DEPARTMENT OF STANDARDS MALAYSIA SCHEME FOR THE ACCREDITATION OF CERTIFICATION BODIES (The ACB Scheme) ACB 1 Issue 2, 15 February 2007 (Amd. 5, 18 April 2012) TERMS AND CONDITIONS GOVERNING THE SCHEME FOR THE ACCREDITATION OF CERTIFICATION BODIES (ACB) Authority To Issue Director General Department of Standards Malaysia INDEX TOPIC PAGE 1. Scope and Application 1 2. References 1 3. Definitions 2 4 General 3 5. Prescription of Accreditation Criteria 5 6. Eligibility 5 7. Conditions for Accreditation 5 8 Significance of Accreditation 6 9. Notification of Change 7 10. Appeals 7 ACB 1: Terms and Conditions Governing The Scheme for the Accreditation of Certification Bodies (ACB) _____________________________________________________________________ 1. SCOPE AND APPLICATION 1.1 This document prescribes the terms and conditions governing the accreditation of certification bodies by the Department of Standards Malaysia (STANDARDS MALAYSIA). This document should be read in conjunction with the relevant published policy and procedure documents governing the ACB scheme, including the following documents: MS ISO/IEC 17021: Requirements for bodies providing audit and certification of management systems MS ISO/IEC Guide 65: General requirements for bodies operating product certification systems IAF GD 5:2006: IAF guidance on the Application of ISO/IEC Guide 65 MS ISO/IEC 17024: Conformity assessment – General requirements for bodies operating certification of persons MS ISO/IEC 27006: Information technology-Security techniquesRequirements for bodies providing audit and certification of information security management systems ISO/TS 22003:2007: Food safety management systems - Requirements for bodies providing audit and certification of food safety management systems ACB-HALAL PRODUCT: STANDARDS MALAYSIA Requirements for Bodies Operating Halal Product Certification System ACB-OSH: STANDARDS MALAYSIA Requirements for Bodies Operating Assessment and Certification of Occupational Safety and Health Management Systems ACB-HACCP: STANDARDS MALAYSIA Requirements for The Accreditation of Bodies Operating Certification of HACCP Based Food Safety Systems ACB-FMC : Competency Requirements for Bodies Operating Forest Management Certification ACB-FMC : Audit Duration (Natural Forest) for Bodies Operating Forest Management Certification ACB-FMC : Peer Review Process Requirements for Bodies Operating Forest Management Certification ACB-FMC 2-1 : Competency Requirements for Bodies Operating Forest Management Certification ( Forest Plantation) under the Malaysian Timber Certification Scheme ACB-FMC 2-2 : Audit Duration for Bodies Operating Forest Management Certification ( Forest Plantation) under the Malaysian Timber Certification Scheme Issue 2, 15 February 2007 (Amd. 5, 18 April 2012) Page 1 of 8 ACB 1: Terms and Conditions Governing The Scheme for the Accreditation of Certification Bodies (ACB) _____________________________________________________________________ ACB-FMC 2-3 : Peer Review Process Requirements for Bodies Operating Forest Management Certification ( Forest Plantation) under the Malaysian Timber Certification Scheme ACB-FMC 2-4 : Requirements for Stakeholder Consultation for Forest Audit for Bodies Operating Forest Management Certification ( Forest Plantation) under the Malaysian Timber Certification Scheme ACB-OPSC : Audit Duration for Bodies Operating Oil Palm Supply Cha in Management Systems Certification ACB-OPSC : Competency Requirements for Bodies Operating Oil Palm Supply Chain Management Systems Certification ACB-WEMS : STANDARDS MALAYSIA requirements for Bodies Operating Work Environment Management Systems Certification ACB 7: The conduct of accreditation assessments IAF Mandatory documents 2. REFERENCES 2.1 ISO/IEC 17000 – Conformity assessment – Vocabulary and general principles 2.2 MS ISO/IEC 17011 – Conformity assessment – General requirements for accreditation bodies accrediting conformity assessment bodies 3. DEFINITIONS 3.1 For the purpose of this document, definitions in the relevant ISO standards and the relevant ISO/IEC Guides shall apply. The following definitions and abbreviations shall also apply. (a) Accreditation: Third-party attestation related to a conformity assessment conveying formal demonstration of its competence to carry out specific conformity assessment tasks. (b) Accreditation certificate: Formal document or a set of documents, stating that accreditation has been granted for the defined scope. [Note: The certificate of accreditation is valid for three (3) years.] (c) Accreditation criteria: Includes the appropriate accreditation standard, and all STANDARDS MALAYSIA approved policies and procedures at the time of application, and those approved from time to time subsequent to accreditation, that are applicable to the accreditation program under which accreditation is sought. (d) ACB Symbol: Symbol issued by STANDARDS MALAYSIA under the Scheme for the Accreditation of Certification Bodies (the ACB Scheme) to