DEPARTMENT OF LABOUR TR 84-03

Transcription

1 DEPARTMENT OF LABOUR TR DEPARTMENT OF LABOUR (DoL) AND SANAS TECHNICAL REQUIREMENTS FOR THE APPLICATION OF SANS/ISO/IEC 17020: 2012 IN THE REGULATORY ASSESSMENT OF OCCUPATIONAL HYGIENE INSPECTION BODIES Approved by: Chief Executive Officer: Ron Josias Executive - Accreditation: Mpho Phaloane Revised By: Assessment Specialist: Eben Smit Date of Approval: Date of Implementation: SANAS Page 1 of 21

2 CONTENTS 0. Introduction Scope Normative References Terms and Definitions General Requirements Structural Requirements Resources Process Requirements Management System Requirements List of Approved Inspection Authorities APPENDIX 1: Schedule of Accreditation APPENDIX 2: Amendment Record SANAS Page 2 of 21

3 0. Introduction TR General requirements for Occupational Hygiene Inspection Bodies specialising in: Asbestos Regulations GN R 155 dated 10 February 2002, Lead Regulations GN R 236 dated 28 February 2002, Noise-Induced Hearing Loss Regulations GN R 307 dated 7 March 2003, Regulations for Hazardous Chemical Substances GN R 1179 dated 25 August 1995 and Regulations for Hazardous Biological Agents GN R 1390 dated 27 December 2001 Note 1: When new or existing Regulations under the Occupational Health and Safety Act are published in Government Notices, requiring the use of Occupational Hygiene Inspection Bodies then the revised or new requirement updates the scope of this document. Note 2: DoL AIA Brochure is also applicable. The structure of this document reflects that of the standard SANS/ISO/IEC including titles of clauses and their numbering. To facilitate future reference to the explanations the paragraphs of this document are consecutively numbered within each commented sub-clause. The interpretative guidance notes are intended neither to add to nor subtract from the requirements of SANS/ISO/IEC They are intended to clarify the requirements to assist Inspection Bodies for Occupational Hygiene Inspections in practically implementing the standard SANS/ISO/IEC and to minimise differences of interpretation. This document should be read in conjunction with the standard SANS/ISO/IEC The term "shall" is used throughout this document to indicate those provisions, which, reflecting the requirements of SANS/ISO/IEC17020, are mandatory. The term "should" is used to indicate those provisions, which, although they constitute guidance for the application of the requirements, is expected to be adopted by an Inspection Body for Occupational Hygiene Inspections. Any variation from the guidance by an Inspection Body shall be an exception. Such variations will only be permitted on a case-by-case basis after the Inspection Body has demonstrated to the SANAS that the exception meets the requirements of the relevant clause of SANS/ISO/IEC and the intent of this Guidance in some equivalent way. Note: The term for AIA and Inspection Body is considered synonymous throughout this document. In case of dispute concerning application of this document, Department of Labour and SANAS will adjudicate on unresolved matters. It is intended that after a certain period of use, the content of this document will be revised. Copyright The copyright of this text is held by SANAS / Department of Labour. The text may not be copied for resale. SANAS Page 3 of 21

4 1. Scope TR The following inspections or examinations are required to be performed by Occupational Hygiene Inspection Bodies (Approved Inspection Authorities) in terms of Regulations promulgated under the Occupational Health and Safety Act: Asbestos Regulations GN R 155 dated 10 February 2002, (Regulations 8 & 18) Lead Regulations GN R 236 dated 28 February 2002, (Regulations 7 & 14) Noise-Induced Hearing Loss Regulations GN R 307 dated 7 March 2003, (Regulations 7) Regulations for Hazardous Chemical Substances GN R 1179 dated 25 August 1995, (Regulations 6 & 12) Regulations for Hazardous Biological Agents GN R 1390 dated 27 December 2001 (Regulation 12) Note 1: When new or existing Regulations under the Occupational Health and Safety act are published in Government Notices, requiring the use of Occupational Hygiene Inspection Bodies then the revised or new requirement updates the scope of this document. Note 2: DoL AIA Brochure is also applicable. 1a Inspection or Examination performed by Occupational Hygiene Inspection Bodies may fall in two (2) categories namely functional and analytical. Functional testing is within the scope of SANS/ISO/IEC Analytical testing, for example air or metallurgical analysis, is a Laboratory activity and therefore does not fall within the scope of SANS/ISO/IEC Approved Inspection Authorities wishing to undertake such Laboratory type analytical testing as part of an Occupational Hygiene Inspection Body will need to do so in accordance with the relevant requirements in SANS/ISO/IEC 17025: b If accredited Occupational Hygiene Inspection Bodies decisions are reliant upon analytical test results or the results of any sub-contracted specialist service, these tests or services shall, where possible, be carried out by appropriately accredited, as part of the ILAC Multilateral Arrangement, organisations and the results must be in the form of an endorsed certificate or report. 2. Normative References The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. 2.1 ISO/IEC 17000, Conformity assessment Vocabulary and general principles 2.2 Asbestos Regulations GN R 155 dated 10 February 2002, 2.3 Lead Regulations GN R 236 dated 28 February 2002, 2.4 Noise-Induced Hearing Loss Regulations GN R 307 dated 7 March 2003, 2.5 Regulations for Hazardous Chemical Substances GN R 1179 dated 25 August 1995 and 2.6 Regulations for Hazardous Biological Agents GN R 1390 dated 27 December DoL Brochure - Requirements for approval as an Approved Inspection Authority - OHS 3/1/1/8/1/ v1/ Terms and Definitions 3.1 Inspection 3.1a Throughout these interpretative notes the word product should be understood to include the words product design, service, process and plant as specified in clause 2.1.of the standard. 3.1b In recognition of the wide range of industries represented by Inspection Bodies alternative terminology could be used for what is inspected. 3.1c For professional judgement to be exercised the staff member responsible for the Occupational Hygiene Inspection Bodies, referred to in Clause 6.1, shall personally perform the Occupational Hygiene Inspections or effectively supervise the Occupational Hygiene Inspection Bodies. SANAS Page 4 of 21

