Continual improvement of

the quality management

system

Management
responsibility
Requirements

Satisfaction
Customer

Customer
Measurement,
Resource analysis and
management improvement

Product
Input realization Product Output
 Understanding of ISO 9001:2000
Section 4 Quality management system

4.1 General requirements

1. Identify key processes

2. Establish process-process interaction

3. Determine key process index

4. Provide resources and information

5. Monitor, measure and analyse

6. Implement actions and continue to

improve
 Understanding of ISO 9001:2000
Section 4 Quality management system

4.2 Documentation requirements

1. Quality policy

2. Quality objectives

3. Quality manual

4. Documents

5. Records
 Understanding of ISO 9001:2000
Section 5 Management responsibility

5.1 Management commitment

1. Emphasize customer’s requirements

2. Establish quality policy

3. Establish quality objectives

4. Conduct management reviews

5. Provide resources
 Understanding of ISO 9001:2000
Section 5 Management responsibility

5.2 Customer focus

1. Determine customer’s requirements

2. Communicate with customer

3. Collect customer’s feedback

4. Measure customer satisfaction

5. Reflection and improvement

 Understanding of ISO 9001:2000
Section 5 Management responsibility

5.3 Quality policy

1. Meet organization purpose

2. Include commitment to ISO 9001

3. Platform to establish and review quality

objectives

4. Everyone knows and understands

5. Review for continuing stability

 Understanding of ISO 9001:2000
Section 5 Management responsibility

5.4 Planning

1. Establish quality objectives

2. Quality objectives are consistent with the

quality policy

3. Quality objectives are measurable

4. Execution of QMS

5. Integrity of QMS = QMS change

 Understanding of ISO 9001:2000
Section 5 Management responsibility

5.5 Responsibility, authority and

communication

1. Responsibility and authority

• Defined
• Communicated

1. Management representative
• QMS PDCA
• Report on QMS results and needs
• Promote awareness

1. Internal communication
• QMS communication processes
• Execute those processes
 Understanding of ISO 9001:2000
Section 5 Management responsibility

5.6 Management Review

1. General

• Review QMS at planned interval

• Continuing suitability
• Adequacy
• Effectiveness
• Opportunity for improvement
• Need for changes to QMS (QP,QO)
• Records of reviews
 Understanding of ISO 9001:2000
Section 5 Management responsibility

5.6 Management Review

2. Review input
• Audit results
• Customer feedback
• Process and product
• Corrective and preventive actions
• FU actions from last review
• Changes that could affect QMS
• Recommendation for improvement

2. Review output
(include any decisions and actions for:)
• Improvement of the effectiveness of
QMS and its processes
• Improvement of product related to
customer requirements
• Resource needs
Understanding of ISO 9001:2000
Section 6 Resource management

6.1 Provision of resources

Determine and provide resources for:

1. implementing and maintaining QMS

2. continuously improving QMS

effectiveness

3. enhancing customer satisfaction by

meeting customer requirement.
Understanding of ISO 9001:2000
Section 6 Resource management

6.2 Human resources

1. Identify work affecting product quality

2. Determine competent staff for 1.

– Education, training, skill and exp

1. Provide training or appropriate actions

1. Evaluate the actions effectiveness

2. Staff aware of their relevant and

importance, understand their
contribution to QP

3. Records of education, training, skills

and experience.
Understanding of ISO 9001:2000
Section 6 Resource management

6.3 Infrastructure

1. Determine infrastructure needed to

achieve conformity to product
requirements.

2. Provide and maintain.

1. Infrastructure includes, as applicable:

• Building, workspace and associated
utilities,
• Process equipment (both hardware
and software)
• Supporting services (such as
transport or communication)
Understanding of ISO 9001:2000
Section 6 Resource management

6.4 Work environment

Determine and manage

the work environment needed
to achieve
conformity to
product requirements.
Understanding of ISO 9001:2000
Section 7 Product realization

7.1 Planning of product realization

1. Plan and develop the processes needed for

product realization.

2. Determine, as appropriate:
– Quality objectives and product
requirements
– processes needs, documents and
resources
– verification, validation, monitoring,
inspection and test activities
– criteria for product acceptance
– records

1. The output of the planning

Understanding of ISO 9001:2000
Section 7 Product realization

7.2 Customer-related processes

1. Determination of product requirements:

– customer requirements,
– requirements for intended use,
– statutory and regulatory requirements,
– additional organization requirements

1. Review of product requirements to ensure:

(prior to commitment to supply to customer)
– Product requirements are defined
– Differences are resolved
– Ability to meet defined requirements

1. Customer communication relates to:

– Product information
– Enquires, contract or order handling
– Customer feedback, including complaints
 Understanding of ISO 9001:2000
Section 7 Product realization

7.3 Design and development

1. Design and development planning,

determine
– R&D stages, and update
– Review, verification and validation
– Responsibilities and authority for
R&D
– Effective communication

