Organization: QUALITY SYSTEM CHECKLIST AND AUDIT GUIDE EXCERPT Standard: ISO 9001:2000

Question Audit Guidelines Organization's ISO 9001:1994 Fully Documented? Fully Implemented?
(those relating to new/ revised requirements are in italics) Documents Cross Reference Y or N (and comments) Y or N (and comments)
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Quality management system - General requirements
4.1 Has the organization established, (Note: clause 4.2 defines
documentation requirements)
documented, and implemented a quality
management system (QMS) in accordance Review quality manual and
with the requirements of ISO 9001:2000? interview key members of top
Specifically: management to determine if
the organization has adopted a
systematic approach for: Quality manual 4.2.1
and/or process flow
a) Are QMS processes identified? 1) identifying and managing charts / diagrams.
QMS processes. Interviews
b) Have the sequence and interaction of should assess the degree to
which “process ownership”,
QMS processes been determined? involvement, & responsibility
is known – as well as the
approach adopted for
managing interfaces associated
with the following QMS
processes (or elements) and
their related sub-processes:
Clause:
4. Quality Mgt. System
5. Management Responsibility
6. Resource Management
7. Product Realization
c) Have the criteria and methods required to 8. Measurement, Analysis and
ensure the effective operation and control of Improvement
QMS processes (including outsourced 2) ensuring the criteria,
processes) been defined? methods, information and
responsibilities for managing
d) Are resources and information available to QMS processes (including
outsourced processes) are in
support QMS process operation and place.
monitoring?
3) ensuring that data is
e) Are QMS processes monitored, measured, collected, analyzed and used to
and analyzed? assess QMS process
effectiveness and to identify
f) Are actions implemented to achieve planned needed actions or
results and continual improvement of QMS improvements.
processes?

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 Organization: QUALITY SYSTEM CHECKLIST AND AUDIT GUIDE Standard: ISO 9001:2000
Question Audit Guidelines Organization's ISO 9001:1994 Fully Documented? Fully Implemented?
(those relating to new/ revised requirements are in italics) Documents Cross Reference Y or N (and comments) Y or N (and comments)
Quality management system – Documentation requirements - General Clause 4.2.1
4.2.1 Is the quality system documented as Review quality manual to Quality manual 4.2.1
ensure it complies with
required by ISO 9001:2000? Specifically, requirements of clause 4.2.2
and that it contains
a) and b) Are the quality policy, quality documented statements of a
objectives and quality manual documented? quality policy and quality
objectives.
4.2.1c) Are there documented procedures as Review quality manual to Quality manual 4.2.1
ensure it contains or references
required by the standard ? at a minimum: documented procedures as
Control of Documents (clause 4.2.3) required by the standard and
other documented procedures Documented 4.2.2
Control of Records (clause 4.2.4) as appropriate for the size and procedures
Internal Audit (clause 8.2.2) type of the organization, the
Control of Nonconforming Product (clause 8.3) complexity and interaction of
processes, and competence of
Corrective Action (clause 8.5.2) personnel.
Preventive Action (clause 8.5.3)
Others, as appropriate, which may include:
Planning (5.4, 7.1, 8.1, 8.5.1) Validation of Special Proc. (7.5.2) Review QMS processes to Other QMS
Internal Commun. (5.5.3) Product ID/Traceability (7.5.3) ensure they are adequately documentation
Management Review (5.6) Customer Property (7.5.4) defined in procedures, process
Resource Management (6) Preservation of Product (7.5.5)
or job descriptions, work
Competency&Training (6.2.2) Ctl of Monitor/Meas Devices (7.6)
Customer Processes (7.2) Cust Sat. Monitoring/Meas (8.2.1) instructions, or other
Design and Development (7.3) Process Monitoring/Meas (8.2.3) appropriate system
Purchasing(7.4) Product Monitoring/Meas (8.2.4) documentation.
Operations Control (7.5.1) Analysis/ Improvement (8.4, 8.5)
4.2.1 d) and e) Does the QMS identify all (Note: QMS documents and Other QMS 4.5.1
records are controlled per documentation and 4.16
other appropriate documentation and records clauses 4.2.3 and 4.2.4) records
needed to ensure effective planning, operation
Ensure applicable standards
and process control , including those required and statutory/regulatory
by: documents and related record
requirements are identified in
Applicable international, national, regional and the QMS.
Industry sector standards? Review other external or
Relevant statutory and regulatory internal documents to ensure
requirements? QMS identifies documentation
and records needed to
Other requirements for documentation and effectively manage the
Records imposed by customers, other organization's products,
processes and activities.
Interested parties, or the organization itself?

