AS9100 Rev C - ISO9001:2008 Quality Management Systems (QMS)

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Review corrective actions for previous IA findings
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Review corrective actions for any customer complaints
Review corrective actions for any customer audit findings

1. QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS

1. QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS

1.1 SCOPE

General This standard includes ISO 9001:20081 quality management system requirements and specifies additional aviation, space and defense industry requirements, definitions and notes as shown in bold, italic text. It is emphasized that the requirements specified in this standard are complementary (not alternative) to contractual and applicable statutory and regulatory requirements. Should there be a conflict between the requirements of this standard and applicable statutory or regulatory requirements, the latter shall take precedence.
This International Standard specifies requirements for a quality management system where an organization
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
NOTE 1 In this International Standard, the term “product” only applies to
a) product intended for, or required by, a customer,
b) any intended output resulting from the product realization processes.
NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.

1.2 Application

All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.
Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.
This standard is intended for use by organizations that design, develop and/or produce aviation, space and defense products; and by organizations providing post-delivery support, including the provision of maintenance, spare parts or materials for their own products.
Organizations whose primary business is providing maintenance, repair and overhaul services for aviation commercial and military products; and original equipment manufacturers with maintenance, repair and overhaul operations that operate autonomously, or that are substantially different from their manufacturing/production operations; should use the IAQG-developed 9110 standard (see Bibliography).
Organizations that procure parts, materials and assemblies and resell these products to a customer in the aviation, space and defense industries, including organizations that procure products and split them into smaller quantities for resale, should use the IAQG-developed 9120 standard (see Bibliography).

2. NORMATIVE REFERENCES

The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 9000:2005, Quality management systems — Fundamentals and vocabulary

3. TERMS AND DEFINITIONS

For the purposes of this document, the terms and definitions given in ISO 9000 apply. Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”.

3.1 Risk

An undesirable situation or circumstance that has both a likelihood of occurring and a potentially negative consequence.

3.2 Special Requirements

Those requirements identified by the customer, or determined by the organization, which have high risks to being achieved, thus requiring their inclusion in the risk management process. Factors used in the determination of special requirements include product or process complexity, past experience and product or process maturity. Examples of special requirements include performance requirements imposed by the customer that are at the limit of the industry’s capability, or requirements determined by the organization to be at the limit of its technical or process capabilities.

3.3 Critical Items

Those items (e.g., functions, parts, software, characteristics, processes) having significant effect on the product realization and use of the product; including safety, performance, form, fit, function, producibility, service life, etc.; that require specific actions to ensure they are adequately managed. Examples of critical items include safety critical items, fracture critical items, mission critical items, key characteristics, etc.

3.4 Key Characteristic

An attribute or feature whose variation has a significant effect on product fit, form, function, performance, service life or producibility, that requires specific actions for the purpose of controlling variation.
NOTE Special requirements and critical items are new terms and, along with key characteristics, are interrelated. Special requirements are identified when determining and reviewing requirements related to the product (see 7.2.1 and 7.2.2). Special requirements can require the identification of critical items. Design output (see 7.3.3) can include identification of critical items that require specific actions to ensure they are adequately managed. Some critical items will be further classified as key characteristics because their variation needs to be controlled.

4.1 General Requirements

Has the organization established, documented, implemented and maintained a quality management system?
AS9100C - Does the organization’s quality management system address customer and applicable statutory & regulatory quality management system requirements?
Does the organization continually improve the effectiveness of its quality management system in accordance with the requirements of this International Standard?
HAS THE ORGANIZATION:
determined the processes needed for the quality management system and their application throughout the organization (see 1.2)?
determined the sequence and interaction of these processes?
determined criteria and methods needed to ensure that both the operation and control of these processes are effective?
ensured the availability of resources and information necessary to support the operation and monitoring of these processes?
monitored, measured where applicable, and analysed these processes?
implemented actions necessary to achieve planned results and continual improvement of these processes?
Are these processes managed by the organization in accordance with the requirements of this International Standard?
Where the organization chooses to outsource any process that affects product conformity to requirements, has the organization ensured control over such processes?
Is the type and extent of control of such outsourced processes defined within the quality management system?
NOTE 1 Processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization, measurement, analysis & 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
a) the potential impact of the outsourced process on the organization’s capability to provide product that conforms to requirements,
b) the degree to which the control for the process is shared,
c) the capability of achieving the necessary control through the application of 7.4.

4.2.1 Documentation Requirements - General

Has the organization documented their quality management system?
Does the documentation include documented statements of a quality policy and quality objectives?
a quality manual?
documented procedures and records required by this International Standard?
Control of documents?
Control of quality records?
Internal audits?
Control of non-conformity?
Corrective action?
Preventive action?
Documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes?
AS9100C - Has the organization ensured that personnel have access to, and are aware of, relevant quality management system documentation & changes?
NOTE 1 Where the term “documented procedure“ appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. A single document may address the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document.
NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to:
a) Size of organization and type of activities,
b) The complexity of the processes & their interactions, and
c) The competence of personnel.
NOTE 3 The documentation can be in any form or type medium.

