This document re-states the requirements of AS/NZS ISO9001:2008 for QMS and has been developed to assist CI in the assessment if QMS for compliance with the International Standard. This report presents the requirements of AS/NZS ISO 9001:2008 on the outcome of internal audits to the business. Scope of the Audit The objective of the audit was to determine the conformance of the CI requirements of ISO9001:2008. To that end the steps in the audit process included: - Compliance to the specifications of ISO9001:2008 Methodology The following methodology was used to conduct the audit: - Process review - questioning and investigation of process and attached audit questionnaire..
Has the organisation established, documented, implemented and maintained a quality management system and continually improved its effectiveness in accordance with the requirements of this International Standard?
Has the organisation:
a) Identified the processes needed for the quality management system and their application throughout the organisation;
b) Determined the sequence and interaction of these processes;
c) Determined criteria and methods needed to ensure that both the operation and control of these processes are effective;
d) Ensured the availability of resources and information necessary to support the operation and monitoring of these processes;
e) Monitored, measured and analysed these processes; and
f) Implemented actions necessary to achieve planned results and continual improvement of these processes?
Are these processes managed by the organisation in accordance with the requirements of this International Standard?
Does the QMS documentation include:
a) Documented statements of quality policy and quality objectives;
b) A quality manual;
c) Documented procedures and records required by the international standard;
d) Documents, including records needed by the organisation to ensure the effective planning, operation and control of it's processes.
Has the organisation established and maintained a quality manual that includes:
a) The scope of the quality management system, including details 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 procedures of the QMS?
Are documents required by the QMS controlled?
Has a documentation procedure defining the controls needed been established:
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 determined by the organisation to be necessary for the planning and operation of the quality system 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.
Are the records established to provide evidence of conformity to requirements and of the effective operation of the QMS controlled?
Has a documented procedure been established that defines the controls needed for the identification, storage, protection, retrieval, retention time, and disposal of records?
Are records legible, readily identifiable and retrievable?
Has top management provided evidence of its commitment to the development and implementation of the QMS and continually improving its effectiveness by:
a) Communicating to the organisation 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;
e) Ensuring the availability of resources?
Has top management ensured that customer requirements are determined and fulfilled with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1)?
Has top management ensured that the quality policy:
a) Is appropriate to the purpose of the organisation;
b) Includes a commitment to comply with requirements and continually improve the effectiveness of the QMS;
c) Provides a framework for establishing and reviewing quality objectives;
d) Is communicated and understood within the organisation; and
e) Is reviewed for continuing suitability?
Has top management ensured that quality objectives, including those needed to meet requirements for product (see 7.1 a), are established at relevant functions and levels within the organisation?
Are the quality objectives measurable and consistent with the quality policy?
Has top management ensured that:
a) the planning of the QMS 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 QMS is maintained when changes to the QMS are planned and implemented?
Has top management ensured that the responsibilities and authorities are defined and communicated within the organisation?
Has top management appointed a member of the organisation's management who, irrespective of other responsibilities, has responsibility and authority that includes:
a) Ensuring that processes needed for the quality management systems are established, implemented and maintained;
b) Reporting to top management on the performance of the quality management system and any need for improvement, and
c) Ensuring the promotion of awareness of customer requirements throughout the organisation?
Has top management ensured that appropriate communication processes are established within the organisation and that communication takes place regarding the effectiveness of the QMS?
Has top management reviewed the organisations QMS, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness?
Has this review included assessing opportunities for improvement and the need for changes to the QMS, including the quality policy and quality objectives?
Are records from management reviews maintained (see 4.2.4)?
Does input to management reviews 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) Planned changes that could affect the QMS, and
g) Recommendations for improvement?
Does output from mama gent reviews include any decisions and actions related to:
a) Improvement of the effectiveness of the QMS and it's processes,
b) Improvement of product related to customer requirements, and
c) Resource needs?
Has the organisation determined and provided the resources needed:
a) To implement and maintain the QMS and continually improve its effectiveness, and
b) To enhance customer satisfaction by meeting customer requirements.
Are personnel performing work affecting conformity to procure requirements competent on the basis of appropriate education, training, skills and experience?
Does the organisation:
a) Determine the necessary competence for personnel performing work affecting conformity of product requirements,
b) Where applicable, provide training or take other actions to achieve the necessary competence,
c) Evaluate the effectiveness of the actions taken,
d) Ensure that it's 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 (see 4.2.4)?
Has the organisation determined, provided and maintained 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, communication or information systems).
Has the organisation determined and managed the work environment needed to achieve conformity to product requirements?
Has the organisation planned and developed the processes needed for product realisation?
Is this planning of product realisation consistent with the requirements of the other processes of the QMS (see 4.1)?
In planning product realisation, has the organisation determined the following as appropriate:
a) Quality objectives and requirements for the product;
b) The need to establish processes and documents, and to provide resources specific to the product;
c) Required verification, validation, monitoring, measurement, 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 fulfil requirements (see 4.2.4)?
