A01-09 REFERENCES, ACRONYMS AND DEFINITIONS
Approved By: Reviewed By: Date of Approval: Date of Implementation:
Chief Executive Officer: Ron Josias SANAS Executive Committee Quality Manager: Yolanda Vinnicombe 2013-06-13 2013-06-13
© SANAS
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CONTENTS:
1.
Purpose and Scope........................................................................................................................ 3
2.
References .................................................................................................................................... 3
3.
Acronyms ....................................................................................................................................... 4
4.
Definitions ...................................................................................................................................... 7
ADDENDUM 1: Amendment Record. ...................................................................................................... 17
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A 01-09
1.
Purpose and Scope The purpose of this document is to have a centralised point of reference to confirm the References, Acronyms and Definitions as used in SANAS documentation. This document is applicable to all of SANAS and its stakeholders
2.
References Act 18, 2006: Act 19, 2006:
Measurement Units and Measurement Standards Act, 2006. Accreditation for Conformity Assessment, Calibration and Good Laboratory Practice Act, 2006. Act 25, 2002 Electronic Communication and Transactions Act, 2002 BBBEE Codes: BBBEE Codes of Practice IAF and ILAC Guidance: IAF and/or ILAC Documents on the Application of ISO/IEC Standards ILAC and IAF Policies: ILAC and IAF Policies as published from time to time ISO/IEC Guide 34: General Requirements for the Competence of Reference Material Producers ISO/IEC Guide 65: General Requirements for Bodies Operating Product Certification Systems ISO/IEC Guide 99: International Vocabulary of Metrology – Basic and General Concepts and Associated Terms (VIM) ISO/IEC 9001: Standard for Quality Management Systems ISO/IEC 14001: Environmental Management Standard ISO/IEC 17011: General Requirements for Accreditation Bodies Accrediting Conformity Assessment Bodies ISO/IEC 17020: Conformity Assessment – General Criteria for the Operation of Various Types of Bodies Performing Inspection ISO/IEC 17021: Requirements for Bodies Providing Audit and Certification of Management Systems ISO/IEC 17024: Conformity Assessment – General Requirements for Bodies Operating Certification of Persons ISO/IEC 17025: General Requirements for the Competence of Testing and Calibration Laboratories ISO/IEC 17030: General Requirements for Third-Party Marks of Conformity ISO/IEC 17043: Conformity assessment – General requirements for proficiency testing ISO/IEC 18001 Occupational Health and Safety Management Systems - Requirements ISO/IEC 19011: Guidelines for Quality and/or Environmental Management Systems Auditing ISO 15189: Medical Laboratories - Particular Requirements for Quality and Competence King III Corporate Governance King III Report OECD: OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring PFMA: Public Finance Management Act 1 of 1999 SANS 10227: Criteria for the Operation of Inspection Authorities Performing Inspection in Terms of the Pressure Equipment Regulations SANS 10378: General Requirements for the Competence of Verification Laboratories in Terms of the Trade Metrology Act 77 of 1973. SANS 14065 Requirements for greenhouse gas (GHG) validation and verification bodies for use in accreditation or other forms of recognition SANS 50010: Measurement and Verification of Energy Savings SANS 1162: Responsible Tourism – Requirements. th SI of units: The International System of Units, BIPM, 8 Ed 2006, ISBN 92-822-2213-6. VICH: International Cooperation on Harmonisation of Technical Requirements for the Registration of Veterinary Medicinal Products
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CIPM:
3.
Acronyms A2LA: AB: AAC: AF: AFRAC: AFRIMETS: AFSA: AFSEC: AGM: AIA (1): AIA (2): APLAC: ARC: ARSO: ASGISA: AUC: BBBEE: BEE: BIPM:
BMC: BoD: BRC: BSI: BTS CAD: CAB: CB: CEMAC: CEN:
CENELEC: CGPM: CNLA: CEO: CFO:
American Association for Laboratory Accreditation, USA Accreditation Body - Authoritative Body that Performs Accreditation Approval Advisory Committee Advisory Forum African Cooperation in Accreditation Intra-Africa Metrology System Arbitration Foundation of South Africa African Electrotechnical Standardisation Commission Annual General Meeting Approved Inspection Authorities Association of Inspection Authorities Asia Pacific Laboratory Accreditation Co-operation Agricultural Research Council African Regional Standards Organisation Accelerated and Shared Growth Initiative – South Africa African Union Commission Broad Based Black Economic Empowerment Black Economic Empowerment Bureau International des Poids et Mesures (International Bureau of Weights and Measures) Best Measurement Capability Board of Directors British Retail Certification British Standards Institute Blood Transfusion Service Complaint, Appeal and Dispute Conformity Assessment Body Certification Body Economic and Monetary Community of Central Africa European Committee for Standardisation (Comitè Européen de Normalisation) European Committee for Electrotechnical Standardisation Conférence Générale des Poids et Mesures Chinese National Laboratory Accreditation Chief Executive Officer Chief Financial Officer
CMC: COA: COF: COFRAC: COMESA: COTII: CRM: CSIR: CSoA: DEA: DOA: DOE: DOH: DOL: the dti: EA: EAC: ECCAS: ECOWAS: ECSA: EEC: EGAC: EMS: ENAO: ENE EU: EXCO FM: FCL: FSL: GCLP: GCP: GCPV: GFSI: GHG: GLP: GMP: HACCP: HR:
