qms guidelines appendix c 1

8/12/2019 Qms Guidelines Appendix c 1

1/9

Quality Management Systems Guidelines

1

Appendix C - Quality Management System assessment checklistThis checklist has been designed to assist Government agencies and others in assessing a serviceproviders Quality Management System. It may also assist agencies, other customers and serviceproviders as a guide in developing their Quality Management Systems. The number references are toclause 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, andjustifications 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 anddisposal of records needed to provide evidence of conformity of contract work and of theeffective operation of the Quality Management System?

5 MANAGEMENT RESPONSIBILITY

5.1 Management commitment

Has senior management shown evidence of its commitment by:

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?

5.2 Customer focus

Are processes documented and implemented by senior management, covering processes fordetermining and meeting customer requirements, and enhancing customer satisfaction?


2/9


3/9


4/9


4

Is a review carried out and recorded, before submitting a tender, to check that thecustomers tender documents adequately define the requirements for work under thecontract? (Clause 7.2.2)

Is action taken to resolve any differences with requirements previously expressed orotherwise expected? (Clause 7.2.2)

Does the review of tender documents include confirmation that the service provider hasthe ability to meet the defined requirements confirmed? (Clause 7.2.2)

Does the service provider deal with changes to customer requirements and ensure thatdocuments are amended and personnel are made aware of the changes? (Clause 7.2.2)

Does the service provider deal with customer communications/feedback, includingcustomer 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 thedesign processes?

Is provision made for the interfaces between different groups involved in the designprocesses to be managed to ensure effective communication and clear assignment ofresponsibility?

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 andcompleteness?

7.3.3 Design and development outputsIn 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 thatenables 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?


5/9


5

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 evaluatewhether the design meets requirements and to identify any problems and propose any necessaryactions?

For records of the results of design reviews and any necessary actions to be maintained?7.3.5 Design and development verification


For the design to be verified at appropriate stages to confirm that the design outputs have metthe 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


For the design to be validated (preferably before delivery/use) to show that the resultingdesigned 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


For design changes to be identified, reviewed (including the consequences with other productparts), 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 processIn the processes documented and implemented by the service provider, is provision made:

For providing effective control over planning for, placing orders for, and verifying purchasedproducts/services, and over the suppliers/service providers, to ensure that specifiedrequirements are met?

For the service provider to evaluate and select its service providers on the basis of their ability tomeet specified requirements, including their past performance?

For the service provider to establish criteria for selection, evaluation and re-evaluation of itsservice providers?

For records to be maintained of the results of the control and evaluation processes and anynecessary actions arising from the processes?

7.4.2 Purchasing information


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?


6/9


7/9


7

7.5.5 Preservation of product (may be addressed in QMP)


For the service provider to preserve the product during internal processing and delivery tomaintain 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 theservice provider to:

Determine the monitoring and measurement to be undertaken to provide evidence of conformityof product/service to specified requirements?

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

Implement the monitoring and measurement required?8 MEASUREMENT, ANALYSIS AND IMPROVEMENT

8.1 General


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

demonstrate conformity of the product/service requirements?(may be addressed inQMP)

ensure conformity of and with the Quality Management System? continually improve the effectiveness of the Quality Management System?

8.2 Monitoring and measurement8.2.1 Customer satisfaction


For the service provider to follow a determined method to monitor and measure performance asthe 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 theinformation 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 theQuality 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 andwork 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 directlyresponsible 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, andfor reporting results and maintaining records?


8/9


8

For the management responsible for the area being audited to ensure that actions are takenwithout 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 theverification 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 serviceprovider allow for monitoring, and where applicable, measuring the ability of quality managementprocesses 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 serviceprovider allow for progressively (as planned) monitoring and measuring the characteristics ofproducts/services to ensure requirements have been met?

8.3 Control of nonconforming product


For the controls and related responsibilities for ensuring that a product/service which does notconform to product/service requirements is identified and controlled to prevent its unintended useor delivery?

For the service provider to deal with a nonconforming product or service by one or more of thefollowing ways:

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 thenonconformity when a nonconforming product/service is detected after delivery or use hasstarted?

8.4 Analysis of data

In the processes documented and implemented by the service provider, is provision made for theservice provider to determine, collect and analyse (including trends) appropriate data todemonstrate the suitability and effectiveness, and for the improvement, of the QualityManagement 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 forthe service provider to continually improve the Quality Management System?

8.5.2 Corrective action


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

reviewing nonconformities (including customer complaints)?


9/9


9

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


For the action the service provider will take to eliminate the causes of potential nonconformitiesin 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?

qms guidelines appendix c 1

Documents