currently cannot be strictly made in SI units provide confidence in measurements by establishing traceability to appropriate measurement standards such as:

- the use of certified reference materials provided by a competent supplier to give a reliable physical or chemical characterisation of a material?

0035.6.2.1.2

●

- the use of specified method and/or consensus standards that are clearly described and agreed by all parties concerned?

0035.6.2.1.2

●





Measurement traceability (Cont’d)

Calibration (Cont’d)Does your laboratory participate in a suitable programme of interlaboratory comparisons where possible?

0035.6.2.1.2

●

Testing ●If your laboratory is a testing laboratory, do the requirements given in 5.6.2.1 of HOKLAS 003 apply for measuring and test equipment with measuring functions used, unless it has been established that the associated contribution from the calibration contributes little to the total uncertainty of the test result?

0035.6.2.2.1

●

When this situation arises, does your laboratory ensure that the equipment used can provide the uncertainty of measurement needed?

0035.6.2.2.1

●

Where traceability of measurements to SI units is not possible and/or not relevant, are the same requirements for traceability to, for example, certified reference materials, agreed methods and/or consensus standards, as for calibration laboratories (see 5.6.2.1.2 of HOKLAS 003) complied with?

0035.6.2.2.2

●

Reference standards and reference materialsDoes your laboratory have a programme and procedure for the calibration of its reference standards?

003 5.6.3.1 ●

Are reference standards calibrated by a body that can provide traceability as described in 5.6.2.1 of HOKLAS 003?

003 5.6.3.1 ●

Are such reference standards of measurement held by the laboratory used for calibration only and for no other purpose, unless it can be shown that their performance as reference standards would not be invalidated?

003 5.6.3.1

Are reference standards calibrated before and after any adjustment? 003 5.6.3.1 ●





Measurement traceability (Cont’d)Reference standards and reference materials (Cont’d)

Are reference materials, where possible, traceable to SI units of measurement, or to certified reference materials?

003 5.6.3.2 ●

Are internal reference materials checked as far as is technically and economically practicable?

003 5.6.3.2 ●

Are checks needed to maintain confidence in the calibration status of reference, primary, transfer or working standards and reference materials carried out according to defined procedures and schedules?

003 5.6.3.3 ●

Does your laboratory have procedures for safe handling, transport, storage and use of reference standards and reference materials in order to prevent contamination or deterioration and in order to protect their integrity?

003 5.6.3.4 ●

Sampling Does your laboratory have a sampling plan and procedures for sampling when it carries out sampling of substances, materials or products for subsequent testing or calibration?

003 5.7.1 ●

Are sampling plan as well as the sampling procedure available at the location where sampling is undertaken?

003 5.7.1 ●

Are sampling plans, whenever reasonable, based on appropriate statistical methods?

003 5.7.1 ●

Does the sampling process address the factors to be controlled to ensure the validity of the test and calibration results?

003 5.7.1 ●

Where the customer requires deviations, additions or exclusions from the documented sampling procedure, are these recorded in detail with the appropriate sampling data and included in all documents containing test and/or calibration results, and communicated to the appropriate personnel?

003 5.7.2 ●





Sampling (Cont’d)Does your laboratory have procedures for recording relevant data and operations relating to sampling that forms part of the testing or calibration that is undertaken?

003 5.7.3 ●

Do these records include the sampling procedure used, the identification of the sampler, environmental conditions (if relevant) and the diagrams or other equivalent means to identify the sampling location as necessary and, if appropriate, the statistics the sampling procedures are based upon?

003 5.7.3 ●

Handling of test and calibration items Does your laboratory have procedures for the transportation, receipt, handling, protection, storage, retention and/or disposal of test and/or calibration items, including all provisions necessary to protect the integrity of the test or calibration item, and to protect the interests of the laboratory and the customer?

003 5.8.1

Does your laboratory have a system for identifying test and/or calibration items? 003 5.8.2

Is the identification retained throughout the life of the item in the laboratory? 003 5.8.2

Is the system designed and operated so as to ensure that items cannot be confused physically or when referred to in records or other documents?

003 5.8.2

Does the system, if appropriate, accommodate a sub-division of groups of items and the transfer of items within and from the laboratory?

003 5.8.2

When there is doubt as to the suitability of an item for test or calibration, or when an item does not conform to the description provided, or the test or calibration required is not specified in sufficient detail, does your laboratory consult the customer for further instructions before proceeding and record the discussion?

003 5.8.3

Upon receipt of the test or calibration item, are abnormalities or departures from normal or specified conditions, as described in the test or calibration method recorded?

003 5.8.3





Handling of test and calibration items (Cont’d) Does your laboratory have procedures and appropriate facilities for avoiding deterioration, loss or damage to the test or calibration item during storage, handling and preparation?

003 5.8.4 ●

Are handling instructions provided with the item followed? 003 5.8.4 ●

When items have to be stored or conditioned under specified environmental conditions, are these conditions maintained, monitored and recorded?

003 5.8.4 ●

Where a test or calibration item or portion of an item is to be held secure, does your laboratory have arrangements for storage and security that protect the condition and integrity of the secured items or portions concerned?