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Comité international des poids et mesures (International Committee of weights and measures) Calibration and Measurement Capability Certificate of Accreditation Clearance of Findings Comite Francais d’acreditation Common Market for Eastern and Southern Africa Council of Trade and Industry Institutions Certified Reference Material Council for Scientific and Industrial Research Certificate and Schedule of Accreditation Department of Environmental Affairs Department of Agriculture, Forestry and Fisheries Department of Energy Department of Health Department of Labour Department of Trade and Industry European Co-operation for Accreditation East African Community Economic Community of Central African States Economic Community of West African States Engineering Council of South Africa. Employment Equity Commission Egyptian Accreditation Council Environmental Management System Ethiopian National Accreditation Office Estimates of National Expenditure European Union SANAS Executive Committee Field Manager Forensic Chemical Laboratory Forensic Science Laboratory Good Clinical Laboratory Practice Good Clinical Practice Good Clinical Practice for Veterinary Global Food Safety Initiative Greenhouse Gas Good Laboratory Practice Good Manufacturing Practice Hazard Analysis and Critical Control Point Human Resources
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A 01-09 HSRC: HPCSA: IAAC: IAF: IAS: ICT: IEC: ILAC: ILC: IMC: IPAP: IRCA: ISO: ISO CASCO: IT: ISRAC: JAS-ANZ: JCRB: JCTLM: JWG: KCDB KENAS: MAD: MAURITAS: MCC: MIG: MLA: MoA: MoU: MRA: MTEF: NA: NAB: NAFP: NATA: NBS: NDT: NDT: NEDLAC:
Human Sciences Research Council Health Professions Council of South Africa Inter American Accreditation Cooperation International Accreditation Forum International Accounting Standards Information and Communication Technology International Electrotechnical Commission International Laboratory Accreditation Co-operation Interlaboratory Comparison Integrated Marketing Communications Industrial Policy Action Plan International Register of Certified Auditors International Organisation for Standardization ISO Council Committee on Conformity Assessment Information Technology Israel laboratory Accreditation Authority Joint Accreditation System – Australia New Zealand Joint Committee of Regional Metrology Organisations Joint Committee for Traceability in Laboratory Medicine Joint Working Group Key comparison database Kenyan Accreditation Service Mutual Acceptance of Data Mauritius Accreditation Service Medicines Control Council Metrology Instrumentation Group Multilateral Arrangement Memorandum of Agreement Memorandum of Understanding Mutual Recognition Arrangement Medium Term Expenditure Framework Norwegian Accreditation National Accreditation Body National Accreditation Focal Point National Association of Testing Laboratories, Australia National Bureau of Standards Non Destructive Testing National Department of Tourism National Economic Development and Labour Advisory Council
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NEPAD: NGO: NLA: NMI: NMISA: NMS&M: NNR: NPL: NR: NRCS: NSI: NT: NVLAP: OIML: OECD: OHS: OHS Act: OHSAS: OHSMS: PAIA: PBMR: PCS: PDI: PFMA: PMC: PPE: PSA: PT: PTB: QA: QMS: R&D: REC: RF: RMP: RvA: SAATCA: SABS: SACNASP:
New Partnership for African’s Development National Governmental Organisations National Laboratory Association National Metrology Institute National Metrology Institute of South Africa National Measuring Standards & Metrology National Nuclear Regulator National Physical Laboratory Nominated Representative National Regulator for Compulsory Specification National Standards Institute National Treasury National Voluntary Laboratory Accreditation Program Organisation International de Mètrologie Lègale Organisation for Economic Cooperation and Development Occupational Health and Safety Occupational Health and Safety Act 85 of 1993 as Amended Occupational Health and Safety Assessment Services Occupational Health and Safety Management Systems Promotion of Access to Information Act 2 of 2000 Pebble Bed Modular Reactor Product Certification Service Previously Disadvantaged Individual Public Finance Management Act Project Management Committee Property, Plant and Equipment Public Servants Association Proficiency Testing Physikalisch Technische Bundesanstalt Quality Assurance Quality Management System Research and Development Regional Economic Community Reference Material Reference Material Producer Raad Voor Accreditatie (Netherlands Accreditation Body). Southern African Auditor and Training Certification Association South African Bureau of Standards South African Council for Natural Scientific Professions
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SADC: SADCA:
SADCAS: SADCMEL: SADCMET: SADCSTAN: SAHRC: SAIMC: SAIPE: SANAS: SANS: SAQI: SASQC: SAZ: SANAS: SAQA: SAQCC: SETA: SI: SoA: SOP: SQAM: SRCME: SRM: STANSA: STC: TA: TBT: TPA: TS: TUNAC: UKAS: UNECA: UNIDO: UoM:
Southern African Development Community Southern African Development Community Cooperation in Accreditation Southern African Development Community Accreditation Service SADC Cooperation in Legal Metrology SADC Cooperation in Measurement Traceability SADC Cooperation in Standardisation South African Human Rights Commission South African Institute for Measurement and Control South African Institute of Production Engineers South African National Accreditation System South African National Standard South African Qualifications Institute South African Society of Quality Control Standards Association of Zimbabwe South African National Accreditation System South African Qualification Authority South African Qualification Certification Committee Services Sector Education and Training Authority International System of Units Schedule of Accreditation Standard Operating Procedure Standardisation Quality Assurance, Accreditation and Metrology SADC Resource Centre for Metrology Education Standard Reference Material Standards South Africa Specialist Technical Committee Technical Assessor Technical Barriers to Trade Twinning Partnership Arrangement Technical Signatory Tunisian Accreditation Council United Kingdom Accreditation Service United Nations Economic Commission for Africa United Nations Industrial Development Organisation Uncertainty of Measurement © SANAS
VIM: VUP: WADA: WHO: WTO:
International Vocabulary of Metrology Vessels under Pressure World Anti-Doping Agency World Health Organisation World Trade Organisation
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4.
