AUDIT PROGRAMME PROCEDURES

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1 AUDIT PROGRAMME PROCEDURES 1

2 AUDIT PROGRAMME PROCEDURES 1. Scope and field of application This procedure aims at the examination by the certification body of the feasibility of certification audits relating to certification schemes in operation. 2. Normative references For the application of the present documents, the following standards are necessary. ISO 9000 Quality Management Systems - Fundamentals and Vocabulary," and ISO Conformity assessments-requirements for bodies providing audit and certification of management systems 3. Terms and definitions For the purposes of this document, the terms and definitions given in ISO 9000 and ISO apply, unless superseded by the terms and definitions given below. 3.1 audit systematic, independent and documented process for obtaining audit evidence (3.3) and evaluating it objectively to determine the extent to which the audit criteria (3.2) are fulfilled NOTE 1 Internal audits, sometimes called first-party audits, are conducted by, or on behalf of, the organization itself for management review and other internal purposes, and may form the basis for an organization's self-declaration of conformity. In many cases, particularly in smaller organizations, independence can be demonstrated by the freedom from responsibility for the activity being audited. NOTE 2 External audits include those generally termed second- and third-party audits. Second-party audits are conducted by parties having an interest in the organization, such as customers, or by other persons on their behalf. Third-party audits are conducted by external, independent auditing organizations, such as those providing registration or certification of conformity to the requirements of ISO 9001 or ISO NOTE 3 When two or more auditing organizations cooperate to audit a single auditee (3.7), this is termed a joint audit. 3.2 audit criteria set of policies, procedures or requirements NOTE Audit criteria are used as a reference against which audit evidence (3.3) is compared. 3.3 audit evidence records, statements of fact or other information, which are relevant to the audit criteria (3.2) and verifiable NOTE Audit evidence may be qualitative or quantitative. 2

3 3.4 audit findings results of the evaluation of the collected audit evidence (3.3) against audit criteria (3.2) NOTE Audit findings can indicate either conformity or nonconformity with audit criteria or opportunities for improvement. 3.5 audit conclusion outcome of an audit (3.1), provided by the audit team (3.9) after consideration of the audit objectives and all audit findings (3.4) 3.6 audit client organization or person requesting an audit (3.1) NOTE The audit client may be the auditee (3.7) or any other organization which has the regulatory or contractual right to request an audit. 3.7auditee organization being audited 3.8 auditor person with the competence (3.14) to conduct an audit (3.1) 3.9 audit team one or more auditors (3.8) conducting an audit (3.1), supported if needed by technical experts (3.10) NOTE 1 One auditor of the audit team is appointed as the audit team leader. NOTE 2 The audit team may include auditors-in-training technical expert person who provides specific knowledge or expertise to the audit team (3.9) NOTE 1 Specific knowledge or expertise is that which relates to the organization, the process or activity to be audited, or language or culture. NOTE 2 A technical expert does not act as an auditor (3.8) in the audit team audit programme set of one or more audits (3.1) planned for a specific time frame and directed towards a specific purpose NOTE An audit programme includes all activities necessary for planning, organizing and conducting the audits audit plan description of the activities and arrangements for an audit (3.1) 3

4 3.13 audit scope extent and boundaries of an audit (3.1) NOTE The audit scope generally includes a description of the physical locations, organizational units, activities and processes, as well as the time period covered competence demonstrated personal attributes and demonstrated ability to apply knowledge and skills. 4. Responsibilities The Certification Manager, the Audit Programme Responsible, the Management Systems Responsible and the personnel of the Certification Body. 5. Description of the Procedure 5.1 Annual Audit Programme The last month of each year the annual audit programme of certification activities for the coming year is elaborated in order to identify the needs for adequate time and resources (auditors, etc) so that certification procedures take place in a regular way without peak periods Initially, during the elaboration of the annual audit programme, the following is to be taken into account: Existing information in database, Surveillance /reassessment audits to be conducted one month before the expiration of the certification. The interval between audits to be greater than 12 months. Any suggestions/conclusion of lead auditor from previous audit reports Any special requirements for the auditee. All the above information is collected and reviewed by the Planning Responsible, who determines the final required audit mandays. 5.2 Review of New Application for Certification In order to approve any client s request for certification it is necessary to submit appropriately filled the relevant application accompanied by all required attached documents The Audit Programme Responsible reviews the submitted application and the document attached and, if it is needed, contacts the audit client for more clarifications and 4