003 5.8.4 ●

Assuring the quality of test and calibration resultsDoes your laboratory have quality control procedures for monitoring the validity of tests and calibrations undertaken?

003 5.9.1 ●

Are the resulting data recorded in such a way that trends are detectable and, where practicable, statistical techniques are applied to the reviewing of the results?

003 5.9.1 ●

Is this monitoring planned and reviewed and does it include, but not be limited to, the following:

- regular use of certified reference materials and/or internal quality control using secondary reference materials?

003 5.9.1a ●

- participation in interlaboratory comparison or proficiency-testing programmes? 003 5.9.1b ●





Assuring the quality of test and calibration results (Cont’d)Is this monitoring planned and reviewed and does it include, but not be limited to, the following: (cont’d)

- replicate tests or calibrations using the same or different methods? 003 5.9.1c ●

- retesting or recalibration of retained items? 003 5.9.1d ●

- correlation of results for different characteristics of an item? 003 5.9.1e ●

Are quality control data analysed and, where they are found to be outside pre-defined criteria, does planned action taken to correct the problem and to prevent incorrect results from being reported?

003 5.9.2 ●

Reporting the resultsAre the results of each test, calibration, or series of tests or calibrations carried out by the laboratory reported accurately, clearly, unambiguously and objectively, and in accordance with any specific instructions in the test or calibration methods?

003 5.10.1 ●

Are the results reported, usually in a test report or a calibration certificate, and do they include all the information requested by the customer and necessary for the interpretation of the test or calibration results and all information required by the method used?

003 5.10.1 ●

Does this information normally include that required by 5.10.2, and 5.10.3 or 5.10.4 of HOKLAS 003?

003 5.10.1

In the case of tests or calibrations performed for internal customers, or in the case of a written agreement with the customers and the results are reported in a simplified way, is any information listed in 5.10.2 to 5.10.4 of HOKLAS 003, which is not reported to the customer, readily available in the laboratory which carried out the tests and/or calibrations?

003 5.10.1





Reporting the results (Cont’d)Does each test report or calibration certificate include at least the following information, unless the laboratory has valid reasons for not doing so?

- a title (e.g. “Test Report” or “Calibration Certificate”)? 0035.10.2a

- the name and address of laboratory, and location where the tests and/or calibrations were carried out, if different from the address of the laboratory?

0035.10.2b

- unique identification of the test report or calibration certificate (such as serial number), and on each page an identification in order to ensure that the page is recognised as a part of the test report or calibration certificate, and a clear identification of the end of the test report or calibration certificate?

0035.10.2c

-- the name and address of the customer? 0035.10.2d

- identification of the method used? 0035.10.2e

- a description of, the condition of, and unambiguous identification of the item(s) tested or calibrated?

0035.10.2f

- the date of receipt of test or calibration item(s) where this is critical to the validity and application of the results, and the date(s) of performance of the test or calibration?

0035.10.2g

- reference to the sampling plan and procedures used by the laboratory or other bodies where these are relevant to the validity or application of the results?

0035.10.2h

- the test or calibration results with, where appropriate, the units of measurement? 0035.10.2i

- the name(s), function(s) and signature(s) or equivalent identification of person(s) authorising the test report or calibration certificate?

0035.10.2j





Reporting the results (Cont’d)Does each test report or calibration certificate include at least the following information, unless the laboratory has valid reasons for not doing so? (cont’d)

- where relevant, a statement to the effect that the results relate only to the items tested or calibrated?

0035.10.2k

In addition to the requirements listed in 5.10.2 of HOKLAS 003, do test reports, where necessary for the interpretation of the test results, include the following:

- deviations from, additions to, or exclusions from the test method, and information on specific test conditions, such as environmental conditions?

0035.10.3.1a

- where relevant, a statement of compliance/non-compliance with requirements and/or specifications?

0035.10.3.1b

- where applicable, a statement on the estimated uncertainty of measurement, information on uncertainty is needed in test reports when it is relevant to the validity or application of the test results, when a customer’s instruction so requires, or when the uncertainty affects compliance to a specification limit?

0035.10.3.1c

- where appropriate and needed, opinions and interpretations (see 5.10.5 of HOKLAS 003)?

0035.10.3.1d

- additional information which may be required by specific methods, customers or groups of customers?

0035.10.3.1e

In addition to the requirements listed in 5.10.2 and 5.10.3.1of HOKLAS 003, do test reports containing the results of sampling include the following, where necessary for the interpretation of test results:

- the date of sampling? 0035.10.3.2a





Reporting the results (Cont’d)In addition to the requirements listed in 5.10.2 and 5.10.3.1of HOKLAS 003, do test reports containing the results of sampling include the following, where necessary for the interpretation of test results: (cont’d)

- unambiguous identification of substance, material or product sampled (including the name of manufacturer, the model or type of designation and serial numbers as appropriate)?

0035.10.3.2b

- the location of sampling, including any diagrams, sketches or photographs? 0035.10.3.2c

- a reference to the sampling plan and procedures used? 0035.10.3.2d

- details of any environmental conditions during sampling that may affect the interpretation of the test results?

0035.10.3.2e

- any standard or other specification for the sampling method or procedure, and deviations, additions to or exclusions from the specification concerned?