Definitions 4.1
“Accreditation” means third–party attestation related to a CAB conveying formal demonstration of its competence to carry out specific conformity assessment tasks;
4.2
“Accreditation Act” means the Accreditation for Conformity Assessment, Calibration and Good Laboratory Practices Act ( Act 19 of 2006);
4.3
“Accreditation Body” means an authoritative body that performs accreditation; Note: The authority of an accreditation body is generally derived from government.
4.4
“Accreditation Certificate” means a formal document or a set of documents, stating that accreditation has been granted for the defined scope;
4.5
“Accreditation Cycle” means the period of validity of the Accreditation Certificate, commencing on the date on which Accreditation is granted, and ending on the date on which Accreditation ceases to be effective for whatever reason, including, expiration, withdrawal or suspension;
4.6
“Accreditation Criteria” means the requirements and conditions that have to be met before a Laboratory, Body, Proficiency Scheme Provider or Certification body can be considered for accreditation by SANAS;
4.7
“Accreditation Procedures” means the Accreditation requirements and procedures developed and utilised by SANAS to define the accreditation process;
4.8
“Accreditation Process” means the process of evaluating a CAB’s compliance with the requirements of Accreditation, which commences upon the receipt of an application form from a CAB and ends at the end of the Accreditation Cycle;
4.9
“Accreditation Requirements” means any and all requirements relating to Accreditation, including those specified in any accreditation standard, guide, regulation and/or any IAF/ILAC mandatory document which applies to a CAB, the Act and any policies, procedures and requirements of SANAS which applies to a CAB;
4.10
“Accreditation Schedule for Calibration Laboratory” means a document describing the parameters, ranges and best measurement capabilities for which a calibration laboratory is accredited. The document also contains other information including the names of authorised signatories of Laboratory Certificates;
4.11
“Accreditation Schedule for Testing Laboratory” means a document that defines the scope of accreditation in terms of materials/products tested, types of tests, properties measured and range of measurements. The techniques and test methods for which accreditation applies are identified as well as the names of authorised signatories of test reports;
4.12
“Accreditation Symbol” means a symbol issued by SANAS to be used by an accredited body to indicate its accreditation status;
4.13
“Accredited Facility” means an organisation or facility that has been accredited by SANAS or by a member of the recognition arrangements of ILAC or IAF;
4.14
“Accounting Authority” means the Board of SANAS, as determined by the PFMA;
4.15
“Advanced Electronic Signature” means an electronic signature which results from a process which has been accredited by an authority provided for in Section 37 of the Act, 25 of 2002;
4.16
“Adverse Decisions” means any decision made by SANAS that impedes the attainment of accreditation including a refusal to accept and application, a refusal to proceed with an assessment, corrective action requests, changes in the accreditation scope or decisions to deny, suspend or withdraw accreditation”;
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4.17
“Advisory Forum” means a forum consisting of representatives of bodies with an interest in accreditation, established by the BoD, and whose main objective is to provide strategic advice and guidance on any other matter to the BoD;
4.18
“Applicant” means any juristic person who has submitted as application for accreditation to SANAS;
4.19
“Application” means an application made in terms of the application form for accreditation and includes a reapplication;
4.20
“Application Form” means the form prescribed by SANAS for use by a CAB for the purpose of making Applications, including all the required supporting documentation as specified in the application form, which is available at www.sanas.co.za;
4.21
“Approval Advisory Committee (AAC)” means a SANAS committee whose task is to evaluate whether adequate information has been provided by the assessment team, and who on the basis of this information, determines whether the requirements for accreditation have been fulfilled, and whether accreditation can be granted or extended;
4.22
“Assessment” means a process undertaken by SANAS to assess the competence of a CAB, based on particular standard(s) and /or other normative documents and for a defined scope of accreditation; Assessing the competence of a CAB involves assessing the competence of the entire operations of the CAB, including the competence of the personnel, the validity of the conformity methodology and the validity of the conformity assessment results;
4.23
“Assessment Personnel” means an appropriately qualified person(s) assigned by SANAS to, alone or as part of an assessment team, perform an assessment or a person(s) assigned by SANAS to advise SANAS on accreditation decisions or give technical input;
4.24
“Assessment Report” means the report compiled by the Lead Assessor in conjunction with the assessment team. Parts of this report are presented to the applicant and his//her representatives immediately following completion of the assessment. The full report is submitted to the AAC for approval;