4.2.2 Quality Manual

Has the quality manual been established?
Is the quality manual maintained?
The scope of the quality management system including details of and justification for any exclusions (see 1.2)?
the documented procedures established for the quality management system, or reference to them?
a description of the interaction between the processes of the quality management system?

4.2.3 Control of Documents

Are all documents required by the quality management system controlled?
Are records controlled according to the requirements given in 4.2.4?
Are records considered to be a special type of document?
Has a documented procedure been established to define the controls needed to approve documents for adequacy prior to issue?
to review and update as necessary and re-approve documents?
to ensure that changes and the current revision status of documents are identified?
to ensure that relevant versions of applicable documents are available at points of use?
to ensure that documents remain legible and readily identifiable?
to ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled?
to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose?

4.2.4 Control of Records

Have records been established to provide evidence of conformity to requirements and of the effective operation of the quality management system?
Has a documented procedure been established to define the controls needed for the identification of records?
Are they controlled?
Storage of records?
Protection of records?
Retrieval of records?
retention time of records?
disposition of records?
Are records legible?
Are records readily identifiable? a) What methods are used?
Are records readily retrievable? a) What methods are used?
AS9100C - Does the organization have a documented procedure to defines the method for controlling records created by and/or retained by suppliers?

5.1 Management Commitment

Is there evidence of commitment by top management toward the development, implementation and improvement of the quality management system and continually improving its effectiveness by:
a) communicating to the organization the importance of meeting customer’s, statutory and regulatory requirements?
b) establishing the quality policy?
c) ensuring that quality objectives are established?
d) conducting management reviews, and
e) ensuring the availability of resources?

5.2 Customer Focus

Does top management ensure that customer requirements are determined?
Does top management ensure that customer requirements are met?
Is this with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1)?
AS9100C - How does 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?

5.3 Quality Policy

How has top management ensured that the quality policy:
a) is appropriate to the purpose of the organization?
b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system?
c) provide a framework for establishing and reviewing quality objectives?
d) is communicated & understood within the organization? and
e) is reviewed for continuing stability?

5.4 Planning

5.4.1 Quality Objectives

How has top management ensured that quality objectives, including those needed to meet requirements for product (see 7.1a), are established at relevant functions & levels within the organization? Quality objectives shall be measurable and consistent with the quality policy.
Are the quality objectives measurable?
Are the quality objectives consistent with the quality policy?

5.4.2 Quality Management System Planning

Does top management ensure that:
a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives?
b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented?

5.5.1 Responsibility and Authority

Does top management ensure that responsibilities and authorities are defined and communicated within the organization?

5.5.2 Management Representative

Has top management appointed a member of its management:
who, irrespective of other responsibilities, has responsibility and authority that includes ensuring that processes needed for the quality management system are established, implemented and maintained?
reporting to top management on the performance of the quality management system and any need for improvement?
ensuring the promotion of awareness of customer requirements throughout the organization?
Has top management appointed a member of the organization’s management who, irrespective of other responsibilities, shall have responsibility & authority that includes:
a) ensuring that processes needed for the quality management system are established, implemented and maintained?
b) reporting to top management on the performance of the quality management system, & any need for improvement?
c) ensuring the promotion of awareness of customer requirements throughout the organization, and
AS9100C - d) 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.

5.5.3 Internal Communication

How does top management ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness if the quality management system?

5.6.1 Management Review - General

Does the top management review the organization’s quality management system, at planned intervals, to ensure its continuing stability, adequacy and effectiveness?
Does this reviews include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy & objectives?
Are records from management reviews maintained? (see 4.2.4)

5.6.2 Review Input

Does management review inputs including:
Results of audits?
Customer feedback?
Process performance and product conformity?
Status of preventive and corrective actions?
Follow-up actions from previous management reviews?
Changes which could effect the quality management system? and
Recommendations for improvement?

5.6.3 Review Output

Does the output from management reviews include decisions & actions related to:
a) Improvements to the quality management system and its processes?
b) Improvements to product related to customer requirements?
c) Resource needs?

6.1 Provision of Resources

Has the organization determined and provided the resources needed:
a) to implement and maintain the quality management system & continually improve its effectiveness? and
b) to enhance customer satisfaction by meeting customer requirements?

6.2.1 Human Resources - General

How does the organization determine personnel performing work affecting conformity to product requirements are competent on the basis of 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, Awareness & Training

How has the organization:
a) determined the necessary competency for personnel performing work affecting conformity to product requirements?
b) where applicable, provided training or taken other actions to achieve the necessary competence?
c) evaluated the effectiveness of the action(s) taken?
d) ensured that its personnel are aware of the relevance & importance of their activities & how they contribute to the achievement of the quality objectives? And
e) maintained appropriate records of education, training, skills & experience (see 4.2.4)

6.3 Infrastructure

How does the organization determine, provided and maintain the infrastructure needed to achieve conformity to product requirements? Infrastructure includes, as applicable:
a) Buildings, workspace and associated utilities,
b) Process equipment (both hardware and software), and
c) Supporting services (such as transportation, communication or information systems).