Is the output of this planning in a form suitable for the organisations method of operation?
Has the organisation 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 and intended use,
c) Statutory and regulatory requirements applicable to the product, and
d) Any additional requirements considered necessary by the organisation?
Has the organisation reviewed the requirements related to the product?
Is this review conducted prior to the organisations commitment to supply a product to the customer (e.g. Submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and does it ensure that:
a) Product requirements are defined,
b) Contract or order requirements differing from those previously expressed are resolved, and
c) The organisation has the ability to meet the defined requirements?
Are records of the results of this review and actions arising from this review maintained (see 4.2.4)?
Where the customer provides no documented statement of requirements, are the customer requirements confirmed by the organisation before acceptance?
Where product requirements are changed, does the organisation ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements?
Has the organisation determined and implemented effective arrangements for commutative with customers in relation to:
a) Product information,
b) Enquiries, contracts or order handling, including amendments, and
c) Customer feedback, including customer complaints?
Has the organisation planned and controlled the design and development of product?
During the design and development planning, has the organisation determined:
a) The design and development stages,
b) The review verification and validation that are appropriate to each design ad development stage, and
c) The responsibilities and authorities for design and development?
Has the organisation managed the interfaces between different groups involved in design and development to ensure that effective communication and clear assignment of responsibility?
Is planning output updated, as appropriate, as the design and development progresses?
Are inputs relating to product requirements determined and records maintained (see 4.2.4)?
Do they 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?
Are the inputs reviewed for adequacy to ensure the requirements are complete, unambiguous and not in conflict with each other?
Are the outputs of design and development in a form suitable for verification against the design and development input and approved prior to release?
Do the design and development outputs:
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 is safe and proper use?
At suitable stages, are systematic reviews of design and development conducted:
a) To evaluate the ability of the results of design and development to fulfil requirements, and
b) To identify any problems and propose necessary actions?
Do participants in such reviews include representatives of functions concerned with the design and development stage(s) being reviewed?
Are records of the results of the reviews and any necessary actions maintained (see 4.2.4)?
Is verification performed to ensure that the design and development outputs have satisfied the design and development input requirements?
Are records of the results of the verification and any necessary actions maintained (see 4.2.4)?
Has design and development validation been performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of fulfilling the requirements for the specified or known intended use or application?
Wherever practicable, is validation completed prior to the delivery or implementation of the product?
Are records of the results if validation and any necessary actions maintained (see 4.2.4)?
Have design and development changes been identified and records maintained?
Are the changes reviewed, verified and validated, as appropriate, and approved before implementation?
Does the review of design and development changed include evaluation of the effect of the changes on constituent parts and delivered product?
Are records of the results of the review of changes and any necessary actions maintained (see 4.2.4)?
Has the organisation ensured that purchased product confirms to specified purchase requirements?
Is the type and extent of control applied to the supplier and the purchased product dependant upon the effect of the purchased product on subsequent product realisation or the final product?
Has the organisation evaluated and selected suppliers based on their ability to supply product in accordance with the organisations requirements?
Are the criteria for selection, evaluation and re-evaluation established?
Are records of the results of evaluations and any necessary actions arising from the evaluation maintained (see 4.2.4)?
Does purchasing information describe 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) QMS requirements?
Has the organisation ensured the adequacy of specified purchase requirements prior to their communication to the supplier?
Has the organisation established and implemented the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements?
Where the organisation or it's customer intends to perform verification at the suppliers premises, has the organisation stated the intended verification arrangements and method of product release in. The purchasing information?
Has the organisation planned and carried out production and service provisions under controlled conditions?
Do these controlled conditions include, as applicable:
a) The availability of information that describes the characteristics of the product,
b) The availability of work instructions,
c) The use of suitable equipment,
d) The availability and use if initiating and measuring equine t,
e) The implantation of onto ring and measuring equipment, and
f) The implementation of product release, delivery and post delivery activities?
Has the organisation validated any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement and as a consequence definition ex become apparent only after the product is in use or the service has been delivered?
Does validation demonstrate the ability of these processes to achieve planned results?
Has the organisation established arrangements for these processes including, as applicable:
a) Defined criteria for review and approval of processes,
b) Approval of equipment and qualification if personnel,
c) Use of specific methods and procedures,
d) Requirements for records (see 4.2.4), and
Where appropriate, has the organisation identified the product by suitable means throughout product realisation?
Has the organisation identified the product stasis with respect to monitoring and measurement requirements throughout product realisation?
Where traceability is a requirement, has the organisation controlled the unique identification of the product and maintained product records (see 4.2.4)?
Has the organisation exercised care with customer property while it is under the organisations control or being used by the organisation?
Has the organisation identified, verified, protected and safeguarded 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, does the organisation report this to the customer and maintain records (see 4.2.4)?
Has the organisation preserved the product during internal processing and delivery to the intended destinations order to maintain conformity to requirements?