4.25
“Assessor” means a person assigned by SANAS to, alone or as part of an assessment team, perform an assessment of a CAB;
4.26
“Audit” means the systematic, independent, documented process for obtaining records, statements of fact or other relevant information and assessing them objectively to determine the extent to which specified requirements are fulfilled;
4.27
“Bilateral Arrangement” means an arrangement whereby two parties recognise or accept each other’s conformity assessment results;
4.28
“Blood Bank” means an organisation that acts as a repository for blood samples and specializes in blood typing, antibody identification, and transfusion services;
4.29
“Blood Transfusion Service” means an organisation that performs pre-transfusion and post-transfusion testing of human biological specimens;
4.30
“Calibration” means a set of operations that establish, under specified conditions, the relationship between values of quantities indicated by a measuring instrument or measuring system, or values represented by a material measure or a reference material, and the corresponding values realised by standards;
4.31
“Calibration and Measurement Capability” means a calibration and measurement capability available to customers under normal conditions as described in the laboratory’s scope of accreditation granted by a signatory to the ILAC arrangement or as published in the BIPM key comparison database (KCDB) of the CIPM MRA.
4.32
“Calibration Laboratory” means a body that performs a set of operations that establish, under specified conditions, the relationship between values of quantities indicated by a measuring instrument or measuring © SANAS
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A 01-09 system, or values represented by a material measure or reference material, and corresponding values realised by standards whatever their uncertainty; 4.33
“CE Mark” means a mark which indicates compliance with all European directives applicable to that product;
4.34
“Certification Body” means an organisation that certifies other organisations in respect of the compliance of their management systems, schemes or products with recognised specifications or standards;
4.35
“Certificate of GLP Compliance” means a formal document or set of documents stating that GLP compliance has been demonstrated;
4.36
“Certified Reference Material (CRM)” means a reference material, accompanied by documentation issued by an authoritative body and providing one or more specified property values with associated uncertainties and traceabilities, using valid procedures;
4.37
“Clearance of Findings Visit (COF)” means a process undertaken by a SANAS assessor(s) to assess the implementation of corrective actions raised during an assessment. It is during this visit that the CA’s are verified as cleared;
4.38
“Combined Mark” means collectively, the Accreditation Symbol and the ILAC and/or IAF logos;
4.39
“Compliance Certificate” means a formal document or a set of documents, stating that GLP/GCP Compliance has been granted for a defined scope;
4.40
“Compliance Cycle” means the period of validity of the GLP/GCP Compliance Certificate, commencing on the date on which GLP/GCP Compliance is granted, and ending on the date on which the Compliance Status ceases to be effective for whatever reason, including, expiration, withdrawal or suspension;
4.41
“Compliance Monitoring Process” means the process of periodic inspection of an Organisation and/or auditing of studies for the purpose of verifying adherence of GLP/GCP Principles, which process shall commence upon the receipt of an Application Form from an Organisation and shall end at the end of Cycle;
4.42
“Compliance Requirements” means any and all requirements relating to GLP/GCP compliance including those specified in any GLP/GCP principle, guideline, regulation and/or any OECD/VICH documents which applies to an Organisation, the Act and any policies procedures and requirements of SANAS which applies to an Organisation;
4.43
“Compliance Status” means any status indicating that a facility has been awarded a Certificate of GLP/GCP Compliance;
4.44
“Compliance Symbol” means a symbol issued by SANAS to a compliant facility to indicate its GLP/GCP Compliance Status
4.45
“Complainant” means a person / body who has a complaint related to the activities of a CAB or SANAS;
4.46
“Compliant Facility” means an organisation or facility that has been granted GLP / GCP Compliance Status by SANAS;
4.47
“Confidential Information” means any information designated as confidential information in the relevant Accreditation Requirements;
4.48
“Conformity Assessment” means the demonstration that specified requirements relating to a product, process, system, person or body are fulfilled;
4.49
“Conformity Assessment Body (CAB)” means a conformity assessment body, which is a body that performs Conformity Assessments and that can be the object of Accreditation and includes an Applicant and/or accredited body, which shall in turn include calibration, testing and verification laboratories, certification bodies, inspection bodies, rating agencies and any other type of body that may be added to SANAS’ scope of activity;
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4.50
“Consult” means to provide any service that assists an entity to implement a system or any element of a system including:
i)
