QUALITY AUDIT CHECKLIST

FOR
ISO 9001:2000
(Partial Checklist Only)












Document: QACL-9001:00
Issue: 1
Revision: 0
Date: November 23, 2001
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REVIEWED BY: APPROVED BY: November 23, 2001
DOC: QACL-9001:00 REPORT No.: DATE: AUDITOR(s):



EVALUATION CODE: AC = Acceptable IR = Improvement Required UN = Unacceptable N/A = Not Applicable

DETAILS
REV
LEVEL
REV
DATE
SEC. Para.
DESCRIPTION OF CHANGE
0 Nov. 23, 2001 All All Original Issue









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REVIEWED BY: APPROVED BY: November 23, 2001
DOC: QACL-9001:00 REPORT No.: DATE: AUDITOR(s):



EVALUATION CODE: AC = Acceptable IR = Improvement Required UN = Unacceptable N/A = Not Applicable


QUALITY MANAGEMENT SYSTEM
AUDIT QUESTION CODE OBSERVATIONS
4.1 General Requirements
4.1.1 Has the organization established, documented,
implemented, maintained a quality management system
and continually improved its effectiveness in accordance
with the requirements of the ISO 9000:2000 International
Standard?

4.1.1.1 To implement the quality management system, has the organization:
a) Identified the processes needed for the quality
management system and their application?

b) Determined the sequence and interaction of these
processes?

c) Determined the criteria and methods required to ensure
the effective operation and control of these processes?

d) Ensured the availability of information necessary to
support the operation and monitoring of these
processes?

e) Monitored, measured and analyzed these processes?
f) Implemented action necessary to achieve planned
results and continual improvement of these processes?

4.1.1.2 Does the organization manage these processes in
accordance with the requirements of the ISO 9000:2000
International Standard?

4.1.1.3 Where processes that effect product conformity and
requirements are outsourced, does the organization
ensure control over these processes?

4.1.1.4 Is control over outsourced processes identified within the
quality system?

4.2 Documentation Requirements
4.2.1 General
4.2.1.1 Does the quality management system documentation include:
a) Documented statements of a quality policy and quality
objectives?

b) A quality manual?
c) Documented procedures required by the ISO 9001:2000
International Standard?

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REVIEWED BY: APPROVED BY: November 23, 2001
DOC: QACL-9001:00 REPORT No.: DATE: AUDITOR(s):



EVALUATION CODE: AC = Acceptable IR = Improvement Required UN = Unacceptable N/A = Not Applicable

QUALITY MANAGEMENT SYSTEM
AUDIT QUESTION CODE OBSERVATIONS
d) Documents needed by the organization to ensure the
effective planning, operation and control of its
processes?

e) Records required by the ISO 9001:2000 Standard?
Note 1 Where the term documented procedure appears within this checklist, this requires the procedure to be
established, documented, implemented and maintained.
4.2.1.2 Has the extent of the quality management system documentation been dependent on the following:
a) Size and type of the organization;
b) Complexity and interaction of the processes;
c) Competence of personnel.
Note 2 Documentation may be any form or type of medium.
4.2.2 Quality Manual
4.2.2.1 Has a quality manual been established and maintained that includes the following:
a) The scope of the quality management system, including
details of, and justification for, any exclusions?

b) Documented procedures or reference to them?
c) A description of the interaction of the processes included
in the quality management system?

4.2.3 Control of Documents
4.2.3.1 Are documents required for the quality management
system controlled?

4.2.3.2 Has a documented procedure been established to define the controls needed:
a) To approve documents for adequacy prior to issue?
b) To review, 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?

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

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REVIEWED BY: APPROVED BY: November 23, 2001
DOC: QACL-9001:00 REPORT No.: DATE: AUDITOR(s):



EVALUATION CODE: AC = Acceptable IR = Improvement Required UN = Unacceptable N/A = Not Applicable

QUALITY MANAGEMENT SYSTEM
AUDIT QUESTION CODE OBSERVATIONS
4.2.4 Control of Records
4.2.4.1 Are records established and maintained to provide
evidence of conformance to requirements and of
effective operation of the quality management system?

4.2.4.2 Do records remain legible, readily identifiable and
retrievable?

4.2.4.3 Has a documented procedure been established to define
controls needed for the identification, storage, protection,
retrieval, retention time and disposition of records?


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REVIEWED BY: APPROVED BY: November 23, 2001
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EVALUATION CODE: AC = Acceptable IR = Improvement Required UN = Unacceptable N/A = Not Applicable


MANAGEMENT RESPONSIBILITY
AUDIT QUESTION CODE OBSERVATIONS
5.1 Management Commitment
5.1.1 Does top management provide evidence of its commitment to the development and implementation of the
quality management system and continual improvement of 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?
e) Ensuring the availability of resources?
5.2 Customer Focus
5.2.1 Does top management ensure that customer
requirements are determined and fulfilled with the aim of
enhancing customer satisfaction?

5.3 Quality Policy
5.3.1 Does top management ensure that the quality policy:
a) Is appropriate to the purpose of the organization?
b) Includes a commitment to comply with requirements and
to continual improvement of the quality system?

c) Provides a framework for establishing and reviewing
quality objectives?

d) Is communicated and understood within the
organization?

e) Is reviewed for continuing suitability?
5.4 Planning
5.4.1 Quality Objectives
5.4.1.1 Does top management ensure that quality objectives,
including those needed to meet product requirements,
are established at relevant functions and levels within the
organization?

