DCMA ISO 9001:2000 / SAE AS9100 Rev. B

DCMA ISO 9001:2000 / SAE AS9100 Rev. B

AUDIT CHECKLIST

October 7, 2004

CLAUSE 4.1 General requirements

General Clause Description

The organization shall establish, document, implement and maintain a quality management system and continually improve its

effectiveness in accordance with the requirements of this International Standard.

The organization shall

a) identify the processes needed for the quality management system and their application throughout the organization (see 1.2),

b) determine the sequence and interaction of these processes,

c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective,

d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes,

e) monitor, measure and analyse these processes, and

f) implement actions necessary to achieve planned results and continual improvement of these processes.

These processes shall be managed by the organization in accordance with the requirements of this International Standard.

Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system.

NOTE: Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement.

Clause # / DESCRIPTION / ORGANIZATION PROCEDURE # / REV. & DATE / ADEQUACY
YES / NO / COMPLIANT
YES / NO / REMARKS/COMMENTS
4.1 / General Requirement
Has the organization established, documented, implemented, maintained and continually improved a Quality Management System in accordance with the ISO 9001: 2000 standard?
Does the organization:
a) Identified the processes needed for the Quality Management System?
b) Determined the sequence and interaction of these processes?
c) Determined criteria and methods required to ensure effective operation and control of the identified processes;
d) Ensure availability of resources and information required to support the operation and monitoring of processes;
e) measure, monitor and analyze the processes and implement action to achieve planned results and continual improvement.

CLAUSE 4.2 Documentation requirements

Sub-clause 4.2.1 General

General Sub-clause Description:

The quality management system documentation shall include

a) documented statements of a quality policy and quality objectives,

b) a quality manual,

c) documented procedures required by this International Standard,

d) documents needed by the organization to ensure the effective planning, operation and control of its processes, and

e) records required by this International Standard (see 4.2.4).

NOTE 1 Where the term “documented procedure” appears within this International Standard, this means that the procedure is established, documented, implemented and maintained.

NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to

a)the size of organization and type of activities,

b) the complexity of processes and their interactions, and

c) the competence of personnel.

NOTE 3 The documentation can be in any form or type of medium.

Clause / DESCRIPTION / ORGANIZATION PROCEDURE # / REV. & DATE / ADEQUACY
YES / NO / COMPLIANT
YES / NO / REMARKS/COMMENTS
4.2.1 / General
Does the organization have documented statements of their quality policy?
Does the organization have documented statements of their quality objectives?
Does the organization have a quality manual?
Has the organization developed documented procedures which address each of the applicable
requirements of the standard?
What specific documents has the organization identified it uses to ensure effective planning, operation and control of their processes?
Has the organization established documented procedures for:
a) Control of documents
b) Control of quality records
c) Internal Audits
d) Corrective action
e) Preventative
AS9100 / f) Assurequality system requirements imposed by the regulatory authorities are documented

Sub-clause 4.2.2 Quality manual

General Sub-clause Description:

The organization shall establish and maintain a quality manual that includes

a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2),

b) the documented procedures established for the quality management system, or reference to them, and

c) a description of the interaction between the processes of the quality management system.

Clause / DESCRIPTION / ORGANIZATION PROCEDURE # / REV. & DATE / ADEQUACY
YES / NO / COMPLIANT
YES / NO / REMARKS/COMMENTS
4.2.2 /

Quality manual

Has the organization established and maintained a quality manual?
AS9100 / Does the quality manual :
a)reflect the scope of the organizations Quality Management System (QMS)?
b)detail any exclusions (see 1.2) to Clause 7 and express justification?
c)include documented procedures or make reference to them?
d)describe the interaction between the processes of the QMS?
Assure the documented procedures, reflect the relationship between the requirements of AS9100
and the documented procedures and is clearly shown.

Sub-clause 4.2.3 Control of documents

General Sub-clause Description:

Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.

A documented procedure shall be established to define the controls needed

a) to approve documents for adequacy prior to issue,

b) to review and update as necessary and re-approve documents,

c) to ensure that changes and the current revision status of documents are identified,

d) to ensure that relevant versions of applicable documents are available at points of use,

e) to ensure that documents remain legible and readily identifiable,

f) to ensure that documents of external origin are identified and their distribution controlled, and

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

Clause # / DESCRIPTION / ORGANIZATION PROCEDURE # / REV. & DATE / ADEQUACY
YES / NO / COMPLIANT
YES / NO / REMARKS/COMMENTS
4.2.3 / Control of documents
Has a documented procedure been established to control all documents?
Does the procedure include controls for:
a)approval of documents for adequacy prior to issue?
b) review, update, and (as necessary)
re-approval of documents?
c)ensuring changes and current revision status of documents are identified?
d)ensuring that relevant versions of applicable documents are available at points of use;
e)ensuring that documents remain legible and readily identifiable;
f) ensuring that documents of external origin are identified and their distribution controlled;
AS9100 / g)preventing the unintended use of obsolete documents, and applying suitable identification to them if they are retained
for any purpose.
Has the organization coordinated document changes with customers and/or regulatory authorities in accordance with contract or regulatory requirements?