0035.10.3.2f

In addition to the requirements listed in 5.10.2 of HOKLAS 003, do calibration certificates include the following, where necessary for the interpretation of calibration results:

- the conditions (e.g. environmental) under which the calibrations were made that have an influence on the measurement results?

0035.10.4.1a

- the uncertainty of measurement and/or a statement of compliance with an identified metrological specification or clauses thereof?

0035.10.4.1b

- evidence that the measurements are traceable? 0035.10.4.1c





Reporting the results (Cont’d)Does the calibration certificate relate only to quantities and the results of functional tests?

0035.10.4.2

If a statement of compliance with a specification is made, does this identify which clauses of the specification are met or not met?

0035.10.4.2

When a statement of compliance with a specification is made omitting the measurement results and associated uncertainties, does your laboratory record those results and maintain them for possible future reference?

0035.10.4.2

When statements of compliance are made, is the uncertainty of measurement taken into account?

0035.10.4.2

When an instrument for calibration has been adjusted or repaired, are the calibration results before and after adjustment or repair, if available, reported?

0035.10.4.3

Does calibration certificate (or calibration label) exclude any recommendation on the calibration interval except where this has been agreed with the customer, unless this requirement is superseded by legal regulations?

0035.10.4.4

When opinions and interpretations are included, does your laboratory document the basis upon which the opinions and interpretations have been made?

003 5.10.5

Are opinions and interpretations clearly marked as such in a test report? 003 5.10.5

When the test report contains results of tests performed by subcontractors, are these results clearly identified?

003 5.10.6

Does the subcontractor report the results in writing or electronically? 003 5.10.6

When your laboratory subcontracts a calibration, does the laboratory performing the work issue the calibration certificate to your laboratory?

003 5.10.6


Reporting the results (Cont’d)



HOKLAS Requirements Clause * OK QM Clause Remarks / Questions to be asked at laboratoryIn the case of transmission of test or calibration results by telephone, telex, facsimile or other electronic or electromagnetic means, are the requirements of HOKLAS 003 met (see also 5.4.7 of HOKLAS 003)?

003 5.10.7

Is the format designed to accommodate each type of test or calibration carried out and to minimise the possibility of misunderstanding or misuse?

003 5.10.8 ●

Are material amendments to a test report or calibration certificate after issue made only in the form of a further document, or data transfer, which includes the statement:

“Supplement to Test Report [or Calibration Certificate], serial number...[or as otherwise identified]”, or an equivalent form of wording?

003 5.10.9

Do such amendments meet all the requirements of HOKLAS 003? 003 5.10.9

When it is necessary to issue a complete new test report or calibration certificate, is this uniquely identified and does it contain a reference to the original that it replaces?

003 5.10.9

HKAS Regulations

The obligations of an accredited organisationAfter obtaining accreditation, will your laboratory at all times:-



HOKLAS Requirements Clause * OK QM Clause Remarks / Questions to be asked at laboratory(a) comply with the accreditation criteria, including accreditation regulations

specified in HKAS 002 and HOKLAS Supplementary Criteria No.33, technical and non-technical requirements and other conditions as specified by HKAS Executive under your terms of accreditation;

002 5.1a

(b) represent honestly and truthfully to any person concerned that it is only accredited for activities stated in the scope of accreditation;

002 5.1b

(c) pay such fees and charges as determined by HKAS Executive; 002 5.1c

(d) endeavour to ensure the accreditation granted by HKAS is not used in a misleading manner;

002 5.1d

(e) be a legal entity; and 002 5.1e

(f) conform with the Business Registration Ordinance (Cap 310)? 002 5.1f

For any customers for which your laboratory performs any accredited activity, does your laboratory maintain for such activity a quality standard which is in conformity with the accreditation criteria as set by HKAS?

002 5.2

Will your laboratory maintain the same quality standard at all times, no matter whether or not the HKAS accreditation symbol is used in the report or certificate covering the result of such activity?

002 5.2

When making any statement in relation to your laboratory’s accreditation status in situation where non-accredited activities are mentioned, will your laboratory ensure that such a statement is accompanied by a statement indicating which activities are not accredited?

002 5.3

HKAS Regulations (continued)

The obligations of an accredited organisation (Cont’d)Does your laboratory aware of the following accreditation regulation:

“Upon termination of accreditation for all activities of an organisation as specified in a certificate of accreditation, the organisation shall return such certificate of accreditation to HKAS Executive forthwith.”?

002 5.4



HOKLAS Requirements Clause * OK QM Clause Remarks / Questions to be asked at laboratoryWill your laboratory cooperate with HKAS Executive and its assessment teams and provide them with full support during an on-site assessment and in any other situation such as to provide all necessary information for assessment of the laboratory’s competence and its conformity with the accreditation criteria?

002 5.5

Upon the request of HKAS Executive, will your laboratory provide HKAS Executive with a copy of the documentary standard for which it seeks HKAS accreditation for use during the assessment?

002 5.5

Does your laboratory ensure that it will use its accreditation status only in a manner that will not bring HKAS or any of its accreditation schemes into disputes and will not make any statement regarding its accreditation status that HKAS Executive may reasonably consider it to be misleading?

