Information
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Document No.
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Audit Title
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Client
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Conducted on
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Auditor
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Personnel involved on the audit
4.2.2 Quality Manual
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Does the organisation have a documented quality manual?<br>
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Does the quality manual include the scope of the quality management system? <br>
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Details of and justification for any exclusions (see 1.2)?
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Does the Quality Manual include an Interaction Diagram?
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Does the QM contain the procedures or reference to them?<br>
4.2.3 Control of Documents
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Has a documented procedure been established to define the controls needed to approve documents?<br>
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Are all documents required by the quality management system effectively controlled?<br>
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Are changes and the current revision status of documents are identified?<br>
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Are versions of applicable documents available at points of use?<br>
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Do procedures ensure that documents remain legible and readily identifiable?<br>
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Are appropriate documents of external origin identified and controlled?<br>
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Do procedures effectively prevent the unintended use of obsolete documents?<br>
4.2.4 Control of Records
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Are documented procedure established to define what record are required?
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Do these procedure define how records should be protected from deterioration? <br>
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Do procedures define the retention time of records and are they in accordance with contract requirements?<br>
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Are procedures available to control the disposal of records?<br>
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Are records legible and readily retrievable?<br>
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Are virus protection procedures implemented and maintained?
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Is there a backup procedure?
5.2 Customer Focus
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Does top management ensure that customer requirements are determined?<br>
5.3 Quality Policy
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Does top management ensure that the quality policy is appropriate to the purpose of the organisation?<br>
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Does the Q Policy include a commitment to comply and continually improve the effectiveness of the QMS?<br>
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Does the Q Policy provides a framework for establishing and reviewing quality objectives?<br>
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Has the Q Policy been communicated and understood within the organisation?<br>
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Is the Q Policy reviewed for continuing suitability?<br>
5.4.1 Quality Objectives
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Does top management ensure that quality objectives, including those needed to meet requirements for product [see 7.1 a)], are established at relevant functions and levels within the organization. <br>
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Are the quality objectives measurable?<br>
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Are the quality objectives consistent with the quality policy?<br>
5.5.1 Responsibility and Authority
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Does top management ensure that responsibilities and authorities are defined and communicated within the organization?<br>
5.5.2 Management Representative
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Has top management appointed a management representative?
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Are responsibilities in line with ISO9001?<br>
5.5.3 Internal Communication
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Are communication processes established within the organisation?<br>
5.6 Management Review - General
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Does top management review the quality management system, at planned intervals?<br>
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Are records from management reviews available (see 4.2.4)?<br>
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Does the input to management review include those defined in section 5.6.2?
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Does the output include actions to improve the effectiveness of the quality management system?<br>
6.1 Provision of Resources
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Has the organisation determined resources needed to implement and effectively maintain the QMS?<br>
6.2 Competence, Awareness & Training
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Has the organisation determined the necessary competence for personnel?<br>
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Is training or taken other actions provided to achieve the necessary competence?<br>
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Is there a system for evaluating the effectiveness of the training and other actions taken?<br>
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Are personnel aware of the relevant importance of their activities and how they contribute to the achievement of the quality objectives?<br>
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Are records of education, training, skills and experience maintained (see 4.2.4)?
6.3 Infrastructure
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Has the organisation determined, provided and maintained the infrastructure needed to achieve conformity to product requirements?<br>
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Does this infrastructure include, as applicable buildings, workspace and associated utilities?<br>
6.4 Work Environment
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Has the organization determined and managed the work environment needed to achieve conformity to product requirements?<br>
7.2 Review of Requirements relating to the Product and Service?
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Are quotations provided prior to a contract being awarded?
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Does the organization formally review the requirements related to the product/service?<br>
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Are Contract Agreements reviewed and approved in accordance with Documented procedures?<br>
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Are Product Specifications and Service Levels documented and agreed?<br>
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Does the organisation have the ability to meet the defined contract requirements?<br>
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Are records resulting and actions arising from the review maintained (see 4.2.4)?<br>
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Where the client provides no documented statement of requirement, have the customer requirements been confirmed by the organisation before acceptance?<br>
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Where requirements are changed, does the organisation ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements?<br>
7.3 Design and Development?
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Does the organization plan and control the design and development of product?<br>
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the review, verification and validation that are appropriate to each design and development stage?<br>
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the responsibilities and authorities for design and development?<br>
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Wherever practicable, is validation completed prior to the delivery or implementation of the product?<br>
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Are records of the results of validation and any necessary actions maintained (see 4.2.4)?<br>
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Are design and development changes identified and records maintained?<br>
7.4.1 Purchasing Process
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Does the organisation ensure that subcontracted services conform to specified requirements?<br>
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Has the criteria for the selection, evaluation and re-evaluation of subcontractors been established?<br>
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Are records and actions arising from the evaluations maintained (see 4.2.4)?<br>
7.4.2 Purchasing Information
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Do purchasing documents clearly describe the services purchased, including where appropriate:<br>
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requirements for qualification of personnel?<br>
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quality management system requirements?<br>
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Does the organization ensure the adequacy of specified purchase requirements prior to their communication to the supplier?<br><br><br><br>
7.4.3 Verification of Purchased Product
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Has the organisation established procedures for ensuring that purchased product meets specified purchase requirements?<br>
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Where the organization or its customer intends to perform verification at the supplier's premises, has the organization stated the intended verification arrangements and method of product release in the purchasing information?<br>
7.5.3 Identification and traceability
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Where appropriate, does the organisation identify products by suitable means?<br>
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Does the organisation identify the status of each product with respect to monitoring and measurement?<br>
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Where traceability is a requirement, does the organisation control and record the unique identification of the product and maintain records (see 4.2.4)?<br>
7.5.4 Customer property
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Does the organisation identify, verify, protect and safeguard customer property?<br>
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If any customer property is lost, damaged or otherwise found to be unsuitable for use, is this reported to the customer?<br>
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If any customer property is lost, damaged or otherwise found to be unsuitable are records maintained (see 4.2.4)?<br>
7.5.5 Preservation of products
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Does the organization preserve the conformity of product during internal processing and delivery to the intended destination in order to maintain conformity to requirements?<br>
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As applicable, does this preservation include identification, handling, packaging, storage and protection?<br>
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Are special storage conditions understood and controlled?