be used by accredited certification bodies to indicate their accredited status. Issue 2, 15 February 2007 (Amd. 5, 18 April 2012) Page 1 of 8 ACB 1: Terms and Conditions Governing The Scheme for the Accreditation of Certification Bodies (ACB) _____________________________________________________________________ (e) Assessment: Process undertaken by an accreditation body to assess the competence of a CAB, based on particular standard(s) and / or other normative documents and for a defined scope of accreditation. (f) Assessor: Person assigned by an accreditation body to perform, alone or as part of an assessment team, an assessment of a CAB (g) Authorised management representative: A person, with the necessary authority, usually the senior executive officer, of the certification body formally appointed or nominated by its top management to represent it in all matters pertaining to accreditation. (h) Certification: Third-party attestation related to products, process, system or persons (i) Conformity assessment body: Body that performs conformity assessment services and that can be the object of accreditation e.g: testing and calibration laboratories, certification bodies, inspection bodies. (j) Malaysian Standards and Accreditation Council, MSAC (hereinafter referred to as the Council): An Advisory Council established under Section 13 of the Standards of Malaysia Act 1996 with delegated functions under the said Act in advising the Minister on policies, criteria and procedures for the administration of a national accreditation system. (k) Malaysian National Accreditation Committee (MyNAC): A Committee of the Council established under Section 14 of the Standards of Malaysia Act 1996 and act on behalf of the Council for discharging the duties and functions of the Council in connection with accreditation matters. 4. GENERAL 4.1 The Department of Standards Malaysia (STANDARDS MALAYSIA) is the sole authority for processing application and undertaking, assessment of certification bodies applying for accreditation. 4.2 The Director General is empowered under Section 16 of the Standards of Malaysia Act 1996 to make accreditation decision such as granting, maintaining, extending, reducing, suspending and withdrawing accreditation. 4.3 STANDARDS MALAYSIA will set the procedures and conditions by which applications for accreditation will be made and the circumstances in which accreditation may be granted, maintained, extended, reduced, refused, suspended or withdrawn. Under special circumstances, STANDARDS MALAYSIA may also consider procedures and conditions under which accreditation may be transferred from one legal entity to another legal entity such as in a situation resulting from organisational restructure. Application for transfer will be considered on a case to case basis. Issue 2, 15 February 2007 Page 3 of 8 ACB 1: Terms and Conditions Governing The Scheme for the Accreditation of Certification Bodies (ACB) _____________________________________________________________________ 4.4 STANDARDS MALAYSIA will prescribe how monitoring of compliance with the Accreditation Criteria will be carried out. 4.5 The Director General of STANDARDS MALAYSIA will grant and maintain accreditation to certification bodies which: (a) comply with the Accreditation Criteria; (b) has sufficient evidence to demonstrate that its arrangements for management review and internal audit have been implemented, are effective and will be maintained; (c) has sufficient evidence to demonstrate that adequate resources can be deployed to conduct audits meeting the requirements of relevant standard and the corresponding IAF Guidance; (d) pay such fees as are due to STANDARDS MALAYSIA in the manner prescribed by STANDARDS MALAYSIA and, (e) give undertakings as STANDARDS MALAYSIA may require. 4.6 The frequency with which certification bodies are normally subject to surveillance and re-assessment will be prescribed by STANDARDS MALAYSIA. As a general rule, surveillance visits would normally be carried out at intervals of around 6 months and re-assessment every 3 years. 4.7 However, after the first cycle of 3 years, the frequency of surveillance will be reduced as follows: i) Surveillance I : 11 months after the renewal of its Certificate of Accreditation ii) Surveillance II : 11 months from Surveillance I iii) Re-assessment : 10 months from Surveillance II Over and above this, STANDARDS MALAYSIA reserves the right to carry out unscheduled surveillance visits or re-assessment at intervals other than those prescribed if circumstances indicate that continued confidence in the accredited programme can not be sustained without such unscheduled action taking place. 