5 inspection means examination of a product design, product (3.3), process or installation and determination of its conformity with specific requirements or, on the basis of professional judgement, with general requirements. NOTE: Inspection of a process may include inspection of persons, facilities, technology and methodology. [ISO/IEC : 4.3] In terms of Occupational Hygiene, Inspection means: the anticipation, recognition, evaluation and control of conditions arising in or from the workplace, which may cause illness or adverse health effects to persons or, on the basis of professional judgement, with general requirements. 3.2 Occupational Hygiene Inspection Bodies An Occupational Hygiene Inspection Body is a legal entity approved by the Regulator s Chief Inspector. The Occupational Hygiene Inspection Body is accredited by SANAS in respect of the competence of its personnel, equipment, procedures and environment, in accordance with the requirements of SANS/ISO/IEC 17020: 2012 and any additional requirements that might be determined by the Chief Inspector of Occupational Health and Safety from time to time. 3.2a A Occupational Hygiene Inspection Body may consist of one (1) person provided the requirements of all relevant clauses of SANS/ISO/IEC are fulfilled. An Occupational Hygiene Inspection Body can be an organisation, or part of an organisation. 3.2b Approved Occupational Hygiene Inspection Authorities may consist of the following types or a combination of regulations for: Asbestos Regulations GN R 155 dated 10 February 2002, Lead Regulations GN R 236 dated 28 February 2002, Noise-Induced Hearing Loss Regulations GN R 307 dated 7 March 2003, Regulations for Hazardous Chemical Substances GN R 1179 dated 25 August 1995 and Regulations for Hazardous Biological Agents GN R 1390 dated 27 December Approved Inspection Authority "approved inspection authority" means any person who, with the aid of specialized knowledge or equipment or after such investigations, tests, sampling or analyses as he may consider necessary, and, whether for reward or otherwise, renders a service by making special findings, purporting to be objective findings, as to- (a) (b) (c) the health of any person; the safety or risk to health of any work, article, substance, plant or machinery, or of any condition prevalent on or in any premises; or the question of whether any particular standard has been or is being complied with, with respect to any work, article, substance, plant or machinery, or with respect to work or a condition prevalent on or in any premises, or with respect to any other matter, and by issuing a report, stating such findings, to the person to whom the service is rendered; and is accredited by the South African National Accreditation System in terms of Accreditation for Conformity Assessment, Calibration and Good Laboratory Practice Act, 2006 (Act No. 19 of 2006) and registered by the Chief Inspector with respect to a particular service: Provided that an inspection authority registered by the chief inspector with respect to any particular service must be a registered inspection authority with respect to that service only; [definition of the AIA in terms of the bill] 3.4 Occupational Hygiene "occupational hygiene" means the anticipation, recognition, evaluation and control of conditions arising in or from the workplace, which may cause illness or adverse health effects to persons; SANAS Page 5 of 21

6 [definition of the AIA in terms of the bill] 3.5 Occupational Hygiene Assistant occupational hygiene assistant means a person who is registered as an Occupational Hygiene Assistant with a professional occupational hygiene organisation recognised by the Chief Inspector of the Department of Labour and is qualified, trained, experienced and expected to be primarily engaged in the measurement of health stressors (e.g. exposure sampling, noise and illumination surveys, etc.). He/she would be working under the mentorship and supervision of a registered Occupational Hygienist or be engaged in the study of appropriate subjects 3.6 Occupational Hygiene Technologist occupational hygiene technologist means a person who is registered as an Occupational Hygiene Technologist with a professional occupational hygiene organisation recognised by the Chief Inspector of the Department of Labour and is qualified, trained and experienced in the planning of occupational hygiene monitoring surveys, as well as their evaluation and interpretation, advising on basic control procedures and the writing of occupational hygiene monitoring/survey reports. 3.7 Occupational Hygienist occupational hygienist means a person who is registered as an Occupational Hygienist with a professional occupational hygiene organisation recognised by the Chief Inspector of the Department of Labour and is a qualified, trained and experienced scientist or engineer who can conduct occupational hygiene monitoring and provide professional advice and recommendations on workplace associated hazards. 4. General Requirements 4.1 Impartiality and independence 4.1.3a Risks to the impartiality of the inspection body shall be considered whenever events occur which might have a bearing on the impartiality of the inspection body or its personnel b The inspection body shall describe any relationships that could affect its impartiality to the extent relevant, using organisational diagrams or other means. Examples of relationships that could influence the impartiality include: - Relationship with a parent organisation - Relationships with departments within the same organisation - Relationships with related companies or organisations - Relationships with regulators - Relationships with clients - Relationships of personnel - Relationships with the organisations designing, manufacturing, supplying, installing, purchasing, owning, using or maintaining the items inspected 4.1.5a The inspection body shall have a documented statement emphasising its commitment to impartiality in carrying out its inspection activities, managing conflicts of interest and ensuring the objectivity of its inspection activities. Actions emanating from the top management shall not contradict this statement b One way for the top management to emphasise its commitment to impartiality is to make relevant statements and policies publicly available Confidentiality No interpretation required, as per the requirements of ISO/IEC Structural Requirements SANAS Page 6 of 21

