Professional Documents
Culture Documents
AUDIT NO.: ORGANIZATION: Requirement Assessor Notes *S/U/OFI 4 Quality management system 4.1 General Requirements The organization shall establish, document, 1) Has the organization established and implement and maintain a quality management maintained an quality management system, the system and continually improve its effectiveness in requirements of which are described in the accordance with the requirements of this whole of clause 4? International Standard. The organization shall a) identify the process needed for the quality Note: The organization is requested to submit management system and their application documentation to support compliance with the throughout the organization, criteria identified in a) and b) with the quality b) determine the sequence and interaction of policy manual to SAI for review. Examples of these processes, acceptable documentation are: c) determine criteria and methods needed to 1) Process map(s) ensure that both the operation and control 2) Procedures of these processes are effective, Flow Chart(s) d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes, e) monitor, measure and analyses these processes, and f) implement actions necessary to achieve planned in accordance with the requirements of this International Standard. Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced process shall be identified within the quality management system.
NOTE: Processes needed for the quality management system referred to above should include processes for management, provision, product realization and measurement.
Audit Point
Document
Reference
Audit Point
Document
Reference
1) Does the quality management system documentation include a) documented statements of a quality policy and quality objectives, b) a quality manual, c) documented procedures required by this International Standard, d) documents needed by the organization to ensure the effective planning, operation and control of its processes, e) records required by the International Standard, and f) quality system requirements imposed by the applicable regulatory authorities? 2) Does the organization ensure that personnel have access to quality management system documentation and are aware of relevant procedures, and that customer and/or regulatory authorities representatives shall have access to quality management system documentation?
1) Has the organization established and maintained a quality manual that includes a) b) the scope of the quality management system, including details of and justification for any exclusions the documented procedures established for the quality management system, or reference to them, and
Is the relationship between the requirements of this International Standard and the documented procedures clearly shown? c) a description of the interaction between the processes of the quality management system.
Records shall be available for review by customers Are records available for review by customers and and regulatory authorities in accordance with regulatory authorities in accordance with contract contract or regulatory requirements. or regulatory requirements? CRS-02-02R-R1 Improvement 07/12/2005 * S = Satisfactory; U = Unsatisfactory; OFI = Opportunity for Page 5 of 43
1) 5.1 Management commitment Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by a) communicating to the organization the a) importance of meeting customer as well as statutory and regulatory requirements, b) establishing the quality policy, c) ensuring that quality objectives are b) established, d) conducting management reviews, and e) ensuring the availability of resources. c) d) e)
Is there evidence of top managements commitment to the development and implementation of the quality management system and continually improving its effectiveness by communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements, establishing the quality policy, ensuring that quality objectives are established, conducting management reviews, and ensuring the availability of resources?
5.2 Customer focus Top management shall ensure that customer 1) Has top management ensured that customer requirements are determined and are met with the requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 aim of enhancing customer satisfaction? and 8.2.1).
c) d) e)
5.4 Planning 5.4.1 Quality objectives 1) Has top management ensured that quality Top management shall ensure that quality objectives, including those needed to meet objectives, including those needed to meet requirements for product are established at requirements for product are established at relevant functions and levels within the relevant functions and levels within the organization? organization. The quality objectives shall be measurable and consistent with the quality policy. 2) Are the quality objectives measurable and consistent with the quality policy? CRS-02-02R-R1 Improvement 07/12/2005 * S = Satisfactory; U = Unsatisfactory; OFI = Opportunity for Page 7 of 43
5.5 Responsibility, authority, and communication 5.5.1 Responsibility and authority 1) Has top management ensured that Top management shall ensure that responsibilities responsibilities and authorities are defined and and authorities are defined and communicated communicated within the organization? within the organization.
1) Has top management appointed a member of management who, irrespective of other responsibilities, shall have responsibility and authority that include a) ensuring that processes needed for the quality management system are established, implemented and maintained, reporting to management on the performances of the quality management system and any need for improvement, ensuring the promotion of awareness of customer requirements throughout the organization, and the organizational freedom to resolve matters pertaining to quality and maintain product conformity?
b)
c)
NOTE: The responsibility of management representative d) can include liaison with external parties on matters relating to the quality management system.
