1. Quality Management Systems
ISO 9001 : 2000
Quality Management Systems
4-SYSTEM REQUIREMENTS
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2. Quality Management Systems
Q M S REQUIREMENTS
1- The organization shall define and manage
the processes necessary to ensure that
product and/or service conforms to
customer requirement.
Quality Management Systems
ISO 9001
2- The organization shall establish a quality
management system covering all the
requirements of the ISO 9001 Standard.
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400

3. Quality Management Systems
Q M S REQUIREMENTS
3- The organization shall prepare quality
management procedures that describe
the processes required to implement
the quality system.
Quality Management Systems
ISO 9001
The system procedures depend upon :
1- Size and type of organization
2- Complexity and interaction of the processes
3- Methods used and skills and training of the
personnel involved in performing the work
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4. Quality Management Systems
Q M S REQUIREMENTS
The system procedures shall include :
1- System level procedures that describe the
activities required to implement the QMS.
2- Procedures that describe the sequence
and interactive nature of the processes
necessary to ensure the conformity of the
product and/or service
3- Instructions that describe the operating
practice and control of process activities
Quality Management Systems
ISO 9001
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5. Quality Management Systems
From Supplier to Organisation
ISO
ISO
Subcontractor
Supplier
Quality Management Systems
ISO 9001
Organisation
Supplier
Client
Client
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6. Quality Management Systems
Q M S REQUIREMENTS
Define and manage
the processes
Quality Management Systems
ISO 9001
Establish a quality
management system
Organization
Prepare system
procedures
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400

7. Quality Management Systems
ISO 9001
Quality Management Systems
5-MANAGEMENT RESPONSIBILITY
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8. Quality Management Systems
MANAGEMENT RESPONSIBILITY
5.1 General requirements
5.2 Customer requirements
5.3 Legal requirements
5.4 Policy
5.5 Planning
5.6 Quality management system
5.7 Management review
Quality Management Systems
ISO 9001
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500

9. Quality Management Systems
MANAGEMENT RESPONSIBILITY
General
requirements
Customer
requirements
Legal
Quality Management Systems
ISO 9001
Quality
management
system
Planning
System
Management review
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500

10. Quality Management Systems
GENERAL REQUIREMENTS
Top management shall demonstrate
its commitment to :
- Creating and maintaining awareness of the
importance to fulfil customer requirements
- Establishing the quality policy and the
quality objectives and planning
- Establishing a quality management system
- Performing management review
- Ensuring the availability of resources
Quality Management Systems
ISO 9001
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501

11. Quality Management Systems
CUSTOMER REQUIREMENTS
Customer
needs
Customer
expectations
Quality Management Systems
ISO 9001
Customer
requirements
Understood
Met
721
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520

12. Quality Management Systems
LEGAL REQUIREMENTS
Establish
Maintain
Quality Management Systems
ISO 9001
Procedure
Identify and have access to legal requirements
applicable to quality
aspects of its
products and/or services
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530

13. Quality Management Systems
Organisation
needs
Customer
Appropriate
Meeting
requirements
Continual
improvement
Commitment
Continuing
suitability
Review
Quality Management Systems
ISO 9001
POLICY
Establishing
objectives
Reviewing
Framework
Understood
Implemented
Communicated
Organisation
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540

14. Quality Management Systems
OBJECTIVES
Policy
Quality Management Systems
ISO 9001
Coherence
Requirements
for products
and services
Commitment
for continual
improvement
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551

15. Quality Management Systems
QUALITY PLANNING
Planing shall covers :
Process
required
Realisation
processes
Resources
needed
Quality
Characteristics
Verification
activities
Criteria for
acceptability
Quality
records
Quality Management Systems
ISO 9001
TO REACH THE OBJECTIVE
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552

16. The company shall establish a : Quality Management Systems
representative
Internal
communication
Responsibility
and authority
Quality Management Systems
ISO 9001
QUALITY MANAGEMENT
SYSTEM
Control of
documents
Control of
records
Quality manual
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560

17. Quality Management Systems
RESPONSIBILITY AND AUTHORITY
Function
Quality Management Systems
ISO 9001
Responsibility
Authority
Degree of
freedom
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18. Quality Management Systems
MANAGEMENT REPRESENTATIVE
Top management shall appoint a member
of the management who shall have defined
authority that includes :
- ensuring that the system is implemented and
maintain
Quality Management Systems
ISO 9001
- reporting to top management on the performance
of the system including needs for improvement
- ensuring awareness of customer requirements
throughout the organization
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563

19. Quality Management Systems
INTERNAL COMMUNICATION
LEVELS AND
FUNCTIONS
Quality Management Systems
ISO 9001
EFFECTIVENESS
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564

