ISO 9001:2000 Checklist

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Question Answer Notes:
Clause
4.1 General Requirements

A quality management system has been

established, documented, implemented,
maintained, and continually improved? Yes No

Does the quality management system include:

a. identification of the processes needed for the

quality management system? Yes No

b. determination of the sequence and interaction

of these processes? Yes No

c. determined criteria and methods required

ensuring the effective operation and control of
these processes? Yes No

d. the availability of information necessary to

support the operation and monitoring of these
processes? Yes No

e. methods to measure monitor and analyze

these processes? Yes No

f. implemented action necessary to achieve

planned results and continual improvement? Yes No

Are processes that are outsourced that may affect

product or service conformity identified and
documented? Yes No

4.2.1 General Documentation Requirements

Does the quality management system

documentation include documented procedures
and records required ensuring effective operation
and control of its processes? Yes No

Is the extent of the quality management system

documentation appropriate to:

a. Size and type of the organization? Yes No

b. Complexity and interaction of the processes? Yes No

c. Competence of personnel? Yes No

Does the quality system documentation include:

a. a documented quality policy and quality

objectives? Yes No
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b. a quality manual? Yes No

c. documented procedures required by ISO

9001:2000? Yes No

d. documents required by the organization? Yes No

e. quality records required by ISO 9001:2000? Yes No

4.2.2 Quality Manual

Has a quality manual been established which

includes:

a. Scope of quality system, including details and

justifications for exclusions? Yes No

b. Procedures or references to procedures? Yes No

c. Sequence and interaction of QMS processes

or reference to them? Yes No

4.2.3 Control of Documents

Are documents required for the quality

management system controlled? Yes No

Is there a documented procedure for:

a. the approval of documents for adequacy prior

to issue? Yes No

b. the review, updating as necessary and re-

approval of documents? Yes No

c. the identification of the current revision status

of documents? Yes No

d. ensuring that relevant versions of applicable

documents are available at points of use? Yes No

e. for ensuring that documents remain legible,

readily identifiable and retrievable? Yes No

f. for ensuring that documents of external origin

are identified and their distribution is
controlled? Yes No

g. preventing the unintended use of obsolete

documents, and to apply suitable identification
to them if they are retained for any purpose? Yes No
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4.2.4 Control of Quality Records

Are quality records for resources and system

planning available? Yes No

Do these records provide evidence of conformance

to requirements and of effective operation of the
quality management system? Yes No

5.1 Management Commitment

How has top management demonstrated

commitment to the development and improvement
of the quality management system? Yes No

a. communicating to the organization the

importance of meeting customer as well as
regulatory & legal requirements? Yes No

b. establishing the quality policy? Yes No

c. ensuring that quality objectives are

established? Yes No

d. conducting management reviews? Yes No

e. Ensuring the availability of resources? Yes No

5.2 Customer Focus

Does top management ensure that customer

requirements are determined and fulfilled with the
aim of achieving customer satisfaction? Yes No

5.3 Quality Policy

Has as top management ensured that the quality

policy:

a. is appropriate to the purpose of the

organization? Yes No

b. includes a commitment to meeting

requirements and to continual improvement? Yes No

c. provides a framework for establishing and

reviewing quality objectives? Yes No

d. is communicated and understood at within the

organization? Yes No

e. is reviewed for continuing suitability? Yes No

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5.4 Planning

5.4.1 Quality Objectives

What are the quality objectives that have been

established at relevant functions and levels within
the organization? Yes No

Are the quality objectives measurable and

consistent with the quality policy? Yes No

Do quality objectives include those needed to meet

requirements for product/service? Yes No

5.4.2 Quality Management System Planning

How has Top Management ensured that:

a. processes of the quality management system

are carried out in order to meet the
requirements? Yes No

b. is the output of quality planning documented? Yes No

how?

c. are changes conducted in a controlled

manner and is the integrity of the QMS
maintained during changes? Yes No

d. how and what method is used when planning

changes that may affect the quality
management system? Yes No

5.5 Responsibility, authority and Communication

5.5.1 Responsibility and authority

How are the functions and their interrelations within

the organization, including responsibilities and
authorities, defined and communicated? Yes No