002 5.6

Does your laboratory maintain complete integrity and impartiality in all circumstances? Does your laboratory issue and implement a pertinent code of conduct for all its directors, officers, employees and other personnel involved in its operation? Will the authorised representative report any impropriety or unlawful act of the laboratory or any iniquitous management and/or staff to HKAS Executive? Will the authorised representative further report immediately any corrupt practice to the ICAC (or similar authority or the police when outside the jurisdiction of the HKASR)?

002 5.7

Will your laboratory notify HKAS Executive within one calendar month if a new authorised representative has been appointed?

002 5.8


The obligations of an accredited organisation (Cont’d)Will the authorised representative or in his absence, other responsible person of the laboratory inform HKAS Executive in writing immediately of any changes or intended changes in the laboratory’s circumstances which may affect its conformity with relevant accreditation criteria?

002 5.9



HOKLAS Requirements Clause * OK QM Clause Remarks / Questions to be asked at laboratoryDoes your laboratory implement the following HKAS regulation on confidentiality:“An accredited organisation shall pay due regard to the confidentially of its customer’s information and shall make internal rules and guidelines in order to ensure protection of its customer’s information. Confidential information about a particular customer shall not be disclosed to a third party without the consent of the customer, except where the law requires such information to be so disclosed. However, an applicant organisation or an accredited organisation shall allow HKAS Executive to examine all its records which are relevant to the scope of accreditation in order to assess its competence and compliance with the relevant accreditation criteria. An applicant organisation and an accredited organisation shall obtain consent from their customers for the disclosure of any relevant information to HKAS.”?

002 5.10

Does your laboratory ensure that no unofficial contact with assessors, technical experts and/or AAB members will be made on any matter relating to or in connection with the assessment of any activity for the purpose of granting or maintaining accreditation?

002 5.11

Are all communications concerning the laboratory’s assessment make between the authorised representative or his/her representative or its chief executive or his/her representative and HKAS Executive?

002 5.11

Does your laboratory have a clear policy in writing concerning the provision or receipt of advantages by its staff? Does the policy document contain a statement notifying its staff the law under Section 9 of the Prevention of Bribery Ordinance (Cap. 201)? Does your laboratory further ensure that the policy is made known to all its staff members?

002 5.12


The obligations of an accredited organisation (Cont’d)Does your laboratory have a policy and procedure in writing for handling and resolving complaints, disputes and appeals made to it by its customers or other parties?

002 5.13

Does your laboratory keep records of all complaints, disputes and appeals and actions taken for a minimum of 3 years and make available to HKAS Executive for inspection upon request?

002 5.13



HOKLAS Requirements Clause * OK QM Clause Remarks / Questions to be asked at laboratoryWhere a complaint, dispute or appeal received from your customers or other parties raise any doubt on your compliance with your polices or procedures, will your laboratory ensure that the relevant areas of its accredited activities are promptly audited?

002 5.14

If a complaint, dispute or appeal received from your customers or other parties relating to any of your accredited activities is not satisfactorily resolved within 60 days from the date of receipt, will your laboratory notify HKAS Executive in writing of this matter?

002 5.15

Is your laboratory aware that any concerned party may lodge complaints with HKAS on any of your accredited activities?

002 5.16

Is your laboratory aware of the following HKAS regulation?

Upon the request of HKAS Executive, an accredited organisation shall confirm the authenticity or otherwise of a report, certificate or other document purporting to have been issued by it for an accredited activity. Where such a report, certificate or document is found to be a forged document, the organisation shall cooperate with HKAS Executive in the investigation of its cause and taking mutually agreeable steps to prevent recurrence.

002 5.17

An accredited organisation shall not provide certification service to any other party for any standard used by HKAS as accreditation criteria. HKAS Executive will take immediate action to suspend the accreditation of an accredited organisation in violation of this requirement.

002 5.18


Use of HKAS accreditation symbols and claims of accreditation statusDoes your laboratory implement the following HKAS regulation:-“An accredited organisation may use the relevant HKAS accreditation symbol as described in HKAS Supplementary Criteria No. 1 and claim its accreditation status provided that the following conditions are complied with:-



HOKLAS Requirements Clause * OK QM Clause Remarks / Questions to be asked at laboratory(a) all advertising and promotional materials (including letterheads) shall not, in

the opinion of HKAS Executive, give a false or misleading impression regarding the accreditation status of the organisation;

002 8.1a

(b) HKAS Supplementary Criteria No. 1 and requirements relevant to the accreditation scheme concerned as described in the relevant specific regulations, are conformed with at all times; and

002 8.1b

(c) any statement made by the organisation in connection with its accreditation status shall not, in the opinion of HKAS Executive, give a false or misleading impression to any third party of its accreditation status.”?

002 8.1c

Is your laboratory aware of that an organization shall not allow its accreditation be used to imply that any subject of its accredited activities, for example, a product, process, system or person is approved by HKAS or HKAS Executive and shall take suitable actions to stop any incorrect reference to accreditation.

002 8.2

Does your laboratory ensure that its customers, on receiving any report or certificate which bears a HOKLAS accreditation symbol are aware that the subject of the activity (e.g. the sample, instrument, product, design or system tested, calibrated, certified or inspected) as referred to in such report or certificate is in no way approved nor disapproved by HKAS or HKAS Executive?

