slides about iso 9001 international standard quality management

2. Discussion Topics
 Introduction to Quality and Standardization
 Evolution of Quality Management System
(ISO 9000)
 Quality Management System - Requirements
(ISO 9001:2008)

3. Introduction to Quality and
Standardization

4. What is Quality after all?

5. Quality…!
 ‘Fitness for use’ – Juran
 ‘Conformance to requirements’ – Crosby
 ‘Customer satisfaction/delight’ – Deming
 ‘Degree to which a set of inherent characteristics
fulfils requirements’ - ISO 9000:2000

6. Customer Satisfaction
“ Degree to which the customer’s requirements have been
fulfilled ”
Performance < 1 - Dissatisfaction
Satisfaction = = 1 - Satisfaction
Expectation > 1 - Delight

7. Standardization
The process of developing and agreeing upon Standards.

8. Aims of Standardization
 Fitness for purpose
 Interchangeability
 Variety reduction
 Compatibility
 Guarding against factors that affect the
health and safety of consumers
 Environmental protection
 Better utilization of resources
 Better communication and
understanding
 Better communication and
understanding
 Removal of trade barriers

9. Standard?
Standards are documented agreements
containing technical specifications or
precise criteria to be used consistently as
a guideline of characteristics, to ensure
that materials, products, processes and
services are fit for their intended purpose.

10. TYPES OF STANDARDS
Vocabulary standards:
Glossaries, signs and symbols; A few examples are Paper Vocabulary, List
of Equivalent Terms Used in the Plastic Industry, Vocabulary for the Refractory
Industry and Vocabulary of Information Processing.
Measurement standards:
Material measure or physical property that defines or reproduces the unit of
measurement of a base or derived quantity. Such as units of measures; The
seven basic units of the SI system e.g. meter, Kg, Ampere etc.
Product standards:
Cover specifications for dimensions, performance, health, safety,
environmental protection and documentation; Standards for inspection, test
methods and analysis.
Management Standards:
Standards that focus on organization, such as for logistics, maintenance,
inventory management, quality management, project management and
production management such as ISO 9000, ISO 14000, ISO 17025, SA 8000,
HACCP etc.

11. Attributes of a standard
A standard generally has three attributes:
1. Level: such as at the company, national or international level.
1. Subject: such as engineering, food, textile or management.
1. Aspect: such as specification, testing and analysis, packaging and
labeling (more than one aspect may be covered in a single standard: a
standard may include specification of items such as the product, its
sampling and inspection, related tests and analysis, packaging and
labeling).
 For example the term “Pakistan Standard Specification of Biscuits”,
means that the standard is a national standard (level), in the food area
(subject), and provides specifications (aspect) for the biscuits.

12. Infrastructure for Standardization in Pakistan
Standards Institute
PSQCA
Legal framework in Pakistan
LABORATORIES
Microbe Chemical Textile
TESTING SERVICES
System
certifiers..
System
auditors
System
consultants
Laboratory
accreditation
ISO 17025
Accreditation Board
PNAC
Legal
metrology
ISO
OIML
BIPM
ENTERPRISES
Factory
metrology
lab
Trade
transaction
ILAC
IAF
NPSL
HACCP ISO14000 ISO 9000
An institution for training and monitoring Auditors

13. Renowned Standardization Bodies
ISO International Organization for Standardization
ASTM American Society for Testing and Materials
DIN Deutsches Institut für Normung
EN European Norms
IEC International Electrotechnical Commission
BSI British Standards Institute

14. Certification
1. Means Compliance with a standard or
specification (e.g. Systems or Product
Standards).
2. May be general in the scope of
recognition
3. Considers total business .

15. Accreditation
1. It means recognition of competence in a
specific area and scope.
2. Its scope is highly specific.
3. Evaluates people, skills and knowledge.

