WHY ISO 17025 ACCREDITATION

WHY ISO 17025 ACCREDITATION

1. Opportunity to increase the business because of clients’ confidence.

2. Company is listed as an Accredited Laboratory in Malaysia Standards website and directory. This gives rise to the recognition to the laboratory.

3. This allows laboratory to tap into the local and international clients operating in Malaysia.

4. Laboratory quality is audited yearly and given the quality assurance and technical competence by accreditation body.

5. Safe time and money by eliminating and reducing the need for re-testing.

6. Increase reputation and integrity of laboratory local and international.

7. Laboratory is in continuously improvement and development under ISO 17025 accreditation.

8. Competence and technical sound staff in carrying out testing and reporting of results.

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LABORATORY ACCREDITATION SCHEME OF MALAYSIA

LABORATORY ACCREDITATION SCHEME OF MALAYSIA

SAMM POLICY 8 (SP8) – REQUIREMENTS FOR THE ACCREDITATION OF SITE CALIBRATION AND TESTING LABORATORIES

1 INTRODUCTION AND SCOPE

1.1 SAMM Accreditation Standard (MS ISO/IEC 17025) set forth the criteria of competence for accreditation of calibration / testing performed by a laboratory or an organisation that carries out calibration and/or testing:

(a) at or from a permanent location,

(b) at or from a temporary facility, or

(c) in or from a mobile facility.

1.2 The accreditation requirements and procedures applicable to a permanent laboratory need no further explanation.

1.3 This document sets forth the requirements for accreditation of three (3) categories of site calibration / testing described in Section 2.11 of this document.

1.4 The requirements of this document apply to a large cross-section of calibration/testing laboratories and service organisations that perform calibration of measurement equipment / testing at customers’ premises or sites.

2 DEFINITIONS

2.1 Permanent Laboratory (Base Laboratory): A laboratory or organisation that performs calibration and/or testing at a permanent location or premises.

2.2 Site Calibration / testing: Calibration / testing (including sampling where it forms part of the documented test procedure) performed by staff of an organisation outside the premises / grounds in which the permanent laboratory or the permanent base of the organisation is located.

Note: The location in which the permanent facilities are sited shall be defined. Any calibration/testing outside this location shall be considered as site calibration/testing.

2.3 Site: Any location where site calibration / testing as defined in 3.2 above is performed, e.g. manufacturers' premises, construction sites, dockyards, buildings and open spaces.

NOTE: For the purpose of assessment, sites shall be accessible to SAMM assessors during calibration / testing.

2.4 Site Laboratory: A calibration / testing laboratory set up in a dedicated area on site on a short-term basis until the completion of a contract.

2.5 Mobile Laboratory: Fully equipped van or purpose-built transportable calibration / testing laboratory. If a mobile laboratory is left permanently on one site it will be subject to the same terms of accreditation as a site laboratory.

NOTE: Please consult Department of Standards Malaysia (STANDARDS MALAYSIA) Accreditation Division (SAMM officer) if you have any difficulty in categorising site calibration / testing appropriate to your application. For this purpose applicants are advised to provide an estimated period for which the site laboratory or mobile laboratory will be sited in a location.

As a general guide, site laboratory is normally located at a site not exceeding three years.

2.6 Pre-assessment (Preliminary Assessment): One or more assessments conducted at an applicant's calibration / testing laboratory and if applicable, its calibration / testing sites prior to Compliance Assessment.

2.7 Compliance Assessment: An initial on-site assessment conducted by an assessment team at the premises of a laboratory and if applicable, its calibration / testing sites for verifying, by means of an independent, impartial and objective audit and ascertaining full compliance with SAMM accreditation criteria and requirements. Compliance assessment is also conducted prior to award of accreditation.

2.8 Surveillance Assessment: One or more on-site assessments, conducted by assessment team(s), at periodic intervals at the premises of an accredited laboratory and if applicable, its calibration / testing sites for verifying, by means of an independent, impartial and objective audit the continued compliance of the laboratory quality system with SAMM accreditation criteria and requirements.

2.9 Re-assessment: An on-site assessment conducted normally prior to expiry of an accreditation certificate, by an assessment team at the premises of a laboratory and if applicable, its calibration / testing sites for verifying, by means of an independent, impartial and objective audit and ascertaining full compliance with SAMM accreditation criteria and requirements. The conduct of reassessment may also be applicable to a request or procedure for restoration of an inoperative accreditation, or for restoration of a suspended accreditation.

