Reference Documentation

  • EN 9100:2009
    Aerospace series Quality management systems Requirements (based on ISO 9001:2000) and Quality systems Model for quality assurance in design, development, production, installation and servicing (based on ISO 9001:1994)

  • AS Interpretation Rev. 0 - May 9, 2007 - Bureau Veritas Certification Interpretations of The Standard. Guidance for Quality Management System Auditors. Expectations for Companies Certifying to AS9100

  • IAQG

  • FINMECCANICA - AGUSTAWESTLAND
    QRS-01 Quality Requirements for Suppliers

  • MQ Rev. E - Ed.1 01-2014 Manuale Qualità

  • POE-T1 Edition 2 Revision 0 - 10 February 2016 - TEMA Production Organization Exposition

Company Informations

  • TEMA is EN9100 Certified by DNV GL Business Assurance Italia Srl.
    Cert. No. 10687-2007-AQ-ITA-SINCERT

  • Sector EA: 18 - 19 - 21

  • Products and Services:
    Design, Development, Manufacturing, Assembly, Overhauling and Maintenance of electromechanic parts and equipment for the Aerospace and Defense industry

  • EN9100:2009 Cert. No. 10687-2007-AQ-ITA-SINCERT Exp. Date: 06 September 2016
    ENAC IT.145.0364 Maintenance Organization Approval Certificate
    ENAC IT.21G.0048 Production Organization Approval Certificate
    QRS01 AgustaWestland Cert. No. A/0058

  • Execution of a Full EN9100 Internal Audit as required by QMS and planned as per Tema GAP, General Audit Plan.

Opening Meeting

  • This Internal Audit checklist is conforms to the TEMA General Audit Plan, to the requirements of EN9100 International Standard and to the Quality Management System requirements established by TEMA, and include customer contractual requirements.

  • Opening meeting notes:

4. Quality Management system

4.1. General Requirements

  • The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard EN9100:2009

  • 4.1a) Did the organisation determine the processes needed for the QMS and their application throughout the organization?

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  • 4.1b) Did the organisation determine the sequence and interaction of these processes?

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  • 4.1c) Did the organisation determine criteria and methods needed to ensure that both the operation and control of these processes are effective?

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  • 4.1d) Did the organisation ensure the availability of resources and information necessary to support the operation and monitoring of these processes?

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  • 4.1e) Do the organisation monitor, measure where applicable, and analyse these processes?

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  • 4.1f) Do the organization implement actions necessary to achieve planned results and continual improvement of these processes.

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  • 4.1 The organization’s quality management system shall also address customer and applicable statutory and regulatory quality management system requirements.

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  • 4.1 N1N2N3 Outsourcing Processes
    NOTE 1 Processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization, measurement, analysis and improvement.
    NOTE 2 An “outsourced process” is a process that the organization needs for its quality management system and which the organization chooses to have performed by an external party.
    NOTE 3 Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory and regulatory requirements. The type and extent of control to be applied to the outsourced process can be influenced by factors such as.

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4.2. Documentation Requirements

  • Did the organisation establish and maintain a documented Quality Manual?

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  • Do the Quality Manual include:

  • 4.2.2a) The scope of the Quality Management System, including details of and justification for any exclusions?

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  • 4.2.2b) The documented procedures established for the QMS, or reference to them?

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  • 4.2.2c) A description of the interaction between the processes of the QMS?

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  • BV Certification: Points of reference may be throughout the manual when discussing pertinent subjects (imbedded in the text). All of the referenced procedures may be listed together in an appendix / attachment to the manual. Or, the pertinent procedure(s) may be called out at the beginning or end of each major section of the manual. A cross reference matrix is especially effective - linking specific clauses in the Standard – to corresponding paragraphs in the quality manual – down to specific paragraphs in the detailed procedure (or W/I as appropriate). Regardless of the approach, the intent of the Standard is that there be a clear, unbroken, definitive trail from a particular requirement in the Standard, into and through the quality manual, down to the procedural (and or work instruction) level – such that users of the documentation can clearly and readily arrive at a description of how that requirement in the Standard is satisfied / fulfilled in the organizations system documentation.

  • 4.2.1 Do the organization ensure that personnel have access to, and are aware of, relevant quality management system documentation and changes ?

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  • BV Certification: It is expected that all personnel have access to relevant documentation, in any appropriate format. Documentation can include procedures, work instructions, forms, travelers, drawings and work standards. For complex operations, job packages should be at the workstation. In other situations, it is sufficient for the co-worker to demonstrate knowledge of where the relevant documentation is located.
    The right of access by “customer and/or regulatory authorities” appears in several clauses throughout the standard. A broad statement permitting right of access to quality documentation at the organization’s facilities, coupled with flow down to suppliers and sub-tier suppliers (see section 7.4) is sufficient to satisfy this requirement.

4.2.3. Control of Documents

  • A documented procedure for the control of documents is available.

  • The procedure defines the controls needed:

  • 4.2.3a) to approve documents for adequacy prior to use.

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  • 4.2.3b) to review and update as necessary and re-approve documents.

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  • 4.2.3c) to ensure that changes and current revision status of documents are identified.

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  • 4.2.3d) to ensure that relevant versions of applicable documents are available at points of use.

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  • 4.2.3e) to ensure that documents remain legible and readily identifiable.

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  • 4.2.3f) to ensure that documents of external origin determined by the organisation to be necessary for the planning and operation of the QMS are identified and their distribution controlled.

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  • BV Certification: Documents of external origin – Documents of external origin are those that are produced from outside the organization that are used by the organization in support of the quality management system processes. The procedure must address if documents of external origin are applicable and if so how these documents are controlled by the facility. The auditor expects to see that controls are in place to ensure current versions are used and documents are controlled within the facility.

  • 4.2.3g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.

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  • Do the organization coordinate document changes with customers and/or regulatory authorities in accordance with contract or regulatory requirements ?

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  • BV Certification: The degree and type of documentation change “coordination” (if required at all) will be defined by the customer and/or regulator agency. Additionally, the organization may add to (but not contradict) details. “Coordination” may be as little as mere notification, to distributing approved copies, up to and including formal approval by the customer / agency) prior to implementation. Documents typically subject to this requirement include pre-approved contracts, statements of work, inspection/test plans, “frozen” or “fixed” process plans and routings. The BV Certification auditor will seek documented, objective evidence that such “coordination” has taken place (as appropriate) and as prescribed in the organizations documented procedure.

4.2.4. Control of Records

  • Requirements of EN9130 Record retention shall be applied

  • A documented procedure for the control of records is avalable ?

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  • The procedure defines the controls needed for the:

  • b) storage of records (EN9130 Ch5 Records to be retained)?

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  • a) identification of records and period of retention (EN9130 Ch5 Records to be retained and Ch6 Periods of retention)?

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  • d) retrieval of records (EN9130 Ch7 Methods of Retention, Storage, Retrieval?

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  • c) protection of records?

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  • f) disposition of records (EN9130 Ch8 Disposal of Records)?

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  • All records are legible, readily identifiable and retrievable?

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  • e) retention of records (EN9130 Ch9 Record Retention Matrix)?

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  • The procedure define the method for controlling records that are created by and/or retained by suppliers ?

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  • BV Certification: Records shall be available for review by the customer and regulatory authorities in accordance with contract or regulatory requirements.
    BV Certification: This requirement most obviously applies to records maintained by the organization. It equally applies to pertinent quality records retained by the organization’s suppliers and by the supplier’s sub-tier sources. Pertinent records (at any level in the supply chain) may be kept on-site, or at an off-site repository or by a remote records management service. In any event, retrieval of such records should be relatively convenient and timely – so as not to impede “availability” to customers and regulatory authorities. Compliance to this requirement is often managed and assured by / through purchase order “flowdown” requirements – from the organization to the lowest level supplier / subcontractor involved. Such “flowdown” typically invokes the “right of access” to all pertinent quality records that may exist at any/all levels in the supply chain.