7 5.1. Administrative Requirements TR a The Inspection Body should be a registered juristic person (corporate body). Company name, address, names of directors, contact numbers and registration number shall be made available. No Sole Proprietor b Approval is granted by the Department of Labour (DoL). While accreditation is a prerequisite for approval, the possession of such accreditation does not imply an assurance that approval will be granted. The DoL may set additional conditions before approval is granted c Upon obtaining accreditation and subsequently approval, a certificate that contains the name, location, and registration mark of the Inspection Bodies, the name of the responsible person (however named) and approved signatories, and the type (scope) shall be issued. The certificate of approval issued by the DoL, and certificate of accreditation from SANAS shall be prominently displayed at all times a The inspection body shall describe its activities by defining the general field and range of inspection (e.g. categories/sub-categories of products, processes, services or installations) and the stage of inspection, (see note to clause 1 of the standard) and, where applicable, the regulations, standards or specifications containing the requirements against which the inspection will be performed a The level of provisions should be commensurate with the level and nature of liabilities that may arise from the inspection body s operations b It is not the role of accreditation bodies to approve the level of insurance cover or reserves held by their customers. The types of liability covered by insurance, for example, may include employers liability, public liability and professional indemnity. Note: Inspection Bodies should pay particular attention to insurance cover when undertaking inspection work in another country, where legal requirements may differ from those in the body s home country Organisation and Management 5.2.1a A one person organisation may be accredited provided all relevant clauses of SANS/ISO/IEC are effectively implemented a The size, structure, composition and management of an inspection body, taken together, shall be suitable for the competent performance of the activities within the scope for which the inspection body is accredited b To maintain the capability to perform the inspection activities implies that the inspection body shall take steps to keep it appropriately informed about applicable technical and/or legislative developments concerning its activities c Inspection bodies shall maintain their capability and competence to carry out inspection activities performed infrequently (normally with intervals longer than one year). An inspection body may demonstrate its capability and competence for inspection activities performed infrequently through dummy inspections and/or through inspection activities conducted on similar products d The level of risk at a workplace should determine what expertise (as determined by Professional Body recognized by the Department of Labour Chief Inspector for Occupational Hygiene registration level either Assistant, Technologist, Hygienist) the inspection body should use to do the work. The basis is, that work should not be carried out by Inspection Body staff that do not have sufficient expertise to carry out the work in a manner which will adequately protect worker health a The inspection body shall maintain an up-to-date organisational chart or documents clearly indicating the functions and lines of authority for staff within the inspection body. The position of the technical manager(s) and the member of management referenced in clause shall be clearly shown in the chart or documents a It may be relevant to provide information concerning personnel which carry out work tasks for both the inspection body and for other units and departments. SANAS Page 7 of 21

