1 Scope
1.1 General
[company name] has implemented a quality management system based on AS/NZS ISO 9001:2008 (the standard). The resultant system describes [company name]’s ability to provide a service that meets customer and applicable regulatory requirements. The system also addresses customer satisfaction through effective application of the quality management system including continual improvement and prevention of nonconformity.
The scope for certification is the provision of the design, development, implementation and ongoing support of documented
management systems.
1.2 Exclusions
None
2 Normative reference
ISO 9001:2008
3 Terms and definitions
All terms and references are as per those specified in AS/NZS ISO 9001:2008.
4 Quality management system
4.1 General requirements
[company name] has established, documented, implemented, maintained and continuously improved a quality management system in accordance with the standard. In the implementation of the quality management system, [company name] has
a) identified the processes needed for the quality management system,
b) determined the sequence and interaction of these processes,
c) determined the criteria and methods required to ensure the effective operation and control of these processes,
d) ensured the availability of information necessary to support the operation and monitoring of these processes,
e) measured, monitored and analysed these processes, and implemented action necessary to achieve planned results and continual improvement, and
f) implemented actions needed to achieve planned results and continual improvement of these processes.
[company name] ensures adequate controls of out-sourced processes, and manages these processes through the provision of resources, product realisation and measurement.
4.2 Documentation requirements
4.2.1 General requirements
The quality management system documentation includes
a) documented statements of a quality policy and quality objectives,
b) a quality manual,
c) documented procedures required by the Standard,
d) documents needed to ensure effective planning, operation and control of processes, and
e) records.
4.2.2 Quality manual
[company name] has established and will maintain a quality manual that includes
a) the scope of the quality management system, including details of and justification for any exclusions
b) the documented procedures established for the quality management system, or reference to them, and
c) a description of the interaction between the processes of the quality management system.
4.2.3 Control of documents
Documents required by the quality management system are controlled. Records are controlled according to the requirements given in 4.2.4. A documented procedure has been established to define the controls needed
a) to approve documents for adequacy prior to issue,
b) to review and update as necessary and re-approve documents,
c) to ensure that changes and the current revision status of documents are identified,
d) to ensure that relevant versions of applicable documents are available at points of use,
e) to ensure that documents remain legible and readily identifiable,
f) to ensure that documents of external origin are identified and their distribution controlled, and
g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.
4.2.4 Control of records
Records are established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records remain legible, readily identifiable and retrievable. A documented procedure has been established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.
5 Management responsibility
5.1 Management commitment
Top management provides evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by
a) communicating to all personnel the importance of meeting customer as well as statutory and regulatory requirements,
b) establishing the quality policy,
c) ensuring that quality objectives are established,
d) conducting management reviews, and
e) ensuring the availability of resources.
5.2 Customer focus
Top management ensures that customer requirements are determined and are met with the aim of enhancing customer satisfaction
5.3 Quality policy
Top management ensures the quality policy
a) is appropriate to the purpose of the [company name],
b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system,
c) provides a framework for establishing and reviewing quality objectives,
d) is communicated and understood within [company name], and
e) is reviewed for continuing suitability.
5.4 Planning
5.4.1 Quality objectives
Top management ensures that quality objectives, including those needed to meet requirements for are established at relevant functions and levels within the [company name]. The quality objectives are measurable and consistent with the quality policy.
5.4.2 Quality management system planning
Top management ensures
a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and
b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.
5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority
Top management ensures that responsibilities and authorities are defined and communicated within [company name].
5.5.2 Management representative
Top management has appointed the managing consultant who, irrespective of other responsibilities, has the following responsibilities and authorities
a) ensures that processes needed for the quality management system are established, implemented and maintained,
b) reports to top management on the performance of the quality management system and any need for improvement, and
c) ensures the promotion of awareness of customer requirements throughout [company name].
5.5.3 Internal communication
Top management ensures that appropriate communication processes are established within [company name] and that communication takes place regarding the effectiveness of the quality management system.
5.6 Management review
5.6.1 General
Top management reviews [company name]’ quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review includes assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. Records from management reviews are maintained.
5.6.2 Review input
The input to management review shall include information on
a) results of audits,
b) customer feedback,
c) process performance and product conformity,
d) status of preventive and corrective actions,
e) follow-up actions from previous management reviews,
f) changes that could affect the quality management system, and
g) recommendations for improvement.
5.6.3 Review output
The output from the management review shall include any decisions and actions related to
a) improvement of the effectiveness of the quality management system and its processes,
b) improvement of product related to customer requirements, and
c) resource needs.
6 Resource management
6.1 Provision of resources
[company name] has determined and will provide the resources needed
a) to implement and maintain the quality management system and continually improve its effectiveness, and
b) to enhance customer satisfaction by meeting customer requirements.
6.2 Human resources
6.2.1 General
Personnel performing work affecting product quality are competent on the basis of appropriate education, training, skills and experience.
6.2.2 Competence, awareness and training
[company name] will
a) determine the necessary competence for personnel performing work affecting product quality,
b) provide training or take other actions to satisfy these needs,
c) evaluate the effectiveness of the actions taken,
d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and
e) maintain appropriate records of education, training, skills and experience.