1. Design and development inputs

– Function and performance
requirements
– Statutory and regulatory
requirements
– Previous similar design data
– Other essential requirements
Understanding of ISO 9001:2000
Section 7 Product realization

7.3 Design and development

3. Design and development output

– Meet input requirements
– Information for purchasing,
production and for service provision
– Product acceptance criteria
– Product characteristic of safety and
usage

3. Design and development review

4. Design and development verification

5. Design and development validation

6. Control of design and development

changes
Understanding of ISO 9001:2000
Section 7 Product realization

7.4 Purchasing

1. Purchasing process
• Purchased product meets requirements
• Type and extend of control applied to
supplier and purchased product
• Evaluate and select suppliers
• Criteria for selection, evaluation and re-
evaluation
• Records of evaluations

1. Purchasing information (describe purchase)

• Requirements for approval of product,
procedures, processes and equipment
• Requirements for qualification of personnel,
and
• QMS requirements

1. Verification of purchased product

Understanding of ISO 9001:2000
Section 7 Product realization

7.5 Production and service provision

1. Control of production and service provision

Plan and carry out under controlled conditions:
– Product information
– Work instruction
– Suitable equipment
– Monitoring and measuring devices
– Monitor and measure
– Release, delivery and post delivery activities

1. Validation of processes
– Result output cannot be verified by subsequent
monitoring and measurement
– Deficiencies become apparent after delivery
– To establish arrangement including:
a) defined criteria for review and approval of the
processes
b) approval of equipment and qualification of personnel
c) use of specific methods and procedures
d) requirements for records
e) revalidation
 Understanding of ISO 9001:2000
Section 7 Product realization

7.5 Production and service provision

3. Identification and traceability

– Identify throughout product realization
– Product status wrt monitoring and
measurement requirements
– Control and record the unique identification
of the product for traceability

3. Customer property
– exercise care with customer property
– identify, verify, protect and safeguard
– report on lost, damage or unsuitable for
usage
– records

3. Preservation of product
– Preserve the conformity of product
– Identification, handling, packaging, storage
and protection
Understanding of ISO 9001:2000
Section 7 Product realization

7.6 Ctrl of monitoring and measuring devices

• Determine the monitoring and measurement to be

undertaken

• Determine the monitoring and measurement devices

needed

• Establish processed to ensure that monitoring and

measurement can be carried out.

• Measuring equipment is to be:

–Calibrated
–Adjusted or re-adjusted
–Identified with calibration status
–Safeguarded from unauthorized adjustment
–Protected from damage or deterioration

• Out of calibration control

• Records
 Understanding of ISO 9001:2000
Section 8 Measurement, analysis and improvement

8.1 General

Plan and implement the monitoring, measure-

ment, analysis and improvement processes
needed:
1.to demonstrate conformity of the product

2.to ensure conformity of the QMS, and

3.to continually improve the QMS

effectiveness.

Determine the applicable methods and the

extend of their use.
 Understanding of ISO 9001:2000
Section 8 Measurement, analysis and improvement

8.2 Monitoring and measurement

1. Customer satisfaction
– QMS performance measurement
– Monitor information of customer perception of meeting
requirements
– Determine method of obtaining information
– Determine method of using obtained data

1. Internal audit
– QMS conformity
– QMS implementation and maintenance

1. Processes monitoring and measurement

– Apply suitable methods for QMS processes
– Methods to show processes ability
– Corrective action for results not achieved

1. Product monitoring and measurement

– Product characteristics vs requirements
– Evidence of conformity
– Records indicate authority for release
– Product release prior planned arrangement
 Understanding of ISO 9001:2000
Section 8 Measurement, analysis and improvement

8.3 Control of nonconforming product

1. Nonconforming product is identified and controlled

to prevent its unintended use or delivery.

2. Responsibilities and authorities are defined.

3. Action on nonconforming product:

a) Eliminate nonconforming product
b) Authorized for concession
c) Preclude its original use

4. Records of nonconforming nature and action.

5. Re-verify on corrected nonconforming product

6. Take action appropriate to the effects, or potential

effects, if nonconforming product is detected after
delivery or use has started.
 Understanding of ISO 9001:2000
Section 8 Measurement, analysis and improvement

8.4 Analysis of data

1. Determine, collect and analyze

2. Suitability and effectiveness of QMS

3. Evaluate area for QMS continuous

improvement

4. Information relating to:

a) Customer satisfaction

b) Conformity to product requirements

c) Characteristics and trends of processes and

products (preventive action)

d) Suppliers.
 Understanding of ISO 9001:2000
Section 8 Measurement, analysis and improvement

8.5 Improvement

1. Continual improvement (QMS)

Through the use of quality policy, quality
objectives, audit results, analysis of data ,
corrective and preventive actions and
management reviews

1. Corrective action
– Action to eliminate the cause of NC
– To prevent recurrence
– actions appropriate to the effects of NC
encountered

1. Preventive action
– Actions to eliminate causes of potential NC
– To prevent occurrence
– actions appropriate to the effects of the potential
problems