DURATION OF MANAGEMENT SYSTEMS AUDIT I-25cl 1. DEFINITIONS 2. APPLICATION 2.1 General 2.2 Audit duration 2.3 Audit days 2.4 Calculation of the effective number of personnel 3. METHODOLOGY FOR DETERMINING AUDIT TIME 4. INITIAL MANAGEMENT SYSTEMS CERTIFICATION AUDITS (Stage 1 plus Stage 2) 5. SURVEILLANCE 6. RECERTIFICATION 7. FACTORS FOR ADJUSTMENTS OF AUDIT DURATION 8. TEMPORARY SITES 9. MULTI-SITE AUDIT DURATION 10. CONTROL OF EXTERNALLY PROVIDED FUNCTIONS OR PROCESSES (OUTSOURCING) Annex A - Quality Management Systems (ISO 9001, ISO/TS 29001, Technical Regulation of Customs Union - TR CU 032 2013), EMS and OH&S MS Annex B – Environmental Management System and Occupational Health and Safety Management System Annex C – Factors affecting the Management System audit duration 2 1. DEFINITIONS 1.1 Management systems certification scheme Conformity assessment system related to management systems to which the same specified requirements, specific rules and processes apply. 1.2 Client organization Entity or defined part of an entity operating a management system. 1.3 Permanent site Location (physical or virtual) where a client organization performs work or provides a service on a continuing basis. 1.4 Temporary site Location (physical or virtual) where a client organization performs specific work or provides a service for a finite period of time and which is not intended to become a permanent site. 1.5 Audit time Time needed to plan and accomplish a complete and effective audit of the client organization’s management system. 1.6 Duration of management system certification audits Part of audit time spent conducting audit activities from the opening meeting to the closing meeting, inclusive. Note: Audit activities normally include: conducting the opening meeting performing document review while conducting the audit communicating during the audit APPROVED: 01.02.2016 C-IMS Certification page 1 of 14 DURATION OF MANAGEMENT SYSTEMS AUDIT I-25cl assigning roles and responsibilities of guides and observers collecting and verifying information generating audit findings preparing audit conclusions conducting the closing meeting 1.7 Audit day The duration of an audit day is normally 8 hours and may not include a lunch break depending upon local legislation. 1.8 Effective number of personnel The effective number of personnel consists of all personnel involved within the scope of certification including those working on each shift. When included within the scope of certification, it shall also include non-permanent (e.g. contractors) and part time personnel. 1.9 Risk category (QMS only) For QMS, the provisions in this document are based on three categories, dependant on the risks posed by failure of the product or service of the client organization. These categories can be considered as high, medium or low risk. High risk activities (e.g. nuclear, medical, pharmaceutical, food, construction) normally require more audit time. Medium risk activities (e.g. simple manufacturing) are likely to require the average time to carry out an effective audit and low risk activities less time. (See Annex A, Table 1). 1.10 Complexity category (EMS and OH&S MS only) For EMS and OH&S MS, the provisions specified in this document are based on five primary complexity categories of the nature, number and gravity of the environmental aspects and risks of an organization that fundamentally affect the audit time. (See Annex B, Table 1). 2. APPLICATION 2.1 General In determining the audit time C-IMS Certification considers among others the following aspects: a) requirements of the relevant management system standard or requirements based on modules of CONTSTAND scheme (see document I-07); b) complexity of the client’s organization and management system; c) technological and regulatory context; d) any outsourcing of any activities included in the scope of the management system; e) results of any prior audits; f) size and number of sites and multi-site considerations; g) risks associated with products, processes or activities of the organization; h) whether the audits are combined, joint or integrated. C-IMS Certification does not apply specific criteria for a specific certification scheme. In certification of management systems against standards ISO 9001, ISO/TS 29001, ISO 14001 and OHSAS the time spent by any team member that is not assigned as an auditor (i.e. technical experts, translators, interpreters, observers and auditors-in-training) is not included into the established above duration of an audit. In an assessment of a QMS based on modules of CONTSTAND scheme the time spent by a technical expert is included into the audit time. APPROVED: 01.02.2016 C-IMS Certification page 2 of 14 DURATION OF MANAGEMENT SYSTEMS AUDIT I-25cl NOTE The use of translators and interpreters can necessitate additional audit time. 2.2 Audit duration The audit time for all types of audits includes the total time on-site at a client's location and time spent off-site carrying out planning, document review, interacting with client personnel and report writing. The duration of a management system certification audit should typically not be less than 80% of the audit time calculated following the Table 1 of Annex A (QMS - ISO 9001:2008 and ISO/TS 29001:2010 or a module of CONTSTAND scheme) and Table1, Annex B (EMS and OH&S MS).This applies to initial, surveillance and recertification audits. Travel (en-route or between sites) and any breaks are not included in the on-site duration of management system certification audits. 