6.4 Work Environment

Has the organization determined and managed 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 & other factors (such as noise, temperature, humidity, lighting or weather).

7. Product Realization

7.1 Planning of Product Realization

Has the organization planned & developed the processes needed for realization of product?
In planning product realization, has the organization determined the following, as appropriate:
a) Quality objectives and requirements for the product?
b) The need to establish processes and documents and provide resources specific to the product?
c) required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance;
d) records are needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4);
AS9100C - e) configuration management appropriate to the product;
AS9100C - f) resources to support the use and maintenance of the product. Is the output of this planning in a form suitable for the organization’s method of operation?
AS9100C - Note: Quality objectives and requirements for the product include consideration of aspects such as:
a) product & personal safety,
b) reliability, availability & maintainability,
c) Producibility & inspectability,
d) Suitability of parts & materials used in the product,
e) Selection & development of embedded software, and
f) Recycling or final disposal of the product at the end of its life.
NOTE 1: A document specifying the processes of the quality management system (including the product realization processes) and 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.

7.1.1 Project Management

AS9100C - As appropriate to the organization and the product, does the organization plan and manage product realization in a structured and controlled manner to meet requirements at acceptable risk, within resource and schedule constraints?

7.1.2 Risk Management

AS9100C - Has the organization established implemented and maintained a process for managing risk to the achievement of applicable requirements, that includes as appropriate to the organization and the product:
AS9100C - a) assignment of responsibilities for risk management
AS9100C - b) definition of risk criteria (e.g., likelihood, consequences, risk acceptance)
AS9100C - c) identification, assessment and communication of risks throughout product realization
AS9100C - d) identification, implementation and management actions to mitigate risks that exceed the defined risk acceptance criteria, and
AS9100C - e) acceptance of risk remaining after implementation of mitigating action

7.1.3 Configuration Management

AS9100 C - Has the organization established, implemented & maintained a configuration management process that includes, as appropriate to the product:
AS9100C - a) configuration management planning
AS9100C - b) configuration identification
AS9100C - c) change control
AS9100C - d) configuration status accounting, and
AS9100C - e) configuration audit.

7.1.4 Control of Work Transfers

AS9100C - Has the organization established, implemented and maintained 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 work to requirements?

7.2.1 Determination of Requirements Related to the Product

How does the organization to determine:
a) requirements specified by the customer, including requirements for delivery and post-delivery activities?
b) Product requirements not specified by the customer but necessary for intended or specified use, where known?
c) Regulatory and statutory requirements related to the product, and?
d) any additional requirements considered necessary by the organization?
AS9100C - Note: Requirements related to the product can include special requirements.
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.

7.2.2 Review of Requirements Related to the Product

Does the organization review the requirements related to the product?
Is this review conducted prior the organization’s commitment to supply a product to the customer (e.g., submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and to ensure that:
a) product requirements are defined?
b) contracts or orders requirements differing from those previously expressed are resolved?
c) the organization has the ability to meet the defined requirements?
AS9100C - d) Special requirements of the product are determined? And
AS9100C - e) risk (e.g., new technology, short delivery time frame) have been identified (see 7.1.2)
Are records of the results of the review and actions arising from the review maintained?
Where the customer provides no documented statement of requirements, are the customer requirements confirmed by the organization before acceptance?
Where product requirements are changed, does the organization ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements?
NOTE: In some situations, such as internal sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material.

7.2.3 Customer Communication

Has the organization determined & implemented effective arrangements for communicating with customers in relation to:
a) Product information?
b) Enquiries, contracts or order handling, including amendments? and
c) Customer feedback, including customer complaints?

7.3.1 Design and Development Planning

Does the organization plan and control design develop-ment of the product?
During design & development planning, has the organization determined:
a) the design and development stages?
b) the review, verification and validation that are appropriate to each design and development stage? and
c) the responsibilities and authorities for design and development?
AS9100C - Where appropriate, how does the 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?
AS9100C - Does the organization ensure 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.
AS9100C - Does the organization design and development planning consider the ability to produce, inspect, test and maintain the product?
How does the organization manage interfaces between different groups involved in design and development to ensure effective communication & clear assignment of responsibility?
How is the planning output updated, as appropriate, as the design and/or 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.

7.3.2 Design & Development Inputs

Are inputs related to product requirements determined and records maintained (see 4.2.4). Do these inputs including:
a) functional and performance requirement?
b) applicable statutory and regulatory requirements?
c) where applicable, information derived from previous similar designs? and
d) other requirements essential for design and development?
Are those inputs reviewed for adequacy, and requirements complete, unambiguous and not in conflict with each other?