Sub-clause 4.2.4 Control of records

General Sub-clause Description:

Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.

Clause # / DESCRIPTION / ORGANIZATION
PROCEDURE # / REV. & DATE / ADEQUACY
YES / NO / COMPLIANT
YES / NO / REMARKS/COMMENTS
4.2.4 / 4.2.4 Control of records
Has the organization identified the records required to provide evidence of conformity to requirements and the effective operation of the Quality Management System?
What methods does the organization use to ensure that records remain legible, readily identifiable and retrievable?
AS9100 / What documented procedures define the controls used for the identification, storage, protection, retrieval, retention time, and disposition of records?
Assure documented procedures define the method for controlling records that are created by and/or kept by suppliers.
Assure records are available for review by customers and regulatory authorities in accordance with contract or regulatory requirements.
Clause / DESCRIPTION / ORGANIZATION
PROCEDURE # / REV. & DATE / ADEQUACY
YES / NO / COMPLIANT
YES / NO / REMARKS/COMMENTS
4.3 / 4.3 Configuration Management
AS9100 / Configuration Management:
Verify the organization has established, and documents a configuration management process adequate to the product.
NOTE Guidance on configuration management is given in ISO 10007.

CLAUSE 5 Management responsibility

CLAUSE 5.1. Management commitment

General Clause Description

Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by

a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements,

b) establishing the quality policy,

c) ensuring that quality objectives are established,

d) conducting management reviews, and

e) ensuring the availability of resources.

Clause # / DESCRIPTION / ORGANIZATION PROCEDURE # / REV. & DATE / ADEQUACY
YES / NO / COMPLIANT
YES / NO / REMARKS/COMMENTS
5.1 / Management commitment
Is there evidence of commitment by top management towards the development, implementation and improvement of the
Quality Management System.
Does the top management communicate to the organization the importance of meeting customers, statutory and regulatory requirements?
Has the organization establishing a quality policy?
What are the quality objectives the organization has established?
Does the top management conduct Management Reviews of their Quality Management System?
Does top management provide the resources necessary to implement and to improve the effectiveness of the QMS?

CLAUSE 5.2 Customer focus

General Clause Description

Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1).

Clause # / DESCRIPTION / ORGANIZATION PROCEDURE # / REV. & DATE / ADEQUACY
YES / NO / COMPLIANT
YES / NO / REMARKS/COMMENTS
5.2 / Customer focus
What methodologies has top management developed to ensure that customer requirements have been determined?
What methodologies has top management developed to ensure customer requirements
have been met?
How do these methodologies ensure top managements' goals to enhance customer satisfaction are achieved?
What methodologies does top management employ to enhance customer satisfaction with
the product or service they provide?

CLAUSE 5.3 Quality policy

General Clause Description

Top management shall ensure 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) provides a framework for establishing and reviewing quality objectives,

d) is communicated and understood within the organization, and

e) is reviewed for continuing suitability.

Clause # / DESCRIPTION / ORGANIZATION
PROCEDURE # / REV. & DATE / ADEQUACY
YES / NO / COMPLIANT
YES / NO / REMARKS/COMMENTS
5.3 / Quality policy
a) Has top management established a quality policy?
b) Does the quality policy include a statement of a commitment to meeting requirements, and continual improvement of the quality system?
c) Does the quality policy provide a framework for establishing and reviewing quality objectives?
d) How is the quality policy communicated within the organization?
e) How does top management ensure the quality policy is understood within the organization?
f) How and when is the quality policy reviewed for continuing suitability?

CLAUSE 5.4 Planning

Sub-clause 5.4.1 Quality objectives

General Sub-clause Description:

Top management shall ensure that quality objectives, including those needed to meet requirements for product (see 7.1 a) are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.

Clause # / DESCRIPTION / ORGANIZATION PROCEDURE # / REV. & DATE / ADEQUACY
YES / NO / COMPLIANT
YES / NO / REMARKS/COMMENTS
5.4.1 / Quality objectives
Are quality objectives established by top management at relevant functions and levels within the organization?
Do the established quality objectives also include those needed to meet the requirements of the product/service?
Are these quality objectives measurable?
Are these quality objectives consistent with the quality policy of the organization?

Sub-clause 5.4.2 Quality management system planning

General Sub-clause Description:

Top management shall 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, and

b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

Clause # / DESCRIPTION / ORGANIZATION
PROCEDURE # / REV. & DATE / ADEQUACY
YES / NO / COMPLIANT
YES / NO / REMARKS/COMMENTS
5.4.2 / Quality management system planning
What policy, process, or procedure is used to ensured that when planning the quality management system (QMS), the system created reflects:
a)those requirements identified in clause 4.1?
b)the identified quality objectives?
How does top management ensure that the integrity of the QMS is maintained when changes are planned and implemented?