002 8.2

Upon termination of the accreditation of any activities carried out by an accredited laboratory, whether or not voluntarily made, will your laboratory immediately remove all reference to the accreditation status of the laboratory in any report, certificate, letterhead, brochure and advertising material?

002 8.3


Specific regulations for HKASHas your laboratory documented the code of conduct within its management system for stating its policies on impartiality, confidentiality, professionalism, integrity, conflict of interest, and the organisation’s commitment to complying with the Prevention of Bribery Ordinance (Cap 201) of Hong Kong or applicable laws and regulations of the country where the accredited organisation is located?

HKAS SC-06 2.1

Does the code of conduct cover at least the following aspects:

(a) acceptance of advantage;HKAS SC-06

2.2a




(b) offer of advantage;HKAS SC-06

2.2b

(c) entertainment;HKAS SC-06

2.2c

(d) compliance with laws of Hong Kong or of relevant jurisdictions;HKAS SC-06

2.2d

(e) compliance with relevant requirements of applicable professional standards;HKAS SC-06

2.2e

(f) conflict of interest;HKAS SC-06

2.2f

(g) use of company assets;HKAS SC-06

2.2g

(h) confidentiality of company information;HKAS SC-06

2.2h

(i) outside employment;HKAS SC-06

2.2i

(j) relationship with customers, suppliers and contractors;HKAS SC-06

2.2j

(k) procedures for reporting suspected violation and established mechanism for the prompt and fair adjudication of alleged violations; and

HKAS SC-06 2.2k

(l) disciplinary actions to be taken against violations.HKAS SC-06

2.2l

HKAS Regulations (continued)Specific regulations for HKAS (Cont’d)

Does your laboratory determine the contents of the code of conduct in accordance with its circumstances to ensure that all personnel working for it act lawfully, ethically, professionally, and honestly and protect the impartiality, independence and integrity of the organisation?

HKAS SC-06 2.3

Does your laboratory ensure that all personnel including its directors, staff and other personnel working for it understand and practise the code of conduct?

HKAS SC-06 3.1



HOKLAS Requirements Clause * OK QM Clause Remarks / Questions to be asked at laboratoryHas your laboratory provided training to all personnel as part of the orientation training when they join the organisation and refresher training to all personnel periodically thereafter?

HKAS SC-06 3.2

Does your laboratory periodically remind all personnel working for it the code of conduct?

HKAS SC-06 3.3

Is the code of conduct accessible to all personnel working for the organisation? HKAS SC-06 3.4

Is the authorised representative aware that he/she shall report any impropriety or unlawful act of the organisation or any iniquitous management and/or staff to HKAS Executive in accordance with HKAS 002 clause 5.7?

HKAS SC-06 3.5

Does your laboratory periodically review the code’s suitability and adequacy; and implement improvement as appropriate?

HKAS SC-06 3.6

HKAS Regulations (continued)Specific regulations for HOKLAS

Is your laboratory aware of the following accreditation regulation on accreditation procedure:

“An assessment team may require a laboratory to demonstrate a test, a calibration or other laboratory activities as part of an assessment. It may also require the laboratory to participate in proficiency testing in order to evaluate its standard and competence. The specific laboratory activities to be demonstrated will be selected from those covered in the proposed scope of accreditation at the discretion of the assessment team.”?

HOKLAS SC-33

2.1



HOKLAS Requirements Clause * OK QM Clause Remarks / Questions to be asked at laboratoryIs your laboratory aware of the following accreditation regulation on accreditation procedure:

“HKAS Executive shall conduct a reassessment on the accredited activities of a laboratory:-(a) within twelve months after the date of the notification letter in which HKAS

Executive has granted the accreditation to the laboratory;HOKLAS

SC-332.2a

(b) every two years after the due date of the first reassessment or at such time intervals as specified for the Monitoring Plan adopted by the laboratory;

HOKLAS SC-33

2.2b

(c) at such other times as may be specified in the terms of accreditation; HOKLAS SC-33

2.2c

(d) upon notification by the authorised representative, or in his absence, other responsible person of an accredited laboratory, of any change in the structure and circumstances of the laboratory since the last assessment or reassessment and in the opinion of HKAS Executive, such change may affect the laboratory’s competence or conformity with the accreditation criteria; and

HOKLAS SC-33

2.2d

HKAS Executive may, at its discretion, vary the reassessment schedule. HOKLAS SC-33

2.2


Specific regulations for HOKLAS (Cont’d)Is your laboratory aware of the following accreditation regulation on accreditation procedure: (cont’d)

“HKAS Executive shall conduct a surveillance visit to an accredited laboratory if neither reassessment, assessment for extension of accreditation, nor surveillance visit to it has been conducted within the past twelve months’ period or at such time intervals as specified for the Monitoring Plan adopted by the laboratory. HKAS Executive may, at its discretion, vary the surveillance visit schedule.”?

