Checklist

ISO 9000:2000 CHECKLIST
QUALITY MANAGEMENT SYSTEM AUDIT CHECKLIST

REF ELEMENT DESCRIPTION S OBS NCR
4.0 Quality Management System
4.1 General requirements
4.2 General documentation requirements
5.0 Management Responsibility

5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning
5.5 Administration
5.6 Management review
6.0 Resource Management

6.1 Provision of resources
6.2 Human resources
6.3 Facilities
6.4 Work environment
7.0 Product Realization

7.1 Planning of realization processes
7.2 Customer related processes
7.3 Design and/or development
7.4 Purchasing
7.5 Production and service operations
7.6 Control of measuring and monitoring devices
8.0 Measurement, Analysis and Improvement

8.1 Planning
8.2 Measurement and monitoring
8.3 Control of nonconformity
8.4 Analysis of data
8.5 Improvement
Auditors Name: Signature: Date:

4.0 Quality Management System S OBS NCR
4.1 General requirements
Quality system
Established
Documented
Implemented
Maintained
Continually improved
Implementation of the
Quality System includes:-
a) Quality system Processes identified

b) Process sequence and interaction identified
c) Effective process operation and control
criteria and methods determined
d) Information available to support process
operation and monitoring
e) Processes
Measured
Monitored
Analyzed
Action necessary to achieve

planned results and continual
improvement
Implemented
4.0 Quality Management System (Cont) S OBS NCR
4.2 General documentation requirements
Quality system documentation includes:-
A Quality Manual
a) Documented procedures for

Document control
Quality records
Internal audit
Control of nonconformity
Corrective action
b) Documents required to ensure

the effective operation and
control of
Processes
Extent of QMS documentation

Dependent on
a) Size and type of organisation

b) Complexity and interaction of the processes
c) Competence of personnel
5.0 Management Responsibility S OBS NCR
5.1 Management commitment
Evidence of top management

Commitment to QMS
for development
for improvement
by
a) Communicating importance of meeting

customer, legal and regulatory
requirements to the organisation
b) Establishing quality policy and objectives
c) Conducting management reviews
d) Providing necessary resources
Customer focus
5.2
Customer needs and expectations
Determined
Converted into requirements
Fulfilled
Ensured by
Top management
5.0 Management Responsibility (cont) S OBS NCR
5.3 Quality Policy
Quality Policy
a) Appropriate to organization’s purpose
b) Includes commitment to meeting
requirements and continual improvement
c) Provides a framework for establishing
and reviewing quality objectives
d) Is communicated and is understood at
appropriate organizational levels
e) Is reviewed for continuing suitability
is included in
document control
5.4 Planning
5.4.1 Quality objectives

established
at relevant functions
levels
are measurable
Quality planning
5.4.2
Resources needed to achieve
Quality objectives
identified
planned
Planning output
documented
Quality Planning includes
a) Processes of the QMS
b) Resources Needed
c) Continual improvement of the QMS
Planning ensures changes are

conducted in
controlled manner
QMS integrity is
maintained during changes
5.5 Administration
5.5.1 General
administration of the QMS
5.5.2 Responsibility and authority
Functions within the organization

defined
communicated
including
responsibilities
authorities
interrelations
5.5.3 Management representative
Member or members of the management

appointed
by
top management
with
authority and responsibility
for
a) Ensuring QMS processes are established
and maintained
b) QMS performance reporting, to top
management, including needs for
improvement
c) Customer requirements awareness
promotion within the organisation
Liaison with external parties on the QMS

where required
Internal communication
5.5.4
communication between various
levels and functions
ensured
regarding QMS
processes
and
effectiveness
5.5.5 Quality manual
established
maintained
controlled
Including
a) QMS scope, including exclusions and
justification for them
b) Documented procedures or reference to
them
c) Sequence and interaction of processes
5.5.6 Control of documents
QMS documentation
controlled
Procedure
established
a) to approve documents for adequacy prior

to issue
b) to review, update and re-approve
documents
c) to identify current revision status of
documents
d) to ensure relevant versions of applicable
documents are available at points of use
e) to ensure documents remain legible,
identifiable and retrievable
f) to ensure external documents are
identified and their distribution controlled
g) to control obsolete documents, including
identification of any retained for any
purpose
5.5.7 Control of quality records
Records required for the QMS

controlled
maintained to provide
evidence of
conformance to requirements
effectiveness of the QMS
Documented procedure
Including established
identification
storage
retrieval
protection
retention time
disposition
5.6 Management review
5.6.1 General
QMS review conducted
at planned intervals
by top management
for continuing suitability