4.8 STANDARDS MALAYSIA may, at its discretion, suspend accreditation, (a) if a certification body is providing certification to any standard used as a basis for accrediting laboratories (i.e ISO/IEC 17025 or ISO 15189); (b) if a certification body fails to submit the evidence of corrective action within the agreed time frame; (c) if a certification body fails to complete the total number of witness audits for one cycle of accreditation; (d) based on the outcome of any assessment; (e) results of investigation into a complaint; Issue 2, 15 February 2007 (Amd. 1, 27 August 2009) Page 4 of 8 ACB 1: Terms and Conditions Governing The Scheme for the Accreditation of Certification Bodies (ACB) _____________________________________________________________________ 4.9 STANDARDS MALAYSIA may, at its discretion, withdraw accreditation, (a) if a certification body, being a Company, enters into liquidation, whether compulsory or voluntary (but not including liquidation for the purposes of re-construction), or has a receiver of its business appointed, or (b) if a certification body fails in any respects to comply with the law of the country, (c) if, in the view of STANDARDS MALAYSIA, a certification body has made unreasonable or irresponsible use of sub-contracting. (d) if suspension is not satisfactorily lifted; (f) if lapse of suspension period without any satisfactory action from CABs 4.10 STANDARDS MALAYSIA may, at its discretion, reduce the scope of an accreditation or require reassessment in the light of changes as stipulated in clause 9.2 of this document. 4.11 All information gained by STANDARDS MALAYSIA, its Advisory Council, Committees, Panels and its representatives and staff in the assessment of certification bodies will be confidential between STANDARDS MALAYSIA and the certification body and such information will be handled within STANDARDS MALAYSIA on a strict ‘need to know’ basis and will not, subject to the law of the land, be divulged without the prior written consent of the certification body. 5. PRESCRIPTION OF ACCREDITATION CRITERIA 5.1 STANDARDS MALAYSIA is responsible for formulating all policies, criteria, accreditation and operational procedures, affecting the accreditation of certification bodies. 5.2 STANDARDS MALAYSIA will set the relevant Accreditation Criteria based on or adopted directly from ISO/IEC or other international harmonised documents, against which an applicant certification body should be assessed. The Council reserves the right, if necessary, to formulate its own guidelines or to adopt / use the relevant international interpretative documents as guidelines for assessment of compliance. 6. ELIGIBILITY 6.1 Any certification body in Malaysia willing to demonstrate compliance with the criteria and requirements for accreditation of STANDARDS MALAYSIA may apply for accreditation. Whether a certification body operates on a “profit” or “not for profit” basis shall not be a consideration for the purpose of determining eligibility. 7. CONDITIONS FOR ACCREDITATION 7.1 The certification body shall: Issue 2, 15 February 2007 Page 5 of 8 ACB 1: Terms and Conditions Governing The Scheme for the Accreditation of Certification Bodies (ACB) _____________________________________________________________________ (a) offer to all clients a standard of service consistent with the Accreditation Criteria to which it has been accredited by STANDARDS MALAYSIA. (b) offer STANDARDS MALAYSIA and its representatives such reasonable accommodation and cooperation as necessary, to enable STANDARDS MALAYSIA to monitor compliance with the Accreditation Criteria. This shall apply to all premises where the conformity assessment services take place. (c) at all times comply with the Accreditation Criteria. This includes the commitment to adapt to changes in the requirements for accreditation notified by STANDARDS MALAYSIA from time to time. (d) provide access to STANDARDS MALAYSIA to information, documents and records as necessary for the assessment and maintenance of accreditation, including those that provide insight into the level of independence and impartiality of the CB from its related bodies, where applicable. When requested, the records of all complaints, appeals and disputes and subsequent actions shall also be made available to STANDARDS MALAYSIA. (e) arrange for the witnessing of CB’s auditing or assessment of its client when requested by STANDARDS MALAYSIA. (f) only claim that it is accredited in respect of those scopes / activities which are the subject of the certificate of accreditation and which are carried out in accordance with the Accreditation Criteria. (g) not use the accreditation report or certificate (nor any part thereof) and the ACB Symbol in such a manner as to bring the arrangements for accreditation into disrepute, and shall not make any statement, and shall take such immediate steps as STANDARDS MALAYSIA may require to correct any statement, which STANDARDS MALAYSIA considers to be misleading. (h) pay such fees for application, assessment, surveillance other services and if applicable, other additional costs incurred, as shall be from time to time determined by STANDARDS MALAYSIA. (i) endeavour to ensure that the fact of accreditation shall not be used for promotional or publicity purposes in any way that