Information
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Document No.
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Audit Title
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Client / Site
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Conducted on
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Prepared by
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Location
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Personnel
4. MANAGEMENT REQUIREMENTS
4.1 Organisation
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Has the company defined and documented its organisation structure?
4.1.3 Scope of Management System
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Has the organisation clearly describes the scope of the ISO17025 management system?
4.1.5a Managerial and Technical Personal
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Do managerial and technical personnel have the authority and resources needed to carry out duties and to identify and initiate actions to prevent or minimise departures from the management system or testing/calibration procedures?
4.1.5b Undue Pressure
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Are arrangements in place so that management and personnel are free from internal and external commercial, financial and other pressures that might adversely affect the quality of their work?
4.1.5c Customer Confidentiality
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Are policies and procedures related to customer confidentiality, including electronic storage and transmission of results in place?
4.1.5d Operational Integrity
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Are policies and procedures in place to avoid involvement in activities that compromise the confidence in its competence, impartiality, judgement or operational integrity?
4.1.5e Organisation Chart
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Does the organisation have a management structure that defines the relationships between quality management, technical operations, support services and parent organisation (if applicable)?
4.1.5f Responsibility and Authority
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Has the organisation defined the responsibility and authority of all personnel who manage, perform or verify work affecting the quality of the tests and/or calibrations?
4.1.5g Laboratory Supervision
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Are staff involved in calibration and testing activities appropriately supervised?
4.1.5h Technical Management
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Does the organisation have competent technical personnel responsible for technical operations and resources?
4.1.5i Quality Manager
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Has the organisation appointed a member of staff, with direct access to senior management, as quality manager who has defined responsibility and authority for implementing and maintaining the management system?
4.1.5j Managerial Deputies
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where practical, has the organisation appointed deputies for key managerial personnel?
4.1.5k Importance of Roles
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Are personnel aware of their relevance and importance of their activities and how they contribute to the objectives of the management system?
4.1.6 Appropriate Communication
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Are appropriate processes in place for communicating the effectiveness of the management system?
4.2 Management System
4.2.1 Policies and Procedures
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Has the organisation documented its policies and procedures and are they communicated, available, understood and implemented?
4.2.2 Quality Policy Statement
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Has the organisation documented a quality policy statement and does it satisfy all the requirements of ISO17025?
4.2.2, 4.2.5, 4.2.6 Quality Manual
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Does the quality manual satisfy the requirements of ISO17025?
4.2.3 Commitment to Management System
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Is their evidence of a commitment to development, implementation and continual improvement of the management system?
4.2.4 Customer Requirements
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Has the organisation communicated the importance of meeting customer, statutory and regulatory requirements?
4.2.7 Changes to Management System
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Is the integrity of the management system maintained when changes are made?
4.3 Document Control
4.3.1 Procedures
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Are procedures in place to control all documentation included in the management system?
4.3.2.1 Approval and Issue
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Are documents reviewed and approved by authorised personnel prior to issue, and are they included on a master list which identifies the revision status and distribution?
4.3.2.2 Availability
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Are all necessary quality documentation available at points of use?
4.3.2.2 Obsolete Documents
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Are obsolete documents removed or suitably marked to prevent inadvertent use?
4.3.2.3 Identification
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Are all management system documents uniquely identified with the date of issue and/or revision identification, page numbering, total number of pages or a mark to signify the end of the document, and the issuing authority(ies)?
4.3.3.1 Document Changes
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Are changes to documents reviewed and approved by the same function that performed the original review, or a designate?
4.3.3.2 Altered or New Text
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Where practical, is altered or new text identified in the document or the appropriate attachments?
4.3.3.3 Handwritten Amendments
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Where hand written amendments are allowed, are procedures in place that define the authorities, clear marking, initialling, dating, and re-issue?
4.3.3.4 Electronic Documents
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Are procedures in place that describe how changes in documents maintained electronically are made and controlled?