HOKLAS SC-33

2.3

Is your laboratory aware of the following HKAS regulation:

“Upon granting of accreditation for a test category to a laboratory, HKAS

HOKLAS SC-33

2.4



HOKLAS Requirements Clause * OK QM Clause Remarks / Questions to be asked at laboratoryExecutive shall issue to it a certificate of HOKLAS accreditation for such test category.”?

Does your laboratory at all times comply with the following HOKLAS accreditation criteria?

HKAS002, HOKLAS003, relevant HOKLAS Supplementary Criteria and relevant HKAS Supplementary Criteria.

HOKLAS SC-33

3.1

Does your laboratory ensure that its accreditation status will not use in a way that may be interpreted by any person that any product, material or any other subject of an activity for which HOKLAS accreditation has been granted has been approved or disapproved by HKAS or HKAS Executive? Will your laboratory further endeavour to ensure that no person use any certificate, report, statement or documentation issued by it for such activity in a misleading manner?

HOKLAS SC-33

3.2

Is your laboratory aware of the following HKAS regulation on cooperation:

“A laboratory accredited under HOKLAS shall afford its customers or their representative reasonable cooperation to monitor the laboratory’s performance (in so far as to their respective contracts are concerned). This cooperation shall include:

(a) to perform any reasonable check tests or calibrations or checks for other laboratory activities, including to prepare, pack and dispatch the test pieces, samples and other items for such check activities, which serve to verify its capability or standard of service as requested by the customer; and

HOKLAS SC-33

3.3a


Specific regulations for HOKLAS (Cont’d)Is your laboratory aware of the following HKAS regulation on cooperation: (cont’d)

(b) to allow each of its customers or their representatives reasonable access to the laboratory in order to observe any test, calibration or other activity performed by it for the customer. However, the laboratory shall ensure that the confidentiality of its other customers will be protected and their information will not be divulged to any third party (subject to clause 5.10 of HKAS 002).”?

For avoidance of doubt, the laboratory may also take reasonable steps to protect its proprietary information and agree with its customers the cost the customers have to pay to the laboratory for performing or taking part in such

HOKLAS SC-33

3.3b



HOKLAS Requirements Clause * OK QM Clause Remarks / Questions to be asked at laboratorymonitoring activities.

Is your laboratory aware of the following HKAS regulation on subcontracting:

“If an accredited laboratory intends to subcontract any part of its activities to which HOKLAS accreditation has been granted, it shall ensure that the activities of the laboratory to which the activities will be subcontracted have been accredited by HKAS or an accreditation body recognised by HKAS under a mutual recognition arrangement. A list of such accreditation bodies is available at the HKAS website. The accredited laboratory shall notify its customer concerned in writing of its intention to subcontract the activities and the extent of such subcontract. It shall obtain agreement from the customer regarding such arrangement and shall further keep records of such agreement. In the report or certificate, the accredited laboratory shall identify the activities performed and the results obtained by such subcontractor.”?

HOKLAS SC-33

3.4

Does your laboratory take part in proficiency testing (PT) 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?

HOKLAS SC-33

3.5

Is the performance of your laboratory in any proficiency testing activity relevant to its scope of accreditation acceptable to HKAS Executive?

HOKLAS SC-33

3.5


Specific regulations for HOKLAS (Cont’d)Is your laboratory aware of the following HKAS regulation on proficiency testing:

“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.”?

HOKLAS SC-33

3.6

Does your laboratory establish a one-year PT participation plan with the coverage being representative and adequate to demonstrate your laboratory’s competence in performing tests under its scope of accreditation?

HOKLAS SC-33

3.7

Where suitable PT programme does not exist or is not practical, has your HOKLAS



HOKLAS Requirements Clause * OK QM Clause Remarks / Questions to be asked at laboratorylaboratory included suitable alternative means aiming to demonstrate the laboratory’s competence in the plan?

SC-33 3.7

Has the plan been 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)?

HOKLAS SC-33

3.7

Has any change to the plan been documented and justified? HOKLAS SC-33

3.7

When the laboratory updates its PT plan, does your laboratory ensure its continual suitability in relation to its scope of accreditation?

HOKLAS SC-33

3.7


Specific regulations for HOKLAS (Cont’d)Is your laboratory aware of the following HKAS regulation on proficiency testing:

“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.”?

HOKLAS SC-33

3.8

Is your laboratory aware of the following HKAS regulation on proficiency testing: HOKLAS SC-33



HOKLAS Requirements Clause * OK QM Clause Remarks / Questions to be asked at laboratory“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.”?

3.9

Where the performance of an accredited laboratory in a PT activity is unsatisfactory, has your laboratory investigated the cause and take effective corrective actions?

HOKLAS SC-33

3.10

Are relevant records of corrective actions kept?HOKLAS

SC-33 3.10


Specific regulations for HOKLAS (Cont’d)

Are the actions taken effective to achieve satisfactory performance in PT activity for the test in question?

HOKLAS SC-33

3.10

If the laboratory cannot rectify the unsatisfactory PT performance for an accredited activity within a reasonable timeframe (e.g. three months), has your laboratory notified HKAS Executive in writing of the actions taken to address the problem and the measures taken to deal with request for the problematic activity?