5. Management Responsibility

5.1. Management commitment

  • Do top management show evidence of their commitment by:

  • 5.1a) communicating to the organisation the importance of meeting customer as well as statutory and regulatory requirements?

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  • 5.1b) establishing the quality policy?

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  • 5.1c) ensuring that quality objectives are established?

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  • 5.1d) conducting management reviews?

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  • 5.1e) ensuring the availability of resources?

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5.2. Customer Focus

  • 5.2 Is top management involved in determining customer requirements with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1)?

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  • 5.2 Do Top management ensure that product conformity and on-time delivery performance are measured and that appropriate action is taken if planned results are not, or will not be, achieved ?

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5.3. Quality Policy

  • 5.3a) Is the policy statement appropriate to the purpose of the organisation?

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  • 5.3b) Do the policy statement include a commitment to comply with requirements and continually improve the effectiveness of QMS?

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  • 5.3c) Do the policy statement provide a framework for establishing and reviewing quality objectives?

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  • 5.3d) Is the policy statement communicated and understood within the organization?

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  • 5.3e) is the policy statement reviewed for continuing suitability?

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5.4. Planning

5.4.1. Quality Objectives

  • 5.4.1a Are quality objectives established at relevant functions and levels within the organization?

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  • 5.4.1b Are the objectives measurable and consistent with the quality policy?

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5.4.2. Quality Management system Planning

  • 5.4.2a) Is planning of the QMS carried out in order to meet the requirements given. In 4.1 as well as the quality objectives?

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  • 5.4.2b) Is the integrity of the QMS maintained when changes to the system are planned and implemented?

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5.5. Responsibility, Authority and Communication

5.5.1. Responsibility and Authority

  • 5.5.1 Are responsibilities and authorities defined and communicated within the organization?

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5.5.2. Management Representative

  • Is the management representative formally appointed?

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  • Is the management representative part of the organisations management?

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  • Do the management representatives responsibilities include:

  • 5.5.2a) ensuring that processes needed for the QMS are established, implemented and maintained?

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  • 5.5.2b) reporting to top management on the performance of the QMS and any need for improvement?

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  • 5.5.2c) ensuring the promotion of awareness of customer requirements throughout the organisation?

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  • 5.5.2d) the organizational freedom and unrestricted access to top management to resolve quality
    management issues. NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system.

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  • BV Certification: The Management Representative (MR) need not be a member of the Quality organization, though this is most often the case. Any management-level individual from any organization / discipline is acceptable. Of utmost importance is that the MR has freedom within the company’s organizational, political, cultural and communication arenas. This freedom necessitates that the MR have access mobility, both vertically and horizontally, and especially across departmental boundaries. It is expected that the MR have at least a dotted-line relationship with executive management that may be exercised on an exception basis – if/when internal “influences” impede the MR’s normal “freedom”. It is sometimes difficult to observe / demonstrate the MR’s organizational freedom. More apparent are situations where this freedom is limited, restricted or even nonexistent. This problem may be evident in cases of unresolved Quality problems, recurring problems,ineffective/untimely corrective action responses, low customer satisfaction and perception, ineffective internal audits, lack of system/process improvement, etc.

5.5.3. Internal Communication

  • 5.5.3 Are the appropriate communication processes established for internal communication?

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  • 5.5.3 Do communication take place regarding the effectiveness of the QMS?

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5.6. Management Review

5.6.1. General

  • 5.6.1 Do management review the QMS at planned intervals?

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  • 5.6.1 Do the review include assessing opportunities for improvement and the need for changes to the QMS, including the quality policy and quality objectives?

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5.6.2. Review Input

  • Do the input to the review include information on:

  • 5.6.2a) results of audits?

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  • 5.6.2b) customer feedback?

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  • 5.6.2c) process performance and product conformity?

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  • 5.6.2d) status of preventive and corrective actions?

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  • 5.6.2e) follow-up actions from previous management reviews?

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  • 5.6.2f) changes that could affect the QMS?

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  • 5.6.2g) recommendations for improvement?

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5.6.3. Review Output

  • Do the output of the review include any decisions and actions related to:

  • 5.6.3a) improvement of the effectiveness of the QMS and its processes?

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  • 5.6.3b) improvement of product related to customer requirements?

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  • 5.6.3c) resource needs?

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6. Resource Management

6.1. Provision of Resources

  • Did the organisation determine and provide the resources needed:

  • 6.1a) to implement and maintain the QMS and continually improve its effectiveness?

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  • 6.1b) to enhance customer satisfaction by meeting customer requirements?

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6.2. Human Resources

6.2.1. General

  • Are personnel performing work affecting conformity to product requirements competent on the basis appropriate education, training, skills and experience? NOTE Conformity to product requirements can be affected directly or indirectly by personnel performing any task within the quality management system.

6.2.2. Competence, Training and Awareness

  • Do the organisation:

  • 6.2.2a) determine the necessary competence for personnel performing work affecting conformity to product requirements?

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  • 6.2.2b) where applicable, provide training or take other actions to achieve the necessary competence?

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  • 6.2.2c) evaluate the effectiveness of the actions taken?

  • 6.2.2d) 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?

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  • 6.2.2e) maintain appropriate records of education, training, skills and experience?

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6.3. Infrastructure

  • Do the organisation determine, provide and maintain the infrastructure needed to achieve conformity to product requirements?

  • Are the following infrastructure needs determined, provided and maintained:

  • 6.3a) buildings, workspace and associated utilities?

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  • 6.3b) process equipment (both hardware and software)?

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  • 6.3c) supporting services ( such as transport, communication and information systems)?

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6.4. Work Environment

  • Do the organisation determine and manage the work environment needed to achieve conformity to product requirements?
    NOTE The term "work environment" relates to those conditions under which work is performed including physical, environmental and other factors (such as noise, temperature, humidity, lighting or weather).

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  • BV Certification: The organization must identify and manage all those factors of the work environment that are needed to supply a conforming product. These factors may include among others:
    Human Factors
    Creative work methods;
    Opportunities for greater involvement of personnel;
    Safety rules and guidance;
    Ergonomics;
    Special facilities for people.
    Physical Factors
    Heat;
    Noise;
    Light;
    Hygiene;
    Humidity;
    Cleanliness; Vibration;
    Pollution;
    Airflow.
    Different types of businesses and industry sectors may vary dramatically with regard to an acceptable work environment, so it is the organization’s management who determines the adequacy of the work environment provided by the organization.
    For instance;
    A training provider may need to ensure the training area is adequately lighted and contains appropriate seating and visual aid capabilities.
    Some manufacturing facilities may require “clean rooms” or humidity-controlled areas.
    Companies handling items easily damaged by electrostatic discharge may require special flooring or equipment, and chemical storage areas may require special protective barriers.
    As an additional example, an employee might perform a particular function that requires repetitive wrist movements (i.e., tightening a screw). As the day wears on, it is possible that the overuse of the wrist could result in poorly torqued screws resulting in a possible quality defect. The company should identify such a situation and provide a means of eliminating the potential defect (i.e., air-driven screwdrivers). Evidence could consist of records of decreased quality defects and/or medical problems related to that activity.

