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 provider’s 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: ü = Yes û = No O = Not applicable
4 QUALITY MANAGEMENT SYSTEM
4.2.2 Quality manual
Does the Quality Manual include:
q a description of the scope of the Quality Management System, including details of, and justifications for, any exclusions?
q documented procedures, as part of the Quality Management System, or reference to them?
q 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:
q approve documents for adequacy prior to use?
q review and update as necessary and re-approve documents?
q ensure the changes to, and the current version status of, documents are identified?
q ensure that applicable documents are available at point of use?
q ensure that documents remain legible and readily identifiable?
q ensure that documents of external origin are identified and their distribution controlled?
q 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
q 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:
q communicating to service provider personnel the importance of meeting customer, statutory and regulatory requirements?
q establishing and implementing the quality policy?
q ensuring quality objectives are established?
q conducting management reviews?
q ensuring the availability of appropriate resources?
5.2 Customer focus
q Are processes documented and implemented by senior management, covering processes for determining and meeting customer requirements, and enhancing customer satisfaction?
5.3 Quality policy
q Is documented quality policy appropriate for the product/services that the service provider wants to provide to the customer?
q Does quality policy include a commitment to comply with customer requirements and continually improve the effectiveness of the Quality Management System?
q Does quality policy provide a framework for establishing and reviewing quality objectives?
q Are there procedures for communicating the quality policy, and for senior management to verify it is understood?
q 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
q 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?
q 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
q Does the planning process documented and implemented meet the quality management requirements and quality objectives?
q Are there procedures for reviewing the planning process implementation, and for senior management to regularly verify process suitability and the achievement of objectives?
q 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?
q 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?
5.5 Responsibility, authority and communication
q Are persons identified with their responsibilities and authorities defined and communicated within the service provider organisation?
q 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?
q Is the corporate management representative appointed with appropriate responsibilities and authority (Clause 5.5.2)?
5.6 Management review
q Has senior management planned, carried out and recorded regular reviews of the Quality Management System and verified its suitability, adequacy and effectiveness?
q 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:
q to implement the Quality Management System and continually improve its effectiveness?
q to enhance customer satisfaction by better meeting customer requirements?
6.2 Human resources
Has the service provider documented and implemented procedures for processes to:
q determine the necessary competence of personnel performing work affecting conformity to product and service quality requirements?
q 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?
q ensure personnel are aware of how their roles contribute to achieving quality objectives?
q maintain appropriate records of education, training, skills and experience?
6.3 Infrastructure (may be addressed in QMP)
q 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?
6.4 Work environment (may be addressed in QMP)
q 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?
7 PRODUCT REALISATION
7.1 Planning of product realisation
q Has the service provider documented and implemented procedures for a process to plan product realisation, including determining the following, as appropriate:
q quality objectives and requirements for the product/service?
q the need to establish processes, documents and provide resources specific to the product/service?
q required verification, validation, monitoring, measurement, inspection and test activities specific to the product/service and the criteria for product/service acceptance?
q records needed to provide evidence that the realisation processes and resulting product/service meet requirements?
q 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:
q Does the service provider determine the customer’s requirements, including those specified, those not specified but necessary for the customer’s intended use, and relevant statutory and regulatory requirements? (Clause 7.2.1)
q Is a review carried out and recorded, before submitting a tender, to check that the customer’s tender documents adequately define the requirements for work under the contract? (Clause 7.2.2)
q Is action taken to resolve any differences with requirements previously expressed or otherwise expected? (Clause 7.2.2)
q 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)
q 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)
q 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:
q 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?
q Is provision made for personnel/group responsibility and authority to be determined for the design processes?
q 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:
q Is provision made to determine and record design input requirements, including:
q functional and performance requirements?
q applicable statutory and regulatory requirements?
q other essential requirements and, where applicable, information from previous similar designs?
q 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:
q 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:
q all design input requirements have been met?
q appropriate information is provided to enable the procurement of relevant materials and products/services?
q relevant acceptance criteria for completed work are provided or referenced?
q characteristics essential for safe and proper use of products (during construction and post-construction, as applicable) are specified?
7.3.4 Design and development review
In the processes documented and implemented by the service provider, is provision made:
q 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?
q 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:
q For the design to be verified at appropriate stages to confirm that the design outputs have met the design input requirements?
q 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:
q 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?
q 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:
q For design changes to be identified, reviewed (including the consequences with other product parts), verified and validated, as appropriate, and approved before being implemented?
q 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:
q 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?
q 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?
q For the service provider to establish criteria for selection, evaluation and re-evaluation of its service providers?
q 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:
q For the description of the product/service to be purchased, including where applicable:
q requirements for approval of service, product, procedures, processes and equipment?
q requirements for qualifications of personnel?
q quality management system/plan/ITP requirements?
q verification arrangements, including at its service provider’s premises and the method of product release?
q 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:
q For the service provider to ensure the purchased product/service meets the specified requirements (including release/accept the product/service and the specification)?
q 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:
q To plan, document, implement and monitor the controlled conditions needed for each work process, including:
q information that describes the product/service characteristics?
q the availability of work instructions, as necessary?
q the use of suitable equipment?
q the availability and use of monitoring and measuring equipment?
q the implementation of monitoring and measurement?
q the implementation of product release, delivery and post-delivery activities, as applicable?
q 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:
q To identify work processes for which the resulting output cannot be fully verified by subsequent monitoring, inspection and testing?
q 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?
q 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:
q 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?
q To identify samples and test results against the lot or work area to which they relate?