2.10 Organisations (including Companies, Consultancies, Partnerships): legal entity comprising one or more individuals who do not have a permanent laboratory but who measure, examine, test, calibrate or otherwise determine the characteristics or performance of equipment, materials or products on site.

2.11 Site calibration /testing categories. Three categories of site calibration /testing have been identified and defined as follows:-

a) CATEGORY I: Site calibration / testing is performed by staff sent out on- site by a permanent laboratory that holds SAMM accreditation.

b) CATEGORY II: Site calibration / testing is performed in a site Laboratory or mobile laboratory, (or by staff sent out by a site laboratory or mobile laboratory), which is under the responsibility of the permanent laboratory that holds SAMM accreditation.c) CATEGORY III: Site calibration / testing is performed on site by calibration / testing personnel of an organisation that does not have a permanent calibration / testing laboratory.under Category III, calibration / testing may be performed using:

i) portable test equipment,

ii) a site laboratory,

iii) a mobile laboratory or

iv) equipment from a mobile or site laboratory.

3 ACCREDITATION CRITERIA AND REQUIREMENTS

3.1 The accreditation criteria and requirements applicable to any of the above three (3) categories of laboratories are identical to those applicable to the permanent laboratory.

These requirements are as documented in SAMM Accreditation Standard MS ISO/IEC 17025, SAMM policy and other SAMM documents.

3. 2 Laboratory quality manual shall address the requirements contained in this document. Procedures shall exist and address the nature of site calibration / testing and it shall include the application of quality assurance system in such activities providing technical confidence and integrity in the same way calibration / test data are generated in a permanent laboratory.

4 APPLICATION FOR ACCREDITATION OF SITE CALIBRATION / TESTING

4.1 Categories I and II

a) an organisation operating a permanent laboratory already holding SAMM accreditation may submit application for extension of accreditation for site calibration / testing under Category I or II as defined in this document.

b) an organisation operating a permanent laboratory that also performs Category I or II site calibration / testing may submit simultaneous applications for accreditation for both the permanent laboratory and site calibration / testing.

c) However, if there are reasons to expect that administrative, operational or logistic problems are likely to be encountered in the assessment of both the permanent and site laboratories, STANDARDS MALAYSIA Accreditation Division will normally recommend that application for site calibration / testing be deferred after the permanent laboratory has gained SAMM accreditation.

Note: Application for accreditation solely for site calibration / testing under Categories I and II will not be accepted from an organisation that does not hold SAMM accreditation for its permanent laboratory if that organisation has a permanent laboratory for the same calibration / testing activities.

d) an organisation is required to make a separate application for accreditation for site calibration / testing even though the permanent laboratory has been accredited for the same scope.

4.2 CATEGORY III

An organisation not possessing a permanent laboratory may submit application for accreditation under Category III. Applicants under this Category should familiarize themselves with and understand the requirements of SAMM Accreditation Criteria MS ISO/IEC 17025, SAMM Policy and other relevant SAMM documents. Failure to comply with the requirements of these documents would result in failure in obtaining accreditation or would cause unnecessary delay in the processing of application.

5 ACCREDITATION PROCEDURES

5.1 Categories I, II and III for SITE CALIBRATION / TESTING

a) Application details

In addition the following requirements apply:

i) a list of the calibration/measurement or tests for which accreditation for site calibration / testing is sought.

ii) the types of site calibration/testing, site location involved, description of site/location (e.g. as detailed in contract) and a register of current site calibration / testing activities.

iii) In the case of Category II, description and identification of each site or mobile laboratory and the nature of site calibration/testing.

iv) In the case of Category III, an applicant must provide a description and identification of each mobile laboratory, if any, and provide details of the nature of business or organisation.

Note: For Categories I and II, relevant section(s) of the laboratory quality manual covering the quality assurance / control arrangements for site calibration / testing should be submitted with the application. For category III, a copy of Quality manual should be submitted. These arrangements shall satisfy the requirements of the SAMM Accreditation Standard MS ISO/IEC 17025, SAMM Policy and other relevant documents.

5.2 Assessment

a) On receipt of application, SAMM staff will check the application information for completeness. Once application could be accepted, applicant will be invoiced for the appropriate application fees.

b) Lead Assessor will:

i) perform adequacy audit and examine the relevant controlled documents held in the organization; ii) perform as appropriate pre-assessment and/or compliance assessment and evaluate both the operation of the quality system and the calibration / testing competence on, as the case may be, the permanent, site (including customer’s site) , and mobile laboratory(ies).