8 5.2.5a In order to be considered as available, the person shall be either employed or otherwise contracted b In order to ensure that the inspection activities are carried out in accordance with ISO/IEC 17020, the technical manager(s) and any deputy(ies), shall have the technical competence necessary to understand all significant issues involved in the performance of inspection activities a In an organization where the absence of a key person causes the cessation of work, the requirement for having deputies is not applicable a The position categories involved in inspection activities are inspectors and other positions which could have an effect on the management, performance, recording or reporting of inspections b The job description or other documentation shall detail the duties, responsibilities and authorities for each position category referred to in 5.2.7a c Positions, which could affect the quality of inspection services, including managerial and inspectors as well as clerical staff shall be described. 6. Resources 6.1 Personnel 6.1.1a Where appropriate, inspection bodies shall define and document competence requirements for each inspection activity, as described in 5.1.3a b For personnel involved in inspection activities, see 5.2.7a c Competence requirements shall include knowledge of the inspection body s management system and ability to implement administrative as well as technical procedures applicable to the activities performed d When professional judgment is needed to determine conformity, this shall be considered when defining competence requirements e Department of Labour (DoL) requirement Legal Knowledge Certificates (LKCs). LKCs must cover the Full Scope of Accreditation as per STC decision below. The Occupational Hygiene Legal Knowledge Certificate was last offered by Pretoria Technikon in The certificates that were issued listed all the modules, which were HCS, Lead, Asbestos, Environmental Regulations for Workplaces (this module included a clause on noise) and from 2003 they added Noise Induced Hearing Loss Regulations on the certificate. Therefore we are requesting that the applicant s scope be aligned to what is listed on such certificates. If the certificate from Pretoria Technikon does not list the modules, the applicant must explain the discrepancy and provide proof of knowledge. The current universities which have been offering recognised courses are CPUT, DUT NMMU, and NWU. Pretoria University started offering in Therefore from 2010 to end of 2012 there were no recognised courses offered. [STC Minutes 21 August 2015 item 7.1] 6.1.2a All requirements of ISO/IEC apply equally for both employed and contracted persons a The procedure for formally authorising inspectors shall specify that the relevant details are documented, e.g. the authorised inspection activity, the beginning of the authorisation, the identity of the person who performed the authorisation and, where appropriate, the termination date of the authorisation a The mentored working period mentioned in item b normally includes activities where inspections are performed a Identification of training needs for each person shall take place at regular intervals. The interval shall be selected to ensure fulfilment of clause item c. The results of the review of training, e.g. plans for further training or a statement that no further training is required, shall be documented. SANAS Page 8 of 21

9 6.1.8a A major aim of the monitoring requirement is to provide the inspection body with a tool to ensure the consistency and reliability of inspection outcomes, including any professional judgments against general criteria. Monitoring may result in the identification of needs for individual training or needs for review of the inspection body s management system b For other personnel involved in inspection activities, see 5.2.7a c There should be evidence that the Inspection Body uses hygienist/s to exercise sufficient oversight of assistants and technologists. Particularly where assistants carry out work there should be proof of active oversight of the work carried out by Technologist and Hygienists. Signing off the report, in itself, by the Technical Manager shall not be considered to be sufficient active oversight of the work of assistants a To be considered sufficient, the evidence that the inspector is continuing to perform competently shall be substantiated by a combination of information such as; - satisfactory performance of examinations and determinations, - positive outcome of report reviews, interviews, simulated inspections and other performance assessments (see note to clause 6.1.8), - positive outcome of separate evaluations to confirm the outcome of the inspections (this may be possible and appropriate in the case of e.g. the inspection of construction documentation), - positive outcome of mentoring and training, - absence of legitimate appeals or complaints, and - satisfactory results of witnessing by a competent body, e.g. a certification body for persons b An effective program for the on-site observation of inspectors may contribute to fulfil the requirements in clauses and The program shall be designed considering; - the risks and complexities of the inspections, - results of previous monitoring activities, and - technical, procedural or legislative developments relevant to the inspections. The frequency of on-site observations depends on the issues listed above, but shall be at least once during the accreditation re-assessment cycle, however see application note 6.1.9a. If the levels of risks or complexities, or the results from previous observations, so indicate, or if technical, procedural or legislative changes have occurred, then a higher frequency should be considered. Depending on the fields, types and ranges of inspection covered by the inspector s authorisations, there may be more than one observation per inspector necessary to adequately cover the whole range of required competencies. Also, more frequent on-site observations may be necessary if there is lack of evidence of continuing satisfactory performance c In inspection areas where the inspection body has only one technically competent person the internal observation on-site cannot take place. In such cases the inspection body shall have arrangements in place for external observations on-site, unless other sufficient supporting evidence that the inspector is continuing to perform competently is available (see 6.1.9a) a Records of authorisation shall specify the basis on which authorisation was granted (e.g. the on-site observation of inspections) a Remuneration methods that provide incentives to perform inspections quickly have the potential to negatively affect the quality and outcome of inspection work a Policies and procedures shall assist inspection body personnel in identifying and addressing commercial, financial or other threats or inducements which could affect their impartiality, whether they originate inside or outside the inspection body. Such procedures shall address how any conflicts of interests identified by personnel of the inspection body are reported and recorded. Note, however, that while expectations for inspector integrity can be communicated by policies and procedures, the existence of such documents may not signal the presence of integrity and impartiality required by this clause. SANAS Page 9 of 21

