ISO 9001-2000

Presented by:

Siddharth karakotti

degree to which a set of inherent

characteristic fulfils requirements

Acceptance inspection
Quality control
Quality assurance

In an acceptance inspection system, the

quality characteristics of a product are
compared with the physical sample or
written standards to assess conformity to
product specification.

 part of quality management

focused on fulfilling quality
requirements

 part of quality management

focused on providing confidence that
quality requirements will be fulfilled

 coordinate activities to direct and

control an organisation with regard
to quality

Quality control involves analytical techniques and activities

aimed at monitoring a process and eliminating causes of
nonconformity in order to prevent defects.
Typical quality control techniques & activities include:
appearance & dimensional check of a component
statistical process control monitoring
testing of raw materials
final product testing

Quality assurance activities would include

The quality of issue of working drawings
The review of tender and contract documents
The audit of the quality system to ensure continuous

quality improvement
Calibration of inspection and measuring equipment
Quality assurance is a management system and it implies action the
technical requirement of the product, service or operation have been defined
separately.

Quality assurance is a mean of obtaining the confidence that

an acceptable level of quality has been achieved.
Quality assurance system is a feedback loop. It is about
preventing problems and when problems do arise, taking
immediate steps to ensure those problems are corrected and
do not rise again.

 Understanding

Goals and Purpose of ISO 9001-2000

Understanding

Process Approach of ISO 9001:2000

Documentation

and Actions required for

implementation
Methodology

for implementing the revised standard

11

 Definition

of Terms

Shall is a Requirement-mandatory
Paragraphs marked Notes are for guidance in understanding or
clarifications of associated requirements
Should in note are for guidance.
Such Asare suggestions for guidance only

12

20 clause concept changed to 4 categories

Number of Standards

ISO 8402
ISO 9000
ISO 9001
ISO 9002
ISO 9003
ISO 9004
(Many Parts)

Replaced by:
Replaced by:

ISO 9000

Replaced by:

ISO 9004

ISO 9001

13

Eight Quality Management Principles (Refer ISO 9004) are:

Customer Focused Organization

Leadership
Involvement of People
Process Approach
System Approach to Management
Factual Approach to Decision Making
Continual Improvement
Mutually Beneficial Supplier Relationship
14

0.4 Compatibility with other Management Systems

Intended to be compatible with other internationally

recognized Management System Standards
Aligned with ISO 14001, to enhance compatibility of two
standards
Does not cover requirements of Environmental or OHS or
Financial Management or Risk Management
Standard allows organization to integrate QMS with other
related Management Systems

15

Application

Requirements in Standard are Generic and applicable to all organizations

Where any requirement(s) of the standard that can not be applied due to the
nature of an organization and its products, this can be considered for
EXCLUSION
Exclusions are limited to QMS requirements given in clause 7 and such
exclusions do not
affect the organizations ability or Responsibility to provide product that fulfills
customer and applicable regulatory requirements

16

ISO 9000:2000

Quality Management System -Fundamentals and vocabulary

3. Terms and Definitions

Organisation- Company implementing ISO 9001:2000

Supplier-

Providing product and/or services to

organization

Customer -

Customer End User

Product -

Result of a Process. (Means Service also)

17

Process Approach

A desired result achieved more efficiently when activities and

related resources are managed as a process

Process

Set of interrelated or interacting activities which transforms

inputs into outputs
Inputs and outputs may be tangible or intangible

Inputs and outputs can be

Materials
Components
Information

Equipment
Energy
Financial Resources, etc.
18

Schematic Representation of a Process

PROCEDURE*
(Specified way to carry out an activity or a
process - may be documented or not)

PROCESS

Input
(Includes
Resources)

Output

(Set of interrelated
or interacting activities)

MONITORING AND
MEASUREMENT OPPORTUNITIES
* Note

(Before, during and after the process)

This is the definition

of procedure given in ISO 9000:2000.
This does not necessarily mean one of the 6
documented procedures required by ISO 9001:2000

EFFECTIVENESS
OF PROCESS =
Ability to achieve
desired results
(Focus of ISO
9001:2000