7. Product Realization

7.1. Planning of Product Realisation

  • 7.1 Do the organisation plan and develop the processes needed for product realization ?
    The output of this planning shall be in a form suitable for the organization's method of operations.
    NOTE 1 A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract can be referred to as a quality plan.
    NOTE 2 The organization may also apply the requirements given in 7.3 to the development of product realization processes.

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  • 7.1 Do the organisation determine the following, as appropriate:

  • 7.1a) quality objectives and requirements for the product?

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  • 7.1a)NOTE Quality objectives and requirements for the product include consideration of aspects such as
    – product and personal safety,
    – reliability, availability and maintainability,
    – producibility and inspectability,
    – suitability of parts and materials used in the product,
    – selection and development of embedded software, and
    – recycling or final disposal of the product at the end of its life.

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  • 7.1b) the need to establish processes and documents, and to provide resources specific to the product?

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  • 7.1c) required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance?

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  • 7.1d) records needed to provide evidence that the realisation processes and resulting product meet requirements?

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  • 7.1e) configuration management appropriate to the product

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  • 7.1f) resources to support the use and maintenance of the product.

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  • BV Certification: The resources to support operation and maintenance of the product may include tech manuals, tooling, fixtures, lubricants, etc. This requirement is aimed at operational and maintenance organizations, not at manufacturing organizations. The intent is for the operational and maintenance organizations to positively identify the resources that they require to perform the operational and maintenance activities related to the product in the field.

7.1.1 Project Management

  • 7.1.1 Do the organization plan and manage product realization in a structured and controlled manner to meet requirements at acceptable risk, within resource and schedule constraints as appropriate to the organization and the product,

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7.1.2 Risk Management

  • Do the organization establish, implement and maintain a process for managing risk to the achievement of applicable requirements, that includes as appropriate to the organization and the product ?

  • 7.1.2a) assignment of responsibilities for risk management,

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  • 7.1.2b) definition of risk criteria (e.g., likelihood, consequences, risk acceptance),

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  • 7.1.2c) identification, assessment and communication of risks throughout product realization,

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  • 7.1.2d) identification, implementation and management of actions to mitigate risks that exceed the defined risk acceptance criteria, and

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  • 7.1.2e) acceptance of risks remaining after implementation of mitigating actions.

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7.1.3 Configuration Management

  • Do the organization establish, implement and maintain a configuration management process that includes, as appropriate to the product ? NOTE: See ISO 10007 for guidance.

  • 7.1.3a) configuration management planning?

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  • 7.1.3b) configuration identification?

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  • 7.13c) change control?

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  • 7.1.3d) configuration status Accounting?

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  • 7.1.3e) configuration audit?

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7.1.4 Control of Work Transfers

  • Do the organization establish, implement and maintain a process to plan and control the temporary or permanent transfer of work (e.g., from one organization facility to another, from the organization to a supplier, from one supplier to another supplier) and to verify the conformity of the work to requirements ?

7.2. Customer Related Processes

7.2.1. Determination of Requirements Related to the Product

  • Do the organisation determine:

  • 7.2.1a) requirements specified by the customer, including the requirements for delivery and post-delivery activities?
    NOTE Post-delivery activities include, for example, actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal.

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  • 7.2.1b) requirements not stated by the customer but necessary for specified or intended use, where known?

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  • 7.2.1c) statutory and regulatory requirements applicable to the product?

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  • 7.2.1d) any additional requirements considered necessary by the organisation?

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  • 7.2.1 NOTE Requirements related to the product can include special requirements?

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7.2.2. Review of Requirements Related to the product

  • 7.2.2 Do the organisation review the requirement prior to commitment in order to ensure that:

  • 7.2.2 Product requirements are defined ?

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  • 7.2.2b) contract or order requirements differing from those previously expressed are resolved?

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  • 7.2.2c) the organisation has the ability to meet the defined requirements?

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  • 7.2.2d) special requirements of the product are determined

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  • 7.2.2e) risks (e.g., new technology, short delivery time frame) have been identified (see 7.1.2).

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  • BV Certification: The potential for “risks” exists in virtually every contract or order. The Standard mentions only two of the most obvious examples (i.e. new technology and short delivery time scales). Types of potential risks vary greatly depending upon contractual requirements, requirements of regulatory authorities, design responsibility, product requirements, safety and airworthiness considerations, production processes, operational constraints, business conditions / limitations, materials, procurement sources, outsourcing, etc., etc. Just a few extreme examples that may pose ‘risk’ include: potential labor strikes, facilities relocations or shutdowns, environmental or climatic factors, production capacity limitations, availability of materials, adequacy of procurement sources, absence of key personnel, outage of vital equipment, etc. To a reasonable and practical extent, any and all such potential risks should be identified and their impact evaluated before accepting the contract or order. Records of contract reviews should demonstrate / document some level of deliberate, thoughtful “risk evaluation” activity, delineation of identified risks (if any), and resultant actions taken to mitigate or eliminate the risks.

  • 7.2.2 Do the organisation maintain records of the results of the review and actions arising from the review (See 4.2.4) ?

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  • 7.2.2 Do the organisation ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements where product requirements are changed?

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7.2.3. Customer Communication

  • Do the organisation determine and implement effective arrangements for communicating with customers in relation to:

  • 7.2.3a) product information?

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  • 7.2.3b) enquiries, contracts or order handling, including amendements?

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  • 7.2.3c) customer feedback, including customer complaints?

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7.3. Design and Development

7.3.1. Design and Development Planning

  • During design and development planning, do the organisation determine:

  • 7.3.1a) the design and development stages ?
    - in respect of organization, task sequence, mandatory steps, significant stages and method of configuration control

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  • BV Certification: The organization is responsible for the identification the design and development stages. EN9100 imposes some additional and specific clarification of the information required: which elements of the organization are involved, where in the task sequence the stages begin/terminate, significant stages and configuration control. These additional requirements may be recorded in formal project plans, Gantt charts, checklists or in similar documentation.

  • 7.3.1b) the review, verification and validation that are appropriate to each design and development stage?

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  • 7.3.1c) the responsibilities and authorities for design and development?

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  • 7.3.1 Do the he organization divide the design and development effort into distinct activities and, for each activity, define the tasks, necessary resources, responsibilities, design content, input and output data and planning constraints ?

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  • BV Certification: Where appropriate, due to complexity, the organization shall give consideration to the following activities:
    - structuring the design effort into significant elements;
    - for each element, analyzing the tasks and the necessary resources for its design and development. This analysis shall consider an identified responsible person, design content, input data, planning constraints, and performance conditions. The input data specific to each element shall be reviewed to ensure consistency with requirements.
    BV Certification: Even though this section begins “where appropriate”, all except the very smallest design and development projects will have defined stages and the stages usually will contain multiple tasks. It is clear that the records need to demonstrate some level of planning. It is important that the process owners are identified and that the required technical personnel are indeed available to work on the project. Although not specifically required, a table of engineering manpower allocation (projects with associated engineering hours) would be helpful to ensure that sufficient technical manpower is available. It is important to note that should be evidence of a review of input data to ensure consistency of requirements.

  • 7.3.1 The different design and development tasks to be carried out are based on the safety and functional objectives of the product in accordance with customer, statutory and regulatory requirements ?

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  • BV Certification: This is a check at the planning stage to ensure that the design and development activity actually will address all customer and regulatory requirements. The auditor will expect to see evidence of this check. Refer also to Interpretation for section 4.2.1f, above, for a discussion of regulatory requirements.

  • 7.3.1 The Design and development planning consider the ability to produce, inspect, test and maintain the product ?

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  • 7.3.1 Do the organization manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility ?