16. Evolution of Quality Management
System – ISO 9001:2008
1987 First Published – ISO 9001, 9002 & 9003
1994 First revision – ISO 9001, 9002 & 9003
2000 Second revision - ISO 9001
2008 Third revision – ISO 9001

17. Quality Management System
Management System to direct & control an organization
with regard to quality.

18. Quality management Principles
1. Customer focus
2. Leadership
3. Involvement of people
4. Process Approach
5. System approach to management
6. Continuous Improvement
7. Factual approach to decision making
8. Mutually beneficial supplier
relationships

19. Quality Management Principle No.1
Customer Focus
 Organizations depend on their customers
and therefore should understand current and
future customer needs, should meet
customer requirements and strive to exceed
customer expectations.
Application of this principle is reflected in
ISO 9001:2008 clauses 5.2, 7.2.3 and 8.2.1

20. Customer Focus...
Application of this principle involves :
 Researching and understanding customer needs
and expectations.
 Ensuring that the objectives of the organization are
linked to customer needs and expectations.
 Communicating customer needs and expectations
throughout the organization.
 Measuring customer satisfaction and acting on the
results
 Systematically managing customer relationships.
Ensuring a balanced approach between satisfying
customers and other interested parties (such as
owners, employees, suppliers, financiers, local
communities and society as a whole)

21. Quality Management Principle No.2
Leadership
 Leaders establish unity of purpose and
direction of the organization. They
should create and maintain the internal
environment in which people can
become fully involved in achieving the
organization’s objectives.
This principle is reflected in ISO
9001:2008 clauses 5.3, 5.4, 5.5, 6.1, 6.2

22. Leadership...
Application of this principle involves:
 Considering the needs of all interested parties including
customers, owners, employees, suppliers, financiers,
local communities and society as a whole.
 Establishing a clear vision of the organization’s future.
Setting challenging goals and targets.
 Creating and sustaining shared values, fairness and
ethical role models at all levels of the organization.
 Establishing trust and eliminating fear.
 Providing people with the required resources, training
and freedom to act with responsibility and accountability.
 Inspiring, encouraging and recognizing people’s
contributions.

23. People at all levels are essence of an organization
and their full involvement enables their abilities to be
used for the organization’s benefit. This principle is
reflected in ISO 9001:2008 clauses 5.3(d) and 6.2.
Quality Management Principle No.3
Involvement of people

24. Involvement of people...
Application of this principle involves:
 People understanding the importance of their
contribution and role in the organization.
 People identifying constraints to their performance.
 People accepting ownership of processes and
problems and their responsibility for solving them.

25. Involvement of people...
 People evaluating their performance against their
personal goals and objectives.
 People actively seeking opportunities to enhance their
competence, knowledge and experience.
 People freely sharing knowledge and experience.
 People openly discussing problems and issues.

26. A desired result is achieved more efficiently when
activities and related resources are managed as a
process.
This principle is reflected in almost all clauses of
ISO 9001
Quality Management Principle No.4
Process Approach

27. Application of this principle involves:
 Systematically defining the activities necessary to
obtain a desired result.
 Establishing clear responsibility and accountability for
managing key activities.
 Analyzing and measuring of the capability of key
activities.
Process Approach...

28.  Identifying the interfaces of key activities within and
between the functions of the organization.
 Focusing on the factors - such as resources,
methods, and materials - that will improve key
activities of the organization.
 Evaluating risks, consequences and impacts of
activities on customers, suppliers and other
interested parties.
Process Approach...

29. Identifying, understanding and managing inter-related
processes as a system contributes to the
organization’s effectiveness and efficiency in
achieving its objectives. This principle is reflected in
ISO 9001:2008clauses 4.1& 4.2.
Quality Management Principle No.5
System approach to management

30. System approach to management...
Application of this principle involves:
 Structuring a system to achieve the organization’s
objectives in the most effective and efficient way.
 Understanding the inter-dependencies between the
processes of the system.
 Structured approaches that harmonize and integrate
processes.