How is responsibility and authority defined? Yes No

5.5.3 Internal Communications

What communication channels have been

established within the organization relating to
quality management system effectiveness? Yes No
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5.6 General - Management Review

Does top management review the quality

management system, at planned intervals, to
ensure its continuing suitability, adequacy, and
effectiveness? Yes No

What is the interval? Yes No

Does the review evaluate the need for changes to

the quality management system, including quality
policy and quality objectives? Yes No

How are opportunities for improvement and

changes needed within the quality system
evaluated and documented? Yes No

5.6.2 Review Input

Do inputs to management review include current

performance and improvement opportunities
related to the following:

a. results of audits? Yes No

b. customer feedback? Yes No

c. process performance and product

conformance? Yes No

d. status of preventive and corrective actions? Yes No

e. follow-up actions from earlier management

reviews? Yes No

f. planned changes that could affect the quality

management system? Yes No

g. recommendations for improvement? Yes No

5.6.3 Review Output

Do outputs to management review include current

performance and improvement opportunities
related to the following:

a. improvement of the effectiveness of the QMS

and its processes? Yes No

b. improvement of product or service related to

customer requirements? Yes No
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c. resource needs?
Yes No
6 Resource Management

6.1 Provision of resources

How have resources needed to implement and

improve quality management system processes
been provided? Yes No

Are there adequate resources available to

implement and maintain the QMS and to
continually improve its effectiveness? Yes No

Are resources available to ensure that customer

satisfaction is enhanced? Yes No

Are there defined responsibilities and authorities of

all personnel who can affect quality? Yes No

6.2.2 Competence, Awareness and Training

Are personnel assigned responsibilities in the

quality management systems qualified and
deemed competent based on skills, experience,
and education & training requirements? Yes No

How has the organization:

a. determined the necessary? Yes No

b. competency for personnel? Yes No

c. provided training to satisfy competency

needs? Yes No

d. evaluated the effectiveness of actions taken? Yes No

e. ensured that its personnel are aware of there

part in the QMS? Yes No

f. maintained appropriate records of education,

training, skills, and experience? Yes No

6.3 Infrastructure

Is the infrastructure of the organization such that:

a. buildings, workspace, and associated utilities

are determined, provided, and maintained? Yes No

b. process equipment, hardware, and software

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are determined, provided, and maintained? Yes No

c. supporting services such as transportation or

communication are determined, provided, and
maintained? Yes No

6.4 Work Environment

Does the organization identify and manage the

human and physical factors of the work
environment needed to achieve conformity of
product/service? Yes No

7.1 Planning of Product (Service) Realization

Is planning of the realization processes consistent

with the other requirements of the organization’s
quality management system? Yes No

Are realization processes documented in a form

suitable for the organization’s method of service
deliver and/or operation? Yes No

In planning product realization, has the

organization determined:

a. that quality objectives and requirements for the

product, service? Yes No

b. the need to establish processes and

documents, and provide resources specific to
the product/service? Yes No

c. that verification, validation, monitoring,

inspection and test activities, and the criteria
for product/service acceptability? Yes No

d. the records that are necessary to provide

evidence of conformity of the processes and
resulting product/service fulfill customer
requirements? Yes No

7.2 Customer Related Process

7.2.1 Determination of Requirements Related to the

Product/Service

Has the organization determined customer

requirements including:

a. Product/service delivery requirements

specified by the customer? Yes No
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b. Product/service delivery requirements not

specified by the customer but necessary for
intended or specified use? Yes No

c. obligations related to product, including

regulatory and legal requirements? Yes No

d. Additional requirements determined by the

organization? Yes No

7.2.2 Review of Requirements Related to the Product

(Service)

Does the organization review the identified

requirements together with additional requirements
determined by the organization prior to
acceptance? Yes No