20. QUALITY MANUAL
The organization shall prepare a quality manual which include :
- description of the elements of the system
- interaction of the elements of the system
- any reduction in the scope of the standard
Quality Management Systems
ISO 9001
- system level procedures or reference thereto
The quality manual need not be
a stand-alone document
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21. Quality Management Systems
CONTROL OF DOCUMENTS
Master list
revision status
Relevant
Adequacy
Approved
Quality Management Systems
ISO 9001
Release
Available
Obsolete
documents
Revision
Retained for
legal purposes
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566

22. Quality Management Systems
CONTROL OF RECORDS
Conservation
Evidence
Conformance to
requirements
Effective
operation of
the system
Quality Management Systems
ISO 9001
Identification, storage, retrieval, protection, retention time and disposition
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567

23. Quality Management Systems
MANAGEMENT REVIEW
Management reviews
actions follow-up
Customer
feedback
Results of
audits
Quality Management Systems
ISO 9001
Processes &
product analysis
Preventive &
corrective action
Changing
circumstances
Resource
needs
Quality management
system improvement
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570

24. Quality Management Systems
ISO 9001
Quality Management Systems
6-RESSOURCE MANAGEMENT
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25. Quality Management Systems
RESOURCE MANAGEMENT
The organisation shall
determine and
provide in a timely manner,
the resources needed
to establish and maintain
the quality management system.
Quality Management Systems
ISO 9001
600
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26. Quality Management Systems
RESOURCE MANAGEMENT
Human resources
Information
Quality Management Systems
ISO 9001
Infrastructure
Work environment
600
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27. Education Training Skills Experience
ASSIGNMENT OF PERSONNEL
Personnel shall be competent on the basis of :
Education
Training
Quality Management Systems
ISO 9001
Skills
Experience
621
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28. Quality Management Systems
COMPETENCE TRAINING QUALIFICATION
AND AWARENESS
Identify
training needs
Quality Management Systems
ISO 9001
Maintain
records
Provide
training
AWARENESS
Evaluate
effectiveness
622
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29. COMPETENCE TRAINING QUALIFICATION AND AWARENESS
The organization shall establish and maintain
procedures to make employees aware of :
- Importance of conformance
with the quality policy
Quality Management Systems
ISO 9001
- Significant impacts of their
work activities on quality
- The benefits of improved
personal performance
622
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30. COMPETENCE TRAINING QUALIFICATION AND AWARENESS
The organization shall establish and maintain
procedures to make employees aware of :
- Their roles and
responsibilities in achieving
conformance with
quality policy
Quality Management Systems
ISO 9001
- Potential consequences of
departure from specified
operating procedures
622
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31. Quality Management Systems
INFORMATION ?
The organization
shall determine
Control
of processes
Ensure
conformity
Necessary to
Access
Protection
To ensure
Quality Management Systems
ISO 9001
630
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32. INFRASTRUCTURE
The organization shall define, provide and maintain the infrastructure needed to achieve
the conformity of the product and/or service
Workspace
Associated
facilities
Quality Management Systems
ISO 9001
Equipment
Hardware
Software
Maintenance
Supporting Services
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33. Quality Management Systems
WORK ENVIRONMENT
The organization shall define and implement those human and physical factors needed to achieve conformity of the product and/or service
Health and
safety
conditions
Work
methods
Quality Management Systems
ISO 9001
Work
ethics
Ambient
working
conditions
650
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34. Quality Management Systems
ISO 9001
Quality Management Systems
7-PRODUCT / SERVICE REALIZATION
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35. 552 PRODUCT / SERVICE REALISATION Methods Processes Practices
implemented
Sequences
Interactions
Quality Management Systems
ISO 9001
Determined
552
Elements
output
Planned
Results shall be maintain as quality records
710
710
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36. Quality Management Systems
PRODUCT / SERVICE REALISATION
7.2 Clients C1 C2 C3
Input
Output
Understand
7.3 Design D1 D2 D3
Input
Output
Conceive
7.4 Purchasing A1 A2 A3
Input
Output
Buy
Quality Management Systems
ISO 9001
7.5 Production P1 P2 P3
Input
Output Do
7.6 Measurement M1 M2 M3
Input
Output
Control
710
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37. PRODUCT / SERVICE REALISATION
The organization shall determinate how each
process affects the ability to meet product
and/or service with customer requirements :
Methods
Practices
Criteria
Quality Management Systems
ISO 9001
Verify that processes can be operated to achieve
product / service conformance
Implement arrangements for measurement, monitoring, and follow-up actions
Make available information and data necessary
Keep the results of process control measurement
710
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38. Quality Management Systems To meet the customer requirements
CUSTOMER-RELATED PROCESSES
Identification
of the customer
requirements
Review
of the customer
requirements
Quality Management Systems
ISO 9001
To meet the customer requirements
Customer
communication
720
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39. IDENTIFICATION OF CUSTOMER REQUIREMENTS
The organization shall establish a process
to determine :
The customer requirements
Completeness of the customer product / service requirements
Quality Management Systems
ISO 9001
Requirements not specified but necessary
for fitness for purpose
Obligations related to product / service
legal and regulatory requirements
Requirements for availability, delivery and support of product / service
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721