5.4.1.2 Are the quality objectives measurable and consistent with
the quality policy?



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REVIEWED BY: APPROVED BY: November 23, 2001
DOC: QACL-9001:00 REPORT No.: DATE: AUDITOR(s):



EVALUATION CODE: AC = Acceptable IR = Improvement Required UN = Unacceptable N/A = Not Applicable

MANAGEMENT RESPONSIBILITY
AUDIT QUESTION CODE OBSERVATIONS
5.4.2 Quality Management System Planning
5.4.2.1 Does top management ensure that:
a) The planning of the quality management system is
carried out to meet the general requirements under
paragraph 4.1 as well as the quality objectives?

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

5.5 Responsibility, Authority and Communication
5.5.1 Responsibility and Authority
5.5.1.1 Does top management ensure that responsibilities and
authorities have been defined and communicated within
the organization?

5.5.2 Management Representative
5.5.2.1 Has top management appointed a member(s) of the management who, irrespective of other responsibilities,
has 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?

c) Ensuring the promotion of the awareness of customer
requirements throughout the organization?

NOTE The responsibility of a management representative may include liaison with external parties on matters
relating to the quality management system.
5.5.3 Internal Communication
5.5.3.1 Does top management ensure that appropriate
communication processes are established within the
organization and that communication takes place
regarding the effectiveness of the quality management
system?

5.6 Management Review
5.6.1 General
5.6.1.1 Does top management review the quality management
system, at planned intervals, to ensure its continuing
suitability, adequacy and effectiveness?

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REVIEWED BY: APPROVED BY: November 23, 2001
DOC: QACL-9001:00 REPORT No.: DATE: AUDITOR(s):



EVALUATION CODE: AC = Acceptable IR = Improvement Required UN = Unacceptable N/A = Not Applicable

MANAGEMENT RESPONSIBILITY
AUDIT QUESTION CODE OBSERVATIONS
5.6.1.2 Does the review include assessing opportunities for
improvement and the need for changes to the
organizations quality management system, including
quality policy and quality objectives?

5.6.1.3 Are records from management reviews maintained?
5.6.2 Review Input
5.6.2.1 Do inputs to management review include:
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 earlier management reviews?
f) Changes that could affect the quality management
system?

g) Recommendations for improvement?
5.6.3 Review Output
5.6.3.1 Do the outputs from the management review 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?

c) Resource needs?

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REVIEWED BY: APPROVED BY: November 23, 2001
DOC: QACL-9001:00 REPORT No.: DATE: AUDITOR(s):



EVALUATION CODE: AC = Acceptable IR = Improvement Required UN = Unacceptable N/A = Not Applicable


RESOURCE MANAGEMENT
AUDIT QUESTION CODE OBSERVATIONS
6.1 Provision of Resources
6.1.1 Has the organization determined and provided the resources needed:
a) To implement and maintain the quality management
system and continually improve its effectiveness?

b) To ensure customer satisfaction by meeting customer
requirements?

6.2 Human Resources
6.2.1 General
6.2.1.1 Are personnel who perform work effecting quality,
competent on the basis of appropriate education,
training, skills and experience?

6.2.2 Competency, Awareness and Training
6.2.2.1 Has the organization:
a) Determined the necessary competence needs for
personnel performing activities affecting product quality?

b) Provided training or taken other needs to satisfy these
needs?

c) Evaluated the effectiveness of the actions taken?
d) Ensured that its employees are aware of the relevance
and importance of their activities and how they
contribute to the achievement of the quality objectives?

e) Maintained appropriate records of education, training,
skills and experience (see 4.2.4)?

6.3 Infrastructure
6.3.1 Has the organization determined, provided and maintained the infrastructure needed to achieve the
conformity of product requirements, including as applicable:
a) Buildings, workspace and associated facilities?
b) Process equipment (both hardware and software)?
c) Supporting services (such as transport or
communication)?

6.4 Work Environment
6.4.1 Has the organization determined and managed the work
environment needed to achieve conformity of product
requirements?


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REVIEWED BY: APPROVED BY: November 23, 2001
DOC: QACL-9001:00 REPORT No.: DATE: AUDITOR(s):



EVALUATION CODE: AC = Acceptable IR = Improvement Required UN = Unacceptable N/A = Not Applicable


PRODUCT REALIZATION
AUDIT QUESTION CODE OBSERVATIONS
7.1 Planning of Product Realization
7.1.1 Has the organization planned and developed the
processes needed for product realization?

7.1.2 Is the planning of product realization consistent with the
requirements of other processes of the quality
management system?

7.1.3 In planning product realization, does the organization determine the following as appropriate:
a) Quality objectives and requirements for the product?
b) The need to establish processes and documentation,
and provide resources specific to the product?

c) Required verification, validation, monitoring, inspection
and test activities specific to the product and the criteria
for product acceptance?

d) The records needed to provide evidence that the
realization processes and resulting product meet
requirements (see 4.2.4)?

e) Is the output of this planning in a form suitable for the
organizations method of operations?

Note 1 A document that specifies the processes of the quality management system (including the product realization
processes) and the resources to be applied to a specific product, project or contract, can be referred to as a
quality plan.
Note 2 The organization may also apply the requirements given in 7.3 to the development of product realization
processes.
7.2 Customer-related Processes
7.2.1 Determination of Requirements Related to the Product
7.2.1.1 Has the organization determined:
a) Requirements specified by the customer, including the
requirements for delivery and post-delivery activities?

b) Requirements not specified by the customer but
necessary for specified or intended use where known?

c) Statutory and regulatory requirements related to the
product?

d) Any additional requirements determined by the
organization?