Quality Management Systems Guidelines

Appendix C - Quality Management System assessment checklist

This checklist has been designed to assist Government agencies and others in assessing a service providers Quality Management System. It may also assist agencies, other customers and service providers as a guide in developing their Quality Management Systems. The number references are to clause numbers in the current AS/NZS ISO 9001, Quality management systems Requirements. Key to symbols to be used in check-boxes is: = Yes = No O = Not applicable 4 QUALITY MANAGEMENT SYSTEM 4.2.2 Quality manual Does the Quality Manual include:

a description of the scope of the Quality Management System, including details of, and justifications for, any exclusions? documented procedures, as part of the Quality Management System, or reference to them?

a description of the interaction between the processes of the Quality Management System? 4.2.3 Control of documents Is a documented procedure established to define the controls needed to:

approve documents for adequacy prior to use? review and update as necessary and re-approve documents? ensure the changes to, and the current version status of, documents are identified? ensure that applicable documents are available at point of use? ensure that documents remain legible and readily identifiable? ensure that documents of external origin are identified and their distribution controlled?

prevent unintended use of obsolete documents, and apply suitable identification to obsolete documents where they are to be retained? 4.2.4 Control of records Are procedures documented for the identification, storage, protection, retrieval, retention and disposal of records needed to provide evidence of conformity of contract work and of the effective operation of the Quality Management System? 5 MANAGEMENT RESPONSIBILITY 5.1 Management commitment Has senior management shown evidence of its commitment by:

5.2

communicating to service provider personnel the importance of meeting customer, statutory and regulatory requirements? establishing and implementing the quality policy? ensuring quality objectives are established? conducting management reviews? ensuring the availability of appropriate resources?

Customer focus Are processes documented and implemented by senior management, covering processes for determining and meeting customer requirements, and enhancing customer satisfaction?

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5.3

Quality policy Is documented quality policy appropriate for the product/services that the service provider wants to provide to the customer? Does quality policy include a commitment to comply with customer requirements and continually improve the effectiveness of the Quality Management System? Does quality policy provide a framework for establishing and reviewing quality objectives? Are there procedures for communicating the quality policy, and for senior management to verify it is understood?

Are there procedures for reviewing the quality policy for continuing suitability, and for senior management to regularly verify its suitability? 5.4 Planning 5.4.1 Quality objectives

Are the quality objectives established and documented? Are the quality objectives measurable and consistent with the quality policy and products/services provided, for relevant service provider functions and levels? Are there procedures for reviewing the quality objectives for continuing suitability, and for senior management to regularly verify this suitability? 5.4.2 Quality management system planning

5.5

Does the planning process documented and implemented meet the quality management requirements and quality objectives? Are there procedures for reviewing the planning process implementation, and for senior management to regularly verify process suitability and the achievement of objectives? Have Quality Management Plan templates been included or are procedures documented to ensure that required processes (where they are documented only in the Quality Management Plans) will be consistently applied, where relevant? Are there procedures for ensuring the integrity of the Quality Management System is maintained when changes to the Quality Management System are planned and implemented, and for senior management to regularly verify their implementation and suitability? Responsibility, authority and communication Are persons identified with their responsibilities and authorities defined and communicated within the service provider organisation? Are processes documented for the communication, and reviewing the definition and communication procedure, for continuing suitability, and for senior management to regularly verify this suitability? Is the corporate management representative appointed with appropriate responsibilities and authority (Clause 5.5.2)? Management review Has senior management planned, carried out and recorded regular reviews of the Quality Management System and verified its suitability, adequacy and effectiveness?

5.6

Are the planned system reviews documented? 6 RESOURCE MANAGEMENT 6.1 Provision of resources Has the service provider developed and implemented a process, with documentation, to plan, determine and provide the resources needed:

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to implement the Quality Management System and continually improve its effectiveness? to enhance customer satisfaction by better meeting customer requirements?