10 Table 1. Qualifications Requirements The table below sets out as a guideline, the minimum qualifications and experience requirements that are deemed such to ensure competence to the required functions of Occupational Hygiene Inspection Bodies. FUNCTION QUALIFICATIONS EXPERIENCE SCOPE APPLICABLE Technical Manager Registered Occupational Hygienist 5-Years experience in appropriate field of Occupational Hygiene Inspections Inspection activities. Specific courses / training in the field of Occupational Hygiene Inspection activities Quality Manager (However named) Specific courses / training in the field of Inspection Body management systems Experience in the field of Inspection Body management systems Specific courses / training in the field of Inspection Body management systems Technical Signatory Registered Occupational Hygienist 5-Years experience in appropriate field of Occupational Hygiene Inspections Inspection activities. Specific courses / training in the field of Occupational Hygiene Inspection activities The IB will have to produce evidence that their Occupational Hygiene Practitioners are registered, the availability of a copy of a valid registration certificate with a Professional Body recognized by the Department of Labour Chief Inspector for Occupational Hygiene Facilities and Equipment 6.2.1a Equipment required to carry out inspection in a safe manner may include e.g. personal protective equipment and scaffolding a If controlled environmental conditions are needed, e.g. for the correct performance of the inspection, the inspection body shall monitor these and record the results. If conditions were outside acceptable limits for the inspection to be performed, the inspection body shall record what action was taken. See also clause b Continued suitability may be established by visual inspection, functional checks and/or recalibration. This requirement is particularly relevant for equipment that has left the direct control of the inspection body a In order to enable tracking when items are replaced, the unique identification of an item of equipment may be appropriate even when there is only one item available b When controlled environmental conditions are needed, the equipment used to monitor such conditions shall be considered as equipment that significantly influences the result of inspections c When appropriate (normally for the equipment covered by clause 6.2.6) the definition shall include the required accuracy and measurement range a The justification for not calibrating equipment that has a significant influence on the outcome of inspection (see clause 6.2.4) shall be recorded b Guidelines on how to determine calibration intervals can be found in ILAC G c Equipment identified under the criteria in clause 6.2.4, as clarified in 6.2.4a, must be traceably calibrated to national or international standards where possible. For guidance on measurement traceability, refer to SANAS TR 25 document d Where the calibrations are performed in-house, traceability to national standards shall be assured by using reference standards of measurement for which the Inspection Body holds a current SANAS Page 10 of 21

11 calibration certificate or equivalent from a competent body. The certificate or equivalent shall detail an uncertainty of measurement that is appropriate for the equipment that is to be calibrated from the reference standard. For further information on uncertainty of measurement, see ISO/IEC Guide a According to ILAC P10 it is possible to perform in-house calibration of equipment used for measurements. It is a requirement for accreditation bodies to have a policy to ensure that such in-house calibration services are performed in accordance with the relevant criteria for metrological traceability in ISO/IEC b According to ILAC P10 the preferred routes for conformity assessment bodies who seek external services for calibration of their equipment are defined in sub-sections 1) and 2) of section 2 in ILAC P10. If however, it is not possible to comply with these two routes for any justifiable reason, then it is acceptable to use the routes 3a) or 3b) of section 2 of ILAC P10. It is a requirement for accreditation bodies to have a policy to ensure that such external calibration services meet the relevant criteria for metrological traceability in ISO/IEC c Where traceability to national or international standards of measurement is not applicable, the participation in relevant comparison programs or proficiency tests is an example of how to obtain evidence of correlation or accuracy of inspection results. WG feedback Flow Calibrations: This table is aimed at providing clarity on the minimum records / portfolio of evidence that must be in place for OH AIA accreditation purposes. Field of Inspection Service Rendered Codes and Regulation Calibration of flow calibrators Calibration of flow calibrators Demonstrate traceability to national/international standard Primary standard must be calibrated by a recognized calibration facility. At a frequency determined by the Inspection Body based on best practice such as SANAS TG 05 (Guidelines concerning calibration intervals and recalibration) Proof of engagement / correspondence with a recognized calibration facility Records Examples: Volumetric method e.g. Burette Calibration by a recognized calibration facility Verification of flow calibrators Verification of flow calibrators Demonstrate traceability to national/international standard Secondary standard must be verified against a primary standard in a stable environment. Primary standard used for cross-verification of flow meters (secondary) should not be used in the field. In-house verification procedures / methods must be available Statistical principles should be followed when performing verification Proof of engagement / correspondence with a recognized verification facility Records Example 1: Volumetric method e.g. Burette Use calibrated burette, stop watch and standard soap solution to verify flow on the secondary standard Calculate correction factors and apply to secondary standard Example 2 Use a calibrated primary flow meter to verify secondary SANAS Page 11 of 21