40. REVIEW OF CUSTOMER REQUIREMENTS
The customer requirements, including any
requested changes, shall be reviewed :
Before a commitment to supply
product / service
Requirements clearly defined
Quality Management Systems
ISO 9001
Requirements confirmed before acceptance
Requirements differing from those
previously expressed
Organisation ability to meet the
customer requirements
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722

41. CUSTOMER COMMUNICATION
The organization shall implement arrangements
for communication with customers :
With the aim of meeting customer requirements
Product / service information
Quality Management Systems
ISO 9001
Enquiry and order handling
including amendments
Customer complaints and actions relating to non conforming product / service
Customer responses relating to
performance of the product / service
723
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42. Quality Management Systems
DESIGN AND DEVELOPMENT
- Responsibilities
and authorities
- Input
- Output
- Review
- Verification
- Validation
- Control of changes
Quality Management Systems
ISO 9001
730
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43. Interfaces between groups
DESIGN AND DEVELOPMENT
Plans
Activities
Interfaces between groups
Review
Control
of changes
Verification
Validation
Quality Management Systems
ISO 9001
Inputs
Outputs
731
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44. DESIGN AND DEVELOPMENT INPUTS
Defined, review and recorded
Performances requirements
Regulatory and legal requirements
Quality Management Systems
ISO 9001
Environmental requirements
Requirements from previous similar designs
Other essential requirements
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732

45. DESIGN AND DEVELOPMENT OUTPUTS
Approved before released
Meet the design input requirements
Quality Management Systems
ISO 9001
Contain or make reference to
product/service acceptance criteria 
Define the essential characteristics for
safe and proper use of the product / service
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733

46. At suitable stages systematic reviews Quality Management Systems
DESIGN AND DEVELOPMENT REVIEW
At suitable stages systematic reviews
shall be conducted to :
Propose
solutions
Quality Management Systems
ISO 9001
Evaluate
capability
to fulfil
requirements
Identify
(if any)
problems
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734

47. Quality Management Systems
DESIGN AND DEVELOPMENT VERIFICATION
Planned
performed
&
Quality Management Systems
ISO 9001
Elements
Requirements
Inputs
Outputs
Meet
Results must be recorded
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735

48. to DESIGN AND DEVELOPMENT VALIDATION Performed Confirm
Capability of the Product / Service
in meeting the particular requirements
for a specific intended customer use.
Quality Management Systems
ISO 9001
Prior its delivery or implementation
Results must be recorded
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736

49. Before and interaction CONTROL OF CHANGES Approved Implementation
To determine the effect of changes on the:
Elements of the design and development
Quality Management Systems
ISO 9001
Component parts of the product / service
and interaction
Existing experience on upon post delivery
Need for carrying out re-verification or
re-validation
Results must be recorded
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737

50. Quality Management Systems
PURCHASING
The organization shall : Control its purchased product and/or service
In accordance with its
requirements
Actions shall be recorded
Evaluate and select suppliers
on their ability to supply product and/or service
Quality Management Systems
ISO 9001
741
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51. PURCHASING INFORMATION
Purchasing documents shall contain requirements for
approval or qualification of :
Including any management
system requirements
Prior to release
- Product
- Service
- Procedures
- Processes
- Equipment and
- Personnel
Quality Management Systems
ISO 9001
742
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52. ? VERIFICATION OF PURCHASED P and/or S
The organization shall determine and implement the arrangements for verification of purchased product and/or service
Arrangements necessary for the verification
When the organisation
or the client proposes
to perform
verification activities at
the supplier’s premises ?
Quality Management Systems
ISO 9001
Method of product / service release
Shall be specified in the purchasing documents
743
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53. PRODUCTION AND SERVICE OPERATIONS
Identification
and traceability
Validation
of processes
Quality Management Systems
ISO 9001
Handling, packaging, storage,
preservation and delivery
Customer
property
750
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54. The organization shall
PRODUCTION AND SERVICE OPERATIONS
The organization shall
Production and service operations
including those undertaken after initial delivery
Plan and
control
Quality Management Systems
ISO 9001
751
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55. Quality Management Systems
PRODUCTION AND SERVICE OPERATIONS
Through :
Specifications
Product
Service
Instructions
Equipment
Production
Maintenance
Installation
Quality Management Systems
ISO 9001
Methods
Release
Installation
Delivery
Activity
Measuring
Monitoring
Verification
Work
environment
751
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56. throughout all processes
IDENTIFICATION AND TRACEABILITY
The organization shall make provision for identifying :
Status
product / service
Suitable means
throughout all processes
With respect to required measurements
and verification activities
Any effect on the conformity
with requirements
And to component
parts if
Quality Management Systems
ISO 9001
752
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57. The organization shall
IDENTIFICATION AND TRACEABILITY
The organization shall
Control and record
the unique identification
of the product / service
Throughout all processes
ISO 9001
ISO 14001
ISM
B.V
When required
Quality Management Systems
ISO 9001
Supply - Production - Distribution
752
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58. CLIENT PROPRIETY intellectual propriety
CUSTOMER PROPERTY
The organization shall exercise care with:
Product - Material - Equipment
Identification
Storage
Quality Management Systems
ISO 9001
CLIENT
PROPRIETY
Verification
Maintenance
intellectual propriety
753