6.2 Human resources Has the service provider documented and implemented procedures for processes to:

6.3

determine the necessary competence of personnel performing work affecting conformity to product and service quality requirements? provide personnel with the required skills and experience, and to provide training or take other actions to address deficiencies in competence and evaluate the effectiveness of the actions taken? ensure personnel are aware of how their roles contribute to achieving quality objectives? maintain appropriate records of education, training, skills and experience?

Infrastructure (may be addressed in QMP) Has the service provider documented and implemented a process to determine, provide and maintain the infrastructure (facilities, equipment and services) needed to achieve product/service requirements? Work environment (may be addressed in QMP) Has the service provider documented and implemented a process to determine, identify and manage the work environment (including identifying/assessing risks) needed to achieve product/service requirements? PRODUCT REALISATION Planning of product realisation Has the service provider documented and implemented procedures for a process to plan product realisation, including determining the following, as appropriate:

6.4

7 7.1

quality objectives and requirements for the product/service? the need to establish processes, documents and provide resources specific to the product/service? required verification, validation, monitoring, measurement, inspection and test activities specific to the product/service and the criteria for product/service acceptance? records needed to provide evidence that the realisation processes and resulting product/service meet requirements?

Does planning include the preparation of contract QMPs and associated documents, including guidelines and procedures for determining contract-specific requirements in accordance with Clause 7.2.1?

7.2 Customer-related processes In the processes documented and implemented by the service provider: Does the service provider determine the customers requirements, including those specified, those not specified but necessary for the customers intended use, and relevant statutory and regulatory requirements? (Clause 7.2.1)

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Is a review carried out and recorded, before submitting a tender, to check that the customers tender documents adequately define the requirements for work under the contract? (Clause 7.2.2) Is action taken to resolve any differences with requirements previously expressed or otherwise expected? (Clause 7.2.2) Does the review of tender documents include confirmation that the service provider has the ability to meet the defined requirements confirmed? (Clause 7.2.2) Does the service provider deal with changes to customer requirements and ensure that documents are amended and personnel are made aware of the changes? (Clause 7.2.2) Does the service provider deal with customer communications/feedback, including customer complaints? (Clause 7.2.3)

7.3 Design and development (may be addressed in QMP/design plan) 7.3.1 Design and development planning In the processes documented and implemented by the service provider:

Does the service provider provide for the determination of the design stages, including the review, verification and validation that are appropriate to each design stage? Is provision made for personnel/group responsibility and authority to be determined for the design processes? Is provision made for the interfaces between different groups involved in the design processes to be managed to ensure effective communication and clear assignment of responsibility?

7.3.2 Design and development inputs In the processes documented and implemented by the service provider:

Is provision made to determine and record design input requirements, including:

functional and performance requirements? applicable statutory and regulatory requirements? other essential requirements and, where applicable, information from previous similar designs?

Is provision made for the design inputs to be reviewed for adequacy, including consistency and completeness? 7.3.3 Design and development outputs In the processes documented and implemented by the service provider: Does the service provider provide for the outputs of design and development to be in a form that enables verification against the design inputs and approval prior to release? Does the service provider ensure that in the design outputs:

all design input requirements have been met? appropriate information is provided to enable the procurement of relevant materials and products/services? relevant acceptance criteria for completed work are provided or referenced? characteristics essential for safe and proper use of products (during construction and post-construction, as applicable) are specified?

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7.3.4 Design and development review In the processes documented and implemented by the service provider, is provision made:

For systematic design reviews at suitable design stages by relevant personnel to evaluate whether the design meets requirements and to identify any problems and propose any necessary actions?

For records of the results of design reviews and any necessary actions to be maintained? 7.3.5 Design and development verification In the processes documented and implemented by the service provider, is provision made: For the design to be verified at appropriate stages to confirm that the design outputs have met the design input requirements?

For records of the results of design verification and any necessary actions to be maintained? 7.3.6 Design and development validation In the processes documented and implemented by the service provider, is provision made:

For the design to be validated (preferably before delivery/use) to show that the resulting designed product will be capable of meeting the specified requirements?