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  • 7.3.1 The Planning output is updated, as appropriate, as the design and development progresses ?
    NOTE Design and development review, verification and validation have distinct purposes. They can be conducted and recorded separately or in any combination as suitable for the product and the organization.

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7.3.2. Design and Development Inputs

  • Do the design and development inputs include:

  • 7.3.2a) functional and performance requirements?

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  • 7.3.2b) applicable statutory and regulatory requirements?

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  • 7.3.2c) where applicable, information derived from previous similar designs?

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  • 7.3.2d) other requirements essential for design and development?

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  • 7.3.2 Are the inputs reviewed for adequacy ? Are Requirements complete, unambiguous and not in conflict with each other ?

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  • BV Certification: The auditor will need to review evidence that the inputs (7.3.2 a – d) have been addressed based on the nature of the product being produced, that they have been reviewed for adequacy and that records are maintained of the activity.

7.3.3. Design and Development Outputs

  • 7.3.3 Are the outputs of the design and development in a form suitable for verification against the design and development input and approved prior to release?

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  • 7.3.3 Do the design and development outputs:

  • 7.3.3a) meet the input requirements for design and development

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  • 7.3.3b) provide appropriate information for purchasing, production and service provision?
    NOTE Information for production and service provision can include details for the preservation of product.

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  • 7.3.3c) contain or reference product acceptance criteria?

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  • 7.3.3d) specify the characteristics of the product that are essential for its safe and proper use?

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  • 7.3.3e) Do the organization define the data required to allow the product to be identified, manufactured, inspected, used and maintained ?

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  • 7.3.3e) the drawings, part lists and specifications necessary to define the configuration and the design features of the product ?

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  • 7.3.3e) the material, process, manufacturing and assembly data needed to ensure conformity of the product ?

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  • BV Certification: The auditor should expect to see objective evidence that the outputs (7.3.3 a – d) have been verified against the design inputs. This can be accomplished by reviewing documents, plans, etc. interfacing with the customer or internal processes and by comparison with past proven designs.
    e) identify key characteristics, when applicable, in accordance with design or contract requirements.
    BV Certification: As noted in Definitions, key characteristics may be identified by the customer (and/or regulatory authorities), as well as by the organization. Once key characteristics have been identified, usually at the Planning and/or Design and Development (D&D) Input stage, they must be then addressed also as part of D&D Output. The organization must show that the developed product specifically satisfies the input requirements for key characteristics.

  • BV Certification: All pertinent data required to allow the product to be identified, manufactured, inspected, used and maintained shall be defined by the organization; for example:
    - drawings, part lists, specifications;
    - a listing of those drawings, part lists, and specifications necessary to define the configuration and the design features of the product;
    - information on material, processes, type of manufacturing and assembly of the product necessary to ensure the conformity of the product.
    BV Certification: The standard is clear; all documentation relating to the developed product must be identified as part of the D&D output. These may be included in a summary report or as part of a design review.

7.3.4. Design and Development Review

  • 7.3.4 Do the organisation systematically review the design and development in accordance with planned arrangements to:

  • 7.3.4a) evaluate the ability of the results of design and development to meet requirements?

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  • 7.3.4 b) identify any problems and propose necessary actions?

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  • 7.3.4c) to authorize progression to the next stage?

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  • BV Certification: Design and development (D&D) reviews may vary in terms of purpose, frequency, complexity, formality, attendance and associated output documentation / review records. Regardless, there must be clearly documented evidence that an authorized individual(s) has reviewed the results / progress / status of each prescribed D&D stage / activity. Before the D&D plan can proceed to the next stage – a responsible/authorized person (or personnel) must provide documented, objective evidence of progression approval (signatures being preferred). Progression authorization may appear as a specific signoff on a review checklist, in review minutes, in evaluation reports, on D&D plans, timeline charts, etc. An undocumented, passive agreement or consensus of opinion will not sufficiently meet the intent of this requirement.

  • Are records maintained of the results of the review and any necessary actions taken?
    Participants in such reviews shall 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 shall be maintained (see 4.2.4)?

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7.3.5. Design and Development Verification

  • 7.3.5 Do the organisation perform verification to ensure that the design and development outputs have met the design and development input requirements?

  • Add media

  • 7.3.5 Are records of the results of the verification and any necessary actions maintained?

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7.3.6. Design and Development Validation

  • 7.3.6 Do the organisation perform design and development validation to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known?

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  • Are records of the results of validation and any necessary actions maintained?

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7.3.6.1 Design and Development Verification and Validation Testing

  • 7.3.6.1 Where tests are necessary for verification and validation, these tests shall be planned, controlled, reviewed and documented to ensure and prove the following?

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  • 7.3.6.1a) test plans or specifications identify the product being tested and the resources being used, define test objectives and conditions, parameters to be recorded and relevant acceptance criteria?

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  • 7.3.6.1b) test procedures describe the method of operation, the performance of the test and the recording of the results?

  • Add media

  • 7.3.6.1c) the correct configuration of the product is submitted for the test?

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  • 7.3.6.1d) the requirements of the test plan and the test procedures are observed?

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  • 7.3.6.1e) the acceptance criteria are met?

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  • BV Certification: 7.3.6.1 Documentation of Design and/or Development Verification and Validation: At the completion of design and/or development, the organization shall ensure that reports, calculations, test results, etc., demonstrate that the product definition meets the specification requirements for all identified operational conditions.
    BV Certification: This is added check to ensure, at the conclusion of the D&D effort that documentation and supporting data that was generated during the design and subsequent verification/validation does in fact meet all the input requirements. This clause supports the conclusions that should have been reached at Design Review. The auditor would expect to see evidence that verification and validation satisfy the input requirements.

7.3.6.2 Design and Development Verification and Validation Documentation

  • 7.3.6.2 Do the organization ensure that reports, calculations, test results, etc., demonstrate that the product definition meets the specification requirements for all identified operational conditions at the completion of design and/or development ?

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  • BV Certification: 7.3.6.2 Design and/or Development Verification and Validation Testing: Where tests are necessary for verification and validation, these tests shall be planned, controlled, reviewed, and documented to ensure and prove the following:
    a) test plans or specifications identify the product being tested and the resources being used, define test objectives and conditions, parameters to be recorded, and relevant acceptance criteria;
    b) test procedures describe the method of operation, the performance of the test, and the recording of the results;
    c) the correct configuration standard of the product is submitted for the test; d) the requirements of the test plan and the test procedures are observed;
    e) the acceptance criteria are met.
    BV Certification: When testing is used to support verification and validation, the test results must meet the requirements presented in this clause.

7.3.7. Control of Design and Development Changes

  • 7.3.7 Are design and development changes identified and records maintained?

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  • 7.3.7 Do the organisation review, verify, validate, as appropriate, and approve changes before implementation?

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  • 7.3.7 Are records of the results of the review of changes and any necessary actions maintained?

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  • 7.3.7 Are Design and development changes controlled in accordance with the configuration management process (see 7.1.3) ?

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7.4. Purchasing

7.4.1. Purchasing Process

  • 7.4.1 Do the organisation evaluate and select suppliers based on their ability to supply product in accordance with the organisations requirements?

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  • 7.4.1 Do the organisation have an approved supplier list?

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  • 7.4.1 Do the organisation have criteria for the selection of suppliers ?
    NOTE One factor that can be used during supplier selection and evaluation is supplier quality data from objective and reliable external sources, as evaluated by the organization (e.g., information from accredited quality management system or process certification bodies, organization approvals from government authorities). Use of such data would be only one component of an organization’s supplier control process and the organization remains responsible for verifying that purchased product meets specified purchase requirements.

  • What is the selection criteria for suppliers?