implementation in ownership, management control, employment equity, skills development, preferential procurement, enterprise development and corporate social investment;
ii)
providing specific solutions and assisting the entity to implement the proposed solutions;
iii)
coaching or facilitating an entity towards the development and implementation of activities leading to compliance;
iv)
preparing or producing manuals, handbooks or procedures;
v)
participating in the decision-making process regarding the management system; and
vi)
giving specific advice on the development and implementation of the management system;
4.51
“Contract Research Organisation (CRO)” means an individual or organisation contracted by a sponsor or investigator to perform one or more of the GCP obligations of a sponsor or investigator;
4.52
“Corrective Action (CA’s)” means the documented action taken by the organisation’s management to solve each problem noted as a non-conformity by the assessment team
4.53
“Cross Frontier Accreditation” means providing accreditation services outside the South African borders;
4.54
“Donor Clinic” means an organisation that distributes blood samples on request;
4.55
“Electronic Signature” means data attached to, incorporated in or logically associated with other data and which is intended by the user to serve as a signature;
4.56
“Energy Efficiency Measurement and Verification Body” means a body that performs Energy Efficiency Measurement and Verification conformity assessment services and that can be the object of accreditation;
4.57
“Executive Authority” means the Minister of the dti;
4.58
“Expert” means an appropriately qualified person(s) assigned by SANAS to provide specific knowledge or expertise with respect to the scope of Accreditation to be assessed;
4.59
“Extending accreditation” means the process of enlarging the scope of accreditation;
4.60
“External Accreditation Body” means an accreditation body whose head office is not based in South Africa and who is a member / associate member of the IAF, ILAC or other recognised regional group;
4.61
“External Assessor” means a person employed by an external accreditation body;
4.62
“External National Monitoring Authority” means a national monitoring authority whose head office is not based in South Africa;
4.63
“Extension Assessment” means an assessment scheduled if and when required by the organisation. An extension can also include application for approval of personnel;
4.64
“Extraordinary Assessment” means an unscheduled or unannounced assessment conducted over and above a scheduled assessment to follow up on the investigation and resolution of a complaint against a CAB or to follow up on significant changes in relation to a CAB which may have an effect on the CAB’s Accreditation Status;
4.65
“Extraordinary Circumstance or Event” means a circumstance beyond the control of the CAB, commonly referred to as a “Force Majeure” or “Act of God”. Examples are war, strike, riot, political instability, geopolitical
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A 01-09 tension, terrorism, crime, pandemic, flooding, earthquake, malicious computer hacking, other natural or manmade disasters’ 4.66
“Fees” means any Fees charged by SANAS for its services as stipulated in its current fees;
4.67
“Field Manager (FM)” means the manager responsible for a particular field of accreditation i.e. Specific areas of calibration, testing, inspection, certification, etc.;
4.68
“Franchising” means the practice of using another firm's successful business model. The franchisor allows the use of a certain trademark or trading name to a franchisee;
4.69
“GLP” means Good Laboratory Practice and refers to a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded and reported;
4.70
“GLP Compliance” means monitoring compliance of GLP against the OECD principles of GLP;
4.71
“GLP/GCP Compliance” means compliance with the principles adopted by the: I.
OECD for GLP facilities; and/or
II.
VICH for GCP Veterinary facilities
4.72
“GLP Inspector” means an appropriately qualified person(s) assigned by SANAS to, alone or part of an Inspection team, perform test facility inspections and study audits in order to monitor GLP/GCP compliance or a person(s) assigned by SANAS to advise SANAS on decisions or give technical input;
4.73
“Greenhouse gas (GHG) validation and verification body” means a body that performs Greenhouse gas (GHG) validation and verification conformity assessment services and that can be the object of accreditation;
4.74
“Hazard” means a source or situation with a potential for harm in terms of human injury or ill health, death, damage to property, damage to the workplace environment, environment or a combination of these;
4.75
“IAF Mark” means the IAF symbol contained on the IAF website (www.ilac.org) signifying the ILAC Mutual Recognition Arrangement;
4.76
“ILAC Mark” means the ILAC symbol contained on the ILAC website (www.ilac.org) signifying the ILAC Mutual Recognition Arrangement;
4.77
“Interested Parties” mean parties with a direct or indirect interest in accreditation; Note: Direct interest refers to the interest of those who undergo accreditation; indirect interest refers to the interests of those who use or rely on accredited conformity assessment services. SANAS has extended the ISO/IEC 17011 definition to include business, academia, industry and government institutions with an interest in accreditation.