12 standard Calculate correction factors and apply to secondary standard STC OH of 04 December a When inspection bodies use reference standards of measurement to calibrate working instruments the reference standards of measurement should have a higher degree of accuracy than that required of the working instruments they are used to calibrate a Where equipment is subjected to in-service checks between regular re-calibrations, the nature of such checks, the frequency and acceptance criteria shall be defined a The information provided in 6.2.7a, 6.2.7b and 6.2.7c for programs of calibration of equipment is valid also for programs of calibration of reference materials a When the inspection body engages suppliers to perform activities which do not include the performance of part of the inspection, but which are relevant for the outcome of inspection activities, e.g. order registration, archiving, delivery of auxiliary services during an inspection, the editing of inspection reports or calibration services, such activities are covered by the term services used in this clause b The verification procedure shall ensure that incoming goods and services are not used until conformance with specification has been verified c Analytical Services Requirements for approval as an Approved Inspection Authority - OHS 3/1/1/8/1/ v1/ ANALYTICAL SERVICES The AIA will remain accountable for the results obtained from any analytical laboratory. Therefore prior to using a laboratory for analytical services, the AIA must: 7.1 Instruct the laboratory on the specific method of analysis required. 7.2 Ensure the analytical laboratory has competent laboratory personnel and is making use of nationally/internationally acceptable standards and is accredited by SANAS in terms of SANS Appropriate analytical equipment and facilities are available for the tests required. 7.4 Ensure that an external proficiency testing scheme is used where available and where there is no scheme available, agree on the quality assurance procedures to be employed. 7.5 Have a written agreement with the analytical laboratory. 7.6 Demand a certified statement from the laboratory that the given method was used and any deviation from the method was recorded and the reason for such deviation was motivated and the report provided shall reflect all the relevant signatories a Factors that should be considered in protecting the integrity and security of data include; - backup practices and frequencies, - effectiveness in restoring data from backup, - virus protection, and - password protection. 6.3 Sub-contracting 6.3.1a Inspection activities can overlap with testing and certification activities where these activities have common characteristics (See Introduction of ISO/IEC 17020). For example, examination of a product and testing of the same product can both be the basis for the determination of conformity in an inspection process. It should be noted that ISO/IEC specifies requirements for bodies performing inspection, whereas the relevant standard to apply for bodies performing testing is ISO/IEC or ISO b By definition (ISO/IEC 17011, clause 3.1), accreditation is limited to conformity assessment tasks which the inspection body has demonstrated competence to perform itself. Thus, accreditation cannot be granted for activities referred to in the fourth bullet point under note 1, if the inspection body SANAS Page 12 of 21

13 does not have the required competence and/or resources. However, the task of assessing and interpreting the results of such activities for the purpose of determining conformity may be included in the scope of accreditation, provided adequate competence for this has been demonstrated a In note 2 to the definition of inspection in clause 3.1 it is indicated that in some cases inspection may be examination only, without a subsequent determination of conformity. In such cases clause does not apply since there is no determination of conformity a If the evaluation of the competence of the subcontractor is based partly or in full on its accreditation, the inspection body shall ensure that the scope of the subcontractor s accreditation covers the activities to be sub-contracted. 7. Process Requirements 7.1 Inspection method and procedure 7.1.2a The DoL requires additional documentation to be maintained by the Approved Inspection Authorities, see sections to of DoL s publication Requirements for approval as an Approved Inspection Authority - OHS 3/1/1/8/1/ v1/2012 WG feedback HCS: This table is aimed at providing clarity on the minimum records / portfolio of evidence that must be in place for OH AIA accreditation purposes. Field of Inspection Service Rendered Codes and Regulation The supply of services as an inspection authority for the Regulations for Hazardous Chemical Substances (HCS), Government Notice No. R 1179 of 25 August Weighing / Balance Rooms Regulation 6 Quantifying airborne concentrations of Hazardous Chemical Substances; Regulation 12 Evaluation of engineering measures controlling exposure to Hazardous Chemical Substances. Handling & weighing of various sampling media National / international recognized Standards/Methods, e.g. MDHS, NIOSH, OSHA, HSE, SANS Standard operating procedures compiled based on a nationally / internationally recognized method, with specific reference to: - Minimum equipment requirements - Collection of samples using the correct media - Transportation of samples (chain of custody) - Analysis done at an accredited laboratory - Analysis done in accordance of approved method - Verification of calculations National / international recognized Standards/Methods, e.g. BS EN, NIOSH, HSE, ACGIH, ASHRAE, SANS Minimum measurement parameters: - Capture Velocity - Face Velocity National / international recognized method, e.g. NIOSH 0500, 0600 Standard Operating Procedure (gravimetric weighing) which is included in the quality manual Environmental interferences (conditions) controlled Access controlled Personnel authorized Weighing scale 5 decimal places to a gram Microbalance and calibration weights calibrated by an accredited calibration facility Vibration and anti-static controlled surfaces Sample stabilization equipment STC OH of 04 December a Where appropriate the contract or work order control system shall also ensure that; - contract conditions are agreed SANAS Page 13 of 21

14 - personnel competence is adequate - any statutory requirements are identified - safety requirements are identified - the extent of any subcontracting arrangements required is identified TR For routine or repeat work requests the review may be limited to considerations of time and human resources. An acceptable record in such cases would be an acceptance of the contract signed by an appropriately authorised person b In situations where verbal work orders are acceptable, the inspection body shall keep a record of all requests and instructions received verbally. Where appropriate, the relevant dates and the identity of the client s representative should be recorded c The contract or work order control system should ensure that there is a clear and demonstrable understanding between the inspection body and its client of the scope of the inspection work to be undertaken by the inspection body a The information referred to in this clause is not information provided by a sub-contractor, but information received from other parties, e.g. a regulating authority or the client of the inspection body. The information may include background data for the inspection activity, but not results of the inspection activity. 7.2 Handling inspection items and sample No interpretation required, as per the requirements of ISO/IEC Records 7.3.1a The records should indicate which particular item of equipment, having a significant influence on the result of the inspection, has been used for each inspection activity b The Inspection Body shall retain records of original observations, derived data and sufficient information to establish an audit trail, calibration records, staff records and a copy of each inspection report or inspection certificate issued, for a minimum period of seven (07) years a The records shall include the identity of personnel responsible for the sampling, performance of each inspection and/or test and checking of results b The Inspection Body must report twice annually on 31 March and 30 September of every year to the Chief Inspector as indicated on annexure V, see section 14 of DoL s publication Requirements for approval as an Approved Inspection Authority - OHS 3/1/1/8/1/ v1/ Assessment Reports and Assessment Certificates 7.4.2a ILAC P8 requires accreditation bodies to specify rules for the use of accreditation symbols on reports and certificates. It should be noted that for endorsed reports and certificates, that is reports and certificates making reference to accreditation, such rules shall include the requirement that inspection bodies include a clear disclaimer; - when not accredited for services/tests listed on reports and certificates (see full text in section 8.1), and - when reports and certificates include or are based on results from unaccredited subcontractors (see full text in section 9.3) b The DoL requires additional items to be included in reports, see sections 9.1 to 9.12 of DoL s publication Requirements for approval as an Approved Inspection Authority - OHS 3/1/1/8/1/ v1/ a It may be useful to identify the inspection method in the inspection report/certificate when this information supports an appropriate interpretation of the inspection results. SANAS Page 14 of 21