Adequacy
Effectiveness
Review evaluates need for change to the

QMS
Including quality policy and objectives

5.6.2 Review input
Inputs include
audit results
customer feedback
process performance
product conformance
status of corrective and preventive actions
earlier management review follow-up
changes which could affect the QMS
5.6.3 Review output
Outputs include
actions for
performance and improvement opportunities

QMS improvement
customer product or service improvement
resource needs
6.0 Resource Management S OBS NCR
6.1 Provision of resources
resources needed
determined
provided
in a timely manner
To
a) implement and improve QMS processes
b) address customer satisfaction
6.2 Human resources
6.2.1 Assignment of personnel
Assigned personnel
competent
on the basis of applicable

education
training
skills
experience

6.0 Resource Management (cont) S OBS NCR
6.2.2 Training, awareness and competency
Organisation has:-
a) identified competency needs for
personnel performing activities affecting
quality
b) provided training to satisfy these needs
c) evaluated the effectiveness of training
provided
d) ensured personnel 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
experience
training
qualifications
6.3 Facilities
identified
provided
maintained
In order to achieve
product/service conformance
Including
a) workplace and associated facilities
b) equipment, hardware and software
c) supporting services
Work environment
6.4
Human and physical factors
of the work environment
identified
managed
7.0 Product Realization S OBS NCR
Product realization is the sequence of
processes and sub-processes required to
achieve the product or service
7.1 Planning of realization processes
Planning documented
In form suitable for organization’s method
of operation
Planning determines as appropriate:-

a) quality objectives for the product/service
b) the need to establish processes and
documentation and provide resources
and facilities, specific to the
product/service
c) verification and validation activities and
acceptance criteria
d) records nec3essary for process and
product/service conformity
Customer related processes

7.2
Identification of customer requirements
7.2.1
Customer requirements determined
Including:-
a) product/service requirements e.g.
availability, delivery, support
b) requirements necessary for intended or
specified use
c) product/service obligations e.g. regulatory
or legal
7.0 Product Realization (Cont) S OBS NCR
7.2.2 Review of product requirements
Conducted prior to submission of a tender or

acceptance of a contract
Ensuring that:
a) Product requirements are defined
b) Customer requirements are defined
(even when not stated)
c) Quotation, contract, order differences are
resolved
d) Organization’s ability to meet defined
requirements
Results of reviews
recorded
Changes to requirements
documentation amended
personnel notified
7.2.3
Customer communication
Customer communication arrangements

identified
implemented
Related to:-
a) product information
b) handling of enquiries, contracts, orders
and amendments
c) customer feedback, including complaints
7.3 Design and/or development
7.3.1 Design and/or development planning
Design and/or development or product

planned
controlled
Design and/or development planning

determines
a) the stages of design/development
processes
b) review, verification and validation
activities appropriate to each stage
c) responsibilities and authorities for
design/development activities
Design/development interfaces
managed
to ensure effective communication

clarity of responsibilities
Planning outputs updated as appropriate
as design/development
progresses
7.3.2 Design and/or development inputs
Product requirement related inputs

defined
documented
Including
a) functional and performance requirements
b) applicable regulatory and legal
requirements
c) applicable previous design information
d) any other requirements essential for
design and/or development
inputs reviewed for adequacy

Incomplete, ambiguous
Or conflicting requirements resolved
7.3.3 Design and/or development outputs
Outputs of the design and/or

development process documented
in a manner which enables verification
against design inputs

7.3.3 Design and/or development outputs (cont)
Design and/or development outputs shall:-

a) Meet the design and/or development
input requirements
b) Provide appropriate information for
production and service operations
c) Contain or reference product acceptance
criteria
d) Define product characteristics essential
for safe and proper use
Design and/or development

output documents approved prior to release
7.3.4 Design and/or development review
Systematic review of design

and/or development conducted
at suitable stages
To
a) Evaluate the ability to fulfill requirements
b) Identify problems and propose follow-up
actions.
Review participants include

design stage representatives
Review results and follow-up

actions recorded
7.3.5 Design and/or development verification
Performed
To ensure the output meets
design and/or development inputs
7.3.6 Design and/or development validation
Performed
To confirm product is
capable of meeting requirements
for intended use
Validation completed prior to