6.3 Infrastructure
[company name] has determined, provided and will maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable
a) buildings, workspace and associated utilities,
b) process equipment (both hardware and software), and
c) supporting services (such as transport or communication).
6.4 Work environment
[company name] has determined and will manage the work environment needed to achieve conformity to product requirements.
7 Product realisation
7.1 Planning of product realisation
[company name] has planned and developed the processes needed for product realisation. Planning of product realisation shall be consistent with the requirements of the other processes of the quality management system. In planning product realisation, [company name] has determined the following, as appropriate
a) quality objectives and requirements for the product;
b) the need to establish processes, documents, and provide resources specific to the product;
c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance;
d) records needed to provide evidence that the realisation processes and resulting product meet requirements.
The output of this planning is in a form suitable for [company name]’ method of operations.
7.2 Customer-related processes
7.2.1 Determination of requirements related to the product
[company name] has determined
a) requirements specified by the customer, including the requirements for delivery and post-delivery activities,
b) requirements not stated by the customer but necessary for specified or intended use, where known,
c) statutory and regulatory requirements related to the product, and
d) any additional requirements determined by [company name].
7.2.2 Review of requirements related to the product
[company name] will review the requirements related to the product. This review is conducted prior to [company name]’ commitment to supply a product to the customer (eg. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and ensures that
a) product requirements are defined,
b) contract or order requirements differing from those previously expressed are resolved, and
c) [company name] has the ability to meet the defined requirements.
Records of the results of the review and actions arising from the review shall be maintained. Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by [company name] before acceptance. Where product requirements are changed, [company name] shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.
7.2.3 Customer communication
[company name] has determined and will implement effective arrangements for communicating with customers in relation to
a) product information,
b) enquiries, contracts or order handling, including amendments, and
c) customer feedback, including customer complaints.
7.3 Design and development
7.3.1 Design and development planning
[company name] plans and controls the design and development of product. During the design and development planning, [company name] determines
a) the design and development stages,
b) the review, verification and validation that are appropriate to each design and development stage, and
c) the responsibilities and authorities for design and development.
[company name] manages the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility. Planning output shall be updated, as appropriate, as the design and development progresses.
7.3.2 Design and development inputs
Inputs relating to product requirements are determined and records maintained. These inputs shall include
a) functional and performance requirements,
b) applicable statutory and regulatory requirements,
c) where applicable, information derived from previous similar designs, and
d) other requirements essential for design and development.
These inputs are reviewed for adequacy. Requirements shall be complete, unambiguous and not in conflict with each other.
7.3.3 Design and development outputs
The outputs of design and development are provided in a form that enables verification against the design and development input and shall be approved prior to release. Design and development outputs shall
a) meet the input requirements for design and development,
b) provide appropriate information for purchasing, production and for service provision,
c) contain or reference product acceptance criteria, and
d) specify the characteristics of the product that are essential for its safe and proper use.
7.3.4 Design and development review
At suitable stages, systematic reviews of design and development are performed in accordance with planned arrangements
a) to evaluate the ability of the results of design and development to meet requirements, and
b) to identify any problems and propose necessary actions.
Participants in such reviews include representatives of functions concerned with the design and development stage(s) being reviewed. Records of the results of the reviews and any necessary actions are maintained.
7.3.5 Design and development verification
Verification is performed in accordance with planned arrangements to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions are maintained.
7.3.6 Design and development validation
Design and development validation is performed in accordance with planned arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Wherever practicable, validation is completed prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions are maintained.
7.3.7 Control of design and development changes
Design and development changes are identified and records maintained. The changes are reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes include evaluation of the effect of the changes on constituent parts and product already delivered. Records of the results of the review of changes and any necessary actions are maintained.
7.4 Purchasing
7.4.1 Purchasing process
[company name] ensures that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product is dependent upon the effect of the purchased product on subsequent product realisation or the final product. [company name] evaluates and selects suppliers based on their ability to supply product in accordance with [company name]’ requirements. Criteria for selection, evaluation and re-evaluation are established. Records of the results of evaluations and any necessary actions arising from the evaluation are maintained.
7.4.2 Purchasing information
Purchasing information describes the product to be purchased, including where appropriate
a) requirements for approval of product, procedures, processes and equipment,
b) requirements for qualification of personnel, and
c) quality management system requirements.
[company name] ensures the adequacy of specified purchase requirements prior to their communication to the supplier.
7.4.3 Verification of purchased product
[company name] has established and will implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements. Where [company name] or its customer intends to perform verification at the supplier's premises, [company name] will state the intended verification arrangements and method of product release in the purchasing information.
7.5 Production and service provision
7.5.1 Control of production and service provision
[company name] plans and carries out production and service provision under controlled conditions. Controlled conditions include, as applicable
a) the availability of information that describes the characteristics of the product,
b) the availability of work instructions, as necessary,
c) the use of suitable equipment,
d) the availability and use of monitoring and measuring devices,
e) the implementation of monitoring and measurement, and
f) the implementation of release, delivery and post-delivery activities.