7.5. Products and Services
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Are products and service processes conducted in accordance with contract requirements?<br>
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Are Product Trials and Specifications documented and agreed in an effective manner?
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Are records relating to Service Levels maintained?
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Are changes or amendments to contracts formally approved and documented?<br>
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Are qualified personnel allocated?<br>
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Are specific methods and procedures operated to monitor products and services? <br>
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Are records maintained in accordance with agreed contracts? (see 4.2.4)?<br>
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If a complaint is received are they recorded and resolved in accordance with Documented Procedures?<br>
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Are there any other issues?
7.6 Control of monitoring and measuring equipment
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Are monitoring and measurement equipment calibrated?<br>
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Where necessary is measuring equipment calibrated or verified, or both, at specified intervals, or prior to use?<br>
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Is calibration traceable to international or national measurement standards?<br>
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Where no such standards exist, is the basis used for calibration or verification recorded?<br>
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have identification in order to determine its calibration status?<br>
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be safeguarded from adjustments that would invalidate the measurement result?<br>
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be protected from damage and deterioration during handling, maintenance and storage?<br>
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Does the organization assess and record the validity of the previous results when the equipment is found not to conform to requirements?<br>
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Have records of the results of calibration and verification been maintained (see 4.2.4)?<br>
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When used in the monitoring and measurement of specified requirements, is the ability of computer software to satisfy the intended application confirmed?<br>
8.2.1 Customer satisfaction
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Does the organisation monitor information relating to customer perception as to whether customer requirements have been met?<br>
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Have the methods for obtaining and using this information been determined?<br>
8.2.2 Internal Audit
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Does the organisation conduct internal audits at planned intervals<br>
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Does the audit programme taking into consideration the status and importance areas to be audited?<br>
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Does the audit programme ensure that auditors shall not audit their own work?<br>
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Are records of the audits and their results maintained (see 4.2.4)?<br>
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Does the management responsible for the area being audited ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes?
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Do follow-up activities include the verification of the actions taken and the reporting of verification results (see 8.5.2)?<br>
8.2.3 Monitoring and measurement of processes
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Does the organization apply suitable methods for monitoring and, where applicable, measurement of the quality management processes?<br>
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Do these methods demonstrate the ability of the processes to achieve planned results?<br>
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When planned results are not achieved, is correction and corrective action taken, as appropriate?<br>
8.2.4 Monitoring and measurement of product
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Does the organisation monitor and measure services levels to verify that the requirements have been met?<br>
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Do records of service level monitoring comply with the Contract requirements (see 7.1)?<br>
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Has evidence of conformity with the acceptance criteria been maintained?<br>
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Do records indicate the person(s) authorizing release of reports to the customer (see 4.2.4)?<br>
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Does the organisation ensure that the release of delivery of service shall not proceed until the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer?<br>
8.3 Control of nonconforming product and service
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Does the organisation ensure that services that do not conform to agreed requirements are identified and controlled to prevent its unintended use or delivery?<br>
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Have the controls and related responsibilities and authorities for dealing with nonconforming product been defined in a documented procedure?<br>
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Does the organisation deal with nonconforming product and service in an effective manner? <br>
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When nonconforming service is corrected is it subject to re-verification to demonstrate conformity to the requirements?<br>
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Are records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, maintained (see 4.2.4)?<br><br>
8.4 Analysis of data
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Does the organisation determine, collect and analyse appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made?<br>
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Does this include data generated as a result of monitoring and measurement and from other relevant sources?<br>
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Does the analysis of data provide information relating to customer satisfaction (see 8.2.1)?<br>
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conformity to product requirements (see 7.2.1)?<br>
8.5.2 Corrective action
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Does the organisation take action to eliminate the causes of nonconformities in order to prevent recurrence?<br>
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Has a documented procedure been established to define requirements for reviewing nonconformities (including customer complaints)?<br>
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Do these procedures ensure the causes of nonconformities are determined?<br>
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Do actions ensure that nonconformities do not recur?<br>
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Are records maintained of the results of action taken (see 4.2.4)?<br>
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Are records relating to the effectiveness of the corrective action taken, maintained?<br><br><br><br><br>
8.5.3 Preventive action
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Has the organisation determined action to eliminate the causes of potential nonconformities in order to prevent their occurrence?<br>
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Are preventive actions appropriate to the effects of the potential problems?<br>
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Has a documented procedure been established to define requirements for determining potential nonconformities and their causes?<br>
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evaluating the need for action to prevent occurrence of nonconformities?<br>
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determining and implementing action needed?<br>
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records of results of action taken (see 4.2.4)?<br>
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reviewing the effectiveness of the preventive action taken?<br>