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 Organization: QUALITY SYSTEM CHECKLIST AND AUDIT GUIDE Standard: ISO 9001:2000
Question Audit Guidelines Organization's ISO 9001:1994 Fully Documented? Fully Implemented?
(those relating to new/ revised requirements are in italics) Documents Cross Reference Y or N (and comments) Y or N (and comments)
Quality management system - Documentation requirements - Control of documents Clause 4.2.3
4.2.3 Is a documented procedure established Verify that the documented Document Control 4.5.1
procedure details rules (per procedure.
to control all documents required for the 4.2.3 a-g) for controlling:
QMS? Quality manual
Documented Procedures
External Documents
Work Instructions
Product documentation
(including drawings,
specifications, bills of material,
parts lists, production plans,
control plans, etc.).

4.2.3.a) and b): Are new/revised documents Review documents for All new and 4.5.2,
evidence of review/approval. revised documents. 4.5.3
reviewed for adequacy and approved by
authorized personnel prior to issue or update?

4.2.3 Are documents: Review documents for proper All controlled

identification, revision status, documents, 4.5.2
c) identified by their current revision status, and legibility

d) available at locations where they are Test the distribution system to Master lists,
needed verify documents are available Distribution lists,
and retrievable. etc.
e) legible, readily identifiable and
retrievable?

4.2.3.f) Are external documents identified and Review external documents All applicable 4.5.2
(identified per clause 4.2.1.d) external documents:
their distribution controlled? for proper identification and standards, customer
control. documents, and
statutory/regulatory
documents

4.2.3.g) Are obsolete documents removed Review retained obsolete All obsolete 4.5.2
documents for proper documents
from points of use and/or suitably identified if identification; identify any
retained for any purpose to preclude obsolete documents not
unintended use? removed from points of use.

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 Organization: QUALITY SYSTEM CHECKLIST AND AUDIT GUIDE Standard: ISO 9001:2000
Question Audit Guidelines Organization's ISO 9001:1994 Fully Documented? Fully Implemented?
(those relating to new/ revised requirements are in italics) Documents Cross Reference Y or N (and comments) Y or N (and comments)
Quality management system – Documentation requirements - Control of records Clause 4.2.4
4.2.4 Is a documented procedure established Verify that the documented Quality Records 4.16
procedure stipulates how procedure.
to control the identification, storage, records are identified,
protection, retrieval, retention and disposition collected, indexed, accessed,
of records needed to provide evidence of file, stored, maintained and
product conformity and effective operation of disposed of.
the QMS? Specifically,
 Are records legible and readily Ask for a record and note how Quality Records 4.16
long it takes to retrieve; procedure.
retrievable? identify causes for breakdowns
in record management system.

 Are records stored in a suitable Verify that records are suitably

protected and note any signs of
environment to prevent deterioration, record deterioration, damage or
damage or loss? loss due to inadequate storage.

 Are records retained per established Verify that record holders,

locations and retention periods
procedures and for the specified periods? are stipulated for each record
or record category.
Verify that records are retained
as required by procedures
and/or customer requirements.
Verify that records are
disposed of in a timely manner.
 Are appropriate records maintained to Note: The adequacy of records
is determined throughout the
demonstrate conformance to requirements audit or assessment.
and the effective operation of the QMS?
Including, as a minimum, records for:
Management Review (5.6.1) Supplier Evaluation (7.4.1)
Competency / Training (6.2.2) Product ID/Traceability (7.5.3)
Record Requirements (7.1.d) Cust Property Reports (7.5.4)
Prod Reqmnts Review (7.2.2) Calibration / Verif Results (7.6)
Design Inputs (7.3.2) Internal Audit Results (8.2.2)
Design Reviews (7.3.4) Prod. Conformity/Release (8.2.4)
Design Verification (7.3.5) Prod. Nonconformity/Action (8.3)
Design Validation (7.3.6) Corrective Action Results (8.5.2)
Design Chg. Review (7.3.7) Preventive Action Results (8.5.3)