STANDARDS MALAYSIA may consider to be misleading, and shall take such immediate steps as STANDARDS MALAYSIA may require to correct any such misleading use. (j) make it clear in all contacts with its clients that a certification certificate issued by it in no way implies that the product or service certified is approved by STANDARDS MALAYSIA. (k) upon the suspension of accreditation (however determined) forthwith discontinue its use of a reference to accreditation and withdraw all advertising matter which contains any reference thereto. Issue 2, 15 February 2007 (Amd.1, 25 November 2008) Page 6 of 8 ACB 1: Terms and Conditions Governing The Scheme for the Accreditation of Certification Bodies (ACB) _____________________________________________________________________ (l) fully conform to the requirements of STANDARDS MALAYSIA for claiming accreditation status, when making reference to its accreditation in communication media such as the Internet, documents, brochures, billboards or advertisements. 7.2 The certification body may use in documents, brochures or advertising media, with appropriate variation, the phrases ‘an accredited certification / body listed under accreditation number.’ and ‘listed in STANDARDS MALAYSIA Directory of accredited certification bodies under accreditation number..’. The certification body shall, upon withdrawal of accreditation, take reasonable steps to ensure the prompt withdrawal of all such documents, brochures and advertising media. 7.3 The certification body where relevant shall carry adequate third party indemnity insurance covering its certification / registration activities. 8. SIGNIFICANCE OF ACCREDITATION 8.1 Accreditation should not be regarded as in any way diminishing the normal contractual responsibilities between the certification body and its client. While accreditation is an indication of the integrity and competence of the certification body, it cannot be taken to constitute a guarantee by that the certification body always maintains a particular level of performance. 8.2 Arrangements for charging of fees between a certification body and its client are in no way the responsibility of, and are not subject to the control of STANDARDS MALAYSIA. 9. NOTIFICATION OF CHANGE 9.1 The certification body shall inform STANDARDS MALAYSIA immediately of any changes bearing on the certification body’s compliance with these Terms and Conditions and the accreditation criteria, or otherwise affecting the certification body’s capability or scope of activity. 9.2 The certification body shall inform STANDARDS MALAYSIA immediately of any intended changes to its: i) ii) iii) iv) v) legal, commercial, ownership or organisational status; organisation, top management and key personnel; policies or procedures, where appropriate; premises; equipment, facilities, working environment or other resources, where significant vi) vii) scope of accreditation; and other such matters that may affect the ability of the CB to fulfill requirements for accreditation. 9.3 The certification body shall have procedures to ensure that the information supplied to STANDARDS MALAYSIA is kept up-to-date. 9.4 The certification body will be given due notice of any intended changes relating to the Accreditation Criteria and will also be given such time, as in the Issue 2, 15 February 2007 (Amd.1, 25 November 2008) Page 7 of 8 ACB 1: Terms and Conditions Governing The Scheme for the Accreditation of Certification Bodies (ACB) _____________________________________________________________________ opinion of STANDARDS MALAYSIA is reasonable, to carry out the necessary adjustments to its procedures. Unless otherwise specified, a period of 6 months from the date of notification of change by STANDARDS MALAYSIA will be given for certification body to carry out the necessary adjustments to its procedures. The certification body shall notify STANDARDS MALAYSIA when such adjustments have been completed. STANDARDS MALAYSIA shall verify that each CAB carries out any necessary adjustment. 9.5 A certificate of accreditation may be relinquished by a certification body upon giving one month’s notice in writing. 9.6 Any notice or other communication given or sent by STANDARDS MALAYSIA to a certification body in connection with, or under, these Terms and Conditions, shall be deemed to be duly given or sent if sent by recorded delivery post to the address of the certification body last known to STANDARDS MALAYSIA and shall be deemed to be given at the time when the same would have been delivered in the ordinary course of post. 10. APPEAL 10.1 Appeals by a CB for reconsideration of any adverse decision made by STANDARDS MALAYSIA related to its desired accreditation status, including recommendation for refusal or withdrawal of accreditation will be considered within the STANDARDS MALAYSIA Accreditation System. Appeals shall be handled within the accreditation system always in an impartial and independent manner. Issue 2, 15 February 2007 Page 7 of 7