31. System approach to management...
 Proving a better understanding of the roles and responsibilities
necessary for achieving common objectives and thereby reducing cross-
functional barriers.
 Understanding organizational capabilities and establishing resource
constraints prior to action.
 Targeting and defining how specific activities within a system should
operate.
 Continually improving the system through measurement and evaluation.

32. Continual improvement of the organization’s overall
performance should be a permanent objective of the
organization.
This principle is reflected in ISO 9001 clause 8.5.
Quality Management Principle No.6
Continual Improvement

33. Continual Improvement...
Application of this principle involves:
 Employing a consistent organization-wide approach
to continual improvement of the organization’s
performance.
 Providing people with training in the methods and
tools of continual improvement.

34.  Making continual improvement of products,
processes and systems an objective for every
individual in the organization.
 Establishing goals to guide, and measures to track,
continual improvement.
 Recognizing and acknowledging improvements.
Continual Improvement...

35. Effective decisions are based on the analysis of
data and information.
This principle is reflected in ISO 9001:2008
clauses 5.4.1, 5.6.2, 7.3 and 8.4
Quality Management Principle No.7
Factual approach to decision making

36. Factual approach to decision making
Application of this principle involves:
 Ensuring that data and information are sufficiently
accurate and reliable.
 Making data accessible to those who need it.
 Analyzing data and information using valid methods.
 Making decisions and taking action based on actual
analysis, balanced with experience and intuition

37. An organization and its suppliers are inter-
dependent and a mutually beneficial
relationship enhances the ability of both to
create value.
This principle is reflected in ISO 9001:2008
clause 7.4
Quality Management Principle No.8
Mutually beneficial supplier relationships

38. Application of this principle involves:
 Establishing relationships that balance short-term
gains with long-term considerations.
 Pooling of expertise and resources with partners.
 Identifying and selecting key suppliers.
 Clear and open communication.
Mutually beneficial supplier relationships

39.  Sharing information and future plans.
 Establishing joint development and improvement
activities.
 Inspiring, encouraging and recognizing improvements
and achievements by suppliers.
Mutually beneficial supplier relationships

40. ISO 9000 standards
Three important standards in the family of ISO 9000
International Standard are:
 ISO 9000: Concepts, Principles, Fundamentals and
Vocabulary
 ISO 9001: Sets the QMS Requirements to be met
 ISO 9004: Provides guidance for Continual
improvement of organization’s overall
performance

41. ISO 9001:2008
 Internationally accepted management standard that
has become a world benchmark for good
management practice
 Generic standard i.e. any industry sector viz.
manufacturing or service (education, hospitals,
hotels, banks, transport, accountancy, etc.) can use
it.
 Any type (private, public, government enterprise,
etc) and any size of enterprise can use it (big, small
or tiny)

42. PDCA Methodology
Plan
Do
check
Act

43. Model of Process based Quality Management System
Continual Improvement of the quality
management system
Product
Product
realization
Management
responsibility
Resource
management
Measurement,
analysis &
improvement
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44. ISO 9001:2008
Quality Management System - Requirements
1.0 Scope
2.0 Normative References
3.0 Terms and Definitions
4.0 Quality Management System Requirements
5.0 Management Responsibility
6.0 Resource Management
7.0 Product Realization
8.0 Measurement, Analysis & Improvement

45. 4.1 General Requirements
a) Identification of the processes for the QMS
b) Determine the sequence of these processes
c) Determine criteria for effective operation &
control of these processes
d) Ensure the availability of resources
e) Monitor, measure (where applicable) and
analyze these processes
f) Implement actions necessary for achieving
planned results and continual improvement
Quality Management System - 1

46. 4.2.1 General
The QMS Documentation shall include:
a) Quality Policy & Quality Objectives
b) Quality Manual
c) Documented procedures and records required
by this Standard
d) Documents needed for planning, operation and
control of processes
e) Records required by this Standard
4.2 Documentation Requirements - 1
4.2 Documentation Requirements - 1
Quality Management System - 2