4.78
“Initial Assessment” means the first full assessment of the CAB, which comprises of an Assessment of all the disciplines and/or methods specified on the Application Form;
4.79
Initial Inspection” means the first full inspection or study audit of the organisation, which shall comprise of an inspection of all the areas of expertise specified on the application form;
4.80
“Inspection Body” means an organisation that performs examination of a product design, product, service, process or plant, and determination of their conformity with specific requirements or, on the basis of professional judgement, general requirements;
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4.81
“Interlaboratory Comparison (ILC)” means the organisation, performance and evaluation of measurements or tests on the same or similar items by two or more laboratories or inspection bodies in accordance with predetermined conditions;
4.82
“Intermediate checks” means checks performed to maintain confidence in the calibration status of measuring and test equipment;
4.83
“Key Activities” means activities such as (but not limited to), policy formulation, process and/or procedure development and, as appropriate, contract review, planning of conformity assessments, review, approval and decision on the results of conformity assessment;
4.84
“Laboratory” means any specialised confined environment used for the performance of scientific work, including laboratories involved in testing work;
4.85
“Lead Assessor” means the leader of an assessment team who is given the overall responsibility for specified assessment activities;
4.86
“Loss” means, without limitation all claims, losses, damages, costs, charges, liabilities, penalties, interest, fines and expenses (including legal and other professional charges and expenses on an attorney and own client scale, and VAT thereon);
4.87
“MAD” means mutual acceptance data agreement in the assessment of chemicals;
4.88
“Medical Laboratory” means a body that performs testing of human biological materials to specified test methods;
4.89
“Mentor” means an individual experienced and competent in assessment techniques and the relevant field of assessment, appointed by SANAS, who is tasked to tutor a trainee assessor or technical expert throughout an assessment;
4.90
“Minister” means the minister of Trade and Industry;
4.91
“Monitor” means an individual experienced and competent in assessment techniques or the decision-making process, appointed by SANAS, who is tasked to evaluate the performance of an assessor, trainee assessor, technical expert or decision maker, and who recommends appropriate follow-up actions to improve performance. A monitor may also be tasked to assist a Technical Expert during an assessment with the assessment process, including completion of assessment documentation and interpretation of accreditation requirements;
4.92
“Monitoring Authority” means an authoritative body with the responsibility for monitoring the GLP/GCP Compliance of the organisations within its territories and for discharging other such functions related to GLP/GCP as may be nationally determined;
4.93
“Multi-site Facility” means an organisation having an identified central function (hereafter refer to as an central office – but not necessarily the Head Office of the organisation) at which certain activities are planned, controlled or managed and a network of local sites at which such activities are fully or partially carried out;
4.94
“Multi-Standard Accreditation” means a facility is accredited to more than one (1) Standard i.e. ISO/IEC 17025 and ISO/IEC 17020 or ISO/IEC 17025 and ISO 15189, etc.;
4.95
“Nominated Representative” means a member of staff of a CAB who is responsible for all SANAS matters relating to the Accreditation and/or compliance of a CAB with Accreditation Requirements at all times;
4.96
“Non-Conformance” means an observation that casts doubt on the organisation’s ongoing ability to meet SANAS accreditation criteria. Non-conformances are graded as major and minor:
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A 01-09 4.96.1
“Major Non-Conformance” means a non-conformance against those observations that indicate that the technical competence of the organisation to continually perform work within the limits of its proposed/approved accreditation schedule/scope has either been or is in imminent danger of being seriously compromised;
4.96.2
“Minor Non-Conformance” means a non-conformance against those observations that indicate that although the organisation has failed to conform to the prescribed accreditation requirements, the failure has no immediate or imminent effect on its competence to perform work within the limits of its proposed/approved accreditation schedule/scope.
4.96.3
“Observation” means a comment made by a member of the assessment team when noting a situation or action which may prejudice the organisation’s ability to meet SANAS accreditation requirements during the transition to a new standard / guide process;
4.97
“OECD principles” means OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring;
4.98
“On-Site Assessment / Inspection” means an assessment / inspection conducted at premises of the organisation;
4.99
“Personnel Records” means personnel qualifications, experience etc. which are used to determine eligibility for assessments;
4.100
“Pre-Assessment / Inspection” means a visit undertaken by SANAS to the Premises to determine the Applicant’s capacity and state of readiness for an Initial Assessment / Inspection; Note: In the voluntary domain a pre-assessment is optional, need not cover the entire system in detail and only verbal feedback is given. In the Regulatory domain a pre-assessment is mandatory covering the detail over the entire documented system and feedback in the form of a letter of acknowledgement;
4.101
“Premises” means the location(s) where the CAB conducts its business, which may include the location(s) where the CABs clients conduct their business and/or the location(s) where the GLP/GCP organisation conducts its business, which may include the location(s) of the test site(s);
4.102
“Producers of Certified Reference Materials” means a technically competent body responsible for project planning and management, assignment of and decision on property values, authorisation of property values and issue of the certificate or other statements for the reference materials it produces;
4.103
“Proficiency Testing” means the determination of the calibration or testing performance of a laboratory, or the testing performance of an inspection body against pre-established criteria by means of interlaboratory comparison;
4.104
“Proficiency Testing Scheme” means proficiency testing designed and operated in one or more rounds for a specific area of testing, measurement, calibration or inspection;
4.105
“Re-Application” means any application made for the renewal of Accreditation and/or GLP/GCP Compliance;
4.106
“Re-Assessment / Re-Inspection” means an assessment / inspection performed prior to the expiry of the accreditation / compliance certificate of the respective CAB / Compliant facility, and on re-application for accreditation / compliance, as applicable; It is similar to an initial assessment / inspection, except that experience gained during previous assessments / inspections is taken into account. Note: A Re-assessment can also be performed on an organisation in the event of the lifting of a period of suspension.