HOKLAS SC-33

3.10



HOKLAS Requirements Clause * OK QM Clause Remarks / Questions to be asked at laboratoryIs your laboratory aware of the following HKAS regulation on approved signatory:

“An applicant laboratory shall nominate persons to HKAS Executive for signing endorsed reports and certificates for every test, calibration or other activity in the scope of accreditation. Accreditation for such activity will not be granted unless HKAS Executive is satisfied that at least one nominee meets the requirements for approved signatories as laid down in the accreditation criteria. An accredited laboratory shall maintain at least one approved signatory for each accredited activity. Additional persons may be nominated by an accredited laboratory to HKAS Executive for approval as approved signatories at any time.”?

HOKLAS SC-33

3.11

Is your laboratory aware of the following HKAS regulation on approved signatory:

“An accredited laboratory shall inform HKAS Executive of any change in the availability and duties of any of its HOKLAS approved signatories. HKAS shall withdraw the approval concerning such approved signatory who no longer meets the requirements for approved signatories as laid down in the accreditation criteria. HKAS Executive may suspend the accreditation of a laboratory for a test, calibration or other laboratory activity if it does not have any approved signatory for such activity and has failed to obtain approval from HKAS Executive for a new signatory within three months from the date when it ceased to have any approved signatory for such activity.”?

HOKLAS SC-33

3.12


Specific regulations for HOKLAS (Cont’d)Will the authorised representative of your laboratory, within 14 days from the effective date of any suspension or termination (voluntarily or by HKAS Executive), identify the customers to whom the laboratory has issued results for tests, calibrations or other activities which are found to be unreliable because of the deficiencies discovered during the investigation of the suspension and termination, and inform them that the results are unreliable?

HOKLAS SC-33

4.1

Is your laboratory aware of the following HKAS regulation on suspension:

“Upon suspension of accreditation, a laboratory shall provide to HKAS Executive

HOKLAS SC-33

4.1



HOKLAS Requirements Clause * OK QM Clause Remarks / Questions to be asked at laboratoryan action plan to solve the concerns related to the suspended activity(ies) within four weeks from the date of notice of suspension. Such actions shall be taken to the satisfaction of HKAS Executive within one year from the effective date of suspension.”

Is your laboratory aware of the following HKAS regulation on suspension and termination:

“HKAS Executive may publish information relating to any suspension and termination of accreditation granted by HKAS in any HKAS publications and in the website of HKAS.”?

002 2.10


“An accredited laboratory may display the appropriate HOKLAS accreditation symbol in a report or certificate issued by it for reporting the result(s) of an activity accredited under HOKLAS. Such a document is referred to hereafter as a HOKLAS endorsed report or certificate.”?

HOKLAS SC-33

5.1

HKAS Regulations (continued)Specific regulations for HOKLAS (Cont’d)(a) the HOKLAS accreditation symbol (which includes the HKAS logo, the logo

of the relevant scheme, the laboratory’s registration number and identification code of the accreditation programme) at the top right hand corner of the front page. ;

HOKLAS SC-33

5.2a

(b) on the same page the following statement (except as specified in (d) below):-

(i) for non-medical laboratories“HKAS has accredited this laboratory (Reg. No. HOKLAS 999) under HOKLAS for specific laboratory activities as listed in the HOKLAS directory of accredited laboratories.”

HOKLAS SC-33 5.2.b(i)



HOKLAS Requirements Clause * OK QM Clause Remarks / Questions to be asked at laboratoryIs your laboratory aware of the following HKAS regulation on the use of HKAS accreditation symbols and claims of accreditation status (cont’d):

(b) on the same page the following statement (except as specified in (d) below):-(cont’d)

(ii) for reports and certificates showing calibration results“HKAS has accredited this laboratory (Reg. No. HOKLAS 999) under HOKLAS for specific calibration activities as listed in the HOKLAS directory of accredited laboratories. The results shown in this report (or certificate, where appropriate) are traceable to the International System of Units (S.I.) or recognised measurement standards.”

HOKLAS SC-33 5.2.b(ii)

The word “this laboratory” in the first sentence of the above statement may be replaced by the full identity of the laboratory as listed in the scope of accreditation. When the statement is used alone to claim a laboratory’s accreditation status without displaying the accreditation symbol (See clause 5.3), the same words shall be replaced by the full identity, registration number and identification code of the accreditation programme (in form of e.g., ABC Testing Limited, Registration Number HOKLAS 999 and the appropriate Identification Code such as “TEST”, “CAL” etc.).


Specific regulations for HOKLAS (Cont’d)HOKLAS

SC-33 5.2.c


“For reports and certificates issued for internal use and where it is technically not possible or very difficult to display the accreditation symbol on a report or certificate, claiming of accreditation status may be made with the statements in 5.2 (b) without displaying the accreditation symbol. Such claim without displaying the accreditation symbol is subject to prior written agreement by HKAS Executive. The laboratory should note that an endorsed report or certificate shall bear the accreditation symbol. It should also note that if it selects to claim the accreditation status with one of the statements in 5.2(b) without displaying the accreditation symbol, requirements that govern the issue of HOKLAS endorsed report as detailed in this document and HKAS 002 shall also apply to such reports or

HOKLAS SC-33

5.3



HOKLAS Requirements Clause * OK QM Clause Remarks / Questions to be asked at laboratorycertificates.”

