Chapter 2 - Overview of ISO 9001 2000

Overview of ISO 9001:2000
Chapter 2
Chapter 2
Overview of
ISO 9001:2000
Chapter 2
0 Introduction
0.1 General
Strategic decision - adoption of QMS
QMS design & implementation is organisation specific
Standard can be used by internal & external parties to assess the
ability to meet customer, regulatory and organisation’s own
requirements
QMS requirements are complementary to technical requirements for
product
NOTES are for guidance or clarification only
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0.2 Process approach
• Process approach to quality management encouraged
• Introduces & explains the process model as conceptual

presentation of QMS requirements specified
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Plan
Correct
Do
Verify
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Processes
Controls
(e.g.procedure)
Input Process Output

Activities
+
Resources
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Processes - understand interactions
Process Process
A C
Process Process
Input B D
Output
Controls
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Continual Improvement of the

C Quality Management System S C
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S R responsibility i
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M r Resource Measurement, analysis, t
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S t Product Product S
s realisation
Input
Output
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0.3 Relationship with ISO 9004
ISO 9001 & ISO 9004 - consistent pair

Designed to complement each other
Can be used as stand alone
Different scope - similar structure
ISO 9001 can apply for certification or contractual purposes and
focuses on effectiveness
ISO 9004 aims on improving performance and efficiency
ISO 9004 not an implementation guidance
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0.4 Compatibility with other management systems
• Standard is intended to be compatible with other systems

• It is aligned with ISO 14000 to enhance compatibility
• Standard does not include requirements for other management
systems such as EMS, OHSM, or financial management
• Integration of management systems is possible
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1 Scope (1.1 General)

Standard specifies QMS requirements for use to:
• demonstrate organisation’s ability to consistently provide product
meeting customer & applicable regulatory requirements
• enhance customer’s satisfaction through effective application of the
system including processes for its continual improvement and
assurance of conformity to customer and applicable regulatory
requirements
NOTE:
Product = product intended for or required by customer
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1.2 Application
Requirements are generic
Requirement may be excluded if cannot be applied due to the nature
of organisation and its product
Exclusions must:
• Not affect ability or responsibility to provide conforming product
• Be limited to clause 7
(Cl. 4.2.2: “details of & justification for any exclusion” to be included in the
quality manual”)
Conformity to ISO 9001 may not be stated if exclusions go beyond

above
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2 Normative reference
Amendments or revisions of cited standard do not
apply
Users encouraged to use most recent revision
ISO 9000 : 2000 Quality Management Systems -
Fundamentals and Vocabulary.
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3 Terms and definitions
• ISO 9000 : 2000 applies

Supplier
• New supply chain
terminology Organisation
Customer
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3 Terms and definitions

Product = Result of process
Note: four generic product categories:
hardware
software
services
processed materials
ISO 9000:2000
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4 Quality management system
4.1 General requirements
Establish, document, implement and maintain a QMS and

continually improve its effectiveness in accordance with the
standard
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4.1 General Requirements

Identify the processes necessary for QMS
Determine the sequence and interaction of processes
Determine criteria & methods to ensure effective operation &
control of the processes
Ensure availability of resources and information needed to
support the operation & monitoring of the processes
Measure, monitor and analyse processes
Implement actions necessary to achieve planned results &
continual improvement
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Manage the processes in accordance with the standard

Ensure control of outsourced processes affecting product
conformity
Identify control of outsourced processes within the QMS
Note: Processes needed for QMS include processes for

management activity, provision of resources, product
realisation and measurement.
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4.2 Documentation requirements
4.2.1 General
QMS documentation must include:

Quality Policy
Quality Objectives
Documented procedures required by standard
Documents required by organisation to ensure effective
planning, operation & control processes
Records required by the standard
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4.2.1 General
Note 1 Term documented procedure means that it must be

established, documented, implemented and maintained
Note 2 Extend of documentation may differ due to

• Size & type of organisation
• Complexity & interaction of processes
• Competence of personnel
Note 3 Documentation may be in any type of media (now note 15)
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4.2.2 Quality manual
Quality manual must include as minimum:

The scope of QMS including details of, and justification for,
and exclusions (See 1.2)
Documented procedures or reference thereto
Description of the interaction between the processes of the
QMS
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4.2.3 Control of documents

Documented procedures to:
approve documents prior to issue
review, update as necessary and re-approve documents
to identify the changes and the current revision status of documents
to ensure documents remain legible, readily identifiable
ensure relevant versions of applicable documents are available at points of
use
ensure that documents of external origin are identified and distribution
controlled
obsolete documents are prevented from unintended use and identified if
kept for any reason
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4.2.4 Control of records
Records must be established and maintained