Product delivery or
implementation
Where full validation completion prior to product

delivery or implementation is impractical to
partial validation performed
extent possible
Validation results and follow-up

actions recorded
7.3.7
Design and/or development changes
Identified
Documented
Controlled
Effect on product evaluated

changes verified
validated
approved before implementation
7.4 Purchasing S OBS NCR
7.4.1 Purchasing control
Purchasing processes control
To ensure purchased products conforms to
requirements
Type and extent of control
Dependent upon effect on subsequent
realization processes and their output
Suppliers selected evaluated

Based on ability to supply product in
accordance with specified requirements
Criteria defined for selection

periodic evaluation
Evaluation results and follow up actions
Recorded
7.4.2 Purchasing information
Purchasing documents contain
product information
Incl. as appropriate
a) requirements for approval or qualification of
product; procedures; equipment and
personnel
b) Quality management system requirements
Purchasing documents reviewed
prior to release
Necessary verification activities identified
implemented
If at suppliers, verification arrangements and
method of product release specified
In purchasing information
7.5 Production and service operations S OBS NCR
7.5.1 Operations control
Production and Service operations controlled
Through
a) availability of information that specifies
product characteristics
b) availability of work instructions, where
necessary
c) use and maintenance of suitable
equipment
d) availability and use of measuring and
monitoring devices
e) implementation of monitoring activities
f) implementation of defined processes for
release, delivery and applicable post-
delivery activities
7.5.2 Identification and tracability

Product, where appropriate identified
By suitable means
Throughout production and service
operations
Product status with reference to

measurement and monitoring
requirements identified
Where tracability is a requirement

Product unique identification controlled
recorded
7.5.3 Customer property
Customer property under control
Or in use by organization cared
for
Customer property provided for use

Or incorporation into the product identification
verified
protected
maintained
Customer property that is lost, damaged,

Or found to be unsuitable for use recorded
Reported to the customer
(Customer property may include intellectual

property e.g. information provided in confidence)
7.5.4
Preservation of product
Conformity of product preserved

With customer requirements
During internal processing
Delivery to intended destination
Including
handling
Packaging
Storage
Protection
(this also applies to constituent parts of a product)

Production and service processes
where resulting outputs cannot be
verified by subsequent measurement
or monitoring validated
including any processes where deficiencies

may be found only after the product
is in use or the service has been
delivered
Validation shall demonstrate the ability of the

processes to achieve
planned results
Validation shall demonstrate the ability of the

processes to achieve
planned results
Validation arrangements defined
Including as applicable
a) qualification of processes
b) qualification of equipment and personnel
c) use of defined methods and procedures
d) requirements for records
e) re-validation
7.6 Control of Measuring and Monitoring devices S OBS NCR
Measurements to be made
identified
Measuring and monitoring devices

Required to assure conformity of
Product to specified requirements
identified
Measurement capability consistent with

Measurement requirements
Where applicable measuring

And monitoring devices are/have:-
a) calibrated and adjusted periodically, or
prior to use, against devices traceable to
national or international standards. Where
no such standards exist the calibration
basis used shall be recorded.
b) Safeguarded from adjustments that would
invalidate the calibration
c) Protected from damage and deterioration
during handling, maintenance and storage
d) Calibration results recorded
e) Validity of previous results assessed if
subsequently found to be out of calibration,
and corrective action taken
Software used for measuring

And monitoring validated prior to use
8.0 Measurement, analysis and improvement S OBS NCR
8.1 Planning
Measurement and monitoring activities

To ensure conformity and achieve
Improvement defined
Planned
Implemented
Including determination of the need
For, and use of applicable methodologies
Statistical techniques
8.2 Measurement and monitoring
8.2.1 Customer satisfaction
Information on customer satisfaction

Or dissatisfaction monitored
As one measurement of
performance of the QMS
Methodologies for obtaining