4.107
“Rating Agency (Verification Agency)” means an organisation that rates the status of enterprises in terms of BBBEE compliance;
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4.108
“Records” mean all records associated with the accreditation or GLP requirements, including but not necessarily limited to those associated with complaints, internal audits, management reviews, records of certified facilities maintained by a certification body, data, results, studies, reports or certificates;
4.109
“Reference Material” means a material, sufficiently homogeneous and stable with reference to specified properties, which has been established to be fit for its intended use in measurement or in examination of nominal properties. (ISO/IEC Guide 99:2007 definition);
4.110
“Relevant Authority” means any authority exercising jurisdiction or authority over an Organisation;
4.111
“Regulatory Body” means a governing body that uses accreditation by SANAS, as the basis for their decision to grant an organisation approval to operate within the regulatory domain;
4.112
“Risk” means a combination of the likelihood and consequence(s) of a specified hazardous event occurring;
4.113
“Sampling” means the provision of a sample of the objective of conformity assessment, according to a procedure;
4.114
“Schedule of Accreditation” means the schedule defining the scope of activities for which Accreditation has been granted, and which is attached to the Certificate of Accreditation;
4.115
“Schedule of Compliance” means the schedule defining the scope of activities for which GLP/GCP Compliance has been granted, which schedule is attached to the Certificate of Compliance;
4.116
“Scheme Owner” means regulators or sector-specific scheme owners who have the authority, accountability and legal mandate to appoint or approve CABs to perform work on their behalf;
4.117
“Sector” means a description of the primary activities of a group of organizations with a common range of OHS hazards;
4.118
“SANAS Documents”: 4.118.1
“Advisory Documents” means documentation prefixed by the letter “A”, which contain additional information on aspects concerning SANAS;
4.118.2
“Forms” means documentation prefixed by the letter “F”, which are used for capturing information on aspects concerning SANAS or its assessments;
4.118.3
“Operational Procedures” means ddocumentation prefixed by the letters “OP”, which describe the internal operational procedures of the SANAS office;
4.118.4
“Policy Manual” means SANAS document PM 01, which describe the governing SANAS policies;
4.118.5
“Procedures” means documentation prefixed by the letter “P”, which describe the formalities and requirements for obtaining accreditation / GLP compliance, as appropriate;
4.118.6
“Requirements” means documentation prefixed by the letter “R” which describe the additional mandatory aspects that together with the relevant ISO/IEC documents must be complied with in order to obtain and maintain SANAS accreditation / GLP compliance as appropriate;
4.118.7
“Technical Guidance” means documentation prefixed by the letters “TG”, which contain technical guidance for accredited / GLP compliant organizations;
4.118.8
“Technical Requirements” means documentation prefixed by the letter “TR”, which describe the additional mandatory technical aspects that together with the relevant ISO/IEC documents must be
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A 01-09 complied with in order to obtain and maintain SANAS accreditation / GLP compliance as appropriate; 4.119
“SANAS Logo” means the corporate logo used by SANAS to identify itself;
4.120
“Six-Month Follow-up Assessment” means the first assessment conducted within 12 months of the Initial assessment, to follow-up on any non-conformances raised at the initial assessment and to ensure that the management system is still implemented and functioning properly;
4.121
“Specialist Technical Committee (STC)” means a SANAS committee of technical experts tasked with providing guidance to SANAS on technical matters pertaining to accreditation, in their specific field of expertise;
4.122
“Surveillance Assessment / Inspection” means an Assessment / Inspection carried out by SANAS at certain intervals at a time agreed upon by SANAS and the CAB or GCP/GLP facility to monitor the performance of an Accredited Body or Compliant facility, as applicable;
4.123
“Study Audit” means a comparison of raw data and associated records with the interim or final report in order to determine whether the raw data has been accurately reported, to determine whether testing was carried out in accordance with the study plan and procedures, to obtain additional information not provided in the report and to establish whether practices were employed in the development of data that would impair their validity;
4.124
“Suspension” means the temporary invalidation of a statement of conformity for all or part of the scope of Accreditation or GLP/GCP Compliance, as applicable, and “suspended” has the corresponding meaning;
4.125
“Technical Assessor” means a person with the appropriate technical competence and recognised training in assessment practice and techniques appointed by SANAS to an assessment team for the purpose of assessing the technical competence of the CAB for specific area(s) of the desired scope of accreditation;
4.126