Does your laboratory ensure that the term “HOKLAS”, the HOKLAS accreditation symbol and/or a statement claiming accreditation status under HOKLAS will not use in any report or certificate of laboratory activities except as described above in clause 5.2 and 5.3?

HOKLAS SC-33

5.4

Does your laboratory ensure that the form, size, colour and usage of the HOKLAS accreditation symbol are in accordance with HKAS Supplementary Criteria No. 1?

HOKLAS SC-33

5.5


“A HOKLAS endorsed report or certificate shall be signed by a HOKLAS approved signatory of the issuing laboratory. For printed reports or certificates, such signature shall be made in hand-written form. For reports or certificates in an electronic form, the electronic signature shall be in a form acceptable under the Electronic Transactions Ordinance (Cap. 553). The full name of the approved signatory (as in his/her identify document such as identity card or passport) shall be clearly shown alongside the signature.

Other arrangements of signing HOKLAS endorsed reports or certificates may be acceptable subject to agreement from HKAS Executive. When determining the acceptability of such an arrangement, HKAS Executive will consider all pertinent factors such as the reliability of the arrangement in ensuring proper and traceable authorisation by approved signatories and the demand of users of the accredited service.”

HOKLAS SC-33

5.6

HKAS Regulations (continued)Specific regulations for HOKLAS (Cont’d)Is your laboratory aware of the following HKAS regulation:

“A HOKLAS endorsed report or certificate may contain signatures of others provided that one of the laboratory’s HOKLAS approved signatory has signed the report or certificate. Where signatures other than the approved signatory also appear on the report or certificate, the capacity of the one who signed (such as his capacity as the quality manager) shall appear on the report or certificate.”?

HOKLAS SC-33

5.7

Does HOKLAS endorsed report or certificate issued by your laboratory contain only the results of the tests, calibrations or other laboratory activities for which your laboratory is holding valid HOKLAS accreditation?

HOKLAS SC-33

5.8



HOKLAS Requirements Clause * OK QM Clause Remarks / Questions to be asked at laboratoryIs your laboratory aware of the following HKAS regulation:

“The results of any activity which has not been accredited (whether obtained by the laboratory or its subcontractor) can only be included in a HOKLAS endorsed report or certificate if HKAS Executive has explicitly approved such inclusion in writing. The HOKLAS endorsed report or certificate which contains the said results shall clearly state therein that the activities are not covered by the laboratory’s HOKLAS accreditation.”?

HOKLAS SC-33

5.9

Does your laboratory keep at least one exact copy of the test report or certificate for any accredited activities issued by it for record? Does your laboratory also keep such copies of report or certificate, all original observations and records in relation to any accredited activity performed by it for a period of not less than three years or for a period specified by the HKAS Executive?

HOKLAS SC No.33

5.10

Does your laboratory ensure that each HOKLAS endorsed report/certificate, or any report/certificate with the accreditation status claimed, comply with all relevant accreditation criteria as specified by HKAS Executive from time to time?

HOKLAS SC-33

5.11


Specific regulations for HOKLAS (Cont’d)Is your laboratory aware of the following HKAS regulation:

“An accredited laboratory may issue a HOKLAS endorsed report or certificate which extends the results of a test, a calibration or another laboratory activity on a sample or samples to the properties or qualities of the inspected lot, batch or consignment from which the sample(s) was drawn provided that:

(a) the accredited laboratory’s scope of accreditation covers the sampling involved; and

HOKLAS SC-33 5.12a



HOKLAS Requirements Clause * OK QM Clause Remarks / Questions to be asked at laboratory(b)the sample or samples concerned were taken by staff of the accredited

laboratory using the accredited sampling procedure.”?HOKLAS

SC-33 5.12b


“A HOKLAS endorsed report or certificate may include statements in amplification of results reported therein provided that:-

(a) where a sample, batch or consignment is tested, calibrated or examined to specification requirements such statements shall be limited to information as to whether or not the sample, batch or consignment conforms to the specification requirements and the manner or degree in which it departs from such specification requirements;

HOKLAS SC-33 5.13a

(b) where a sample is not tested, calibrated or examined to specification requirements such statements shall be limited to explanation of the results as is necessary for interpretation of their meaning; and

HOKLAS SC-33 5.13b

(c) where an instrument or measuring device is calibrated such statements shall be limited to:-

HOKLAS SC-33 5.13c

(i) the uncertainty to be associated with its use, or

(ii) the information referred to in (a) or (b) above as appropriate.”?


Specific regulations for HOKLAS (Cont’d)Is your laboratory aware of the following HKAS regulation:

“Opinions or interpretation for which a laboratory is not accredited for providing can only be included in a HOKLAS endorsed report or certificate if HKAS Executive has given its approval for such inclusion in writing. An endorsed report or certificate containing such opinions or interpretations shall in all cases clearly state that the laboratory is not accredited for providing such opinions or interpretation.”?

HOKLAS SC-33

5.14


“Application for any accreditation from HKAS shall be made in appropriate forms. These forms can be downloaded at the HKAS website.”?

HOKLAS SC-33

6.1




End


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