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 Organization: QUALITY SYSTEM CHECKLIST AND AUDIT GUIDE Standard: ISO 9001:2000
Question Audit Guidelines Organization's ISO 9001:1994 Fully Documented? Fully Implemented?
(those relating to new/ revised requirements are in italics) Documents Cross Reference Y or N (and comments) Y or N (and comments)
Management responsibility – Quality policy Clause 5.3
5.3 Has top management established a quality Review the quality manual to Quality manual. 4.1.1
ensure top management has
policy that: established/approved the
quality policy.

a) is appropriate to the organization's purpose? Review other organizational

policy documents to determine
their consistency with the
quality policy.

Review the quality policy to

b) includes a commitment to comply with determine if it promotes
requirements and continually improve the customer satisfaction and
continual improvement.
QMS?

Ask a random sampling of

c) provides a framework for establishing and managers and/or employees if
they understand the process for
reviewing quality objectives? establishing and reviewing
quality objectives (per clause
5.4.1).

Ask a random sampling of

d) is communicated and understood within the employees what the quality
organization? policy is and how they
contribute to attaining its
objectives. Determine if
communications are consistent
with other internal/external
communications (see clauses
5.1.a) , 5.5.1, 5.5.3, 6.2.2.d,
6.3.c), 7.2.3, 7.3.1, and 7.4.2).

Ask top management how the

quality policy is reviewed,
e) is reviewed for continuing suitability? revised, and controlled (per
clause 4.2.3)

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 Organization: QUALITY SYSTEM CHECKLIST AND AUDIT GUIDE Standard: ISO 9001:2000
Question Audit Guidelines Organization's ISO 9001:1994 Fully Documented? Fully Implemented?
(those relating to new/ revised requirements are in italics) Documents Cross Reference Y or N (and comments) Y or N (and comments)
Resource management – Provision of resources Clause 6.1
6.1 Are resources determined and provided as Note: required resources Resource allocation 4.1.2.2
should be identified during plans and related
needed: QMS planning per clause 5.4.2. provisions or
a) to implement and maintain the QMS and procedures
Through observation or regarding their
continuously improve its effectiveness? and interviews, identify any development and
evidence that required update.
b) to enhance customer satisfaction by resources are not provided as
meeting customer requirements? needed.
Resource management – Human resources Clause 6.2
6.2.1 Are responsibilities defined in the QMS Review organization charts, Organization charts, 4.1.2.2
job descriptions, to verify that job descriptions,
assigned to competent personnel? personnel are qualified to etc.
perform work assignments.
6.2.2 Verify that personnel Competency review 4.18
competency is determined on results,
a) Does the organization determine the the basis of appropriate
necessary competence for personnel education, training, skills and Training plans
work experience, and that
performing activities affecting product training needs are identified. Training records
quality?
Review training plans and
records to verify that:
b) Is training provided or other actions taken
required training is provided.
to satisfy competency needs?
c) Is the training provided (or other actions Completed training is
Evaluated for effectiveness.
taken) evaluated for effectiveness?
QMS awareness training is
provided and/or interview
employees to assess awareness.
d) Are employees aware of the relevance and Determine if communications
importance of their activities and how they are consistent with other
contribute to the achievement of the quality internal/external
communications (see clauses
objectives? 5.1.a), 5.3.d , 5.5.1, 5.5.3,
6.3.c), 7.2.3, 7.3.1, and 7.4.2)
Verify adequacy of employee
qualification/training records.
e) Are appropriate training and qualification
records maintained? (see clause 4.2.4)