47. 4.2.2 Quality Manual
a) Scope of QMS / Justification of the Exclusions
b) Documented procedures or reference to them
c) Description of interaction between the processes
of the QMS
4.2 Documentation Requirements - 2
Quality Management System - 3

48. 4.2.3 Control of documents
Establish documented procedure to define method to:
a) Approve documents
b) Review, update and re-approve documents
c) Identify the revision status / changes
d) Ensure availability of relevant versions at point of
use
e) Ensure documents are legible and readily
identifiable
f) Identification and Control the external documents
g) Identification and Control of obsolete documents
4.2 Documentation Requirements - 3
Quality Management System - 4

49. 4.2.4 Control of records
a) Establish / Maintain records to demonstrate
conformity to this International Standard
b) Keep records legible, readily identifiable and
retrievable
c) Establish documented procedure for
identification, storage, protection, retrieval,
specify retention time and their disposition
4.2 Documentation Requirements - 4
Quality Management System - 5

50. Documents
Quality manual
Flow chart of major processes and their
interaction
Document control procedure
Record control procedure.
Description of out sourced services and their
control procedure.
Records
Document updating records
Disposal of quality records
Clause 4
Documentation Requirements

51. a) Communication to the organization the
importance of meeting customer, statutory
and regularity requirements
b) Establish Quality Policy & Quality Objectives
c) Conducting Management Reviews
d) Ensuring the availability of resources
5.1 Management Commitment
Management Responsibility - 1
5.2 Customer Focus
Determine and meet the customer requirements
for enhancing customer satisfaction

52. a) Is appropriate to the purpose of the
organization
b) Includes a commitment to comply with and
continually improve the QMS
c) Provides framework of establishing and
reviewing Quality Objectives
d) Is communicated and understood within
organization
e) Is reviewed for continuing suitability
5.3 Quality Policy
Management Responsibility - 2

53. 5.4.1 Quality Objectives
a) Needed to meet the requirements of the
product are established at relevant functions
within the organization
b) Are measurable and consistent with the
Quality Policy
5.4 Planning - 1
Management Responsibility - 3

54. Specific
Measurable
Achievable
Results orientated
Time bound
SMART Objectives
Management Responsibility - 4

55. 5.4.2 Quality Management System Planning
Top Management shall ensure that
a) Planning is done for meeting the requirements
of this standard (4.1) and Quality Objectives
b) Integrity of the QMS is maintained when
changes to QMS are planned and implemented
Management Responsibility - 5
5.4 Planning - 2

56. 5.5.1 Responsibility and Authority
Are defined and communicated
5.5.2 Management Representative
The Management Shall appoint a Management
Representative responsible to :
a) Ensure that processes for QMS are established,
implemented and maintained
b) Reporting to top management on performance of QMS
and any need for improvement
c) Ensure the promotion of awareness of customer
requirements throughout the organization
5.5 Responsibility, Authority and Communication - 1
Management Responsibility - 6

57. 5.5.3 Internal Communication
Top management shall ensure that
appropriate communication processes are
established within the organization and that
communication takes place regarding the
effectiveness of quality management system.
Management Responsibility - 7
5.5 Responsibility, Authority and Communication - 2

58. 5.6.1 General
The management shall review the QMS at
planned intervals to ensure it’s continued
suitability, adequacy and effectiveness
The review shall include :
a) Assessing opportunities for improvement
and need for changes to the QMS
b) Review of the Quality Policy and Quality
Objectives
Records of the reviews must be kept
5.6 Management Review - 1
Management Responsibility - 8

59. 5.6.2 Review Inputs
The Inputs shall include information on:
a) Results of audits
b) Customer feedback
c) Process performance and product conformity
d) Status of preventive and corrective action
e) Follow-up actions from previous
management review
f) Changes which could affect the QMS
g) Recommendations for improvement
Management Responsibility - 9
5.6 Management Review - 2