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  • 7.4.1 Do the organisation have evaluation criteria for suppliers?

  • What is the evaluation criteria for suppliers?

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  • 7.4.1 Do the organisation have re-evaluation criteria for suppliers?

  • What is the re-evaluation criteria for suppliers?

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  • 7.4.1 Are records of the results of evaluations and any necessary actions arising from the evaluation maintained (see 4.2.4) ?

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  • 7.4.1a) Do the organization maintain a register of its suppliers that includes approval status (e.g., approved, conditional, disapproved) and the scope of the approval (e.g., product type, process family) ?

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  • BV Certification: A “register” could be in most any format and media – hardcopy, electronic, a paper listing, an electronic file as part of a procurement software program, or even a manual card file. The register must be a complete, finite compilation of all approved suppliers / vendors / subcontractors - including those that are customer-designated / approved. The register must include sources that provide goods, products and services that relate to the organization’s products, processes and Quality management system. Compiling the register(s) is a relatively simple and direct task. The second part of this requirement – “ . . . that includes the scope of the approval.” involves more thought. The “scope of approval” should describe the extent (or limitation) on what the source can (or can’t) provide or perform. The description of the “scope” can be narrative or coded. Some examples:
    − Acme Machining – conventional metal machining except for chemical milling and wire EDM.
    − Acme Hardware Distributors – all metal, mechanical fasteners except for rivets.
    − Acme Metal Distributors – all ferrous and non-ferrous metals except for titanium and inconel.
    − Acme Heat Treating – heat treating processes

  • 7.4.1b) Do the organization periodically review supplier performance; the results of these reviews shall be used as a basis for establishing the level of controls to be implemented ?

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  • BV Certification: The periodicity of supplier performance reviews may vary across the organization’s supply base. That is, all suppliers may not have the same review frequency. Also, the type and extent / scrutiny of the review may vary from one supplier to another. These performance reviews should be planned and meaningful - often involving cross-functional involvement (i.e. Quality, Purchasing, Manufacturing, Engineering). The reviews must be based on factual input data. Recorded results are to be used to determine ongoing / future levels or control over the supplier. Favorable performance results might justify relaxing / reducing the type/extent of control – while unfavorable results would suggest the need to “tighten-up” on the supplier.

  • 7.4.1c) Do the organization define the necessary actions to take when dealing with suppliers that do not meet requirements ?

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  • BV Certification: This requirement relates closely to the requirement above (7.4.1 b) regarding supplier performance reviews. Conditions / events that indicate that a supplier is not meeting requirements might include: poor results from performance reviews, occurrences and repetition of nonconformances, corrective action inadequacy and lateness, incoming inspection failures, untimely delivery performance, etc. The organization needs to define / describe specific actions they will take if the supplier is not meeting expectations / requirements. This usually includes an “escalation” process – beginning with simple documented notification, followed by corrective action requests, then possibly special on-site audits and increased controls up to and including removal from the approved supplier listing. The auditor will expect to see documented, objective evidence of actions taken.

  • 7.4.1d) Do the organization ensure, where required, that both the organization and all suppliers use customer-approved special process sources ?

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  • BV Certification: The intent of this requirement includes customer-approved and customer- designated sources as well. The requirement applies not only to the organization and their immediate suppliers – but also to all lower-level, sub-tier sources involved in the contract or order. Compliance to this requirement usually begins with thorough review of customer requirements, identifying those sources that are customer-designated and customer-approved, then “flowing-down” (via purchasing documents) the requirement to all applicable lower-level sources. It is not unusual for this requirement to apply to sources that are 3-4 levels down in the supply chain.

  • 7.4.1e) Do the organization define the process, responsibilities and authority for the approval status decision, changes of the approval status and conditions for a controlled use of suppliers depending on the supplier’s approval status ?

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  • 7.4.1f) Do the organization determine and manage the risk when selecting and using suppliers (see 7.1.2) ?

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  • BV Certification: The organization shall be responsible for the quality of all products purchased from suppliers, including customer-designated sources.
    BV Certification: In the context of this and other requirements of the Standard, “product” includes parts, materials, process services, etc. It is readily apparent that an organization is ultimately responsible for the quality of product purchased from its own suppliers / subcontractors. This requirement extends the scope of the organization’s responsibility to include that for product purchased from customer-designated and/or customer-designated sources. The type and extent of control exercised over customer-designated or customer-approved sources may be justifiably different than that exercised over sources chosen / approved by the organization themselves. Regardless, customer-approval and/or customer-designation of sources does not relieve the organization of the responsibility to procure conforming “product”.

7.4.2. Purchasing Information

  • 7.4.2 Do the purchasing information describe the product to be purchased?

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  • Do the information include, where appropriate:

  • 7.4.2a) requirements for approval of product, procedures, processes and equipment?

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  • 7.4.2b) requirements of qualification of personnel?

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  • 7.4.2c) QMS requirements?

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  • 7.4.2d) the identification and revision status of specifications, drawings, process requirements, inspection/verification instructions and other relevant technical data?

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  • BV Certification: Describing the “applicable issues” is the essence of this requirement. “Issues” refers to the revision level (number, letter, date, etc.) of the document / data that is being invoked on the supplier. “Applicable” infers that the version being invoked is not necessarily the latest / current revision – an earlier version may be desired. Even if the organization does indeed wish to invoke the latest / current version – they must identify the specific revision. It is not sufficient for them to simply state “latest revision”. Doing so gives the supplier insufficient, ambiguous information. The supplier may not have the wherewithal to determine what the latest revision is – and may mistakenly / ignorantly use the “latest” (though outdated) version in their possession.

  • 7.4.2e) requirements for design, test, inspection, verification (including production process verification), use of statistical techniques for product acceptance, and related instructions for acceptance by the organization, and as applicable critical items including key characteristics?

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  • BV Certification: as applicable. When the purchased product is clearly defined (e.g. by specifications, drawings, etc.), an understanding needs to be in place to ensure that the supplier understands that the product must in fact meet requirements. Further, the supplier must understand that correction and/or corrective action will be expected if the delivered products do not meet the purchase requirements. This understanding is normally achieved through a statement to that effect in the purchase order or in the terms and conditions (T&Cs).

  • 7.4.2f) requirements for test specimens (e.g., production method, number, storage conditions) for design approval, inspection/verification, investigation or auditing?

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  • 7.4.2g) requirements regarding the need for the supplier to
    − notify the organization of non conformingproduct?
    − obtainorganizationapprovalfornonconformingproductdisposition,
    − notify the organization of changes in product and/or process, changes of suppliers, changes of manufacturing facility location and, where required, obtain organization approval, and
    − flowdowntothesupplychaintheapplicablerequirementsincludingcustomerrequirements,

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  • 7.4.2h) records retention requirements?

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  • 7.4.2i) right of access by the organization, their customer and regulatory authorities to the applicable areas of all facilities, at any level of the supply chain, involved in the order and to all applicable records?

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  • 7.4.2 Do the organization ensure the adequacy of specified purchase requirements prior to their communication to the supplier ?

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7.4.3. Verification of Purchased Product

  • 7.4.3 Do the organisation do the necessary inspections and other activities for ensuring that purchased product meets specified purchase requirements ?
    The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.
    NOTE 1 Customer verification activities performed at any level of the supply chain should not be used by the organization or the supplier as evidence of effective control of quality and does not absolve the organization of its responsibility to provide acceptable product and comply with all requirements.

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  • 7.4.3 NOTE 2 Do Verification activities include ?
    – obtaining objective evidence of the conformity of the product from the supplier (e.g., accompanying documentation, certificate of conformity, test records, statistical records, process control records),
    – inspection and audit at the supplier’s premises,
    – review of the required documentation,
    – inspection of products upon receipt, and
    – delegation of verification to the supplier or supplier certification.