2.3 Audit days Tables 1 of Annexes A and B present audit durations calculated in auditor days on the basis of 8 hours per day. To comply with local legislation for lunch breaks and working hours it may be needed to adjust the number of days, to achieve the same total number of auditing hours presented in Annexes A and B. The number of auditor days allocated shall not be reduced at the planning stages by programming longer hours per working day. Consideration can be made to allow efficient auditing of shift activities which may require additional hours in a working day. If after the calculation the result is a decimal number, the number of days should be adjusted to the nearest half day (e.g. 5.3 audit days becomes 5.5 audit days, 5.2 audit days becomes 5 audit days). To help ensure the effectiveness of the audit, C-IMS Certification should also consider the composition and size of the audit team (e.g. ½ day with 2 auditors may not be as effective as a one day audit with 1 auditor or 1 audit day with one lead auditor and one technical expert is more effective than 1 auditor day without the technical expert). 2.4 Calculation of effective number of personnel The effective number of personnel is used as a basis for the calculation of audit time. Consideration for determining the effective number of employees include part-time personnel and employees partially in scope, those working on shifts, administrative and all categories of office staff, repetitive processes. 2.4.1 Part time personnel and employees partially in scope Dependent upon the hours worked, part time personnel numbers and employees partially in scope may be reduced or increased and converted to an equivalent number of full time personnel. (e.g., 30 part time personnel working 4 hours/day equates to 15 full time personnel.) 2.4.2 Repetitive process within scope When a high percentage of personnel perform certain activities/positions that are considered repetitive (e.g. cleaners, security, transport, call centers, etc.) a reduction to the number of personnel which is coherent and consistently applied on a company to company basis within the scope of certification is permitted. 2.4.3 Shift work employees C-IMS Certification determines the duration and timing of the audit which will best assess the effective implementation of the management system for the full scope of the client activities, APPROVED: 01.02.2016 C-IMS Certification page 3 of 14 DURATION OF MANAGEMENT SYSTEMS AUDIT I-25cl including the need to audit outside normal working hours and various shift patterns. This shall be agreed with the client. 3. METHODOLOGY FOR DETERMINING AUDIT TIME The methodology used as a basis for the calculation of audit time of management systems for an initial audit (stage 1 + stage 2) involves the utilization of tables presented in Annex A, Annex B and Annex C for management systems audits. Table 1, Annex A (for QMS) is based solely upon the effective number of personnel and the level of risk, but does not provide minimum or maxim audit time. Table 1, Annex B (for EMS and OH&S MS), besides the effective number of personnel, is based also on the environmental complexity of the organization or on occupational health and safety risks and does not provide minimum or maximum audit time. Table 2, Annex B describes complexity categories of environmental aspects and their links with business sectors. Table 3, Annex B describes complexity categories of occupational health and safety risks and their links with business sectors. Using a suitable multiplier, the same tables may be used as the base for calculating audit duration for surveillance audits (clause 4) and recertification audits (clause 6). C-IMS Certification has processes that provide for the allocation of adequate time for auditing of relevant processes of the client. Experience has shown that apart from the number of personnel, the time required to carry out an effective audit depends upon other factors for QMS as well as for EMS and OH&S MS. These factors are described in clause 6. The audit time and justification for this determination are written down in KF-07 q/e/hs/og/i “Application review”. This instruction lists the provisions which should be considered when establishing the amount of time needed to perform an audit. All factors shall be examined by C-IMS Certification during the contract review process and after Stage 1 and throughout the certification