5.5.3 Internal communication Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system.
1) Has top management ensured that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system?
1) Does the output from the management review include any decisions and actions related to a) b) c) improvement of the effectiveness of the quality management system and the process, improvement of product related to customer requirements, and resource needs?
6 Resource management 6.1 Provisions of resources The organization shall determine and 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. 1) Has the organization determined and provided the resources needed a) to implement and maintain the quality management system and continually improve its effectiveness, and to enhance customer satisfaction by meeting customer requirements?
b)
1) Are personnel performing work affecting product quality competent on the basis of appropriate education, training, skills and experience? 2) Has the organization a) determined the necessary competence for personnel performing work affecting product quality, provided training or take other actions to satisfy these needs, evaluated the effectiveness of the actions taken ensured 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 maintained appropriate records of education, training, skills, and experience?
b) c) d)
e)
6.4 Work environment 1) Has the organization determined and managed The organization shall determine and manage the the work environment needed to achieve conformity work environment needed to achieve conformity to to product requirements? product requirements.
NOTE: Factors that may affect the conformity of the product include temperature, humidity, lighting, cleanliness, protection from electrostatic discharge, etc.
b)
c) d)
1) Has the organization reviewed the requirements related to the product and is this review conducted prior to the organizations 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)? 2) Does the review ensure that a) b) c) d) product requirements are defined, contract or order requirements differing from those previously expressed are resolved, the organization has the ability to meet the defined requirements, and risks have been evaluated?
3) Are records of the results of the review and actions arising from the review maintained? 4) Where the customer provides no documented statement of requirement, are the customer requirements confirmed by the organization before acceptance?
Where product requirements are changed, the organization shall ensure that relevant documents 5) Where product requirements are changed, does are amended and that relevant personnel are made the organization ensure that relevant aware of the changed requirements. documents are amended and that relevant personnel are made aware of the changed NOTE: In some situations, such as Internet sales, a requirements?
formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material.
1) Does the organization determine and implement effective arrangements for communication with customers in relation to a) b) c) product information, inquiries, contracts or order handling, including amendment, and customer feedback, including customer complaints?
3) Does the organization evaluate and select The organization shall evaluate and select suppliers based on their ability to supply suppliers based on their ability to supply product product in accordance with the organizations in accordance with the organizations requirements? requirements. Criteria for selection, evaluation and re-evaluation shall be established. Records of the 4) Is the criteria for selection, evaluation and reresults of evaluations and any necessary actions evaluation established? arising from the evaluation shall be maintained. 5) Are records of the results of evaluations and The organization shall: any necessary actions arising from the a) maintain a register of approved sources of evaluation maintained? supply that includes the scope of the approval; Does the organization: b) periodically review source of supply a) maintain a register of approved sources of performance, records of these reviews supply that includes the scope of the shall be used as a basis for establishing approval, the level of controls to be implemented; b) periodically review source of supply c) define the necessary actions to take when performance, records of these reviews shall dealing with suppliers that do not meet be used as a basis for establishing the level requirements; of controls to be implemented, d) prevent the purchase of c) define the necessary actions to take when counterfeit/suspect unapproved products. dealing with suppliers that do not meet requirements, and The organization shall be responsible for the d) prevent the purchase of counterfeit/suspect quality of all products purchased from suppliers, unapproved products? including customer-designated sources. Is the organization responsible for the quality of all products purchased from suppliers, including customer-designated sources? CRS-02-02R-R1 * S = Satisfactory; U = Unsatisfactory; OFI = Opportunity for Improvement 07/12/2005 Page 17 of 43
1) Has the organization established and implemented the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements?