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  • 7.4.3 Where purchased product is released for production use pending completion of all required verification activities, is it identified and recorded to allow recall and replacement if it is subsequently found that the product does not meet requirements ?

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  • 7.4.3 Where the organization delegates verification activities to the supplier, the requirements for delegation are defined and a register of delegations maintained ?

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  • 7.4.3 Where the organization or its customer intends to perform verification at the supplier's premises, the organization state the intended verification arrangements and method of product release in the purchasing information ?

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7.5. Production and Service Provision

7.5.1. Control of Production and Service Provision

  • Do the organisation plan and carry out production and service provision under controlled conditions including, as appropriate:

  • 7.5.1a) the availability of information that describes the characteristics of the product ?

    NOTE This information can include drawings, parts lists, materials and process specifications.

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  • 7.5.1b) the availability of work instructions, as necessary ?
    NOTE Work instructions can include process flow charts, production documents (e.g., manufacturing plans, travelers, routers, work orders, process cards) and inspection documents.

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  • 7.5.1c) the use of suitable equipment ?
    NOTE Suitable equipment can include product specific tools (e.g., jigs, fixtures, molds) and software programs.

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  • 7.5.1d) the availability and use of monitoring and measuring equipment?

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  • 7.5.1e) the implementation of monitoring and measurement?

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  • 7.5.1f) the implementation of product release, delivery and post-delivery activities?

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  • 7.5.1g) accountability for all product during production (e.g., parts quantities, split orders, nonconforming product),

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  • 7.5.1h) evidence that all production and inspection/verification operations have been completed as planned, or as otherwise documented and authorized,

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  • 7.5.1i) provision for the prevention, detection and removal of foreign objects,

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  • BV Certification: The organization must have a process for eliminating foreign objects. The extent of control will vary widely, dependent upon the nature of the product. Service industry, for example, would not be concerned with foreign objects. Manufacturers of solid parts without cavities might control foreign objects by simple cleaning and packaging. Manufacturers of complex parts and assemblies (i.e. with enclosed or deep cavities) would be expected to have more proactive processes. Examples of measures taken to control F.O.D include detailed work instructions, shadow boards (to identify missing tools) and F.O.D training programs.

  • 7.5.1j) monitoring and control of utilities and supplies (e.g., water, compressed air, electricity, chemical products) to the extent they affect conformity to product requirements

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  • BV Certification: The key words here are “to the extent necessary”. Many manufacturing companies control the quality of compressed air through the use of filters and routine maintenance of this equipment. Organizations with sophisticated analytical instrumentation may monitor and control power sources. Other organizations may need no special control of the utilities and supplies. The bottom line is that if there are processes where such control is important, there must be evidence of adequate control.

  • 7.5.1k) criteria for workmanship, specified in the clearest practical way (e.g., written standards, representative samples, illustrations).

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  • 7.5.1 Planning shall consider, as appropriate
     establishing, implementing and maintaining appropriate processes to manage critical items, including process controls where key characteristics have been identified?

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  • 7.5.1 Planning shall consider, as appropriate designing, manufacturing and using tooling to measure variable data?

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  • 7.5.1 Planning shall consider, as appropriate identifying in-process inspection/verification points when adequate verification of conformance cannot be performed at later stages of realization?

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  • 7.5.1 Planning shall consider, as appropriate special processes (see 7.5.2)?

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7.5.1.1 Production Process Verification

  • 7.5.1.1 Do the organization use a representative item from the first production run of a new part or assembly to verify that the production processes, production documentation and tooling are capable of producing parts and assemblies that meet requirements. This process shall be repeated when changes occur that invalidate the original results (e.g., engineering changes, manufacturing process changes, tooling changes).
    NOTE: This activity is often referred to as first article inspection.

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7.5.1.2 Control of Production Process Changes

  • 7.5.1.2 Is Personnel authorized to approve changes to production processes identified ?

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  • 7.5.1.2 Do the organization control and document changes affecting processes, production equipment, tools or software programs ?

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  • 7.5.1.2 Are the results of changes to production processes assessed to confirm that the desired effect has been achieved without adverse effects to product conformity ?

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7.5.1.3 Control of Production Equipment, Tools and Software Programs

  • 7.5.1.3 Production equipment, tools and software programs used to automate and control/monitor product realization processes, are validated prior to release for production and are maintained ?

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  • 7.5.1.3 Are Storage requirements, including periodic preservation/condition checks, defined for production equipment or tooling in storage ?

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7.5.1.4 Post-Delivery Support

  • 7.5.1.4 Post-delivery support shall provide as applicable for the

  • 7.5.1.4b) actions to be taken, including investigation and reporting, when problems are detected after delivery

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  • 7.5.1.4a) collection and analysis of in-service data

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  • 7.5.1.4c) control and updating of technical documentation

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  • 7.5.1.4d) approval, control and use of repair schemes

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  • 7.5.1.4e) controls required for off-site work (e.g., organization’s work undertaken at the customer’s facilities).

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7.5.2. Validation of Processes for Production and Service Provision

  • The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered.
    NOTE: These processes are often referred to as special processes.

  • 7.5.2 Do validation demonstrate the ability of processes to achieve planned results?

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  • Do the organisations arrangements for these processes include, as appropriate:

  • 7.5.2a) defined criteria for review and approval of the processes?

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  • 7.5.2b) approval of equipment and qualification of personnel?

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  • 7.5.2c) use of specific methods and procedures?

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  • 7.5.2d) requirements for records?

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  • 7.5.2e) revalidation?

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7.5.3. Identification and Traceability

  • 7.5.3 Do the organisation identify the product by suitable means throughout product realisation?

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  • 7.5.3 Do the organization maintain the identification of the configuration of the product in order to identify any differences between the actual configuration and the agreed configuration ?

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  • 7.5.3 Do the organisation identify the product status with respect to monitoring and measurement requirements throughout product realisation?

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  • 7.5.3 When acceptance authority media are used (e.g., stamps, electronic signatures, passwords), do the organization establish appropriate controls for the media ?

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  • 7.5.3 Do the organisation control unique identification of the product and maintain records, where traceability is a requirement ?

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  • 7.5.3 NOTE Traceability requirements can include:
    – identification to be maintained throughout the product life,
    – the ability to trace all products manufactured from the same batch of raw material, or from the same manufacturing batch, to the destination (e.g., delivery, scrap),
    – for an assembly, the ability to trace its components to the assembly and then to the next higher assembly, and
    – for a product, a sequential record of its production (manufacture, assembly, inspection/verification) to be retrievable.

7.5.4. Customer Property

  • The organization shall exercise care with customer property while it is under the organization‘s control or being used by the organization. The organization shall identify, verify, protect and safeguard 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, the organization shall report this to the customer and maintain records (see 4.2.4).
    NOTE: Customer property can include intellectual property and personal data.

  • Do the organisation make use of product provided by the customer for use or incorporation into the product ?

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7.5.5. Preservation of Product

  • Do the organisation deal with product?

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  • 7.5.5 Preservation of product shall also include, where applicable in accordance with product specifications and applicable statutory and regulatory requirements, provisions for

  • 7.5.5a) cleaning?

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  • 7.5.5b) prevention, detection and removal of foreign objects?

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  • 7.5.5c) special handling for sensitive products?

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  • 7.5.5d) marking and labeling including safety warnings?

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  • 7.5.5e) shelf life control and stock rotation?

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  • 7.5.5f) special handling for hazardous materials?