cycle and at recertification for their potential impact on the audit duration regardless of the audit type. Therefore the relevant tables for QMS, EMS and OH&S MS which demonstrate the relationship between effective number of personnel and complexity cannot be used in isolation. These tables provide the framework for audit planning and therefore required adjustments for the determination of audit time for all types of audits. The starting point for determining audit time of management systems shall be identified based on the effective number of personnel, then adjusted for the significant factors applying to the client to be audited, and attributing to each factor an additive or subtractive weighting to modify the base figure. In every situation the basis for the establishment of audit time of management systems including adjustments made shall be recorded in the form KF-07q/e/hs/i “Application review sheet” and in the Annex of CF-02 “Audit plan”. C-IMS Certification ensures that any variation in audit time does not lead to a compromise on the effectiveness of audits. Where product or service realization processes operate on a shift basis, the extent of auditing of each shift depends on the processes done on each shift, and the level of control of each shift that is demonstrated by the client. To audit effective implementation, at least one of the shifts shall be audited. The justification for not auditing the other shifts is documented in “Application review sheet” (forms KF-07 q/e/hs) and in the Annex of CF-02 “Audit plan”. The reduction of audit time of management systems shall not exceed 30% of the times established from Tables 1of Annexes A and B. APPROVED: 01.02.2016 C-IMS Certification page 4 of 14 DURATION OF MANAGEMENT SYSTEMS AUDIT I-25cl 4. INITIAL MANAGEMENT SYSTEMS CERTIFICATION AUDITS (STAGE 1 PLUS STAGE 2) Determination of audit time of management systems involved in combined offsite activities should not reduce the total on-site duration of management systems audits to less than 80% of the audit time calculated from the tables following the methodology in Section 3. Where additional audit time is required for planning and/or report writing, this will not be justification for reducing the on-site duration of management systems certification audits. Table 1, Annex A and Table 1, Annex B provide a starting point for estimating the audit time of an initial audit (Stage 1 + Stage 2) for QMS, EMS and OH&S MS respectively. The audit time determined by C-IMS Certification and the justification for the determination is recorded in the form KF-07q/e/hs/I “Application review sheet”. This calculation shall include details on the time to be allocated to cover the entire scope of certification. C-IMS Certification shall provide the audit time determination and the justification to the client organization as part of the contract. 5. SURVEILLANCE During the initial three year certification cycle, surveillance audit duration for a given 2), with the total amount of time spent annually on surveillance being about 1/3 of the time spent on the initial certification audit. C-IMS Certification shall obtain an update of client data related to its management system as part of each surveillance audit. The planned audit time of a surveillance audit shall be reviewed at least at every surveillance and recertification audit to take into account changes in the organization, system maturity, etc. The evidence of review including any adjustments to the audit time of management systems audits shall be recorded in the Annex of CF-02 “Audit plan”. 6. RECERTIFICATION The audit time of the recertification audit should be calculated on the basis of the updated information of the client and is normally approximately 2/3 of the time that would be required for an initial certification audit (Stage 1 + Stage 2) of the organization if such an initial audit were to be carried out at the time of recertification (i.e. not 2/3 of the original time spent on the initial audit). The audit time shall take account of the outcome of the system performance review. The review of system performance does not itself form part of the audit time for recertification audits. 7 . FACTORS FOR ADJUSTMENTS OF AUDIT DURATION The starting point for determining audit duration shall be identified based on the effective number of personnel, then adjusted for the significant factors applying to the client to be audited, and attributing to each additive or subtractive factor, which is to modify the base figure. Factors affecting the audit duration are described in the Annex C. The reduction of the audit duration shall not exceed 30% of time determined according to Tables 1, Annexes A and B. Calculation of the audit duration of integrated management systems is conducted in concordance with requirements of procedure PR/27 “Integrated management system audit”, in this case the audit duration can be reduced by 20%. The total reduction of the audit duration taking into account the above-stated factors can be not more than 50% of the normative figures. In every situation the basis for determination of the audit duration including adjustments made shall be recorded. The reasons for adjustment of the APPROVED: 01.02.2016 C-IMS Certification page 5 of 14 DURATION OF MANAGEMENT SYSTEMS AUDIT I-25cl audit duration shall be written down by the certification manager in the application review sheet KF-07q/e/hs/i and in Appendix to form CF-02 for all audit types. 