For records of the results of design validation and any necessary actions to be maintained? 7.3.7 Control of design and development changes In the processes documented and implemented by the service provider, is provision made:

For design changes to be identified, reviewed (including the consequences with other product parts), verified and validated, as appropriate, and approved before being implemented?

For records of the results of the review of changes and any necessary actions to be maintained? 7.4 Purchasing 7.4.1 Purchasing process In the processes documented and implemented by the service provider, is provision made:

For providing effective control over planning for, placing orders for, and verifying purchased products/services, and over the suppliers/service providers, to ensure that specified requirements are met? For the service provider to evaluate and select its service providers on the basis of their ability to meet specified requirements, including their past performance? For the service provider to establish criteria for selection, evaluation and re-evaluation of its service providers?

For records to be maintained of the results of the control and evaluation processes and any necessary actions arising from the processes? 7.4.2 Purchasing information In the processes documented and implemented by the service provider, is provision made:

For the description of the product/service to be purchased, including where applicable:

requirements for approval of service, product, procedures, processes and equipment? requirements for qualifications of personnel? quality management system/plan/ITP requirements? verification arrangements, including at its service providers premises and the method of product release?

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For the service provider to ensure the adequacy of specified purchase requirements before being communicated to its potential and actual service providers? 7.4.3 Verification of purchased product In the processes documented and implemented by the service provider, is provision made:

For the service provider to ensure the purchased product/service meets the specified requirements (including release/accept the product/service and the specification)?

For the service provider to plan, specify and implement surveillance and inspection of its service providers operations/activities, to verify conformity with quality systems and with specified product/service quality requirements? 7.5 Production and service provision 7.5.1 Control of production and service provision In the processes documented and implemented by the service provider, is provision made:

To plan, document, implement and monitor the controlled conditions needed for each work process, including:

information that describes the product/service characteristics? the availability of work instructions, as necessary? the use of suitable equipment? the availability and use of monitoring and measuring equipment? the implementation of monitoring and measurement? the implementation of product release, delivery and post-delivery activities, as applicable? methods for monitoring the effectiveness of new or changed processes (Clause 8.2.3)?

7.5.2 Validation of processes for production and service provision In the processes documented and implemented by the service provider, is provision made:

To identify work processes for which the resulting output cannot be fully verified by subsequent monitoring, inspection and testing? For work process descriptions, indicating the criteria for process review/approval, equipment approval and operator qualifications, equipment controls, method for validating process outputs and records to be kept, when appropriate?

For performing process validation and keeping validation records, when appropriate? 7.5.3 Identification and traceability In the processes documented and implemented by the service provider, is provision made: For the service provider to progressively identify work output by subdividing work into lots or discrete work areas and uniquely identifying each lot or work area?

To identify samples and test results against the lot or work area to which they relate? 7.5.4 Customer property (may be addressed in QMP) In the processes documented and implemented by the service provider, is provision made:

To identify, verify, protect and safeguard the customers property provided for use or for incorporation into the product? To advise the customer of any loss or damage to, or unsuitability of, the property, to act to correct this, and to keep appropriate records?

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7.5.5 Preservation of product (may be addressed in QMP) In the processes documented and implemented by the service provider, is provision made:

For the service provider to preserve the product during internal processing and delivery to maintain conformity to requirements. As applicable, preservation shall include identification, handling, packaging, storage and protection? 7.6 Control of monitoring and measuring equipment (may be addressed in QMP) In the processes documented and implemented by the service provider, is provision made for the service provider to:

Determine the monitoring and measurement to be undertaken to provide evidence of conformity of product/service to specified requirements? Determine, provide and maintain the monitoring and measurement equipment required to provide evidence of conformity of product/service to specified requirements?