15 7.5 Complains and Appeals TR No interpretation required, as per the requirements of ISO/IEC Complains and Appeals process No interpretation required, as per the requirements of ISO/IEC Management System Requirements 8.1 Options General 8.1.1a It is the responsibility of the Inspection Body to select, define and maintain a management system based on Option A or Option B. SANAS shall assess the appropriateness of the management system defined Option A No interpretation required, as per the requirements of ISO/IEC Option B 8.1.3a The expression this International Standard is a reference to ISO/IEC b Option B does not require that the inspection body's management system is certified to ISO However, when determining the extent of required assessment, the accreditation body should take into consideration whether the inspection body has been certified against ISO 9001 by a certification body accredited by an accreditation body which is a signatory to the IAF MLA, or to a regional MLA, for the certification of management systems. 8.2 Management system documentation (Option A) 8.2.1a Policy statements are intended to demonstrate senior management commitment to the quality system. Objectives shall include measurable targets, which are reviewed at least annually. Policies and objectives shall be reviewed at management review, see clause 8.5. Training records shall show that all staff is familiar with the quality system a In cases where an Inspection Body has a number of offices at different locations, responsibility for the practical maintenance of the quality system in each office should be assigned to a named, local, individual a For easy reference, it is recommended that the inspection body indicates where the requirements of ISO/IEC are addressed, e.g., by means of a cross reference table. 8.3 Control of documents (Option A) No interpretation required, as per the requirements of ISO/IEC Control of records (Option A) 8.4.1a This requirement means that all records needed to demonstrate compliance with the requirements of the standard shall be established and retained b In cases where electronic seals or authorizations are used for approvals, access to the electronic media or seal should be secure and controlled. SANAS Page 15 of 21

16 8.5 Management review (Option A) TR General 8.5.1a A review of the impartiality risk identification process and its conclusions (clauses 4.1.3/4.1.4) shall be part of the annual management review b The management review shall take into account information on the adequacy of current human and equipment resources, projected workloads and the need for training of both new and existing staff c The management review shall include a review of the effectiveness of systems established to ensure adequate competence of the personnel. 8.6 Internal audit (Option A) 8.6.1a Inspection Bodies with more than one operational site shall ensure that all aspects of the management system and all the sites have a full internal audit during an accreditation cycle a The inspection body shall ensure that all requirements of ISO are covered by the internal audit program within the accreditation re-assessment cycle. The requirements to be covered shall be considered for all fields of inspection and for all premises where key activities are performed (see IAF/ILAC A5). The inspection body shall justify the choice of audit frequency for different types of requirements, fields of inspection and premises where key activities are performed. The justification may be based on considerations such as; - criticality, - maturity, - previous performance, - organisational changes, - procedural changes, and - efficiency of the system for transfer of experience between different operational sites and between different fields of operation a Competent externally contracted personnel may carry out internal audits. 8.7 Corrective action (Option A) No interpretation required, as per the requirements of ISO/IEC Preventive action (Option A) 8.8.1a Preventive actions are taken in a pro-active process of identifying potential non-conformities and opportunities for improvement rather than as a reaction to the identification of non-conformities, problems or complaints. 9. List of Approved Inspection Authorities A list of approved inspection authorities will be maintained by the chief inspector and distributed to all provincial offices and labour centre offices of the Department of Labour. Copies of this list will reflect the name and address, contact details, services approved, initial date of approval and the approval number of each Inspection Body. SANS/ISO/IEC 17020: 2012 DoL Regulations SAIOH website SANAS R & TR-documents & SANAS Page 16 of 21