Is this review conducted prior to the commitment to

supply a product to the customer? Yes No

Does the review ensure that:

a. product/service delivery requirements are

defined? Yes No

b. where the customer provides no documented

statement of requirement, the customer
requirements are confirmed before
acceptance? Yes No

c. contract or order requirements differing from

those previously expressed are resolved? Yes No

d. the organization has the ability to meet defined

requirements? Yes No

Are the results of the review, actions, and

subsequent follow up actions recorded (see ISO
Element 4.2.4)? Yes No

Where product/service requirements are changed,

does the organization ensure that relevant
documentation is amended? Yes No

How are verbal orders handled, addressed, and

documented? Yes No

Does the organization ensure that relevant

personnel are made aware of the changed
requirement? Yes No
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How are customer requirements reviewed before

services are provided? Yes No

How are the results of the review of agreements

and any follow-up actions recorded? Yes No

7.2.3 Customer Communication

How does the organization identify and implement

arrangements for communication with Customers
relating to:

a. product information? Yes No

b. enquiries, contracts, or order handling,

including amendments? Yes No

c. customer feedback, including customer

complaints? Yes No

7.3.1/7.3.2 Design and Development Planning and Design

and Development Inputs

What is the design and development planning

methodology described in the design procedure? Yes No

How are the design and development stages

planned and organized? Yes No

Who is responsible to review, verify and validate

each design and development stage? Yes No

How are the interfaces between different groups

involved in design identified and managed? Yes No

Are design and development inputs relating to

product requirements defined and documented? Yes No

Do these inputs include:

a. functional and performance requirements? Yes No

b. Applicable statutory and regulatory

requirements? Yes No

c. Where applicable, information derived from

previous similar designs? Yes No

d. Other requirements essential for design and

development? Yes No
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7.3.3 Design and Development Outputs

Are the outputs of the design and/or development

process documented in a manner that enables
verification against the design and/or development
inputs? Yes No

Does design and/or development output:

a. meet the design and/or development input

requirements? Yes No

b. provide appropriate information for production

and service operations? Yes No

c. contain or reference product acceptance

criteria? Yes No

d. define the characteristics of the product that

are essential to its safe and proper use? Yes No

Are design and/or development output documents

approved prior to release? Yes No

Documentation of design outputs is maintained

and easily accessible? Yes No

A review of design outputs, change notices,

customer complaints, and internal audit reports
indicate consistent adherence to organizational
standards for design output plans, etc.)? Yes No

7.3.4 Design and Development Review

Are systematic reviews of design and/or

development conducted at suitable stages? Yes No

Do these reviews:

a. evaluate the ability to fulfill requirements? Yes No

b. identify problems and propose follow-up

actions? Yes No

Do participants in such reviews include

representatives of functions concerned with the
design and/or development stage(s) being
reviewed? Yes No

Are the results of the reviews and subsequent

follow-up actions recorded? Yes No
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At what stages of the design are plans or other
design documented? Yes No

Where are records of design reviews maintained? Yes No

7.3.5 Design and/or Development Verification

Is design and/or development verification

performed to ensure the output meets the design
and/or development inputs? Yes No

Are the results of the verification and subsequent

follow-up actions recorded? Yes No

7.3.6 Design and/or Development Validation

Is design and/or development validation performed

to confirm that resulting product is capable of
meeting the requirements for the intended use? Yes No

Wherever applicable, is validation completed prior

to the delivery or implementation of the product? Yes No

If full validation is impractical prior to delivery or

implementation, is partial validation performed to
the extent applicable? Yes No

Are the results of the validation and subsequent

follow-up actions recorded? Yes No

7.3.7 Control of Design and Development Changes

Are design and/or development changes identified,

documented, and controlled? Yes No

Does this process include evaluation of the effect

of the changes on constituent parts and delivered
products? Yes No

Are changes verified and validated, as appropriate,

and approved before implementation? Yes No

Are the results of the review of changes and

subsequent follow up actions documented? Yes No

7.4.1 Purchasing Process

Does the organization control its purchasing

processes to ensure purchased product conforms
to requirements? Yes No

Is the type and extent of control dependent upon

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the effect of subsequent realization processes and
their output? Yes No

Does the organization evaluate and select

suppliers based on their ability to supply product in
accordance with the organization’s requirements? Yes No