And using this information determined

8.2.2 Internal audit
Periodic internal audits
conducted
To determine if the QMS
a) conforms to ISO 9000-2000
b) has been effectively implemented
Audit program Planned

Taking into account status and importance of
activities and areas to be audited
Previous audit results
Defined audit
scope
Frequency
Methodology
Audits conducted by personnel

independent
of the activity being audited
Audit procedure
documented
Including responsibilities and requirements

for conducting audits
Ensuring independence
Recording of results
Reporting to management
Timely management action taken on audit

deficiencies
Audit follow-up includes verification of CA

implementation
Reporting of verification results
8.2.3 Measurement and monitoring of processes
Characteristics of product measured
monitored
To verify product requirements are met

conducted at appropriate process stages
Evidence of conformity
to acceptance criteria documented
Authority responsible for

product release recorded
All specified activities

complete prior to product release
service delivery
Unless approved by customer
8.3 Control of nonconformity
Procedure documented
Nonconforming product identified

controlled
corrective
re-verified
Nonconformance after delivery

or use appropriate action taken
Client or end user concession applied for

as required
8.4 analysis of data
appropriate data collected
analyzed
to determine QMS suitability
effectiveness
and to identify improvements
including data from measuring activities
monitoring activities
Data analyzed to provide
information on
a) customer satisfaction/dissatisfaction
b) conformance to customer requirements
c) characteristics of processes, products and
their trends
d) suppliers
Improvement
Planning for continual improvement
Processes necessary for the continual

Improvement of the QMS
planned
managed
QMS continual improvement

Facilitated by use of the quality policy
objectives
audit results
data analysis
corrective action
preventive action
management review
8.5.2 Corrective action
Corrective action taken
To eliminate causes of nonconformities
In order to prevent recurrence
Corrective action
appropriate
to impact of problem
procedure documented
including definition of requirements for:-

a) identifying nonconformities (including
customer complaints)
b) determining the causes of nonconformity
c) evaluating actions to ensure non-
recurrence
d) determining and implementing corrective
action
e) recording results of action taken
f) reviewing corrective action taken
Preventing action
Identified to eliminate causes of

potential nonconformities
Appropriate to impact of
problem
Procedure documented
Including definition of requirements for:-

a) identifying the causes of potential
nonconformities
b) determining and ensuring preventive action
implementation
c) recording results of action taken
d) reviewing preventive action taken

Checklist

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ISO 9000:2000 CHECKLIST

QUALITY MANAGEMENT SYSTEM AUDIT CHECKLIST

5.0 Management Responsibility

6.0 Resource Management

7.0 Product Realization

8.0 Measurement, Analysis and Improvement

Auditors Name: Signature: Date:

a) Quality system Processes identified

Action necessary to achieve

Quality system documentation includes:-

a) Documented procedures for

b) Documents required to ensure

Extent of QMS documentation

a) Size and type of organisation

Evidence of top management

a) Communicating importance of meeting

b) Establishing quality policy and objectives

c) Conducting management reviews

d) Providing necessary resources

5.4.1 Quality objectives

Planning ensures changes are

5.5.2 Responsibility and authority

Functions within the organization

Member or members of the management

Liaison with external parties on the QMS

5.5.6 Control of documents

a) to approve documents for adequacy prior

Records required for the QMS

5.6 Management review

QMS review conducted

for continuing suitability

Review evaluates need for change to the

Including quality policy and objectives

5.6.3 Review output

performance and improvement opportunities

6.2 Human resources

6.2.1 Assignment of personnel

on the basis of applicable

QUALITY MANAGEMENT SYSTEM AUDIT CHECKLIST

7.1 Planning of realization processes

Planning determines as appropriate:-

Customer related processes

Conducted prior to submission of a tender or

Customer communication arrangements

7.3.1 Design and/or development planning

Design and/or development or product

Design and/or development planning

to ensure effective communication

Planning outputs updated as appropriate

Product requirement related inputs

inputs reviewed for adequacy

7.3.3 Design and/or development outputs

Outputs of the design and/or

in a manner which enables verification

against design inputs

Design and/or development outputs shall:-

Design and/or development

7.3.4 Design and/or development review

Systematic review of design

Review participants include

Review results and follow-up

7.3.6 Design and/or development validation