7.3.3 Design & Development Outputs

Are the outputs in a form suitable for verification against the design & development input and have approval prior to release?
Do the design & development outputs:
a) meet the input requirements for design & development?
b) provide appropriate information for purchasing, production and service provisions?
c) contain or reference product acceptance criteria?
d) specify the characteristics of the product essential for its safe and proper use? and
AS9100C - e) specify, as applicable, any critical items, including any key characteristics, and specific actions to be taken for these items?
AS9100C - Has the organization defined the data required to allow the product to be identified, manufactured, inspected, used & maintained: including for example:
AS9100C - a) The drawings, parts list and specifications necessary to define the configuration and
AS9100C - b) The material, process, manufacturing and assembly data needed to ensure conformity of the product?
Note: Information for production and service provision can include details for the preservation of product

7.3.4 Design & Development Review

At suitable stages, does the organization provide for systematic reviews of design and development to be performed iaw planned arrangements (see 7.3.1):
a) to evaluate the ability of result of design & develop-ment to meet requirements?
b) to identify any problems and propose necessary actions? and
AS9100C - c) to authorize progression to the next stage/phase?
Do the participants in such reviews include representatives of functions concerned with the design and development stages being reviewed? Are records of the results of the reviews and any necessary actions maintained? (see 4.2.4)

7.3.5 Design & Development Verification

Are verifications performed iaw planned arrangements (see 7.3.1) to ensure that the design & development outputs have met the design & development input requirements?
Are records of the results of verification and any necessary actions maintained? (4.2.4)

7.3.6 Design & Development Validation

Is design and development validation performed iaw planned arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known?
Where it is practical, is design/development validation completed prior to delivery or implementation of the product?
Are records of the results of validation and any necessary actions maintained? (4.2.4)

7.3.6.1 AS9100C - Design & Development Verification & Validation Testing.

AS9100C - Where tests are necessary for verification and validation, are these tests planned, controlled, reviewed and documented to ensure and prove the following:
AS9100C - 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,
AS9100C - b) test procedures describe the method of operation, the performance of the test and the recording of the results,
AS9100C - c) the correct configuration of the product is submitted for the test,
AS9100C - d) the requirements of the test plan and the test procedures are observed, and
AS9100C - e) the acceptance criteria are met.

7.3.6.2 AS9100C - Design & Development Verification & Validation Documentation.

AS9100C - At the completion of design and/or development, does the organization ensure that reports. calculations, test results, etc. demonstrate that the product definition meets the specification requirements for all identified oper-ational conditions?

7.3.7 Design & Development Changes

Are design and development changes identified and records maintained?
Are all design and develop-ment changes reviewed, verified & validated, as appropriate, and approved before implementation?
Do the reviews of design & development changes include evaluation of the effect of changes on constituent parts and product already delivered?
Are there records of the results of the reviews of changes and any necessary actions taken maintained? (see 4.2.4)
AS9100C - Are design & development changes controlled in accordance with the configuration management process? (see 7.1.3)

7.4.1 Purchasing Process

How does the organization ensure that purchased product conforms to specified purchase requirements?
Is the type & extent of control applied to the supplier and the purchased product dependant upon the effect of the purchased product on subsequent product realization or the final product?
AS9100C - Is the organization responsible for the conformity of all products purchased from suppliers, including product from sources defined by the customer?
Does the organization evaluate and select suppliers based on their ability to supply product iaw the organization’s requirements?
Is the criterion for selection, evaluation, & re-evaluation (of suppliers) established?
Are the records of the results of evaluations & any necessary actions arising from the evaluation maintained?
AS9100C - Note: One factor that can be used during supplier selection & 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 supplier control process and the organization remains responsible for verifying that purchased product meets specified purchase requirements.
AS9100C - Does the organization:
AS9100C - a) 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),
AS9100C - b) periodically review supplier performance; are results of these reviews used as a basis for establishing the level of controls to be implemented,
AS9100C - c) define the necessary actions to take when dealing with suppliers that do not meet requirements,
AS9100C - d) ensure when required that both the organization and all suppliers use customer-approved special process sources,
AS9100C - e) 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, and
AS9100C - f) determine and manage the risk when selecting and using suppliers? (see 7.1.2)

7.4.2 Purchasing Information

Does purchasing information describe the product to be purchased, including where appropriate:
a) requirements for approval of: products? procedures? processes? and equipment?
b) requirements for qualification of personnel?
c) quality management system requirements?
AS9100C - d) the identification and revision status of specification, drawings, process requirements, inspection/verification instructions and other relevant technical data,
AS9100C - e) requirements for design, test, inspection, verification (including production process verification), use of statistical techniques for product acceptance, and related instructions for acceptance by the organi-zation, and as applicable critical items including key characteristics
AS9100C - f) requirements for test specimens (e.g., production methods, number, storage conditions) for design approval, inspection/ verification, investigation or auditing,
AS9100C - g) requirements regarding the need for the supplier to: notify the organization of nonconforming product, obtain organization approval for noncom-forming product disposition, notify the organization of changes in product and/ or process, changes of suppliers, changes in manufacturing facility location and, where required, obtain organization approval, and flow down to the supply chain the applicable requirements including customer requirements,
AS9100C - h) records retention requirements, and
AS9100C - i) 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.
Does the organization ensure the adequacy of specified purchase requirements prior to their communication to the supplier?