Records must be legible, readily identifiable and retrievable.
Documented procedure for control of identification, storage,
retrieval, retention time and disposition of quality records.
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5 Management responsibility
5.1 Management commitment 5.5 Responsibility, authority and

communication
5.2 Customer focus
5.5.1 Responsibility & authority
5.3 Quality policy 5.5.2 Management representative
5.4 Planning 5.5.3 Internal communication
5.4.1 Quality objectives 5.6 Management review

5.4.2 QMS planning 5.6.1 General
5.6.2 Review input
5.6.3 Review output
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5.1 Management commitment
Provide evidence of commitment to the development

implementation and improvement of QMS by:
• communicating the importance of meeting customer and statutory
and regulatory requirements
• establishing quality policy & objectives
• management reviews
• provision of resources
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5.2 Customer focus Determine customer

requirements
Meet requirements
Customer satisfaction
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5.3 Quality policy

a) appropriate to the purpose of the organisation
b) commitment to comply with requirements & continually
improve the effectiveness of the QMS
c) framework for establishing & reviewing quality objectives
d) communicated and understood within the organisation
e) is reviewed for continuing suitability
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5.4.1 Quality objectives

establish quality objectives at relevant functions and levels
objectives must be measurable & consistent with the quality
policy
include those needed to meet requirements for product {see 7.1
(a)}
documented {see 4.2.1 (a)}
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5.4.2 Quality management system planning

planning of the QMS is carried out in order to meet
requirements given in 4.1, as well as the quality objectives
the integrity of the QMS integrity must be maintained when
changes are planned and implemented
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5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority

Responsibilities and authorities shall be
defined and communicated within the organisation.
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5.5.2 Management Representative
Member of the management who has responsibility and authority

that includes
• ensuring that processes needed for the QMS are established,
implemented and maintained
• reporting on performance of QMS including needs for improvement
• ensuring the promotion of awareness of customer needs &
requirements
Note: Responsibility may include liaison with external parties in relation to

QMS
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5.5.3 Internal communication
Ensure appropriate communication within the organisation

regarding the processes of the QMS and their effectiveness.
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5.6 Management Review

5.6.1 General
Review of the QMS by top management at planned intervals to:

• ensure QMS suitability, adequacy & effectiveness
• assess opportunities for improvement
• evaluate the need for changes to QMS including policy & objectives
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5.6.2 Review input

Review performance and improvement opportunities related to:
» audit results
» customer feedback
» process performance & product conformity
» status of preventive and corrective actions
» follow up actions from earlier reviews
» changes that could affect the QMS
» recommendations for improvement
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5.6.3 Review output

Output to include actions related to:
improvement of the effectiveness of the QMS and its processes
improvement of product
resource needs
Results of management review must be recorded
Note changes to 4.1.3

Role of management review
significantly enhanced
Impact: significant
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6 Resource Management
6.1 Provision of resources

6.2 Human resources
6.2.1 General
6.2.2 Competence, awareness and training
6.3 Infrastructure
6.4 Work environment
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6.1 Provision of resources
Determine & provide the resources needed to:

implement, maintain the QMS and continually improve
its effectiveness
enhance customer satisfaction
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6.2 Human Resources
6.2.1 General
Personnel performing work affecting product quality must be
competent on the basis of appropriate education, training, skills
and experience.
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Competence considerations:
Future demands
Anticipated management and workforce succession needs
Changes in the processes and equipment
Individual competencies needed
Statutory and regulatory requirements, standards, directives, etc.
(ISO 9004 :2000)

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6.2.2 Competence, awareness and training

Determine the necessary competence
Provide training or take other action to satisfy those needs
Evaluate the effectiveness of actions taken
Ensure staff are aware of relevance and importance of their
activities and contribution to achieving objectives
Maintain appropriate records of education, training, skills and
experience
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Awareness
The vision for future Creativity

Policy & objectives Innovation
Organisational change & Impact on society
development
Introductory programmes
Improvement activities
Refreshers
(ISO 9004 :2000)

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6.3 Infrastructure
Identify, provide & maintain the infrastructure needed to achieve
product conformity. Infrastructure includes, as applicable:
• buildings, workspace & associated facilities

• equipment (hardware & software)
• supporting services
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Determine and manage the work environment needed to achieve

product conformity
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Human Factors
creative work methods

opportunities for greater involvement of people
safety rules and guidance
ergonomics
special facilities for people
social interaction
(ISO 9004 :2000)
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Physical factors
Heat Cleanliness
Noise Vibration
Light Pollution
Hygiene Air flow
Humidity
(ISO 9004 :2000)