17 APPENDIX 1: Schedule of Accreditation TR ANNEXURE A SCHEDULE OF ACCREDITATION Facility Number: OH0000 TYPE A Permanent Address: ACME Occupational Hygiene Inspection (Pty) Ltd 104 Piet Pompies Street Ververlatevlakte 0001 Postal Address: PO Box 230 Ruimsig Roodepoort 1732 Tel : (012) Fax : (012) pete@pppp.co.za Nominated Representative: Pete Plumber Quality Manager: Pete Plumber Technical Manager: Pete Plumber Issue No. Date of issue Expiry date : 09 : 27 August 2015 : 27 August 2019 Technical Signatory: Pete Plumber - Reg. No (Full Scope) Regulations: 1. Asbestos 2. Lead 3. Noise-Induced Hearing Loss 4. Hazardous Chemical Substances 5. Hazardous Biological Agents Field of Inspection Service Rendered Codes and Regulations Regulatory: Inspection Authority for: Procedures and In-house methods not limited to the following: The supply of services as an inspection authority for Asbestos Regulations, Government Notice No. R 155 of 10 February 2002 Regulation 8 Air monitoring Regulation 21 Demolition OHS Act Legislated: HSG 173: Monitoring Strategies for Toxic Substances HSG 248: Asbestos, The analysts guide for sampling, analysis and clearance procedures, HSE, UK (previously MDHS 39/4: Methods for Determination of Hazardous Substances: Asbestos fibres in air, sampling and evaluation by phase contrast microscopy) OESSM: Occupational Exposure Sampling Strategy Manual Supplementary documents: NIOSH Manual of Analytical Techniques OSHA Index of Sampling and Analytical Methods In-house Methods: xxx Original date of accreditation: 27 August 2015 Page 1 of 3 Accreditation Manager SANAS Page 17 of 21

18 ANNEXURE A Facility No: OH0000 Date of issue: 27 August 2015 Expiry date: 27 August 2019 Field of Inspection Service Rendered Codes and Regulations The supply of services as an inspection authority for Lead Regulations, Government Notice No. R 236 of 28 February 2002 The supply of services as an inspection authority for Noise-Induced Hearing Loss Regulations, Government Notice No. R 307 of 07 March 2003 The supply of services as an inspection authority for the Regulations for Hazardous Chemical Substances, Government Notice No. R 1179 of 25 August Regulation 7 Air monitoring Regulation 7 Noise monitoring Regulation 6 Air monitoring OHS Act Legislated: HSG 173: Monitoring Strategies for Toxic Substances OESSM: Occupational Exposure Sampling Strategy Manual SANS 6164: Standard method for the determination of lead (inorganic and tetraalkyl) in the workplace by atomic absorption and spectrophotometry Supplementary documents: NIOSH Manual of Analytical Techniques OSHA Index of Sampling and Analytical Methods HSE Methods for the Determination of Hazardous Substances (i.e. MDHS 14/4) In-house Methods: xxx OHS Act Legislated: SANS 10083: Code of Practice for the Measurement and Assessment of Occupational Noise for Hearing Conservation Purposes Supplementary documents: DME Guideline for the Compilation of a Mandatory Code of Practice for an Occupational Health Programme (Occupational Hygiene and Medical Surveillance) for Noise. In-house Methods: xxx OHS Act Legislated: OESSM: Occupational Exposure Sampling Strategy Manual HSG 173: Monitoring Strategies for Toxic Substances (previously EH 42) Supplementary documents: NIOSH Manual of Analytical Techniques OSHA Index of Sampling and Analytical Methods AIHA: A Strategy for Assessing and Managing Occupational Exposures HSE Methods for the Determination of Hazardous Substances (i.e. MDHS 14/4) In-house Methods: xxx Original date of accreditation: 27 August 2015 Page 1 of 3 Accreditation Manager SANAS Page 18 of 21

19 ANNEXURE A Facility No: OH0000 Date of issue: 27 August 2015 Expiry date: 27 August 2019 Field of Inspection Service Rendered Codes and Regulations Maintenance of control measures Examinations and tests of engineering control measures The supply of services as an inspection authority for Asbestos Regulations, Government Notice No. R 155 of 10 February 2002 The supply of services as an inspection authority for Lead Regulations, Government Notice No. R 236 of 28 February 2002 The supply of services as an inspection authority for the Regulations for Hazardous Chemical Substances, Government Notice No. R 1179 of 25 August 1995 Regulation 18 Maintenance of control measures Regulation 14 Maintenance of control measures Regulation 12 Maintenance of control measures OHS Act Legislated: None specified Supplementary documents: The Safe Handling of Asbestos-containing Lagging or Insulation, Guidance Note No. 001 (Department of Labour) In-house Methods: xxx OHS Act Legislated: None specified Supplementary documents: ACGIH: Industrial Ventilation: A Manual of Recommended Practice for Operation and Maintenance ANSI/ASHRAE 110: ASHRAE Standard Method of Testing Performance of Laboratory Fume Hoods In-house Methods: xxx OHS Act Legislated: None specified Supplementary documents: ACGIH: Industrial Ventilation: A Manual of Recommended Practice for Operation and Maintenance ANSI/ASHRAE 110: ASHRAE Standard Method of Testing Performance of Laboratory Fume Hoods General Safety Regulations (GNR of 30 May 1986), Regulation 4 relates to use and storage of flammable liquids In-house Methods: xxx Original date of accreditation: 27 August 2015 Page 1 of 3 Accreditation Manager SANAS Page 19 of 21