7.4.3 Verification of Purchased Product

Has the organization established and implemented the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements?
AS9100C - NOTE 1 Customer verifyication 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 responsebility to provide acceptable product and comply with all requirements.
AS9100C - NOTE 2 Verification activities can 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
AS9100C - Where purchased product is released for production use pending completion of all required verification activities, are they identified and recorded to allow recall and replacement if it is subsequently found that the product does not meet requirements?
AS9100C - When the organization delegates verification activities to the supplier, are the requirements for delegation defined and a register of delegation maintained?
Where the organization or its customer intends to perform verification at the suppliers’ premises, does the organization state the intended verification arrangements & method of product release in the purchasing information?

7.5.1 Control of Production & Service Provision

How does the organization plan & carry out production & service provision under controlled conditions?
Does (the organization’s) controlled conditions include as applicable:
a) The availability of informa-tion that describes the characteristics of the product? > Note: This information can include drawings, parts lists, materials & process specifications
b) the availability of work instructions, as necessary? > AS9100C Note: Work instructions can include process flow charts, production documents (e.g., manufacturing plans, travelers, routers, work orders, process cards) and inspecttion documents.
c) use of suitable equipment? > AS9100C Note: Suitable equipment an include product specific tools (e.g., jigs, fixtures, and molds) and software programs.
d) the availability and use of monitoring and measuring equipment?
e) the implementation of monitoring & measurement?
f) The implementation of product release, delivery and post-delivery activities?
AS9100C - g) accountability for all product during production (e.g., parts quantities, split orders, nonconforming product),
AS9100C - h) evidence that all production and inspection /verification operations have been completed as planned, or as otherwise documented and authorized,
AS9100C - i) provision for the prevention, detection and removal of foreign objects,
AS9100C - j) monitoring and control of utilities and supplies (e.i., water, compressed air, electricity, chemical products) to the extent they effect conformity to product requirements, and
AS9100C - k) criteria for workmanship, specified in the clearest practical way (e.g., written standards, representative samples, illustrations).
AS9100C - Planning shall consider, as appropriate:
AS9100C - establishing, implementing and maintaining appropriate processes to manage critical items, including process controls where key characteristics have been identified,
AS9100C - designing, manufacturing and using tooling to measure variable data,
AS9100C - Identifying in-process inspection/verification points when adequate verification of conform-ance cannot be performed at later stages of realization, and
AS9100C - Special processes (see 7.5.2).

7.5.1.1 AS9100C - Production Process Verification

AS9100C - Does 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?
AS9100C - Is this process repeated when changes occur that invalid-date the original results (e.g., engineering changes, manufacturing process changes, tooling changes). > Note: This activity is often referred to as first article inspection.

7.5.1.2 AS9100C - Control of Production Process Changes

AS9100C - Are personnel authorized to approve changes to production processes identified?
AS9100C - Does the organization control & document changes affecting processes, production equipment, tools or software programs?
AS9100C - Are the results of changes to production processes assessed to confirm that the desired effect has been achieved without adverse effects to product conformity?

7.5.1.3 AS9100C - Control of Production Equipment, Tools, & Software Programs

AS9100C - How does the organization validate production equipment, tools & software programs used to automate & control/ monitor product realization processes, prior to release for production and how is this maintained?
AS9100C - How has the organization defined storage requirements, including periodic preservation / condition checks, for production equipment or tooling in storage?

7.5.1.4 AS9100C - Post Delivery Support

AS9100C - Is post delivery support provided as applicable for:
AS9100C - a) collection & analysis of in-service data?
AS9100C - b) actions to be taken, including investigations & reporting when problems are detected after delivery?
AS9100C - c) control and updating technical documentation?
AS9100C - d) approval, control and use of repair schemes?, and
AS9100C - e) controls requirements for off-site work (e.g., organization’s work undertaken at the customer’s facilities)?

7.5.2 Validation of processes for production and service provision

Does the organization validate any processes for production & service provision where the resulting output cannot be verified by subsequent monitoring or measurement &, as a consequence, any deficiencies made apparent only after the product is in use or the service has been delivered?
AS9100C - Note: These processes are often referred to as Special Processes.
Has the organization’s validation demonstrated the ability of these processes to achieve planned results?
Has the organization established arrangement for these processes including, as applicable:,
a) defined criteria for review & approval of the processes to achieve planned results?
b) approval of equipment and qualification of personnel?
c) use of specific methods & procedures?
d) requirements for records (see 4.2.4)?, and
e) revalidation?