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 Organization: QUALITY SYSTEM CHECKLIST AND AUDIT GUIDE Standard: ISO 9001:2000
Question Audit Guidelines Organization's ISO 9001:1994 Fully Documented? Fully Implemented?
(those relating to new/ revised requirements are in italics) Documents Cross Reference Y or N (and comments) Y or N (and comments)
Product realization – Production and service provision - Identification and traceability Clause 7.5.3
7.5.3 Is product identified by suitable means, Review for adequacy the Product 4.8
system of assigning, Identification
where appropriate, throughout product documenting and recording procedures and
realization? product identification related bills of
numbers, including part material, parts lists,
numbers, serial numbers, or etc.
other unique identification as
appropriate for purchased
products, in-process materials
and finished goods.
Verify that product Product
4.8
 Is product status identified with respect to identification and inspection identification tags,
status is maintained throughout labels,
monitoring and measurement all operations.
requirements? Inspection and/or
4.10.5, 4.12
inspection status
instructions or
procedures, process
sheets, travelers

Review traceability plans, Traceability plans

 Is unique identification of the product configuration management, or and related records
4.8
controlled and recorded (see clause 4.2.4) other documents for inclusion
of applicable requirements;
when traceability is a requirement? verify plans are authorized,
available and used in receiving,
storage and production areas,
and records are maintained.
Product realization – Production and service provision - Customer property Clause 7.5.4
7.5.4 Does the organization identify, verify, Verify that customer property Customer 4.7
is examined upon receipt to specifications
protect and safeguard customer property check quantity, identity, and and/or procedures
(including intellectual property) provided for damage. or processes related
use or incorporation into the product? to the verification,
Verify compliance with any identification,
 Are records maintained and reports contractual agreements storage, and
provided to the customer for customer regarding verification, handling of
identification, storage, purchased product
property that is lost, damaged or handling or other appropriate
otherwise unsuitable for use? (see clause control of customer property.
4.2.4)

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 Organization: QUALITY SYSTEM CHECKLIST AND AUDIT GUIDE Standard: ISO 9001:2000
QUALITY SYSTEM ASSESSMENT SUMMARY
Requirement Not Met
ISO 9001:2000 ISO 9001:1994 Met Minor Major Comments
8.1 Measurement, analysis and improvement - General 4.10 + 4.20.1

8.2.1 Measurement, analysis and improvement - Monitoring and measurement - Customer satisfaction
8.2.2 Measurement, analysis and improvement - Monitoring and measurement - Internal audit 4.17

8.2.3 Measurement, analysis and improvement - Monitoring and measurement - of processes 4.9 + 4.20

8.2.4 Measurement, analysis and improvement - Monitoring and measurement - of product 4.10 + 4.20

8.3 Measurement, analysis and improvement - Control of nonconforming product 4.13

8.4 Measurement, analysis and improvement - Analysis of data 4.14 + 4.20

8.5.1 Measurement, analysis and improvement - Improvement - Continual improvement 4.1.1 + 4.1.3 + 4.9 + 4.14 + 4.17

8.5.2 Measurement, analysis and improvement – Improvement - Corrective action 4.14.1 + 4.14.2

8.5.3 Measurement, analysis and improvement – Improvement - Preventive action 4.14.1 + 4.14.3

Overall Strengths and Weaknesses Observed

Strengths Weaknesses and Opportunities for Improvement

Specific observations (opportunities for improvement) and findings

(requiring corrective action) are summarized on the following page.

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 Organization: QUALITY SYSTEM CHECKLIST AND AUDIT GUIDE Standard: ISO 9001:2000
QUALITY SYSTEM REQUIREMENTS
APPLICABILITY CHECKLIST
FOR SELECTED PROCESS(ES)
(for use in planning & conducting process audits)
Selected Process(es) Process Group A Process Group B Process Group C

Sub-Process A-1

Sub-Process A-2

Sub-Process A-3

Sub-Process C-1

Sub-Process C-2

Sub-Process C-3
Sub-Process B-1

Sub-Process B-2

Sub-Process B-3
ISO 9001:2000 Requirement (Check all that are applicable)

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