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  • BV Certification: The organization shall ensure that documents required by the contract/order to accompany the product are present at delivery and are protected against loss and deterioration.
    BV Certification: Organizations generally take precautions to ensure that the proper documents are present at shipping. It is considerably more difficult to ensure that they are present at delivery. Some companies fax duplicate documents to their customers. The auditor might check records of customer complaints to determine whether there have been complaints relating to missing documents and to review any subsequent actions.

7.6. Control of Monitoring and Measuring Equipment

  • 7.6 Do the organisation make use monitoring and measuring equipment?

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  • 7.6 Do the organization maintain a register of the monitoring and measuring equipment and define theprocess employed for their calibration/verification including details of equipment type, unique identification, location, frequency of checks, check method and acceptance criteria ?
    NOTE Monitoring and measuring equipment includes, but is not limited to: test hardware, test software, automated test equipment (ATE) and plotters used to produce inspection data. It also includes personally owned and customer supplied equipment used to provide evidence of product conformity.

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  • 7.6 Do the organization ensure that environmental conditions are suitable for the calibration, inspection, measurement and testing being carried out ?

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  • 7.6a) late or verified at specified intervals or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, they are registered with the criteria used for calibration or verification?

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  • 7.6b) adjusted or re-adjusted as necessary?

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  • 7.6c) identified to enable the calibration status to know?

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  • 7.6d) safeguarded from adjustments that would invalidate the measurement result?

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  • 7.6e) protected from damage and deterioration during handling, maintenance and storage?

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  • f) recalled according to a defined method when calibration is required?

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8. Measurement, Analysis and Improvement

8.1 General

  • 8.1 NOTE According to the nature of the product and depending on the specified requirements, statistical techniques can be used to support
    – design verification (e.g., reliability, maintainability, safety),
    – process control,
    • selection and inspection of key characteristics,
    • process capability measurements,
    • statistical process control,
    • design of experiment,
    – inspection, and
    – failure mode, effect and criticality analysis.

  • 8.1 Do the organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed:
    a) to demonstrate conformity to product requirements ?
    b) to ensure conformity of the quality management system ?
    c) to continually improve the effectiveness of the quality management system ?
    This shall include determination of applicable methods, including statistical techniques, and the extent of their use.

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8.2. Monitoring and Measurement

8.2.1. Customer Satisfaction

  • 8.2.1 Do the organisation monitor information relating to customer perception as to whether the organisation has met customer requirements ?

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  • 8.2.1 Information to be monitored and used for the evaluation of customer satisfaction shall include, but is not limited to, product conformity, on-time delivery performance, customer complaints and corrective action requests. Organizations shall develop and implement plans for customer satisfaction improvement that address deficiencies identified by these evaluations, and assess the effectiveness of the results.

  • 8.2.1 NOTE Monitoring customer perception can include obtaining input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, warranty claims and dealer reports.

  • What method is used?

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8.2.2. Internal Audit

  • 8.2.2 Do the organisation have a documented procedure that defines the responsibilities and requirements for planning and conducting audits, establishing records and reporting results?

  • 8.2.2 Do the organisation conduct internal audits at planned intervals to determine whether the QMS:

  • 8.2.2a) conforms to planned arrangements, to the requirements of the ISO 9001 standard and to the QMS requirements established by the organization ?
    NOTE Planned arrangements include customer contractual requirements.

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  • 8.2.2b) is effectively implemented and maintained ?

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  • 8.2.2Do the organisation have a planned audit program ?

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  • 8.2.2 Is the audit criteria, scope, frequency and methods defined ?

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  • 8.2.2 Is the selection of auditors and conduct of audits objective and impartial to the audit process ?

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  • 8.2.2 Do the organisation maintain records of the audits and their results ?

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  • 8.2.2 Do the responsible management ensure that any necessary corrections and corrective actions are taken to eliminate detected nonconformities and their causes ?

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8.2.3. Monitoring and Measurement of Processes

  • 8.2.3 Do the organisation apply methods for monitoring and, where applicable, measurement of the QMS processes ?

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  • 8.2.3 Do these methods demonstrate the ability of the processes to achieve planned results ?

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  • In the event of process nonconformity, do the organization

  • 8.2.3a) take appropriate action to correct the nonconforming process ?

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  • 8.2.3b) evaluate whether the process nonconformity has resulted in product nonconformity ?

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  • 8.2.3c) determine if the process nonconformity is limited to a specific case or whether it could have affected other processes or products ?

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  • 8.2.3d) identify and control any nonconforming product (see 8.3) ?

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8.2.4. Monitoring and Measurement of Product

  • BV Certification: 8.2.4 First Article Inspection: The organization’s system shall provide a process for the inspection, verification, and documentation of a representative item from the first production run of a new part, or following any subsequent change that invalidates the previous first article inspection result.
    NOTE: See EN 9102 for guidance.
    BV Certification: First article inspection, as opposed to first piece inspection, is performed in response to contract requirements. The auditor would expect to see evidence of representative first article inspection and customer acceptance (e.g. stamp or signature).

  • 8.2.4 Do the organisation monitor and measure the characteristics of the product to verify that product requirements have been met ?
    This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7.1). Evidence of conformity with the acceptance criteria shall be maintained.

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  • 8.2.4 Do records indicate the person(s) authorising release of product for delivery to the customer ?

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  • 8.2.4 Are Measurement requirements for product acceptance documented and include:

  • 8.2.4a) criteria for acceptance and/or rejection ?

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  • 8.2.4b) where in the sequence measurement and testing operations are to be performed ?

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  • 8.2.4c) required records of the measurement results (at a minimum, indication of acceptance or rejection) ?

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  • 8.2.4d) any specific measurement instruments required and any specific instructions associated with their use ?

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  • 8.2.4 When critical items, including key characteristics, have been identified, do the organization ensure they are controlled and monitored in accordance with the established processes ?

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  • 8.2.4 When the organization uses sampling inspection as a means of product acceptance, is the sampling plan justified on the basis of recognized statistical principles and appropriate for use (i.e., matching the sampling plan to the criticality of the product and to the process capability) ?

  • Add media

  • 8.2.4 Where product is released for production use pending completion of all required measurement and monitoring activities, it is identified and recorded to allow recall and replacement if it is subsequently found that the product does not meet requirements ?

  • Add media

  • 8.2.4 Where required to demonstrate product qualification, do the organization ensure that records provide evidence that the product meets the defined requirements ?

  • Add media

  • 8.2.4 Do the organization ensure that all documents required to accompany the product are present at delivery ?

  • Add media

8.3. Control of Nonconforming Product

  • 8.3 Do the organisation have a documented procedure that defines the controls and related responsibilities and authorities for dealing with nonconforming product ? NOTE The term “nonconforming product” includes nonconforming product returned by a customer.

  • 8.3 Do the organization’s documented procedure define the responsibility and authority for the review and disposition of nonconforming product, and the process for approving personnel making these decisions ?

  • Add media

  • 8.3 Do the organisation deal with nonconforming product by one or more of the following ways:

  • 8.3a) by taking action to eliminate the detected nonconformity?

  • Add media

  • 8.3b) by authorising its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer?

  • Add media

  • 8.3c) by taking action to preclude its original intended use or application?

  • Add media

  • 8.3d) by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started?

  • Add media

  • 8.3d)SUB - Do the organization’s nonconforming product control process provide for timely reporting of delivered nonconforming product ?
    NOTE Parties requiring notification of nonconforming product can include suppliers, internal organizations, customers, distributors and regulatory authorities.

  • Add media

  • 8.3e) by taking actions necessary to contain the effect of the nonconformity on other processes or products ?