7.5.3 Identification and traceability

Has the organization identified, where appropriate, the product by suitable means throughout production realization?
AS9100C - Does 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?
Does the organization identify product status with respect to its monitoring & measurement requirements throughout product realization?
AS9100C - When acceptance authority media are used (e.g., stamps, electronic signatures, passwords), has the organization established appropriate controls for the media?
Does the organization control & record the unique identification of the product, where traceability is a requirement? (see 4.2.4)
AS9100C - 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)
AS9100C - Note: For an assembly, the ability to trace its component 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.
Note: In some industry sectors, configuration management is a means by which identification and traceability are maintained. AS9100C - (see 7.1.3)

7.5.4 Customer property

How does the organization exercise care with customer property while it is under the organization’s control or being used by the organization?
Does the organization identify, verify, protect & safeguard customer property provided for use, report this to the customer & maintain records? (see 4.2.4)
Does the process/procedure ensure that any customer property that is lost, damaged or otherwise found to be unsuitable for use is reported to the customer?
Note: Customer property can also include intellectual property and personal data.

7.5.5 Preservation of product

What are the processes/ procedures established by the organization to preserve the conformity of the product during internal processing and delivery to the intended destination in order to maintain conformity to the requirements?
Do these processes/procedures include:
a) Product identification?
b) Product handling?
c) Product packaging?
d) Product storage?
e) Product protection?
Does preservation also apply to the constituent parts of a product also?
AS9100C - Does preservation of the product also include, where applicable iaw product specifications and applicable statutory & regulatory requirements, provisions for:
AS9100C - a) cleaning?
AS9100C - b) prevention, detection & removal of foreign objects?
AS9100C - c) special handling for sensitive products?
AS9100C - d) marking & labeling including safety warnings?
AS9100C - e) shelf life control & stock rotation? and
AS9100C - f) special handling for hazardous materials?

7.6 Control of monitoring and measuring equipment

Has the organization determined the monitoring & measurements to be undertaken?
The measuring, the monitoring, and measuring equipment needed to provide evidence of conformity of product to determined requirements?
AS9100C - Does the organization maintain a register of the monitoring & measuring equipment.
Define the process employed for their calibration/verification including details of equipment type, unique identification, location, frequency of checks, check method & acceptance criteria?
AS9100C - NOTE: Monitoring & measuring equipment includes, but is not limited to: test hardware, test software, automated test equipment (ATE) & plotters used to produce inspection data. It also includes personally owned & customer supplied equipment used to provide evidence of product conformity.
Does the organization have an established process to ensure that monitoring and measurement can be carried out and is carried out in a manner that is consistent with the monitoring & measurement requirements?
AS9100C - Does the organization ensure that environmental conditions are suitable for the calibration, inspection, measurement & testing being carried out?
Where necessary to ensure valid results, is the measuring equipment:
a) calibrated or verified, or both, at specific intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded? (see 4.2.4)
b) adjusted or re-adjusted as necessary?
c) identified in order to determine its calibration status?
d) safeguarded from adjustments that would invalidate the measurement results?
e) protected from damage & deterioration during handling, maintenance & storage?
AS9100C - Has the organization established, implemented & maintained a process for the recall of monitoring & measuring equipment requiring calibration or verification?
Has the organization:
a) Assessed & recorded the validity of previous measuring results when the equipment is found not to conform to requirements?
b) Taken appropriate action on the equipment & any product affected?
Are records of the results of calibrations & validations maintained? (4.2.4)
When used in the monitoring & measurement of specified requirement, does the organization have the ability of computer software to satisfy the intended application, & how is this confirmed? > This shall be undertaken prior to initial use & reconfirmed as necessary.
Note: Confirmation of the ability of computer software to satisfy the intended application would typically include its verification & configuration management to maintain its suitability for use.

8.1 Measurement, analysis and improvement - General

Has the organization planned & implemented 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?
Does this include determine-ation of applicable methods, including statistical techniques, & the extent of their use?
AS9100C - Note: According to the nature of the product & depending on the specified requirements, statistical techniques can be used to support:
a) design verification (e.g., reliability, maintainability, safety),
Process control:,
a) Selection & inspection of key characteristics,
b) Process capability measurements,
c) Statistical process control,
d) Design of experiment, > Inspection, and > Failure mode, effect & criticality analysis.

8.2.1 Customer satisfaction

As one of the measurements of the performance of the quality management system, does the organization monitor information relating to customer perception as to whether the organization has met customer requirements? Are organizational methods to obtain & using this information determined?
AS9100C - Does the information to be monitored & used for the evaluation of customer satisfaction include, but is not limited to, product conformity, on-time delivery performance, customer complaints and corrective action requests?
AS9100C - Has the organization developed & implemented plans for customer satisfaction improvement that address deficiencies identified by these evaluations, & assessed the effectiveness of the results?
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 & dealer reports.