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7 Product realisation
7.1 Planning of product realisation

7.2 Customer related processes
Note: exclusions
7.3 Design & development within this clause
7.4 Purchasing are allowed
7.5 Production & service provision
7.6 Control of measuring & monitoring devices
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7.1 Planning of product realisation
Planning must determine as appropriate:

quality objectives and requirements for the product
the need for processes, documentation, resources specific to the
product
verification and validation activities & acceptance criteria
records
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7.2 Customer related processes
7.2.1 Determination of requirements related to product
7.2.2 Review of requirements related to product
7.2.3 Customer communication

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7.2.1 Determination of requirements related to product
Organisation must determine:

requirements specified by the customer including delivery &
post delivery activities
requirements not specified but necessary for specified or
intended use, where known
statutory and regulatory requirements related to product,
any additional requirements
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7.2.2 Review requirements related to the product
Review identified requirements before commitment to supply

product and ensure that:
• product requirements are defined
• differences between tender & contract are resolved
• organisation has ability to meet the requirements
Record the results
Documentation to be amended in case of changes & personnel

made aware
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7.2.3 Customer communication
Determine and implement effective arrangements for

communication with customers relating to :
• product information
• enquiry, contract & order handling including
amendments
• customer feedback including complaints
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7.3 Design & development
7.3.1 Design & development planning (4.4.1, 4.4.2 & 4.4.3)

7.3.2 Design & development inputs (4.4.4)
7.3.3 Design & development outputs (4.4.5)
7.3.4 Design & development review (4.4.6)
7.3.5 Design & development verification (4.4.7)
7.3.6 Design & development validation (4.4.8)
7.3.7 Control of design & development changes (4.4.9)
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7.3.1 Design & development planning

Plan & control D&D of the product.
Planning to include:
• D&D stages
• required review, verification and validation activities
• responsibilities & authorities for D&D
Interfaces between groups must be managed
Planning to be updated as the D&D progresses
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7.3.2 Design & development inputs

Determine & record product requirements including:
• functional & performance requirements
• applicable statutory and regulatory requirements
• information from previous similar designs
• any other essential requirements
Review input for adequacy
Requirements must be complete, unambiguous and not in conflict
with each other
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7.3.3 Design & development outputs

D&D output in a form allowing verification
D&D output must
• meet the input requirements
• provide information for purchasing, production or service provision
• contain or reference acceptance criteria
• define characteristics essential for proper & safe use
Approve output prior to release
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7.3.4 Design & development review

At suitable stages systematic reviews of D&D to:
• evaluate the ability to meet requirements
• identify problems and propose follow up
Involve all functions concerned
Record the results and any necessary actions
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7.3.5 Design & development verification
Verify D&D to ensure that output meets the input requirements

Record the results of verification and necessary actions
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7.3.6 Design & development validation
Perform D&D validation to confirm that product is capable of

meeting the requirements for the specified or intended use,
where known
Whenever applicable to be completed prior to delivery
Results of validation and necessary actions must be
recorded
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7.3.7 Control of design and development changes
Design & development changes must be identified and records

maintained
Changes must be reviewed, verified and validated as appropriate
and approved before implementation
Record results of review of changes and any necessary actions
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7.4 Purchasing
7.4.1 Purchasing process
7.4.2 Purchasing information
7.4.3 Verification of purchased product

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7.4.1 Purchasing process
Ensure that purchased product meets requirements

Type & extend of control depends on effect purchased product
may have on product realisation or the final product
Evaluate and selects suppliers based on their ability to supply
conforming product
Establish criteria for selection, evaluation and re-evaluation of
suppliers
Results of evaluation and any necessary actions must be recorded
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7.4.2 Purchasing information
Purchasing information must describe the product to be purchased

including where appropriate:
• requirements for approval of product, procedures, processes and
equipment
• requirements for qualification of personnel
• quality management system requirements
Ensure adequacy of specified purchase requirements prior to their
communication to supplier
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7.4.3 Verification of purchased product
Establish & implement inspection or other activities needed to

ensure purchased product conformity
Where organisation or its customer propose verification at
supplier’s premises, organisation must specify in purchasing
information:
• verification arrangements
• method of product release
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7.5 Production and service provision
7.5.1 Control of production and service provision

7.5.2 Validation of processes for production and service
provision
7.5.3 Identification & traceability
7.5.4 Customer property
7.5.5 Preservation of product

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7.5.1 Control of production and service provision