Verification activities may include 2) Where the organization or its customer intends a) obtaining objective evidence of the quality to perform verification at the suppliers of the product from suppliers and premises, has the organization stated the verifying the authenticity of the intended verification arrangements and method accompanying documentation (e.g., of product release in the purchasing certificate of conformity from the information? manufacturer, airworthiness certificate, test reports, statistical records, process 3) Where specified in the contract, is the customer control), or the customers representative afforded the b) review of the required documentation, right to verify at the suppliers premises and and the organizations premises that subcontracted c) inspection of products upon receipt. product conforms to specified requirements? Where the organization or its customer intends to perform verification at the suppliers premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information. Where specified in the contract, the customer or the customers representative shall be afforded the right to verify at the suppliers premises and the organizations premises that subcontracted product conforms to specified requirements. Verification by the customer shall not be used by the organization as evidence of effective control of quality by the supplier and shall not absolve the organization of the responsibility to provide acceptable product, nor shall it preclude subsequent rejection by the customer. CRS-02-02R-R1 Improvement 07/12/2005 * S = Satisfactory; U = Unsatisfactory; OFI = Opportunity for Page 19 of 43
When acceptance authority media are used (e.g., stamps, electronic signatures, passwords), the 3) When acceptance authority media are used, has organization shall establish and document controls the organization established and documented for the media. controls for this media? Where traceability is a requirement, the 4) Where traceability is a requirement, has the organization shall control and record the unique organization controlled and recorded the identification of the product. unique identification of the product? The organization shall establish and maintain documented procedures for product identification 5) Has the organization established and and traceability by suitable means, (e.g., labels, bar maintained documented procedures for product codes, or other) from receipt; during splitting, identification and traceability by suitable means storage packaging, and preservation operations; from receipt; during splitting, storage and until delivery (including subcontracted packaging, and preservation operations; and handling or packaging operations). until delivery? The organizations processes shall provide for: Do these processes provide for: a) maintaining the manufacturers a) maintaining the manufacturers identification and batch/lot traceability; identification and batch/lot traceability; b) the ability to identify and trace products b) the ability to identify and trace products manufactured from the same batch of raw manufactured from the same batch of raw material or from the same manufacturing material or from the same manufacturing batch, as well as the ability to trace the batch, as well as the ability to trace the product to the ultimate destination product to the ultimate destination, and (delivery, scrap) c) maintaining the identification of the c) maintaining the identification of the configuration of the product in order to configuration of the product in order to identify any differences between the actual identify any differences between the configuration and the agreed actual configuration and the agreed configuration? configuration.
NOTE: In some sectors, configuration management is a means by which identification and traceability are maintained. CRS-02-02R-R1
Improvement 07/12/2005
2) Does the organization maintain a register of these monitoring and measuring devices, and The organization shall maintain a register of these define the process employed for their monitoring and measuring devices, and define the calibration, including details of equipment process employed for their calibration, including type, unique identification, location, frequency details of equipment type, unique identification, of checks, check method and acceptance location, frequency of checks, check method and criteria? acceptance criteria.
The organization shall establish processes to 3) Has the organization established processes to ensure that monitoring and measurement can be ensure that monitoring and measurement can carried out and are carried out in a manner that is be carried out and are carried out in a manner consistent with the monitoring and measurement that is consistent with the monitoring and requirements. measurement requirements? The organization shall ensure that environmental 4) Does the organization ensure that conditions are suitable for the calibrations, environmental conditions are suitable for the inspections, measurements and tests being carried calibrations, inspections, measurements and out. tests being carried out? Where necessary to ensure valid results, measuring equipment shall 5) Where necessary to ensure valid results, is a) be calibrated or verified at measuring equipment specified intervals, or prior to a) calibrated or verified at specified use, against measurement intervals, or prior to use, against standards traceable to measurement standards traceable international or national to international or national measurements standards, where measurements standards, and no such standards exist, the basis where no such standards exist, the used for calibration or basis used for calibration or verification shall be recorded; verification recorded; b) be adjusted or re-adjusted as b) adjusted or re-adjusted as necessary necessary c) be identified to enable the c) identified to enable the calibration calibration status to be status to be determined; CRS-02-02R-R1 determined; * S = Satisfactory; U = Unsatisfactory; OFI = Opportunity for Improvement 07/12/2005 Page 24 of 43
In addition, to organization shall assess and record 6) Does the organization assess and record the the validity of the previous measuring results when validity of the previous measuring results when the equipment is found not to conform to the equipment is found not to conform to requirements. The organization shall take requirements and take appropriate action on appropriate action on the equipment and any the equipment and any product affected? product affected. Records of the results of calibration and verification shall be maintained. 7) Are records of the results of calibration and verification maintained? When used in the monitoring and measurements of specified requirements, the ability of computer 8) When used in the monitoring and software to satisfy the intended application shall be measurements of specified requirements, is the confirmed. This shall be undertaken prior to initial ability of computer software to satisfy the use and reconfirmed as necessary. intended application confirmed?