8.2.2 Internal Audit

Does the organization conduct internal audits at planned intervals to determine whether the quality management system:
a) conforms to the planned arrangements (se 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization? and
b) is effectively implemented & maintained
AS9100C - Do planned arrangements include customer contractual requirements?
Is the audit program planned, taking into consideration the status & importance of the processes & areas to be audited, as well as the results of previous audits?
Is the audit criteria, scope, frequency & methods defined?
Does the selection of auditors and conduct of audits ensure objectivity and impartiality of the audit process?
Does the audit plan ensure auditors do not audit their own work?
Is the organization’s documented procedure established to define: (see 4.2.4)
a) responsibilities & requirements for planning and conducting audits?
b) responsibilities & requirements for establishing records & reporting the results of the audits?
c) responsibilities & requirements to maintaining records?
Does the management responsible for the area being audited ensure that any necessary corrections & corrective actions are taken without undue delay to eliminate detected non-conformities & their causes?
Do follow-up activities include the verification of the actions taken, and the reporting of verification results. (see 8.5.2)

8.2.3 Monitoring and measurement of processes

Has the organization applied suitable methods for monitoring and, where applicable, measuring the quality management system processes?
Do these methods demonstrate the ability of the process to achieve planned results?
When planned results are not achieved, are corrections and corrective actions taken, as appropriate?
Note: When determining suitable methods, has the organization considered the type & extent of monitoring or measurement appropriate to each of its processes in relation to their impact on the conformity to product requirements & on the effectiveness of the quality management system?
AS9100C - In the event of process nonconformity, has the organization: (see 8.3)
a) taken appropriate action to correct the nonconforming process?
b) evaluated whether the process nonconformity has resulted in product nonconformity,
c) determined if the process nonconformity is limited to a specific case or whether is could have affected other processes or product, and
d) identified and controlled any nonconforming product?

8.2.4 Monitoring and measurement of product

Does the organization monitor & measure product characteristics to verify that product requirements have been met?
Has the organization established appropriate stages in the product realization process iaw the planned arrangements (see 7.1)?
Does the organization maintain evidence of conformity with the acceptance criteria?
AS9100C - Does the organization document measurement requirements for product acceptance which include:
a) criteria for acceptance and/or rejection?
b) where in the sequence measurement & testing operations are to be performed?
c) required records of the measurements results (at a minimum, indication of acceptance or rejection), and
AS9100C - d) any specific measurement instruments required & any specific instructions associated with their use?
AS9100C - When critical items, including key characteristics have been identified, does the organization ensure they are controlled & monitored iaw the established processes?
AS9100C - When the organization uses sampling inspection as means of product acceptance, is the sampling plan justified on the basis of recognized statistical principles & appropriate for use (i.e., matching the sampling plan to the criticality of the product & to the process capability?
AS9100C - Where product is released for production use pending completion of all required measurement & monitoring activities, is the product identified & recorded to allow recall & replacement if it is subsequently found that the product does not meet requirements?
Do the records indicate the person(s) authorizing release of the product for delivery to the customer? (see 4.2.4)
AS9100C - Where required to demonstrate product qualification, has the organization ensured that records provide evidence that the products meets the defined requirements?
Does the organization hold up product release and service delivery until planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer.)?
AS9100C - Does the organization ensure that all documents required to accompany the product are present at delivery?

8.3 Control of nonconforming product

Does the organization ensures that product which does not conform to product requirements is identified and controlled to prevented its unintended use or delivery?
Is there a documented procedure established to define the controls & related responsibilities & authorities for dealing with nonconforming product?
AS9100C - Note: The term “nonconforming product” includes nonconforming product returned by the customer.
AS9100C - Does the organization’s documented procedure define the responsibilities & authority for the review & disposition of nonconforming product, & the process for approving personnel making these decisions?
Where applicable, does the organization deal w/ noncom-forming product by one or more of the following ways?:
a) by taking action to eliminate the detected nonconformity?
b) by authorized its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer?
c) by taking action to preclude its original intended use or application?
d) by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started?
AS9100C - Does the organization’s nonconforming product control process provide for timely reporting of delivered nonconforming product?
AS9100C - Note: Parties requiring notification of nonconforming product can include suppliers, internal organizations, customers, distributors & regulatory authorities.
AS9100C - e) by taking action necessary to contain the effect of the nonconformity on other processes or products?
AS9100C - Does the organization have procedures in place to ensure that dispositions of USE AS IS or REPAIR shall only be used after approval by an authorized representative of the organization responsible for the design?
AS9100C - Note: Authorized representative includes personnel having delegated authority from the design organization. The organization shall not 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.
AS9100C - Is product dispositioned for SCRAP conspicuously & permanently marked, or positively controlled, until physically rendered unusable?
When nonconforming product is corrected is it subject to re-verification to demonstrate conformity to the requirements?
Does the organization have a process to maintain records of the nature of nonconformities & any subsequent actions taken, including concessions obtained? (see 4.2.4)

8.4 Analysis of data

Has the organization deter-mined, collected & analyzed appropriate data to demon-strate the suitability and effectiveness of the quality management system & to evaluate where continual improvement of the effective-ness of the quality manage-ment system can be made?
Does this include data generated as a result of monitoring & measurement & from other relevant sources?
Does organization’s analysis of data provide information relating to:
a) customer satisfaction? (see 8.2.1)
b) conformity to product requirements? (see 8.2.4)
c) Characteristics & trends of process & products, including opportunities for preventive action? (see 8.2.3 & 8.2.4), and
d) suppliers (see 7.4)
Does the organization continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data,?