7.5.2 Validation of processes for production and service provision
[company name] validates any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered. Validation demonstrates the ability of these processes to achieve planned results. [company name] has established arrangements for these processes including, as applicable
a) defined criteria for review and approval of the processes,
b) approval of equipment and qualification of personnel,
c) use of specific methods and procedures,
d) requirements for records, and
e) re-validation.
7.5.3 Identification and traceability
Where appropriate, [company name] identifies the product by suitable means throughout product realisation. [company name] identifies the product status with respect to monitoring and measurement requirements. Where traceability is a requirement, [company name] controls and records the unique identification of the product.
7.5.4 Customer property
[company name] exercises care with customer property while it is under [company name]’ control or being used by [company name]. [company name] identifies, verifies, protects and safeguards customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, it is reported to the customer and records maintained.
7.5.5 Preservation of product
[company name] preserves the conformity of product during internal processing and delivery to the intended destination. This preservation includes identification, handling, packaging, storage and protection. Preservation also applies to the constituent parts of a product.
7.6 Control of monitoring and measuring devices
[company name] determines the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements. [company name] has established processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements. Where necessary to ensure valid results, measuring equipment is
a) calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded;
b) adjusted or re-adjusted as necessary;
c) identified to enable the calibration status to be determined;
d) safeguarded from adjustments that would invalidate the measurement result;
e) protected from damage and deterioration during handling, maintenance and storage.
In addition, [company name] assesses and records the validity of the previous measuring results when the equipment is found not to conform to requirements. [company name] takes appropriate action on the equipment and any product affected. Records of the results of calibration and verification shall be maintained. When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This is undertaken prior to initial use and reconfirmed as necessary.
8 Measurement, analysis and improvement
8.1 General
[company name] plans and implements the monitoring, measurement, analysis and improvement processes needed
a) to demonstrate conformity of the product,
b) to ensure conformity of the quality management system, and
c) to continually improve the effectiveness of the quality management system.
This includes determination of applicable methods, including statistical techniques, and the extent of their use.
8.2 Monitoring and measurement
8.2.1 Customer satisfaction
As one of the measurements of the performance of the quality management system, [company name] monitors information relating to customer perception as to whether [company name] has met customer requirements. The methods for obtaining and using this information has been determined.
8.2.2 Internal audit
[company name] conducts internal audits at planned intervals to determine whether the quality management system
a) conforms to the planned arrangements, to the requirements of the International Standard and to the quality management system requirements established by [company name], and
b) is effectively implemented and maintained.
An audit program is planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods are defined. Selection of auditors and conduct of audits ensure objectivity and impartiality of the audit process. Auditors do not audit their own work. The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records are defined in a documented procedure. The management responsible for the area being audited ensures that actions are taken without undue delay to eliminate detected non-conformance and their causes. Follow-up activities include the verification of the actions taken and the reporting of verification results.
8.2.3 Monitoring and measurement of processes
[company name] applies suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action is taken, as appropriate, to ensure conformity of the product.
8.2.4 Monitoring and measurement of product
[company name] monitors and measures the characteristics of the product to verify that product requirements have been met. This is carried out at appropriate stages of the product realisation process in accordance with the planned arrangements. Evidence of conformity with the acceptance criteria is maintained. Records indicate the person(s) authorising release of product. Product release and service delivery does not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer.
8.3 Control of nonconforming product
[company name] ensures that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming product are defined in a documented procedure. [company name] deals with nonconforming product by one or more of the following ways:
a) by taking action to eliminate the detected nonconformity;
b) by authorising its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer;
c) by taking action to preclude its original intended use or application.
Records of the nature of non-conformance and any subsequent actions taken, including concessions obtained, are maintained. When nonconforming product is corrected it is subject to re-verification to demonstrate conformity to the requirements. When nonconforming product is detected after delivery or use has started, [company name] takes action appropriate to the effects, or potential effects, of the nonconformity.
8.4 Analysis of data
[company name] determines, collects and analyses 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. This includes data generated as a result of monitoring and measurement and from other relevant sources. The analysis of data provides information relating to
a) customer satisfaction,
b) conformity to product requirements,
c) characteristics and trends of processes and products including opportunities for preventive action, and
d) suppliers.
8.5 Improvement
8.5.1 Continual improvement
[company name] continually improves the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.
8.5.2 Corrective action
[company name] takes action to eliminate the cause of non-conformance in order to prevent recurrence. Corrective actions are appropriate to the effects of the non-conformance encountered. A documented procedure has been established to define requirements for
a) reviewing non-conformance (including customer complaints),
b) determining the causes of non-conformance,
c) evaluating the need for action to ensure that non-conformance do not recur,
d) determining and implementing action needed,
e) records of the results of action taken, and
f) reviewing corrective action taken.
8.5.3 Preventive action
[company name] determines action to eliminate the causes of potential non-conformance in order to prevent their occurrence. Preventive actions are appropriate to the effects of the potential problems. A documented procedure has been established to define requirements for
a) determining potential non-conformance and their causes,
b) evaluating the need for action to prevent occurrence of non-conformance,
c) determining and implementing action needed,
d) records of results of action taken, and
e) reviewing preventive action taken.