6 AWARD OR EXTENSION OF ACCREDITATION

Award or extension of accreditation for site calibration / testing will be granted:

a) after all non-conformities identified during initial assessment have been satisfactorily discharged and documented evidence submitted to SAMM Secretariat.

b) for specific tests / calibrations or types of tests / calibrations considered to be within the competence of the staff of the permanent laboratory.

7 CERTIFICATE OF ACCREDITATION AND SCHEDULE

7.1 For Category I and II site calibration / testing, where the application has been submitted simultaneously with the application for the permanent laboratory, a certificate of accreditation will be issued with separate schedules for accredited calibrations / tests in the permanent laboratory and for those in the site category.

7.2 For Category I and II site calibration / testing, where the application has been submitted as an extension of accreditation after the permanent laboratory has gained accreditation, a schedule will be issued as a supplement.

7.3 For Category III site calibration / testing, a certificate of accreditation bearing the SAMM accreditation number and permanent business address of the organisation will be issued together with a schedule listing the relevant information.

7.4 The certificate for any of the categories shall bear the address of the permanent laboratory or organisation. The accompanying schedule however will give outline details of the sites (for Categories II and III) which calibration / testing is performed.

7.5 The following wordings will be indicated on the Schedule as the case may be:

" The permanent laboratory [name] has been accredited to perform the following site calibration / testing:- " or

" The permanent laboratory [name] has been accredited to set up site laboratories and/or to operate mobile laboratories to carry out the following site calibration / testing:- "

or organisation [name] has been accredited to set up site laboratories and/or to operate mobile laboratories to carry out the following site calibration / testing:- "

8 MAINTENANCE OF ACCREDITATION (SURVEILLANCE OR REASSESSMENT)

8.1 Site calibration / testing activities will be subject to periodic surveillance visits by SAMM assessment teams in accordance with established practice as described in SAMM Policy 1 to ensure continuing compliance with the MS ISO/IEC17025.

8.2 Surveillance visits to one or more calibration / testing sites will be additional to those made to the permanent laboratory. Documents relating to site activities which are held in permanent laboratory will be examined.

8.3 Maintenance of accreditation may be supplemented by a requirement to participate in nominated proficiency test checks.

8.4 Should SAMM have reasons to believe that the SAMM requirements are not being observed, sites may be visited at random with little or no warning. 8.5 Assessors will make recommendations to the SAMM Secretariat after surveillance visits to site and/or permanent laboratory premises. They may recommend:

a) that accreditation be maintained if no non-conformities are identified or if the laboratory discharges any non-conformities identified during surveillance visits within the agreed time-scale.

b) that accreditation be reduced or withdrawn for the site calibration / testing concerned and that a suitably revised site calibration / testing Accreditation Schedule is issued.

c) that accreditation be withdrawn for the calibration(s) / test(s) concerned from the Accreditation Schedules issued for calibration / testing on site and in the permanent laboratory.

d) that accreditation for site calibration / testing be withdrawn completely.

e) that accreditation of the permanent laboratory be suspended or withdrawn as a result of failure to comply with SAMM accreditation criteria when calibration / testing on site. (This would automatically result in withdrawal of accreditation for site calibration / testing or mobile laboratory).

9 SUSPENSION, WITHDRAWAL AND REINSTATEMENT OF ACCREDITATION

9.1 If the accreditation of a permanent laboratory or its site calibration / testing activities is suspended it will be necessary for the laboratory to make rectification before accreditation can be reinstated in accordance with STANDARDS MALAYSIA procedures.

9.2 SAMM is satisfied that the laboratory has discharged the non-conformities that caused the withdrawal of accreditation then the process of initial assessment, etc. will be initiated. All appropriate fees will be paid by the laboratory.

9.3 If the accreditation of a permanent laboratory or its site calibration / testing activities is partially or wholly withdrawn it will be necessary for the laboratory to make fresh application.

10 NOTIFICATION OF CHANGE

10.1 In the event of the closure of a Category II or III site laboratory or the cessation of the use of a site calibration / testing facility or a mobile laboratory it will be the responsibility of the permanent laboratory or organisation to notify SAMM Secretariat with the necessary details.

10.2 The permanent laboratory or organisation shall at all times maintain an up-to- date register of site calibration / testing, site laboratory(ies) and/or mobile laboratory(ies). The register shall be available for inspection by SAMM assessment team upon request.

Source from:

Source from:

Standards Malaysia www.jsm.gov.my

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