60. 5.6.3 Review Outputs
The Outputs shall include any decisions and
actions on:
a) Improvement of the effectiveness of quality
management system and processes,
b) Improvement of product related to customer
requirements
c) Resources needs
Management Responsibility - 10
5.6 Management Review - 3

61. Documents
Quality objectives at organizational and
functional level.
Organization structure and responsibilities of
management representative and key
functionaries whose job affects product quality.
Description of internal communication channel. (
This could be specified in quality manual)
Procedure for management review
Records
Evidence of quality planning
Record of management review
Clause 5
Documentation Requirements

62. The Organization shall determine and provide
resources needed to :
a) Implement and maintain the QMS and
continually improve its effectiveness
b) Enhance customer satisfaction by meeting
customer requirements.
Resource Management - 1
6.1 Provision of Resources

63. 6.2.1 General
Competent persons should perform work effecting quality
6.2.2 Competence, awareness and training
a) Determine the necessary competence for the
personnel performing work effecting quality
b) Provide training and take action to satisfy these
needs
c) Evaluate the effectiveness of the action taken
d) Ensure that its personnel are aware of relevance and
importance of their activities and how they contribute
to the achievement of the quality objectives
e) Maintain appropriate records of education, training,
skills and experience
6.2 Human Resources
Resource Management - 2

64. The organization shall determine, provide and
maintain the infrastructure needed to achieve
product conformity, it includes:
a) Building, workplace and associated utilities
b) Process equipment (both hardware and
software)
c) Supporting services(such as transport or
communication)
6.3 Infrastructure
Resource Management - 3

65. The organization shall determine and manage
the work environment needed to achieve
conformity to product requirements
6.4 Work Environment
Resource Management - 4

66. Documents
Specific requirement of qualification and
competence of personnel
Procedure for identifying training needs and
yearly training plan
List of special facilities or work environments
affecting quality
Procedure for maintenance of buildings
equipment and facilities
Record
Record of training and experience of personnel
Maintenance record
Clause 6
Documentation Requirements

67. Organization shall plan and develop the processes
needed for product realization, while considering the
Following factors as appropriate:
a) Quality objective and requirements for the product
b) Need to establish processes, documents, and
provide resources specific to the product
c) Required verification, validation, monitoring,
inspection and test activities specific to the product
and the criteria for product acceptance
d) Records needed to provide evidence that the
realization processes and resulting product meet
requirements (see 4.2.4)
7.1 Planning of Product Realization
Product Realization - 1

68. 7.2.1 Determination of requirements related to the product
The organization shall determine:
a) Requirements specified by customer including
(delivery conditions & post Delivery activities)
b) Requirements not stated but necessary for the
intended use, where known
c) Statutory & regulatory requirements related to
product
d) Any additional requirement determined by the
organization
7.2 Customer Related Processes - 1
Product Realization - 2

69. 7.2.2 Review of Requirements Related to the Product
Review following before the acceptance of contract :
a) Product requirements are defined
b) Contract or order requirements differing from those
previously expressed are resolved
c) The organization has the ability to meet the defined
requirements.
Results of the reviews must be maintained
Any change in requirements is communicated to all
7.2 Customer Related Processes - 2
Product Realization - 3

70. 7.2.2 Customer Communication
The organization shall define and implement
Effective arrangements for communicating with
customers in relation to :
a) Product information
b) Enquiries, contracts or order handling,
including amendments, and
c) Customer feedback, including customer
complaints
7.2 Customer Related Processes - 3
Product Realization - 4

71. 7.3.1 Design and Development Planning
Organization shall determine the
a) Design and development stages,
b) Review, verification and validation that are
appropriate to each design and development
stage, and
c) Responsibilities and authorities for design
and development Planning output shall be
updated, as appropriate, as the design and
development progresses
7.3 Design and Development - 1
Product Realization - 5