Plan and carry out production & service provision under controlled
conditions. Controlled conditions include as applicable:
a) availability of information describing product characteristics
b) availability of work instructions, as necessary
c) the use of suitable equipment
d) availability & use of measuring & monitoring devices
e) implementation of monitoring and measurement
f) the implementation of release, delivery and post delivery activities
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7.5.2 Validation of processes
Processes where outcome is not verified and/or where deficiencies

may become apparent after delivery must be validated to demonstrate
ability to achieve planned results
Arrangements must be established for these processes including, as
applicable:
criteria for review and approval of the process
approval of equipment
qualification of personnel
use of defined methods & procedures
requirements for records
re-validation
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Considerations:
High value products

Where deficiency will only be apparent when product is in use
Where process can not be repeated
Where product verification is not possible
(ISO 9004:2000)
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Examples of risk assessment:
» FMEA
» Fault tree analysis
» Relationship diagrams
» Reliability prediction
» Simulation techniques
(ISO 9004:2000)
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7.5.3 Identification and traceability

Where appropriate identify product by suitable means throughout
realisation
Identify status with respect to measurement & monitoring
requirements
Where traceability is required control & record unique
identification of product
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7.5.4 Customer property

Care for customer’s property while it is under organisation’s control
or being used by organisation
Identification, verification, protection & safeguarding customer
property provided for use or incorporation
Any customer property that is lost, damaged or found unsuitable
must recorded & reported to customer
Note: Customer property includes intellectual property
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7.5.5 Preservation of product

Preserve conformity of product during internal processing and final
delivery to intended destination
Include identification, handling, packaging, storage and protection
This applies to constituent parts of a product
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7.6 Control of monitoring & measuring devices
Determine monitoring and measurements to be made &

measurement & monitoring devices needed to provide evidence
of conformity of product
Ensure measuring and monitoring is carried out consistently
with monitoring and measurement requirements
Suitability of measuring/monitoring software must be confirmed
prior to use
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7.6 Control of monitoring & measuring devices

Calibrate or verify measuring and monitoring devices (MMD) at specified
intervals or prior to use against international or national standards.
Where no such standard exist record the basis
Adjust or re-adjust as necessary
Identify to enable the determination of calibration status
Safeguard MMD from adjustments invalidating calibration
Protect MMD from damage or deterioration during handling,
maintenance& storage
record results of calibration
assess and record validity of previous results when device found to be
out of calibration
Note: See ISO 10012 for guidance
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8 Measurement, analysis and improvement
8.1 General 8.3 Control of nonconforming

product
8.2 Monitoring/measurement
8.2.1 Customer satisfaction 8.4 Analysis of data
8.2.2 Internal Audit 8.5 Improvement

8.2.3 Monitoring & measurement of 8.5.1 Continual improvement
processes 8.5.2 Corrective action
8.2.4 Monitoring & measurement of 8.5.3 Preventive action
product
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8.1 General
Plan & implement measurement, monitoring analysis and improvement

processes needed to:
demonstrate conformity of the product
ensure conformity of QMS
continually improve the effectiveness of the QMS
This includes determination of applicable methods, including statistical
techniques, and the extent of their use
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8.2.1 Customer satisfaction
Organisation shall monitor information related to customer

perception as to whether the organisation has met customer
requirements.
The methods for obtaining and using this information must be
determined
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8.2.2 Internal audit
Conduct internal audits at planned intervals to determine if :

QMS conforms to the planned arrangements, requirements of the
standard and organisation’s requirements
QMS is effectively implemented & maintained
Plan the audit programme considering:
status and importance of the processes and the areas
results of previous audits
Define audit criteria, scope, frequency & methodologies
Select auditors to ensure objectivity and impartiality.
Auditor must not audit own work.
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8.2.2 Internal audit

The documented procedure must cover:
• responsibilities & requirements for planning and conducting audits
• reporting results and maintaining records
Corrective actions without undue delay
Follow up to verify actions taken & report verification results
Note:
See ISO 10011 for guidance
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8.2.3 Monitoring and measurement of processes
Apply suitable methods for monitoring and, where applicable,

measurement of QMS processes
These methods shall demonstrate the ability of the processes to
achieve planned results
Where planned results are not achieved corrections and
corrective actions must be taken to ensure conformity of the
product
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8.2.4 Monitoring and measurement of product
Monitor & measure product characteristics to verify conformity at