Implement the monitoring and measurement required? 8 MEASUREMENT, ANALYSIS AND IMPROVEMENT 8.1 General In the processes documented and implemented by the service provider, is provision made:

To plan, document and implement the monitoring, measurement (such as performance statistics), analysis and improvement processes/methods, and their use frequency, needed to:

demonstrate conformity of the product/service requirements? (may be addressed in QMP) ensure conformity of and with the Quality Management System? continually improve the effectiveness of the Quality Management System?

8.2 Monitoring and measurement 8.2.1 Customer satisfaction In the processes documented and implemented by the service provider, is provision made: For the service provider to follow a determined method to monitor and measure performance as the customer perceives it, and act to address any lack of performance and misconceptions?

For the determination and/or description of the method, including obtaining and using the information required? 8.2.2 Internal audit In the procedures documented and implemented by the service provider, is provision made:

For the service provider to conduct internal audits at planned intervals to determine whether the Quality Management System conforms to the planned arrangements and specified requirements, and that the Quality Management System is being effectively implemented and maintained? For the audit program to take into consideration the status and importance of the processes and work areas to be audited as well as the results of previous audits? For audits to be conducted with objectivity and impartiality, by auditors who are not directly responsible for or involved in the activity being audited? For the audit criteria, scope, frequency and methods to be defined? For audit results to be recorded and brought to the attention of the responsible personnel for prompt action and follow-up? For the responsibilities and requirements to be defined for planning and conducting audits, and for reporting results and maintaining records?

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For the management responsible for the area being audited to ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes?

For the follow-up activities to include the verification of the actions taken and the reporting of the verification results? 8.2.3 Monitoring and measurement of processes (may be addressed in QMP) In the processes documented and implemented by the service provider, does the service provider allow for monitoring, and where applicable, measuring the ability of quality management processes to achieve planned results? 8.2.4 Monitoring and measurement of product (may be addressed in QMP)

In the processes documented and implemented by the service provider, does the service provider allow for progressively (as planned) monitoring and measuring the characteristics of products/services to ensure requirements have been met? 8.3 Control of nonconforming product In the procedures documented and implemented by the service provider, is provision made:

For the controls and related responsibilities for ensuring that a product/service which does not conform to product/service requirements is identified and controlled to prevent its unintended use or delivery? For the service provider to deal with a nonconforming product or service by one or more of the following ways:

8.4

by taking action to eliminate the detected nonconformity? by authorising its use, release or acceptance under a concession by a relevant authority and, where applicable, by the customer? by taking action to preclude its original intended use or application?

For reworked and repaired products and rectified services to be re-inspected, re-tested or evaluated to demonstrate conformity with the requirements? For records to be maintained of the nature of nonconformities and any subsequent actions taken, including concessions obtained? For the service provider to take action appropriate to the effects, or potential effects, of the nonconformity when a nonconforming product/service is detected after delivery or use has started? Analysis of data

In the processes documented and implemented by the service provider, is provision made for the service provider to determine, collect and analyse (including trends) appropriate data to demonstrate the suitability and effectiveness, and for the improvement, of the Quality Management System (including to suit Clause 8.2)? 8.5 Improvement 8.5.1 Continual improvement

In the procedures documented and implemented by the service provider, is provision made for the service provider to continually improve the Quality Management System? 8.5.2 Corrective action In the procedures documented and implemented by the service provider, is provision made: For the action the service provider will take to eliminate the causes of nonconformities in order to prevent their recurrence, including requirements for:

reviewing nonconformities (including customer complaints)?

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determining the causes of nonconformities? evaluating the action needed to ensure that nonconformities do not recur? determining and implementing the action needed and appropriate to the effects of the nonconformities encountered? recording the results of the action taken? reviewing the effectiveness of the corrective action taken?

8.5.3 Preventive action In the procedures documented and implemented by the service provider, is provision made:

For the action the service provider will take to eliminate the causes of potential nonconformities in order to prevent their occurrence, including requirements for:

determining potential nonconformities and their causes? evaluating the action needed to prevent the occurrence of nonconformities? determining and implementing the action needed? recording the results of the action taken? reviewing the effectiveness of the preventive action taken?