Are criteria for selection and periodic evaluation

defined? Yes No

Are the results of evaluations and subsequent

follow up actions recorded? Yes No

7.4.2 Purchasing Information

Do purchasing documents contain information

describing the product to be purchased? Yes No

Do these documents include where appropriate:

a. requirements for approval or qualification of

product, procedures, processes, equipment,
and personnel? Yes No

b. quality management system requirements? Yes No

Is the adequacy of specified requirements

contained in the purchasing documents and
reviewed prior to their release? Yes No

When purchasing good/services, does the

purchaser provide subcontractors/suppliers with
precise details of the order to ensure item/services
are purchased correctly in the first place? Yes No

NOTE: Sample purchase requisitions to determine

the above.

7.4.3 Verification of Purchased Product

Have activities necessary for the verification of

purchased product been identified and
implemented? Yes No

7.5.1 Control of Production and Service Provision

Does the organization control service operations

through:

a. the availability of information that specifies the

characteristics of the product? Yes No
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b. where necessary, the availability of work

instructions? Yes No

c. the use and maintenance of suitable

equipment for production and service
operations? Yes No

d. the availability and use of measuring and

monitoring devices? Yes No

e. the implementation of monitoring activities? Yes No

f. the implementation of defined processes for

release, delivery, and applicable post-delivery
activities? Yes No

7.5.2 Validation of Processes for Production and

Service Provision

Does the organization validate any production and

service processes where the resulting output
cannot be verified by subsequent measurement or
monitoring? Yes No

Are any processes included where deficiencies

may become apparent only after the product is in
use or the service has been delivered? Yes No

Does validation demonstrate the ability of the

processes to achieve planned results? Yes No

Do defined arrangements for validation include as

applicable:

a. qualification of processes? Yes No

b. qualification of equipment and personnel? Yes No

c. use of defined methodologies and procedures? Yes No

d. requirements for records? Yes No

e. re-validation? Yes No

7.5.3 Identification and traceability

Is product identified by suitable means throughout

production and service operations where
appropriate? Yes No

Is the status of the product with respect to

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measurement and monitoring requirements clearly
identified? Yes No

Where traceability is a requirement, is the unique

identification of product controlled and recorded? Yes No

7.5.4 Customer Property

How does the organization exercise care with

customer property while it is under the
organization’s control or being used by the
organization? Yes No

How is customer property provide for use or

incorporation in product:

a. Identified? Yes No

b. Verified? Yes No

c. Protected? Yes No

d. Maintained? Yes No

If any customer property is lost, damaged, or

otherwise found to be unsuitable for use is it
recorded and reported to the customer? Yes No

7.5.5 Preservation of Product

Is product preserved to ensure that conformity with
customer requirements is maintained during
internal processing and delivery to the intended
destination? Yes No

Does this include identification, handling,

packaging, storage, and protection? Yes No

Do these controls also apply to the constituent

parts of a product? Yes No

7.6 Control of Measuring and Monitoring Devices

How does the organization identify the

measurements to be made and the measuring and
monitoring devices required to assure conformity of
product to specified requirements? Yes No

Are measuring and monitoring devices used and

controlled to ensure that measurement capability is
consistent with the measurement requirements? Yes No

Where applicable, are measuring and monitoring

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devices:

a. calibrated and adjusted periodically or prior to

use, against devices traceable to International
or national standards? Yes No

b. Where no such standards exist, is the basis

used for calibration recorded? Yes No

c. safeguarded from adjustments that would

invalidate the calibration? Yes No

d. protected from damage and deterioration

during handling, maintenance, and storage? Yes No

e. have the results of their calibration been

recorded? Yes No

f. have the validity of previous results

reassessed if they are subsequently found out
of calibration and corrective action taken? Yes No

NOTE: Investigate methods in which measurement

and monitoring devices are controlled to ensure
fitness for use (i.e. identification of calibration
status, traceability of device to calibration record,
method in which frequency of calibration is
determined).