72. 7.3.2 Design and Development Inputs
Inputs related to product requirements including following
shall be determined,
a) Functional and performance requirements,
b) Applicable statutory and regulatory requirements,
c) Where applicable, information derived from previous
similar design, and
d) Other requirements essential for design and
development
The requirements must be complete, unambiguous and
not in conflict in each other
The requirements must be reviewed for adequacy and
records must be maintained
7.3 Design and Development - 2
Product Realization - 6

73. 7.3.3 Design and Development Outputs
The design and development outputs shall:
a) Meet the input requirements for design and
development
b) Provide appropriate information for
purchasing, production and for services
provision
c) Contain or reference product acceptance
criteria
d) Specify the characteristics of the product
that are essential for its safe and proper use
7.3 Design and Development - 3
Product Realization - 7

74. 7.3.4 Design and Development Review
Reviews by representatives of the functions
concerned shall be performed in accordance with
planned arrangements (see 7.3.1) to :
a) Evaluate the ability of the results of design
and development to meet requirements, and
b) Identify any problems and propose
necessary actions.
Records of reviews and any necessary actions
shall be maintained
7.3 Design and Development - 4
Product Realization - 8

75. 7.3.5 Design and development verification
Verification shall be performed in accordance
with planned arrangements (7.3.1) to ensure
that design and development outputs have
met the design and development input
requirements.
Records of the results and any actions shall
be maintained.
7.3 Design and Development - 5
Product Realization - 9

76. 7.3.6 Design and development validation
Validation shall be performed in accordance
with planned arrangements (7.3.1) to ensure
that Resulting product is capable of meeting
requirements for intended use, where known.
Where practicable, validation shall be
completed prior to the delivery or
implementation of the product
Records of the results and any actions shall
be maintained.
7.3 Design and Development - 6
Product Realization - 10

77. 7.3.7 Control of design and development changes
The changes will be reviewed, verified and
validated as appropriate and approved before
implementation.
The review for change shall include evaluation
of the effects of the change on constituent
parts and product already delivered.
Records of the changes and any actions shall
be maintained.
7.3 Design and Development - 7
Product Realization - 11

78. 7.4.1 Purchasing Process
The organization shall ensure that
purchased product conforms to specified
purchase requirements
The type and extent of control applied shall
be dependent upon the effect on the final
product
7.4 Purchasing - 1
Product Realization - 12

79. 7.4.2 Purchasing Information
Purchasing information shall describe the
purchased product, including where appropriate:
a) Requirement for approval of product,
procedures, process and equipment
b) Requirement for qualification of personnel
c) Quality management system requirements
7.4 Purchasing - 2
Product Realization - 13

80. 7.4.3 Verification of the Purchased Product
Establish and implement the inspection
activities necessary for ensuring
conformance of purchased product to
purchase information.
Where verification at the supplier’s premises
is required by organization / customer, it
shall be indicated so in the purchase
information.
7.4 Purchasing - 3
Product Realization - 14

81. 7.5.1Control of Production and Service Provision
Production and service provision shall be carried out
under controlled conditions, as applicable:
a) Availability of information that describes the
characteristics of the product,
b) Availability of work instructions, as necessary,
c) Use of suitable equipment,
d) Availability and use of monitoring and measuring
devices,
e) Implementation of monitoring and measurement, and
f) Implementation of release, delivery and post-delivery
activities.
7.5 Production and Service Provision - 1
Product Realization - 15

82. 7.5.2Validation of processes for production and service
provision
Validation of process shall be done where the resulting
output cannot be verified by subsequent monitoring or
measurement, the following shall be addressed:
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
7.5 Production and Service Provision - 2
Product Realization - 16

83. 7.5.3Identification and Traceability
Identification of product by suitable means
throughout product realization
Identification of the product status with
respect to the monitoring and measurement
requirements
Where traceability is required the
organization shall control and record the
unique identification of the product
7.5 Production and Service Provision - 3
Product Realization - 17

84. 7.5.4Customer Property
The organization shall
a) Identify, verify, protect and safeguard
customer property
b) In case of loss, damage or unsuitable for use
customer must be informed
c) Records must be maintained
7.5 Production and Service Provision - 4
Product Realization - 18