59. Documentation available and approved Quality Management Systems
HANDLING TO DELIVERY
To final destination.
From internal operation
Handling
Storage
Documentation available and approved
Quality Management Systems
ISO 9001
Packaging
Preservation
Delivery
754
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60. HANDLING TO DELIVERY Product release and/or service delivery
shall not proceed until all the specified activities...
Quality Management Systems
ISO 9001
… have been satisfactorily completed and the related documentation is available and authorized
754
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61. VALIDATION OF PROCESSES
When the resulting output cannot be readily or
economical verified by subsequent monitoring
inspection and/or testing
Re-validation
Specific
records
procedures
Quality Management Systems
ISO 9001
Qualification
of equipment
of personnel
Effectiveness
Acceptability
Processes
qualified prior use
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755

62. Quality Management Systems
CONTROL OF MEASURING AND MONITORING DEVICES
Devices
Control
Calibration
Maintenance
Methods
Handling
Preservation
Storage
Quality Management Systems
ISO 9001
Software
Validated
prior to use
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760

63. CONTROL OF MEASURING AND MONITORING DEVICES
Uncertainty
Accuracy
Precision
Specified
Intervals
Calibration
Adjustment
International
National
Quality Management Systems
ISO 9001
Methods for
calibration
Results of
calibration
Environmental conditions
Identification
status
Safeguard again
invalidated
calibration
Validation of previous inspection and test results
760 a-g
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64. Quality Management Systems
ISO 9001
Quality Management Systems
8-MEASUREMENT ANALYSE IMPROVEMENT
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65. Quality Management Systems
MEASUREMENT, ANALYSIS AND
IMPROVEMENT
Measurement
and monitoring
System
improvement
Quality Management Systems
ISO 9001
Control of
nonconformity
Analysis of
data
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800

66. Quality Management Systems
MEASUREMENT AND MONITORING OF
Customer
satisfaction
System
performance
Quality Management Systems
ISO 9001
Processes
Product /
service
Internal
audit
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820

67. CONTROL OF NONCONFORMITY
The organization shall ensure that product
and/or service that does not conform
to requirements is controlled to prevent
unintended use or delivery
Hold Area
Quality Management Systems
ISO 9001
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832

68. NONCONFORMITY REVIEW AND DISPOSITION
The organization shall review nonconformities
and determine the action to be taken
Corrected
or adjusted
Re-assigned
for alternatives
Quality Management Systems
ISO 9001
Responsibility and authority for the review and
resolving of nonconformities
shall be defined
Accepted
under condition
Rejected
unsuitable
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832

69. Quality Management Systems
ANALYSIS OF DATA FOR IMPROVEMENT
Dissatisfaction
Satisfaction
Client
Characteristics
Product /
service
Conformance
Requirements
Quality Management Systems
ISO 9001
Pertinence
Effectiveness
Adequacy
System
Trends
Characteristics
Processes
840
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70. Identification of a nonconformity Quality Management Systems
IMPROVEMENT
Identification of a nonconformity
Review of
the action
effectiveness
Determination of
the causes
Quality Management Systems
ISO 9001
Corrective action
Evaluation of
the need for action
Recording of
the action taken
Implementation of the
action determined
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852

71. Identification of a potential nonconformity Quality Management Systems
IMPROVEMENT
Identification of a potential nonconformity
Review of
the action
effectiveness
Determination of
the causes
Quality Management Systems
ISO 9001
Preventive action
Determination of
the preventive action
Recording of
the action taken
Implementation of the
preventive action
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853