appropriate stages of realisation processes in accordance with
planned arrangements
Evidence of conformity with the acceptance criteria must be
maintained. Records must indicate the person(s) authorising
release of the product
Release or delivery must not proceed until all the planned
arrangements have been satisfactorily completed, unless
otherwise approved by a relevant authority, and where applicable
by the customer
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8.3 Control of nonconforming product
Nonconforming product must be identified and controlled to

prevent unintended use or delivery
Documented procedure to define controls, responsibility and
authority
When non conformance detected after delivery take appropriate
action
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8.3 Control of nonconforming product
Organisation must deal with nonconforming product by one or

more of the following ways:
• action to eliminate detected nonconformity
• concession
• preclude original intended use or application
When the nonconforming product is corrected it must be re-verified
to demonstrate conformity
Records of the nature of nonconformity and any subsequent action
including concessions must be maintained
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8.4 Analysis of data

Determine, collect & analyse appropriate data to demonstrate the
suitability and effectiveness of QMS and to evaluate where
continual improvement of the QMS can be made
Data from measurement & monitoring & other relevant sources
Analyse data to provide info on:
• customer satisfaction
• conformity to product requirements
• process, product characteristics and their trends including opportunities
for preventive action
• suppliers
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8.5 Improvement
8.5.1 Continual improvement

Organisation shall continually improve the effectiveness of the QMS
through use of:
• quality policy
• quality objectives
• audit results
• analysis of data
• corrective actions
• preventive actions
• management review
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Continual Improvement
SPC
Benchmarking
Quality Circles
Risk Assessment
Teamwork for Quality
Quality Function Deployment
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Continual Improvement
Problem Solving Techniques

Cause & effect diagram
Pareto analysis
Flowcharting
Brain storming
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8.5.2 Corrective action

Organisation shall take actions to eliminate the causes of
nonconformities to prevent recurrence.
Corrective actions appropriate to the impact of the problem
Documented procedure shall define requirements for:
• reviewing nonconformities (including customer complaints)
• determining the causes of nonconformities
• Evaluating the need for corrective action
• determining & implementing action needed
• recording results of action taken
• reviewing corrective action taken
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8.5.3 Preventive action

Organisation shall determine action to eliminate the causes of
potential nonconformances to prevent occurrence.
Actions appropriate to the impact of the potential problem
Documented procedure must define the requirements for
• determining potential nonconformances & their causes

• evaluating the need for preventive action
• determining and implementing action needed
• recording the results of action taken
• reviewing preventive action taken

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Chapter 2 - Overview of ISO 9001 2000

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Overview of ISO 9001:2000

0.2 Process approach

• Process approach to quality management encouraged

• Introduces & explains the process model as conceptual

Input Process Output

Processes - understand interactions

Continual Improvement of the

0.3 Relationship with ISO 9004

ISO 9001 & ISO 9004 - consistent pair

0.4 Compatibility with other management systems

• Standard is intended to be compatible with other systems

1 Scope (1.1 General)

Conformity to ISO 9001 may not be stated if exclusions go beyond

3 Terms and definitions

• ISO 9000 : 2000 applies

3 Terms and definitions

4 Quality management system

4.1 General requirements

Establish, document, implement and maintain a QMS and

4.1 General Requirements

Manage the processes in accordance with the standard

Note: Processes needed for QMS include processes for

4.2 Documentation requirements

QMS documentation must include:

Note 1 Term documented procedure means that it must be

Note 2 Extend of documentation may differ due to

4.2.2 Quality manual

Quality manual must include as minimum:

4.2.3 Control of documents

4.2.4 Control of records

Records must be established and maintained

Continual Improvement of the

5.1 Management commitment 5.5 Responsibility, authority and

5.4 Planning 5.5.3 Internal communication

5.4.1 Quality objectives 5.6 Management review

5.1 Management commitment

Provide evidence of commitment to the development

5.2 Customer focus Determine customer

5.3 Quality policy

5.4.1 Quality objectives

5.4.2 Quality management system planning

5.5 Responsibility, authority and communication

5.5.1 Responsibility and authority

5.5.2 Management Representative

Member of the management who has responsibility and authority

Note: Responsibility may include liaison with external parties in relation to

5.5.3 Internal communication

Ensure appropriate communication within the organisation

5.6 Management Review

Review of the QMS by top management at planned intervals to:

5.6.2 Review input

5.6.3 Review output

Note changes to 4.1.3

Continual Improvement of the

6.1 Provision of resources

6.1 Provision of resources

Determine & provide the resources needed to:

6.2 Human Resources

(ISO 9004 :2000)

6.2.2 Competence, awareness and training

The vision for future Creativity

(ISO 9004 :2000)

• buildings, workspace & associated facilities

6.4 Work environment