85. 7.5.5Preservation of Product
The organization shall preserve the
conformity of product during internal
processing and delivery to the intended
destination.
This preservation shall include identification,
handling, packing, storage and protection.
Preservation shall also apply to the
constituent parts of product
7.5 Production and Service Provision - 5
Product Realization - 19

86. The equipments Shall be:
a) Calibrated or verified at specific intervals, or prior to use,
against measurement standards traceable to international
or national measurement standards, where no such
standards exist, the basis used for calibration or verification
shall be recorded
b) Adjusted or re-adjusted as necessary
c) Identified to enable the calibration status to be determined
d) Safeguarded from adjustments that would invalidate the
measurement result
e) Protected from damage and deterioration during handling,
maintenance and storage
f) Records shall be maintained
7.6 Control of Monitoring and Measuring Equipments
Product Realization - 20

87. Documents
Quality plan or other documents showing how
quality is planned in products/projects
Method of capturing customer requirements
Review of orders or contracts to assess
capability to meet customer’s requirements
Specifications for company’s products
Procedure for design and development
Specifications for purchased materials
Clause 7
Documentation Requirements

88. Documents
Procedure for selection and approval of
suppliers
Procedure for review of suppliers performance
Procedure for verification of purchased products
and dealing with non conforming supplies.
Procedures or work instruction for critical
processes.
Procedure for assessing process capability and
approval of processes.
Qualification of operators and processes where
quality cannot be verified after work is
finished.
Clause 7 contnd..
Documentation Requirements

89. Documents
Procedure for maintenance of critical equipment.
Procedure for identification and traceability of
materials (where required).
Inspection and testing plans/instructions.
Procedure for showing inspection/test status of
materials/equipment.
Procedure for calibration measuring devices.
Procedure for handling customer property.
Procedure for preservation, packaging and
storage of product.
Clause 7 contd…
Documentation Requirements

90. Records
Contract review of major contracts
Design review record
Results of design verification/validation
Inspection results of purchased materials.
Record of qualification of operators and
processes where output cannot be assessed for
non conformity.
Inspection and testing records
Record of rework and rejection
Calibration record of measuring devices.
Record of damaged or lost customer property
(where applicable).
Clause 7
Documentation Requirements

91. Organization must plan and implement the
monitoring measurement, analysis and
improvement processes needed to :
a) Demonstrate conformity of the product
b) Ensure conformity of the QMS
c) Continually improve the effectiveness of QMS
Determine applicable method including Statistical
Techniques and extent of their use
8.1 General
Measurement, Analysis and Improvement - 1

92. 8.2.1 Customer Satisfaction
Establish a method for obtaining and using
the information about customer perception
as to whether the organization has met
customer requirements
8.2 Monitoring & Measurement - 1
Measurement, Analysis and Improvement - 2

93. 8.2.2 Internal Audit
Documented procedures Shall be established and
internal audits shall be conducted at regular intervals
to determine whether the QMS :
a) Conforms to standard and other requirements
determined by organization
b) Is effectively implemented and maintained
Audit shall be:
1. Planned, Criteria / Scope / Frequency and method be
defined.
2. Selection / conduct of audit shall ensure impartiality
3. Follow-up activities shall be performed
4. Records shall be maintained
8.2 Monitoring & Measurement - 2
Measurement, Analysis and Improvement - 3

94. 8.2.3 Monitoring and measurement of processes
Apply methods for monitoring and where
applicable measurement of QMS processes.
Methods shall demonstrate the ability of the
processes to achieve the planned results.
In case planned results are not obtained
Corrective / Preventive actions must be taken
to ensure the conformity to the product.
8.2 Monitoring & Measurement - 3
Measurement, Analysis and Improvement - 4