Is software used for measuring and monitoring of

specified requirements validated prior to use? Yes No

8.2.1 Customer Satisfaction

Are measurement and monitoring activities needed

to assure conformity and achieve improvement
been identified and included in the product quality
plan? Yes No

Does this process include the determination of the

need for, and use of, applicable methodologies
including statistical techniques? Yes No

8.2.2 Internal Audit

Are periodic internal quality audits conducted to

determine whether the quality management system
has been effectively implemented and maintained? Yes No

Are internal quality audits planned, including

consideration of the status and importance of the
activities and areas to be audited as well as the
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results of previous audits? Yes No

Is the audit scope, frequency, and methodologies

defined? Yes No

Are audits conducted by personnel other than

those who performed the activity being audited? Yes No

Are there documented procedures that include

the responsibilities and requirements for
conducting audits, ensuring their independence,
recording results, and reporting to management? Yes No

Have personnel conducting internal audits been

trained? Yes No

Are records of internal auditor training maintained

and available? Yes No

Does management take timely corrective action on

deficiencies found during the audit? Yes No

Do follow-up actions include the verification of the

implementation of corrective action and the
reporting of verification results? Yes No

8.2.3 Measuring and Monitoring of Processes

Are product realization processes measured and

monitored by suitable methods to ensure customer
requirements are met? Yes No

Do these methods confirm the continuing ability of

each process to satisfy its intended purpose? Yes No

8.2.4 Measuring and Monitoring of Product (Service)

Are product characteristics measured and

monitored to verify that requirements for the
product are met? Yes No

Is this carried out at appropriate stages of the

product realization process? Yes No

Is evidence of conformity with the acceptance

criteria documented? Yes No

8.3 Control of Nonconformity

Is product, which does not conform to
requirements, clearly identified and controlled to
prevent unintended use or delivery? Yes No
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Are these activities defined in a documented
procedure? Yes No

Is nonconforming product corrected and subjected

to re-verification after correction to demonstrate
conformity? Yes No

When nonconforming product is detected after

delivery or use has started, is appropriate action
taken regarding the consequences of the
nonconformity? Yes No

8.4 Analysis of Data

How is appropriate data collected and analyzed to
determine the suitability and effectiveness of the
quality management system and to identify
improvements that can be made? Yes No

Does this include data generated by measuring

and monitoring activities and other relevant
sources? Yes No

How is this data analyzed to provide information

on:

a. customer satisfaction and/or dissatisfaction? Yes No

b. conformance to customer requirements? Yes No

c. characteristics of processes, product, and their

trends? Yes No

d. suppliers? Yes No

8.5.1 Continual Improvement

Are processes necessary for the continual
Improvement of the quality management system
planned and managed? Yes No

How is continual improvement of the quality

management system facilitated through the use of:
a. quality policy? Yes No

b. quality objectives? Yes No

c. audit results? Yes No

d. analysis of data? Yes No

e. corrective and preventive action ? Yes No

f. management review? Yes No

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8.5.2 Corrective Action

How is corrective action taken to eliminate the

cause of nonconformities in order to prevent
recurrence? Yes No

How is corrective action appropriate to the impact

of the Problems encountered? Yes No

Is there a documented procedure for corrective

action which defines requirements for:

a. identifying nonconformities (including customer

complaints)? Yes No

b. determining the causes of nonconformity? Yes No

c. evaluating the need for actions to ensure that

nonconformities do not recur? Yes No

d. determining and implementing the corrective

action needed? Yes No

e. recording results of action taken? Yes No

f. reviewing corrective action taken? Yes No

8.5.3 Preventive Action

Does the organization identify preventive action to

eliminate the causes of potential nonconformities
to prevent occurrence? Yes No

Are preventive actions taken appropriate to the

impact of the potential problems? Yes No

Is there a documented procedure for preventive

action which defines requirements for:

a. identifying potential nonconformities and their

causes? Yes No

b. determining and ensuring the implementation

of preventive action needed? Yes No

c. recording results of action taken? Yes No

d. reviewing preventive action taken? Yes No

Do the procedures ensure relevant information on

actions taken is submitted for management review? Yes No