“Technical Signatory (TS)” means a person whose competency, as declared by the organisation, is confirmed by SANAS, and whose signature confers validity on the organisation’s certificates, reports and/or results issued under its SANAS accreditation;
4.127
“Technical Expert” means a person with appropriate technical competence but who has not undergone or completed SANAS training in assessment practice and techniques. The Technical Expert is appointed to the assessment team for the purpose of assessing the technical competence of a facility with respect to their schedule of accreditation or for GLP Inspections to assist the Inspectors with the technical component of the inspection activities. A Technical Expert will normally be accompanied by a SANAS registered Assessor/Inspector for the duration of the assessment / inspection;
4.128
“Termination of Assessment” means the termination of an assessment in process by the Lead Assessor due to unfavourable or unforeseen circumstances;
4.129
“Terms and Conditions of Accreditation” means the Terms and Conditions including SANAS and applicable ILAC/IAF mandatory documents governing the Accreditation Process, and as amended from time to time which are available at www.sanas.co.za, www.ilac.org, www.iaf.nu, as relevant;
4.130
“Terms and Conditions of GLP/GCP Compliance” means the Terms and Conditions including SANAS’ and applicable OECD/VICH principles and guidance documents governing the Compliance Monitoring Process, and as amended from time to time which are available at www.sanas.co.za, www.oecd.org, www.vichsec.org, as relevant;
4.131
“Test Site” means the location(s) at which a phase(s) of a study is conducted;
4.132
“Testing Laboratory” means a body that performs testing on specified materials or products to specified test methods;
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4.133
“Test Facility” means a test facility, which includes the persons, premises and operational unit(s) of a GLP facility, that are necessary for conducting the non-clinical health and environmental safety study;
4.134
“VICH” means the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products
4.135
VICH Principles” means VICH principles of GCP and compliance monitoring; and
4.136
“Traceability” means the property of the results of a measurement or the value of a standard whereby it can be related to stated references, usually national or international standards, through an unbroken chain of comparisons all having uncertainties;
4.137
“Uncertainty of Measurement” means a parameter, associated with the result of a measurement that characterizes the dispersion of the values that could reasonably be attributed to the measurement.
4.138
“Verification Laboratory” means a body designated in terms of section 7(2) of the Trade Metrology Act 77 of 1973, to verify measuring systems that are used in terms of the aforesaid Act in order to establish that they comply with all statutory requirements pertaining to such instruments as defined and provided for in that Act;
4.139
“Withdrawal” means the cancellation of the statement of conformity for all or part of the scope of Accreditation / GLP/GCP Compliance, whether self-imposed by a CAB or imposed by SANAS and “Withdraw” has the corresponding meaning.
4.140
“Witnessing” means an observation of the CAB carrying out conformity assessment services within its scope of accreditation.
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A 01-09
ADDENDUM 1: Amendment Record Proposed By:
Section
Change
EXCO
2
EXCO
3
EXCO
3
EXCO / QM
4
EXCO / QM
4
Deleted references to the Accreditation Act, ISO/IEC Guide 43, ISO/IEC Guide 61, ISO/IEC 17000 Corrected title for ISO/IEC 17020 Added references to Act 18, Act 25,ISO/IEC 17043, SANS 14065, SANS 50010, Sans 1162; SI system of Units Added acronyms for: AFSA, AFSEC, AUC, CEMAC, CIPM, COMESA, DEA, ECCAS, ECOWAS, EGAC, ENAO, ENE, GHG, HR, IAS, ILAc, JCTLM, KCDB, KENAS, NDT, NR, NSI, PAIA, PTB, REC, RMP, SAHRC, SANAS, SI, TPA, TS, TUNAC, UNECA, UNIDO, UoM, VUP Deleted acronyms for: DEAT, OFI Added definitions for: Accreditation Act, Accreditation Cycle, Accounting authority, Advanced Electronic Signature; Adverse decisions, Application form, Accreditation Procedures, Assessment personnel, Blood Bank, Blood transfusion services, CAB, Calibration, Calibration and Measurement Capability, Combined mark, Confidential information, Cross Frontier accreditation, Donor clinic, Electronic signature; Energy Efficiency Measurement and verification body, Executive authority, Extraordinary assessment, Fees, GLP compliance, GHG validation and verification body, Interlaboratory comparison, Intermediate checks, Key activities, Key personnel, Medical Laboratory, Multi-site facility, OECD principles, Premises, Proficiency Testing, Records, Sampling, Scheme Owner, Technical signatory, Termination of assessment, Terms and Conditions of accreditation, Testing Laboratory, Traceability, Uncertainty of Measurement Corrected / changed definitions for: Accredited facility, applicant, Approval Committee, Conformity assessment, Lead assessor, Proficiency Testing Scheme, Franchising, Six months follow-up assessment, Surveillance assessment, Withdrawal of accreditation
EXCO / QM
4
Deleted definitions for: Assessment cycle, Certificate of competence, Certification assessor, Compliance criteria, Dispute, Non-conformance, Observation, Public Finance Management Act, Unannounced visits, Appeals, Conformity assessment body
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