8. TEMPORARY SITES In situations where the certification applicant or certified client provides their product(s) or service(s) at temporary sites, such sites shall be incorporated into the audit programmes. Temporary sites could range from major project management sites to minor service/installation sites. The need to visit such sites and the extent of sampling should be based on an evaluation of the risks of the failure of the QMS to control product or service output or on an evaluation of the risks of the failure of the EMS and OH&S MS. Typically audits of temporary sites are performed on-site. However, the following methods could be considered as alternatives to replace some on-site audits: - Interviews or progress meetings with the client and/or its customer in person; - Document review of temporary site activities; In each case, the method of audit should be fully documented and justified in terms of its effectiveness. 9. MULTI-SITE AUDIT DURATION In the case of a management system operated over multiple sites it is necessary to establish if sampling is permitted or not. 9.1 For certification of multiple sites where sampling is not permitted, the starting point for calculating audit time of the management system is the total involved on all of the sites, consistent with Tables 1, Annexes A and B. The proportion of the total time spent on each site shall take into account situations where certain management system processes are not relevant to the site. 9.2 For certification of multiple sites where sampling is permitted, requirements to multi-site audits are described in instruction I-11 “Multi-site certification”. In this case the instruction I-11 shall be used to select sites to be sampled prior to applying the present instruction to each selected site. The total time should never be less than that which would have been calculated for the size and complexity of the operation if all the work had been undertaken at a single site. 10. CONTROL OF EXTERNALLY PROVIDED FUNCTIONS OR PROCESSES (OUTSOURCING) If an organization outsources part of its functions or processes, it is the responsibility of C-IMS Certification to obtain evidence that the organization has effectively determined the type and extent of controls to be applied in order to ensure that the externally provided functions or processes do not adversely affect the effectiveness of the Management System, including the organization’s ability to consistently deliver conforming products and services to its customers or to control its environmental aspects and commitments to compliance with legal requirements. C-IMS Certification will audit and evaluate the effectiveness of the client's management system in managing any supplied activity and the risk this poses to the delivery of objectives, customer and conformity requirements. This may include gathering feedback on the level of effectiveness from suppliers. However auditing the supplier’s management system is not required, considering that it is included in the scope of the organization’s management system only the control of the supplied activity, and not the performance of the activity itself. From this understanding of risk any additional audit time shall be determined. APPROVED: 01.02.2016 C-IMS Certification page 6 of 14 DURATION OF MANAGEMENT SYSTEMS AUDIT I-25cl ANNEX A Table 1 - Quality Management Systems (ISO 9001; ISO/TS 29001, Technical Regulation of Customs Union - TR CU 032 2013) Relationship between effective number of personnel and audit duration (Initial Audit only) Effective Number of Personnel Audit Duration Stage 1 + Stage 2 (days) Effective Number of Personnel 1-5 6-10 11-15 16-25 26-45 46-65 66-85 86-125 126-175 176-275 276-425 426-625 1.5 2 2.5 3 4 5 6 7 8 9 10 11 626-875 876-1175 1176-1550 1551-2025 2026-2675 2676-3450 3451-4350 4351-5450 5451-6800 6801-8500 8501-10700 >10700 Audit Duration Stage 1 + Stage 2 (days) 12 13 14 15 16 17 18 19 20 21 22 Follow progression above Risk categories: High risk Where failure of the product or service causes economic catastrophe or puts life at risk. Examples include but are not limited to: Food; pharmaceuticals; aircraft; shipbuilding; load bearing components and structures; complex construction activity; electrical and gas equipment; medical and health services; fishing; nuclear fuel; chemicals, chemical products and fibres. Medium risk Where failure of the product or service could cause injury or illness. Examples include but are not limited to: Non load bearing components and structures; simple construction activities; basic metals and fabricated products; non-metallic products; furniture; optical equipment; leisure and personal services. Low risk Where failure of the product or service is unlikely to cause injury or illness. Examples include but are not limited to: Textiles and clothing; pulp, paper and paper products; publishing; office services; education; retailing, hotels and restaurants. Note 1: It is expected that business activities defined as low risk may require less audit time than the time calculated using Table 1A, activities defined as medium risk will take the time calculated using 1A, and activities defined as high risk will take more time. Note 2: If a company is providing a mixture of business activities (eg: construction company that builds simple construction – medium risk - and bridges – high risk), it is up to C-IMS Certification to determine the correct audit time, taking into consideration the number of personnel involved in each of the activities. APPROVED: 01.02.2016 C-IMS Certification page 7 of 14 DURATION OF MANAGEMENT SYSTEMS AUDIT I-25cl ANNEX B Table 1 - Environmental Management Systems and Occupational Health & Safety Management Systems Relationship between effective number of personnel, complexity and audit duration (Initial Audit only) Effective Number of Personnel Audit Duration Stage 1 + Stage 2 (days) High 1-5 6-10 11-15 16-25 26-45 46-65 66-85 86-125 126-175 176-275 276-425 426-625 3 3.5 4.5 5.5 7 8 9 11 12 13 15 16 Med Low Complexity 2.5 2.5 3 3 3.5 3 4.5 3.5 5.5 4 6 4.5 7 5 8 5.5 9 6 10 7 11 8 12 9 Effective Number of Personnel Lim 2.5 3 3 3 3 3.5 3.5 4 4.5 5 5.5 6 Audit Duration Stage 1 + Stage 2 (days) High 626-875 876-1175 1176-1550 1551-2025 2026-2675 2676-3450 3451-4350 4351-5450 5451-6800 6801-8500 8501-10700 >10700 17 19 20 21 23 25 27 28 30 32 34 Med Low Complexity 13 10 15 11 16 12 17 12 18 13 19 14 20 15 21 16 23 17 25 19 27 20 Follow progression above Lim 6.5 7 7.5 8 8.5 9 10 11 12 13 14 Complexity categories of environmental aspects High -environmental aspects with significant nature and gravity (typically manufacturing or processing type organizations with significant impacts in several of the environmental aspects); Medium -environmental aspects with medium nature and gravity (typically manufacturing organizations with significant impacts in some of the environmental aspects); Low - environmental aspects with low nature and gravity (typically organizations of an assembly type environment with few significant aspects); Limited -environmental aspects with limited nature and gravity (typically organizations of an office type environment); Special - these require additional and unique consideration at the audit planning stage. Complexity categories of occupational health and safety risks: Limited – absence of hazardous production facilities; technological processes of low intensity; absence of hazardous substances; optimum production environment; no hazardous operations. Low – singular occurrence of hazardous production facilities, registered in supervisory bodies; technological processes of low intensity; low quantity of hazardous substances; acceptable production environment; certain periodic operations of major hazard. APPROVED: 01.02.2016 C-IMS Certification page 8 of 14 DURATION OF MANAGEMENT SYSTEMS AUDIT I-25cl Medium – several technical devices of one type, applied in hazardous production facilities; technological processes of medium intensity; medium quantity of hazardous substances; hazardous production environment; regular operations of major hazard. High – technical devices, applied in hazardous production facilities, are more than one and of different types; technological processes of high intensity; high quantity of hazardous substances; hazardous production environment; regular operations of major hazard. Very high – technical devices, applied in hazardous production facilities, are more than one and of different types; complex technological processes of high intensity, high quantity of hazardous substances of I-II class, hazardous production environment; regular operations of major hazard and high complexity. Table 1 of this Annex covers the above four top complexity categories: high, medium, low and limited, and does not cover “special cases” category. The audit time of management system audits shall be developed and justified on an individual basis in these special cases. Tables 2 and 3 provide the link between the five complexity categories above and the industry sectors that would typically fall into that category. Table 2 (EMS) Complexity category High Medium APPROVED: 01.02.2016 Business sector Mining and quarrying Oil and gas extraction Tanning of textiles and clothing Pulping part of paper manufacturing including paper recycling Oil refining Chemicals and pharmaceuticals Primary productions - metals Non-metallics processing and products covering ceramics and cement. Coal based