95. 8.2.4 Monitoring and measurement of product
Monitor the characteristics of the product at
appropriate stages in accordance with
planned arrangements (see 7.1)
Evidence of conformity and acceptance
criteria must be defined.
No product or service delivery shall not
proceed until the planed arrangement are
satisfactorily completed and approved by
authorized person.
Records shall also be maintained.
8.2 Monitoring & Measurement - 4
Measurement, Analysis and Improvement - 5

96. The nonconforming products must be
identified and controlled to prevent unintended
use or delivery.
Documented procedure stating responsibility
and authority to deal with nonconforming
products shall be defined.
8.3 Control of Nonconforming Product - 1
Measurement, Analysis and Improvement - 6

97. The organization shall deal with nonconforming products
by :
a) Taking action to eliminate the detected non
conformity
b) Authorizing its use, release / acceptance under
concession by relevant authority if allowed by
customer.
c) Take action to prevent its original intended use
Records and actions taken shall be recorded.
Incase of rework product shall be re-verified
Incase the product has been delivered appropriate
actions shall be taken
8.3 Control of Nonconforming Product - 2
Measurement, Analysis and Improvement - 7

98. Determine, collect and analyze appropriate data
to demonstrate the suitability and effectiveness
of the QMS and to evaluate where continual
improvement of the QMS can be made.
Analysis of data shall provide information
relating to:
a) Customer Satisfaction (see 8.2.1)
b) Conformity of product requirements (see 7.2.1)
c) Characteristics and trends of processes and
and products including opportunities of
Corrective action
d) Suppliers
8.4 Analysis of Data
Measurement, Analysis and Improvement - 8

99. 8.5.1 Continual Improvement
The organization shall continually improve the
effectiveness of QMS through the use of :
 Quality Policy
 Quality Objectives,
 Audit Results
 Analysis of data,
 Corrective and Preventive Actions
 Management Review
8.5 Improvement - 1
Measurement, Analysis and Improvement - 9

100. 8.5 Improvement - 2
8.5.2 Corrective Action
Corrective actions shall be taken to eliminate
causes
of nonconformities to prevent their recurrence.
Documented procedure shall be established to
define requirements for:
a) Reviewing nonconformities (including
customer complaints)
b) Determining the causes of nonconformities
c) Evaluating the need for action to ensure that
nonconformities do not recur
Measurement, Analysis and Improvement - 10

101. 8.5 Improvement - 3
d) Determining and implementing action needed
e) Records of the action taken results
f) Reviewing corrective action taken
Measurement, Analysis and Improvement - 11

102. 8.5.3 Preventive Action
Preventive actions shall be taken to eliminate
causes
of potential nonconformities to prevent their
occurrence. Documented procedure shall be
established to define requirements for:
a) Determining potential nonconformities and
their causes
b) Evaluating the need for action to prevent
occurrence of nonconformities
c) Determining and implementing action needed
8.5 Improvement - 4
Measurement, Analysis and Improvement - 12

103. d) Records of results action taken
e) Reviewing preventive action taken
8.5 Improvement - 5
Measurement, Analysis and Improvement - 13

104. Documents
Procedure for measurement and monitoring of
processes for effective control.
Methods for use of statistical techniques for
process control and data analysis for
improvement.
Procedure for inspection and release of final
product.
Procedure for dealing with non conforming
product and use of material under concession.
Procedure for monitoring customer satisfaction
and dealing with customer complaints.
Clause 8
Documentation Requirements

105. Documents
Procedure of internal audit of QMS, along with
check list.
Procedure for corrective and preventive action.
Procedure for collection and analysis of data for
effectiveness and improvement of QMS.
Records
Process monitoring data and corrective action
taken for process control
Record of product non conformities and
products accepted on concession.
Clause 8 contnd..
Documentation Requirements

106. Records
Data analysis and activities for continual
improvement.
Result of internal audits and follow up action.
Data on customer feedback and action taken on
customer complaints.
Clause 8 contnd..
Documentation Requirements

107. No body
Can Achieve
QUALITY
Without
U

108. Thank you !!!