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
Audit Preparation
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Review corrective actions for previous IA findings
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Review corrective actions for previous EA findings
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Review corrective actions for any customer complaints
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Review corrective actions for any customer audit findings
4.1 General Requirements
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Has the organization established, documented, implemented and maintained a quality management system?<br>
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AS9100C - Does the organization’s quality management system address customer and applicable statutory & regulatory quality management system requirements?
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Does the organization continually improve the effectiveness of its quality management system in accordance with the requirements of this International Standard?<br>
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HAS THE ORGANIZATION:<br>
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determined the processes needed for the quality management system and their application throughout the organization (see 1.2)?
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determined the sequence and interaction of these processes?<br>
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determined criteria and methods needed to ensure that both the operation and control of these processes are effective?
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ensured the availability of resources and information necessary to support the operation and monitoring of these processes?<br>
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monitored, measured where applicable, and analysed these processes?<br>
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implemented actions necessary to achieve planned results and continual improvement of these processes?
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Are these processes managed by the organization in accordance with the requirements of this International Standard?<br>
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Where the organization chooses to outsource any process that affects product conformity to requirements, has the organization ensured control over such processes?<br>
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Is the type and extent of control of such outsourced processes defined within the quality management system?<br>
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NOTE 1 Processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization, measurement, analysis & improvement.
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NOTE 2 An “outsourced process” is a process that the organization needs for its quality management system and which<br>the organization chooses to have performed by an external party.
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NOTE 3 Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity<br>to all customer, statutory and regulatory requirements. The type and extent of control to be applied to the outsourced<br>process can be influenced by factors such as<br><br><br>
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a) the potential impact of the outsourced process on the organization’s capability to provide product that conforms to requirements,
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b) the degree to which the control for the process is shared,
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c) the capability of achieving the necessary control through the application of 7.4.
4.2.1 Documentation Requirements - General
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Has the organization documented their quality management system?<br>
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Does the documentation include documented statements of a quality policy and quality objectives?<br>
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a quality manual?<br>
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documented procedures and records required by this International Standard?
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Control of documents?<br>
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Control of quality records?<br>
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Internal audits?<br>
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Control of non-conformity?<br>
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Corrective action?<br>
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Preventive action?<br>
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Documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes?<br>
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AS9100C - Has the organization ensured that personnel have access to, and are aware of, relevant quality management system documentation & changes?
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NOTE 1 Where the term “documented procedure“ appears within this International Standard, this means that the<br>procedure is established, documented, implemented and maintained. A single document may address the requirements<br>for one or more procedures. A requirement for a documented procedure may be covered by more than one document.
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NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to:
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a) Size of organization and type of activities,
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b) The complexity of the processes & their interactions, and
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c) The competence of personnel.
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NOTE 3 The documentation can be in any form or type medium.
4.2.2 Quality Manual
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Has the quality manual been established?<br>
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Is the quality manual maintained?<br>
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The scope of the quality management system including details of and justification for any exclusions (see 1.2)?
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the documented procedures established for the quality management system, or reference to them?<br>
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a description of the interaction between the processes of the quality management system?<br>
4.2.3 Control of Documents
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Are all documents required by the quality management system controlled?<br>
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Are records controlled according to the requirements given in 4.2.4?<br>
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Are records considered to be a special type of document?<br>
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Has a documented procedure been established to define the controls needed to approve documents for adequacy prior to issue?<br>
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to review and update as necessary and re-approve documents?<br>
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to ensure that changes and the current revision status of documents are identified?<br>
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to ensure that relevant versions of applicable documents are available at points of use?<br>
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to ensure that documents remain legible and readily identifiable?<br>
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to ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled?<br>
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to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose?<br>
4.2.4 Control of Records
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Have records been established to provide evidence of conformity to requirements and of the effective operation of the quality management system?<br>
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Has a documented procedure been established to define the controls needed for the identification of records?
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Are they controlled?<br>
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Storage of records?<br>
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Protection of records?<br>
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Retrieval of records?<br>
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retention time of records?<br>
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disposition of records?<br>
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Are records legible?<br>
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Are records readily identifiable?<br>a) What methods are used?
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Are records readily retrievable?<br>a) What methods are used?
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AS9100C - Does the organization have a documented procedure to defines the method for controlling records created by and/or retained by suppliers?
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d) the availability and use of monitoring and measuring equipment?
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Where applicable, does the organization deal w/ noncom-forming product by one or more of the following ways?:<br>
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e) Reviewing the effectiveness of the preventive action taken?
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AS9100C - Note: Examples of preventive action opportunities include risk management, error proofing, failure mode and effect analysis (FMEA), & information on product problems reported by external sources.