electricity generation Civil construction and demolition Hazardous and non hazardous waste processing e.g. incineration Effluent and sewerage processing Fishing/farming/forestry Textiles and clothing except for tanning Manufacturing of boards, treatment/impregnation of wood and wooden products Paper production and printing excluding pulping Nonmetallic processing and products covering glass, clay, lime etc. Surface and other chemically based treatment for metal fabricated products excluding primary production Surface and other chemically based treatment for general mechanical engineering Production of bare printed circuit boards for electronics industry Manufacturing of transport equipment - road, rail, air, ships C-IMS Certification page 9 of 14 DURATION OF MANAGEMENT SYSTEMS AUDIT I-25cl Non coal based electricity generation and distribution Gas production, storage and distribution (note extraction is graded high) Water abstraction, purification and distribution including river management (note commercial effluent treatment is graded as high) Fossil fuel whole sale and retail Food and tobacco - processing Transport and distribution - by sea, air, land Commercial estate agency, estate management, industrial cleaning, hygiene cleaning, dry cleaning normally part of general business services Recycling (utilization), composting, landfill (of non hazardous waste) Technical testing and laboratories Healthcare/hospitals/veterinary Leisure services and personal services excludes hotels/restaurants Low Hotels/restaurants Wood and wooden products excluding manufacturing of boards, treatment and impregnation of wood Paper products excluding printing, pulping and paper making Rubber and plastic injection moulding, forming and assembly – excludes manufacturing of rubber and plastic raw materials which are part of chemicals Hot and cold forming and metal fabrication excluding surface treatment and other chemical based treatments and primary production General mechanical engineering assembly excluding surface treatment and other chemical based treatments Wholesale and retail Electrical and electronic equipment assembly excluding manufacturing of bare printed circuit boards Limited Corporate activities and management, HQ and management of holding companies Transport and distribution - management services with no actual fleet to manage Telecommunications General business services except commercial estate agency, estate management, industrial cleaning, hygiene cleaning, dry cleaning Education services Special cases Nuclear Nuclear electricity generation Storage of large quantities of hazardous material Public administration Local authorities Organizations with environmental sensitive products or services Financial institutions APPROVED: 01.02.2016 C-IMS Certification page 10 of 14 DURATION OF MANAGEMENT SYSTEMS AUDIT I-25cl Table 3 (OH&S MS) Complexity category Very high High Medium APPROVED: 01.02.2016 Business sector Nuclear Nuclear electricity generation Storage of large quantities of hazardous material Organizations with products or services of very high risk for occupational health and safety Extractive industry and quarrying (including oil and gas exploration) Tanning of textiles and clothing Production of coke and refined oil products Chemicals, chemical products and fibers. Pharmaceuticals Main metals Shipbuilding Aerospace industry Power supply (generation and distribution) Gas supply (generation and distribution) Construction Health care and social activity Hospitals Effluent and sewerage processing and waste (garbage) disposal Farming Fishing Food products, beverages and tobacco. Textiles and textile clothing/laundering and dry cleaning Wood and wooden products Cellulose and paper Paper products Non metallic mineral products Rubber and plastic products Manufacture of non metallic products Manufacture of metallic products Machinery and equipment The above-indicated including surface treatment Electrical and optical equipment Electronic and electro-vacuum devices, other (micro) electronic components Other transport equipment Manufacturing Not Elsewhere Classified Utilization (dismantling and separation) Water supply (including water abstraction and distribution) Education C-IMS Certification page 11 of 14 DURATION OF MANAGEMENT SYSTEMS AUDIT I-25cl Publishing Companies Printing Companies Maintenance and repair of motor vehicles and motorcycles Wholesale and Retail Trade Transport and storage Sales Hotels and Restaurants Post and telecommunications Financial Intermediation Information Technology Engineering Services Research and development Public Administration Leisure services, cultural and sport activity Real Estate Renting Other professional services Other Social Services Low Limited Not all organizations in a specific sector will always fall in the same complexity category. CIMS Certification allows flexibility in its application review procedure to ensure that the specific activities of the organization are considered in determining the complexity category. C-IMS Certification documents all cases where it has lowered the complexity category for an organization in a specific sector. ANNEX C Item No. 1 Factors affecting the MS audit duration Magnitude of the factor in % 3 The organization size: - the physical size of the client organization (large or small); - the number of people involved in the activities of the client organization in relation to the scope of the audit including, when relevant, part-time, seasonal contract and casual personnel; - complicated logistics; - the number of sites to be audited. 