As applicable, does this preservation include identification, handling, packaging, storage and protection?
Does this preservation also apply to the constituent parts of the product?
Has the organisation determined the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements?
Has the organisation 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, is measuring equipment:
a) Calibrated or verified or both at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards, where no such standard exist, the basis used for calibration or verification shall be recorded (see 4.2.4):
b) Adjusted or re-adjusted as necessary,
c) Identified in order to determine calibration status,
d) Safeguarded from adjustments that would invalidate the measurement result,
e) Protected from damage and deterioration during handling, maintancne and storage?
In addition, has the organisation assessed and recorded the validity of the previous measuring results when the equipment is found not to conform to requirements?
Has the organisation taken appropriate action on the equipment and any product affected?
Are records of the results of calibration and verification maintained (see 4.2.4)?
When used in the monitoring and measurement of specified requirements, is the ability of computer software to satisfy the intended application confirmed?
Is this undertaken prior to initial use and reconfirmed as necessary?
Has the organisation planned and implemented the monitoring, measurement, analysis and improvement processes needed:
a) To demonstrate conformity to product requirements,
b) To ensure conformity of the QMS, and
c) To continually improve the effectiveness of the QMS?
Does this include determination of applicable methods, including statistical techniques, and the extent of their use?
As one of the measurements of the performance of the QMS, does the organisation monitor information relating to customer perception as to whether the organisation has fulfilled customer requirements?
Are the methods for obtaining and using this information determined?
Has the organisation conducted internal audits at planned intervals to determine whether the QMS:
a) Conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the QMS requirements a stablished by the organisation, and
b) Is effectively implemented and maintained?
Has an audit program been planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits?
Are the audit criteria, scope, frequency and methods defined?
Does the selection of auditors and conduct of audits ensure objectivity and impartiality of the audit process?
Do auditors audit their own work?
Has a documented procedure been established to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results?
Has the management responsible for the area being audited that actions are taken without undue delay to eliminate detected non-conformities and their causes?
Do follow up activities include the verification of the actions taken and the reporting of verification results (see 8.5.2)?
Has the organisation applied suitable methods for monitoring and, where applicable, measurement of the QMS processes?
Do these methods demonstrate the ability of the processes to achieve planned results?
When planned results are not achieved, is correction and corrective action taken as appropriate?
Has the organisation monitored and measured the characteristics if the product to verify that product requirements are fulfilled?
Is this carried out at appropriate stages of the product realisation process in accordance with the planned arrangements?
Is evidence of conformity with the acceptance criteria maintained?
Do records indicate the person(s) authorising release of product to the customer (see 4.2.4)?
Does product release and service delivery not proceed until all the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority, and where applicable by the customer?
Has the organisation ensured that product which does not confirm to product requirements is identified and controlled to prevent its unintended use or delivery?
Has a documented procedure been established to define the controls and related responsibilities and authorities for dealing with non-conforming product?
Where applicable, has the organisation dealt with non-conforming product by one or more of the following ways:
a) By taking action to eliminate the detected non-conformity,
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,
d) By taking action appropriate to the effects, or potential effects, of the non-conformity when non-conforming product is detected after delivery or use has started?
When on-conforming product is corrected, is it subject to re-verification to demonstrate conformity to the requirements?
Are records of the nature of non-conformities and any subsequent actions taken, including concessions obtained, maintained (see 4.2.4)?
Has the organisation. Determined, collected and analysed appropriate dats to demonstrate the suitability and effectiveness of the QMS and to evaluate where continual improvement of the QMS can be made?
Does this include data generate as a result of monitoring and measurement and from other relevant sources?
Does the analysis of data provide information relating to:
a) Customer satisfaction (see 8.2.1),
b) Conformity to product requirements (see 8.4.2),
c) Characteristics and trends of processes and products including opportunities for preventative action (see 8.2.3 and 8.2.4), and
d) Suppliers (see 7.4)?
Has the organisation continually improved the effectiveness of the QMS through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review?
Has the organisation taken action to eliminate the cause of non-conformities in or to prevent re-occurrence?
Are corrective actions appropriate to the effects of the non-conformities encountered?
Is a documented procedure established to define requirements for:
a) Reviewing non-conformities (including customer complaints),
b) Determining the causes of non-conformities,
c) Evaluating the need for action to ensure that non-conformities no not recur,
d) Determining and implementing action needed,
e) Records of the results of actions taken (see 4.2.4), and
f) Reviewing the effectiveness of corrective action taken?
Has the organisation determined action to eliminate the causes of potential non-conformities in order to prevent their occurrence?
Are these preventive actions appropriate to the effects of the potential problems?
A documented procedure shall be established to define requirements for:
a) Determining potential non-conformities and their causes,
b) Evaluating the need for action to prevent occurrence of non-conformities,
c) Determining and implementing action needed,
d) Records of results of action taken (see 4.2.4), and
e) Reviewing the effectiveness of preventable action taken?