8.5.1 Continual improvement

Does the organization use the following information to facilitate continual improvement of the Quality Management System through the use of:
a) Quality policy?
b) Quality objectives?
c) Audit results?
d) Analysis of data?
e) Corrective & preventive action?
f) Management review?
AS9100C - Does the organization monitor the implementtation of improvement activities & evaluate the effectiveness of the results?
AS9100C - Note: Continual improvement opportunities can result from lessons learned, problem resolutions & the benchmarking of best practices.

8.5.2 Corrective action

Has the organization taken action to eliminate the causes of nonconformities in order to prevent recurrence?
Are Corrective Actions appropriate to the effects of the nonconformities encountered?
Is a documented procedure established to defined requirements for:
a) Reviewing nonconformities (including customer complaints)?
b) Determining the cause of nonconformities?
c) Evaluating the need for actions to ensure that nonconformities do not recur?
d) Determining & implementing the corrective action needed?
e) Records of the results of action taken? (see 4.2.4)
f) Reviewing the effectiveness of corrective action taken?
AS9100C - g) flowing down corrective action requirements to a supplier when it is determined that the supplier is responsible for the, nonconformity,
AS9100C - h) specific action where timely and/or effective corrective actions are not achieved, and
AS9100C - i) determining if additional nonconforming product exists based on the causes of the nonconformities & taking further action when required.

8.5.3 Preventive action

Has the organization determined actions appropriate to eliminate the causes of potential nonconformities in order to prevent their occurrence?
Are preventive action shall be appropriate to the effects of the potential problems?
Has the organization estab-lished a documented procedure to define requirements for:
a) determining potential non-conformities & their causes?
b) evaluating the need for actions to prevent occurrence of non-conformities?
c) determining and implementing action needed?
d) recording the results of actions taken? (see 4.2.4), and
e) Reviewing the effectiveness of the preventive action taken?
AS9100C - Note: Examples of preventive action opportunities include risk management, error proofing, failure mode and effect analysis (FMEA), & information on product problems reported by external sources.

AS9100 Rev C - ISO9001:2008 Quality Management Systems (QMS)

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Audit Preparation

1. QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS

1.1 SCOPE

1.2 Application

2. NORMATIVE REFERENCES

3. TERMS AND DEFINITIONS

3.1 Risk

3.2 Special Requirements

3.3 Critical Items

3.4 Key Characteristic

4.1 General Requirements

4.2.1 Documentation Requirements - General

4.2.2 Quality Manual

4.2.3 Control of Documents

4.2.4 Control of Records

5.1 Management Commitment

5.2 Customer Focus

5.3 Quality Policy

5.4 Planning

5.4.1 Quality Objectives

5.4.2 Quality Management System Planning

5.5.1 Responsibility and Authority

5.5.2 Management Representative

5.5.3 Internal Communication

5.6.1 Management Review - General

5.6.2 Review Input

5.6.3 Review Output

6.1 Provision of Resources

6.2.1 Human Resources - General

6.2.2 Competence, Awareness & Training

6.3 Infrastructure

6.4 Work Environment

7. Product Realization

7.1 Planning of Product Realization

7.1.1 Project Management

7.1.2 Risk Management

7.1.3 Configuration Management

7.1.4 Control of Work Transfers

7.2.1 Determination of Requirements Related to the Product

7.2.2 Review of Requirements Related to the Product

7.2.3 Customer Communication

7.3.1 Design and Development Planning

7.3.2 Design & Development Inputs

7.3.3 Design & Development Outputs

7.3.4 Design & Development Review

7.3.5 Design & Development Verification

7.3.6 Design & Development Validation

7.3.6.1 AS9100C - Design & Development Verification & Validation Testing.

7.3.6.2 AS9100C - Design & Development Verification & Validation Documentation.

7.3.7 Design & Development Changes

7.4.1 Purchasing Process

7.4.2 Purchasing Information

7.4.3 Verification of Purchased Product

7.5.1 Control of Production & Service Provision

7.5.1.1 AS9100C - Production Process Verification

7.5.1.2 AS9100C - Control of Production Process Changes

7.5.1.3 AS9100C - Control of Production Equipment, Tools, & Software Programs

7.5.1.4 AS9100C - Post Delivery Support

7.5.2 Validation of processes for production and service provision

7.5.3 Identification and traceability

7.5.4 Customer property

7.5.5 Preservation of product

7.6 Control of monitoring and measuring equipment

8.1 Measurement, analysis and improvement - General

8.2.1 Customer satisfaction

8.2.2 Internal Audit

8.2.3 Monitoring and measurement of processes

8.2.4 Monitoring and measurement of product

8.3 Control of nonconforming product

8.4 Analysis of data

8.5.1 Continual improvement

8.5.2 Corrective action

8.5.3 Preventive action

>>>> END OF CHECKLIST <<<<

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