2 3 3 The organization location: the level of central control; the commonalities of processes and products; the linked processes; seasonal and climate conditions. Complexity of the client’s organization and management system: 3 - accessibility to management system documentation and records; - structure of the management system, including levels of controls, reporting and internal communication; - the number and range of people representing various levels within the client organization to be interviewed; - activities that require visiting temporary sites; - complexity of the interaction between the client organization’s activities; - prior knowledge about the client organization; - activities which are repetitive; - changes to the client organization; - the control and type of shift work; - the client organization’s occupational health and safety and security conditions. APPROVED: 01.02.2016 C-IMS Certification page 12 of 14 DURATION OF MANAGEMENT SYSTEMS AUDIT 4 Technological and regulatory context: I-25cl 3 - the complexity and amount of applicable regulations (e.g. food, pharmaceutical, aerospace, nuclear power industries); - the complexity of the technology used in the client organization; - the complexity of design processes; - the level of automation. 5 Activities included in the scope of the management system: 3 - the applicable requirements of the management system standard, including considerations of eligible exclusion of requirements; - the scope of certification with respect to product, services, activities, processes and sites, including consideration of their complexity; - the activities outsourced by the client organization (e.g. extent, level of control, significance, complexity). 6 Maturity and effectiveness of the management system: 3 - the results and effectiveness of any prior audits performed by the certification body; - the results and effectiveness of any prior external audits conducted by parties other than the certification body; - the effectiveness of the client organization’s internal audit and management review processes; - the level of understanding and commitment to the management system within the client organization; - existing certified management systems; - reliable public information (e.g. media reports, customer feedback, regulatory information or sanctions); - the period for which the management system has been in operation; - the capacity of the client organization to achieve its management system objectives. 7 Risks associated with the products, processes or activities of the client organization: 3 - the existence of hazardous processes, materials or work environment (e.g. sterilization with radiation, chemicals used in leather treatment process); - the risk of non-conformities and their impact (e.g. in health service, food production, air traffic control); - the level of vulnerability within processes and operations; - risks of accidents causing serious environmental impacts. 8 3 Culture: - different cultures; - the need for interpretation and translation.; - staff speaking more than one language. 9 3 Composition of the audit team: - the need for translators or interpreters; - the need for technical experts. 10 Other factors Total 11 Audit of IMS (see PR-27) 3 Reduction/increase not more than 30% Reduction not more than 20% Reduction not more than 50% Total Each factor reduces or increases the initial duration of the audit by 3%. After considering and summing up all factors affecting the reduction or increase of the audit duration, the final duration of the audit is calculated. The maximum value can amount to 30% of the initial man-days established from Table 1, Annex A and Table 1, Annex B. APPROVED: 01.02.2016 C-IMS Certification page 13 of 14 DURATION OF MANAGEMENT SYSTEMS AUDIT I-25cl When performing an Integrated Management System audit, the calculation of the audit duration shall be conducted in concordance with requirements of PR/27, where the maximum reduction of the audit duration can amount to 20%. Then the quantitative values of factors affecting the audit duration shall be summarized in % expression and the total value of the audit duration is calculated in %. The maximum reduction of IMS audit time taking into account all the factors can amount to 50%. APPROVED: 01.02.2016 C-IMS Certification page 14 of 14
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