  • Add media

  • 8.3 Is the Dispositions of "use-as-is" or "repair" only used after approval by an authorized representative of the organization responsible for design ?
    NOTE Authorized representative includes personnel having delegated authority from the design organization.

  • Add media

  • 8.3 Do the organization use dispositions of use-as-is or repair, unless specifically authorized by the customer, if the nonconformity results in a departure from the contract requirements ?

  • Add media

  • 8.3 Is "Product dispositioned for scrap" conspicuously and permanently marked, or positively controlled, until physically rendered unusable ?

  • Add media

  • 8.3 Do the organisation subject corrected nonconforming product to re-verification to demonstrate conformity to the requirements?

  • Add media

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8.4. Analysis of Data

  • 8.4 Do the organisation analyse data generated as a result of monitoring and measurement and from other relevant sources ?

  • 8.3 Do the organisation maintain records of the nature of nonconformities and any subsequent actions taken, including concessions obtained ?

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  • 8.4 Do the analysis of data provide information relating to:

  • 8.4a) customer satisfaction ?

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  • 8.4b) conformity to product requirements?

  • Add media

  • 8.4c) characteristics and trends of processes and product, including opportunities for preventive action?

  • Add media

  • 8.4d) suppliers ?

  • Add media

8.5. Improvement

8.5.1 Continual Improvement

  • 8.5.1 Do the organization monitor the implementation of improvement activities and evaluate the effectiveness of the results ?
    NOTE Continual improvement opportunities can result from lessons learned, problem resolutions and the benchmarking of best practices.

  • Add media

8.5.2. Corrective Action

  • 8.5.2 Do the organisation have a documented procedure defining the requirements for corrective action ?

  • 8.5.2 Do the organisation take action to eliminate the cause of nonconformities in order to prevent recurrence ?

  • Add media

  • 8.5.2 Do the documented procedure define requirements for:

  • 8.5.2a) reviewing nonconformities (including customer complaints)?

  • Add media

  • 8.5.2b) determining the cause of nonconformities?

  • Add media

  • 8.5.2c) evaluating the need for action to ensure that nonconformities do not recur?

  • Add media

  • 8.5.2d) determining and implementing action needed?

  • Add media

  • 8.5.2e) records of the results of actions taken?

  • Add media

  • 8.5.2f) reviewing the effectiveness of the corrective action taken?

  • Add media

  • 8.5.2g) flowing down corrective action requirements to a supplier when it is determined that the supplier
    is responsible for the nonconformity ?

  • Add media

  • 8.5.2h) specific actions where timely and/or effective corrective actions are not achieved ?

  • Add media


  • 8.5.2i) determining if additional nonconforming product exists based on the causes of the nonconformities and taking further action when required ?

  • Add media

8.5.3. Preventive Action

  • 8.5.3 Do the organisation have a documented procedure defining the requirements for preventive action ?

  • 8.5.3 Do the organisation determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence ?

  • Add media

  • NOTE Examples of preventive action opportunities include risk management, error proofing, failure mode and effect analysis (FMEA), and information on product problems reported by external sources.

  • 8.5.3 Do the documented procedure define requirements for:

  • 8.5.3a) determining potential nonconformities and their causes?

  • Add media

  • 8.5.3b) evaluating the need for action to prevent occurrence of nonconformities?

  • Add media

  • 8.5.3c) determining and implementing action needed?

  • Add media

  • 8.5.3d) records of results of action taken?

  • Add media

  • 8.5.3e) reviewing the effectiveness of the preventive action taken?

  • Add media

SPECIAL CUSTOMER REQUIREMENTS

  • FINMECCANICA - AGUSTAWESTLAND
    QRS-01 Quality Requirements for Suppliers

  • Finmeccanica - AgustaWestlandnd Quality Requirements for Suppliers document (QRS01) is applicable to all Suppliers when referred to within the Purchase Order/Contract and/or Agreement and shall be flowed-down to all Sub-tier Suppliers.
    All Suppliers must be approved to supply products.
    The Aerospace industry has standardised business management requirements.

    Aerospace related companies are expected to be registered to EN/AS/JISQ9100 series, as applicable.
    AgustaWestland is flowing down this requirement to their Suppliers.

    This document is in the same format as the EN/AS/JISQ9100 standard and contains AgustaWestland
    specific requirements that are in addition to the standard.

    Depending on Supplier Classification, all the requirements of this document shall apply and may be checked and monitored for compliance by AgustaWestland.
    From 1st July 2015 the new revision of Quality Requirements for Suppliers (QRS01 Issue 3) will be applicable to all suppliers.

    The set of AW requirements that each Supplier signing a Contract, accepting a Purchase Order and delivering parts / services to AW, commits to fulfil are described in the document QRS-01 General Requirements for Suppliers.
    The set of requirements that the Supplier commits to fulfil and flow-down to its Sub- tier Suppliers is composed by a general section (applicable to all categories and types of Suppliers) and a set of dedicated procedures (QRS-XXX) applicable according to the category and type of the Supplier and its approval (see Table 1).
    The entire body of documents (General Requirements plus QRS-XXX) forms the AW Quality Requirement for Suppliers.
    The QRS-01 document is complementary to EN9100 series requirements that shall be fulfilled by the Supplier.

  • QRS01 Issue 3 Associated Docs
    Here below QRS01 associated documents applicable from the 1st July 2015:

    QRS-100 Digital Manufacturing
    QRS-101 FAI
    QRS-102 Control Plan for Deliveries
    QRS-103 Quality Requirements for Subcontracted Parts
    QRS-104 Special Processes / NDT Qualification and Critical Processes Requirements, Equipment and Personnel
    QRS-106 Delivery Documentation
    QRS-107 Management of non-conformance, production permit and continued airworthiness
    QRS-108 Requirements for Preparation of Supplier’s Quality Plan
    QRS-110 DO-PO Arrangement
    QRS-112 Control of Records
    QRS-114 Packaging
    QRS-115 Requirements for Supplier of Design and Development activities for AW
    QRS-116 Qualification and Quality Assurance Software requirements for Suppliers of Equipment’s during Design and Development Phases
    QRS-117 Qualification and Quality Assurance Complex Electronic Hardware requirements for Suppliers of Equipment’s during Design and Development Phases
    QRS-120 Programs Additional Requirements
    QRS-121 Counterfeit Parts
    QRS-122 CMM
    XXX Storage Condition

    Here below the forms applicable to QRS01 Issue 3:

    QRS.101.F01 PN Accountability
    QRS.101.F02 Product Accountability
    QRS.101.F03 Characteristic Accountability
    QRS.104 Appendix 3 RFVA
    QRS-106 Annex 1 MIR
    QRS-106 Annex 2 LOG Card
    QRS.107.F01 Concession
    QRS.107.F02 Deviation Permit
    QRS.110.F01 DO-PO Form
    QRS.110.F02 IPO-PO Form
    QRS.110.F03 SADD Form

  • Do the company has received, accepted and applied all customer requirements (QRS-01) ?

  • Add media

  • How the company has distributed the information (requirements) through the organization ?

  • Add media

Finding Summary

MA - Major Non Conformity

MI - Minor Non Conformity

OSS - Observation (Improvement Opportunities)

N/A - Not Applicable

Improvement Opportunities for PDM

Final Summary

Final Summary:

Topics Analyzed:

General Comments about the Organization:

Strenghts:

Weakness:

Closing Meeting

  • Closing meeting notes:

  • Audit Closure Date

  • Client Management Representative

  • Lead Auditor - QCM

  • Supervisor Auditor - QAM

  • External Auditor

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