CLAUSE 5.5 Responsibility, authority and communication

Sub-clause 5.5.1 Responsibility and authority

General Sub-clause Description:

Top management shall ensure that responsibilities and authorities are defined and communicated within the organization.

Clause # / DESCRIPTION / ORGANIZATION PROCEDURE # / REV. & DATE / ADEQUACY
YES / NO / COMPLIANT
YES / NO / REMARKS/COMMENTS
5.5.1 / Responsibility and authority
Have responsibilities and authorities been defined and communicated to those involved in the effective operation of the Quality Management System?

Sub-clause 5.5.2 Management representative

General Sub-clause Description:

Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and 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 and any need for improvement, and

c) ensuring the promotion of awareness of customer requirements throughout the organization.

NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system.

Clause # / DESCRIPTION / ORGANIZATION PROCEDURE # / REV. & DATE / ADEQUACY
YES / NO / COMPLIANT
YES / NO / REMARKS/COMMENTS
5.5.2 / Management representative
Has a member of management been appointed
as a “Management Representative” by top management?
Does the Management Representative have responsibility and authority that includes:
a) ensuring that the processes of the Quality Management System are established implemented and maintained.
b) reporting to top management on the
performance of the Quality Management
System, including needs for improvement.
c) promoting awareness of customer requirements throughout the organization.
AS9100 / d) the organizational freedom to address matters relating to quality.

Sub-clause 5.5.3 Internal communication

General Sub-clause Description:

Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system.

Clause # /

DESCRIPTION

/ ORGANIZATION PROCEDURE # / REV. & DATE / ADEQUACY
YES / NO / COMPLIANT
YES / NO / REMARKS/COMMENTS
5.5.3 /

Internal communication

What communication process (es) / methods are used to ensure that various levels and functions are aware of the effectiveness of the Quality Management System.
What communication process (es) /methods are used to ensure that various levels and functions are communicating with each other about the effectiveness of the Quality Management System.

CLAUSE 5.6 Management review

Sub-clause 5.6.1 General

General Sub-clause Description:

Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.

Records from management reviews shall be maintained (see 4.2.4).

Clause # / DESCRIPTION / ORGANIZATION PROCEDURE # / REV. & DATE / ADEQUACY
YES / NO / COMPLIANT
YES / NO / REMARKS/COMMENTS
5.6.1 / General
Does the top management review the Quality Management System to ensure its continuing suitability, adequacy and effectiveness?
Are the review conducted at planned intervals?
Are assessing opportunities to improve the QMS discussed during the management review?
Are records from management reviews maintained?

Sub-clause 5.6.2 Review input

General Sub-clause Description:

The input to management review shall include information on

a) results of audits,

b) customer feedback,

c) process performance and product conformity,

d) status of preventive and corrective actions,

e) follow-up actions from previous management reviews,

f) changes that could affect the quality management system, and

g) recommendations for improvement.

Clause # / DESCRIPTION / ORGANIZATION PROCEDURE # / REV. & DATE / ADEQUACY
YES / NO / COMPLIANT
YES / NO / REMARKS/COMMENTS
5.6.2 /

Review input

Does management review input include:
a) results of audits?
b) customer feedback?
c) process performance and product conformance?
d) status of preventative and corrective actions?
e) follow-up actions from previous management reviews?
f) changes that could affect the quality management system?
g) recommendations for improvement?

Sub-clause 5.6.3 Review output

General Sub-clause Description:

The output from the management review shall include any decisions and actions related to

a) improvement of the effectiveness of the quality management system and its processes,

b) improvement of product related to customer requirements, and

c) resource needs.

Clause # / DESCRIPTION / ORGANIZATION
PROCEDURE # / REV. & DATE / ADEQUACY
YES / NO / COMPLIANT
YES / NO / REMARKS/COMMENTS
5.6.3 / Review output
Does the output from management review include actions related to:
a) improvements to the Quality Management System and its processes?
b) improvements to product related to customer requirements?
c) resource needs?

CLAUSE 6 Resource management

CLAUSE 6.1 Provision of resources

The organization shall determine and provide the resources needed

a) to implement and maintain the quality management system and continually improve its effectiveness, and

b) to enhance customer satisfaction by meeting customer requirements.

Clause # / DESCRIPTION / ORGANIZATION PROCEDURE # / REV. & DATE / ADEQUACY
YES / NO / COMPLIANT
YES / NO / REMARKS/COMMENTS
6.1 / Provision of resources
Has the organization implement methods to determine and provide resources needed to:
a) implement and maintain the Quality Management System?
b) continually improve the Quality Management System effectiveness?
c) enhance customer satisfaction by meeting customer requirements.

CLAUSE 6.2 Human resources