5 additional information in order to ensure the readiness of the certification body to respond in a reasonable timeframe. Initial assessment audit can take place at the offices in the following cases : when the auditing activity is of low or moderate complexity, when the auditee occupies few workers (<20) the auditee is already certified for another management system by the same Certification Body. In these cases, the Management System Responsible takes note during the review of the application in order to keep informed the Audit Programme Responsible In some cases the two phases of the initial assessment audits can be conducted at only one, if: the audited activity is of low or moderate complexity, the total duration of the initial assessment does not exceed the 2 mandays. In these cases the Management Responsible takes note during the review of the application in order to keep informed the Audit Programme Responsible If the evaluation of application is positive, the existing data are introduced in the database and the relative audit is planned for the next two months or earlier, if there is any particular reason If the evaluation of application is negative, the client is informed accordingly with reasons for the refusal Auditors in training may be included in audit team but should not audit without direction or guidance If not fully covered by the auditors in the audit team, the necessary knowledge and skills may be satisfied by technical experts operating under the direction of auditors. 5.3 Quarterly Program Planning The quarterly program planning is elaborated by the Audit Programme Responsible at least one month before, and takes into consideration: the overall annual Audit Programme, client requests for changes, eg postponements, new applications for certification, the requirements for the selection of the audit team, namely: all audit team members to be auditors of the same management system, 5

6 one member of the audit team to be lead auditor, one at least member of the audit team to have experience in the area of the auditing activities, exclusion of auditors having conflict of interests such as any audit team member having been former employee or having provided consultant services the last 2 years worked in the auditee, declared availability of auditors, geographical proximity with the auditee, reduction the cost of audits, approved of the audit team by the auditee, need for rotation of members audit team into three-year period, NOTE: the mandays of auditors in training and technical experts are not considered as required mandays of audit. The audit program is approved by the Certification Manager, the database is updated appropriately and the Audit Programme Responsible inform in writing the audit client for the type of audit and on the proposed timing and audit team composition to be approved Any change in the quarterly audit programme is initially assessed by the Audit Programme Responsible, approved or rejected by the Certification Manger, and then is communicated in written to auditee representative / members of audit teams and to the database to be updated accordingly. 6. Calculation of Mandays Audit Calculation Mandays of Initial audit Assessment Equivalent Duration of Initial Equivalent number of number of Evaluation personnel personnel (in Mandays) Duration of initial assessment (in Mandays) 1-5 1, ,

7 >10701 Increase according to the following Employees are considered all individuals involved in the implementation of management system, namely the permanent staff of all shifts, the non-permanent employees (seasonal, temporary, subcontractors ) and part-time staff. Equivalent Number of Employees is considered the total number of employees after the following possible reductions: Number of part-time workers: converted into equivalent number of full-time employees based on work hours. Number of seasonal workers: converted into equivalent number of permanent employees on the basis of work months. Number of employees per shift: converted according to the formula [(number of personnel shift) / (number of shifts - 1)], provided that no significant differences are between different shifts The duration of audit is estimated in mandays and includes the duration of the on- site inspection as well as the time needed for auditors or auditor team to prepare and report audit (review of documents). The on-site audit cannot be less than 80% of the total duration of the inspection. NOTE : Mandays audit is considered to have a duration of 8 hours of work. The estimated number of mandays cannot be reduced by scheduling more hours per day. 7. Reduction / increasing factors of audit mandays All factors indicated below should be taken into account to calculate the real audit mandays based on those included in the table, however, the maximum reduction could not exceed 30%. 7.1 Possible factors for increasing audit duration of the auditing organisation Complicated organization (several buildings or sites of application), Not certified according ISO 9001, Multilingual staff (needed translation services ) Large area comparative to the number of employees, Large number of Regulation. Increased complexity of processes or large number of different activities. 7.2 Possible factors for reducing audit duration of the auditing organisation not responsibility in design and / or non-inclusion several requirements/processes, limited area comparative to the number of employees, Maturity of the existing system, 7

8 Prior knowledge of client s management system (for example, already certified for another standard by the same Certification Body), client's maturity for certification (eg, already certified by another certification body) low complexity of processes, employees working outside the "application site", eg vendors, drivers, installers etc. that could be assessed by records control. 7.3 Calculation of audit mandays surveillance The duration of audit surveillance relative to the duration of the initial audit, is estimated at about 1 / 3 of the duration of the initial audit. 7.4 Calculation of audit mandays reassessment The duration of audit reassessment is calculated on the basis of updated data for clients and is estimated at about the 2 / 3 of the duration for the initial assessment. 8

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