NOTE: See ISO 10012-1 and ISO 10012-2 for guidance. 9)
Audit Point
Document
Reference
2) Does this include determination of applicable methods, including statistical techniques, and the extent of their use?
1) Are measurement requirements for product or service acceptance documented and including: a) criteria for acceptance and/or rejection, b) a record of the measurement results, and c) type of measurement instruments required and any specific instructions associated with their use? 2) Do test records show actual test results when required by specification or acceptance test plan?
8.2.5 Evidence of Conformance Certificate of conformity: when required, the organization shall provide the customer with evidence of the products conformity to its technical specifications. This may include the manufacturers conformance documents, the original airworthiness certificate, test analysis, and/or test reports. When splitting product, copies of original documents shall be annotated with the following information: amount delivered relative to amount received, purchase order number, customers name, and suppliers name. Where there is a formal agreement with the customer, the organization may deliver a certificate of conformity created by the organization that references the original manufacturers conformance documents that are retained and traceable by the organization.
1) When required, does the organization provide the customer with evidence of the products conformity to its technical specifications?
2) When splitting product, are copies of original documents annotated with the following information: amount delivered relative to amount received, purchase order number, customers name, and suppliers name? 3) When there is a formal agreement with the customer, does the organization deliver a certificate of conformity created by the organization that references the original manufacturers conformance documents that are retained and traceable by the organization?
Audit Point 1) Does the organization ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery? 2) Are the controls and related responsibilities and authorities for dealing with nonconforming product defined in a documented procedure?
Document
Reference
The organizations documented procedure shall define the responsibility for review and authority for the disposition of nonconforming product and the process for approving personnel making these decisions. The organization shall deal with nonconforming product by one or more of the following ways: a) by taking action to eliminate the detected nonconformity; b) by authorizing 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.
3) Does the organizations documented procedure define the responsibility for review and authority for the disposition of nonconforming product and the process for approving personnel making these decisions? 4) Does the organization deal with nonconforming product by one or more of the following ways: a) by taking action to eliminate the detected nonconformity; b) by authorizing 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?
Audit Point Are dispositions limited to: scrap; rejection for return to the supplier; rejection for revalidation by the manufacturer; submittal to design authority and customer for USE AS IS disposition?
Document
Reference
Product dispositioned for scrap shall be conspicuously and permanently marked, or positively controlled, until physically rendered unusable. The organization shall ensure, with the manufacturer where necessary, that similar supplies are not similarly affected and shall inform the customer of any nonconformities affecting product already delivered. Records of the nature of nonconformitys and any subsequent actions taken, including concessions obtained, shall be maintained. When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements. When nonconforming product is detected after delivery or use has started, the organization shall take action appropriate to the effects, or potential effects, of the nonconformity.
5) Is product dispositioned for scrap conspicuously and permanently marked, or positively controlled, until physically rendered unusable? 6) Does the organization ensure, with the manufacturer where necessary, that similar supplies are not similarly affected and shall inform the customer of any nonconformities affecting product already delivered? 7) Are records of the nature of nonconformitys and any subsequent actions taken, including concessions obtained, maintained? 8) When nonconforming product is corrected is it subject to re-verification to demonstrate conformity to the requirements? 9) When nonconforming product is detected after delivery or use has started, does the organization take action appropriate to the effects, or potential effects, of the nonconformity?
Audit Point 10) In addition to any contract or regulatory authority reporting requirements, does the organizations system provide for timely reporting of delivered nonconforming product that may affect reliability or safety? 11) Does notification include a clear description of the nonconformity, which includes as necessary parts affected, customer and/or organization part numbers, quantity, and date(s) delivered?
Document
Reference
The analysis of data shall provide information 3) Does the analysis of data provide information relating to relating to a) customer satisfaction a) customer satisfaction b) conformity to product b) conformity to product requirements requirements c) characteristics and trends of c) characteristics and trends of processes and products including processes and products including opportunities for preventive opportunities for preventive action, and action, and d) suppliers. d) suppliers?