AS9100 Rev C - Gap Analysis

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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?
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?
AS9100C - Has the organization ensured that personnel have access to, and are aware of, relevant quality management system documentation & changes?

4.2.2 Quality Manual

Has the quality manual been established and does it meet AS9100 requirements?

4.2.3 Control of Documents

Are all documents required by the quality management system controlled?
Has a documented procedure been established to define the controls needed to approve documents for adequacy prior to issue?

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?
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?

5.2 Customer Focus

Does top management ensure that customer requirements are determined?
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 and does it satisfy AS9100 requirements?
Has it been communicated & understood within the organization?
Is it reviewed for continuing stability?

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?

5.5.1 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?
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?
Do the reviews satisfy AS9100 section 5.6 requirements including quality policy & objectives?
Are records from management reviews maintained? (see 4.2.4)

6.1 Provision of Resources

Has the organization determined and provided the resources needed to implement and maintain the QMS?

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:

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).

7.1 Planning of Product Realization

Has the organization planned & developed the processes needed for realization of product?
a) Quality objectives and requirements for the product?
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:
Does the organisation review requirements specified by the customer, including requirements for delivery and post-delivery activities?
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?
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 development of the product?
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:
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?
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?
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 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?
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 those stated in AS9100?
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?
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.

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

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?
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.
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.
AS9100C - Does the organization ensure that environmental conditions are suitable for the calibration, inspection, measurement & testing being carried out?
AS9100C - Has the organization established, implemented & maintained a process for the recall of monitoring & measuring equipment requiring calibration or verification?
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:
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:
AS9100C - Do planned arrangements include customer contractual requirements?
Is the audit criteria, scope, frequency & methods defined in a procedure?
Does the selection of auditors and conduct of audits ensure objectivity and impartiality of the audit process?
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?
AS9100C - In the event of process nonconformity, has the organization: (see 8.3)

8.2.4 Monitoring and measurement of product

Does the organization monitor & measure product characteristics to verify that product requirements have been met?
Does the organization maintain evidence of conformity with the acceptance criteria?
AS9100C - Does the organization document measurement requirements for product acceptance which include:
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?
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?

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 audits, analysis of data, management reviews etc.?
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?
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 established a documented procedure?
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 - Gap Analysis

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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

5.4.1 Quality Objectives

5.5.1 Responsibility and Authority

5.5.2 Management Representative

5.5.3 Internal Communication

5.6.1 Management Review - General

6.1 Provision of Resources

6.2.1 Human Resources - General

6.2.2 Competence, Awareness & Training

6.3 Infrastructure

6.4 Work Environment

7.1 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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