PRODUCT
(Result of a process)
EFFICIENCY OF
PROCESS =
Results achieved
vs resources used
(Focus of
ISO 9004:2000)

EFFICIENCY
OF
PROCESS =
Results achieved
vs resources used
(Focus of ISO
9004:2000)

19

 Guidance

system

on the Process Approach to quality management

Individual processes rarely occur in isolation. Outputs from one

process typically form part of the inputs into subsequent
processes :
Outputs from
Process A
Inputs to
Process B

Outputs from
Process C

PROCESS C

PROCESS B

PROCESS A
Inputs to
Process A

Outputs from
Process B
Inputs to
Process C

CHAIN OF INTER- RELATED PROCESSES

20

 The

interactions between an organizations processes can often

be complex, resulting in a network of interdependent processes.

Inputs and outputs of these processes can often be related to both external
and internal customers. An example of a network with interacting processes
is shown in Figure 6.

The

model of the network of processes illustrates that customers

play a significant role in defining requirements as inputs.
Customers feedback on satisfaction or dissatisfaction of process
output is an essential input towards the continual improvement
process of the QMS

21

A P
C D

Input E

Output E

PROCESS E

Input A
PROCESS A

AA PP
CC DD

AA PP
CC DD

Output A
Input C
PROCESS C

AA PP
CC DD

Input B
PROCESS B

AA PP
CC DD

PROCESS D

Output C AA PP

CC DD

Output B

Input F
Internal
Customer

Output D

Input D

PROCESS F

AA PP
CC DD

Output F
Internal
Customer

Feedback

Understanding the
Process Approach
22

Continual Improvement of the Quality

Management System

Resource
management

Requirements

Customers
(ISO 9001)
And other
Interested
Parties
(ISO 9004)

Management
Responsibility

Customers
(ISO 9001)
And other
Interested
Parties
(ISO 9004)

INPUT

Product
realization

Measurement,
analysis and
improvement

Product

Satisfaction

OUTPUT

23

PDCA, a dynamic cycle and can be deployed within each process.

PDCA is associated with planning, implementation, controls and
continual improvement of both product realization and other QMS
processes
Plan
Act

Plan

Check

Do

establish the objectives and processes necessary

to deliver results in accordance with customer
requirements and the organizations policies;
Do
implement the processes;
Check monitor and measure processes and product
against policies, objectives and requirements for
the product and report the results;
Act
take actions to continually improve process
performance
24

System approach to management

One of the important quality management principles linked with

Process Approach which states
identifying, understanding and managing interrelated processes
contributing to the organizations effectiveness and efficiency in
achieving its objectives

Processes for Quality Management Systems include

product realization processes

numerous management, monitoring and measurement processes such
as
Resource Management
Communication
Internal Auditing
Management Review
Other processes
Refer next transparency for schematic presentation
25

5. Top Management Processes

Examples
Process to define quality policy
and objectives
Communication Process

4. Quality
Management System
Processes

Management Review
6. Resource Management
Processes

8. Measurement, Analysis and

Improvement Processes

Examples

Examples

Determination and provision of

resources

Processes to demonstrate

Human resources
Infrastructure and definition
Work environment definition

7. Product Realization Processes

Examples
Planning
Customer related processes
Design & Development process
Purchasing process
Production & service provision
Control of monitoring and
measuring devices

Conformity of product
Conformity of management
system
Continual improvement

26

 Requirements

for above processes are stated in

clauses of ISO 9001:2000

Quality Management System (Clause 4)

Management Responsibility (Clause 5)
Resource Management
(Clause 6)
Product Realization
(Clause 7)
Measurement, Analysis & (Clause 8)
Improvement

However General Requirements for a QMS are defined in

clause 4.1 of ISO 9001:2000

27

4.1 General Requirements

Establish, document, implement & maintain a QMS and

continually improve its effectiveness
Implement QMS by

Identifying processes needed for the QMS throughout organization

Determining sequence and interaction between these processes
Determining criteria & methods required to ensure that both operation
and control of these processes are effective
Ensuring the availability of resources & information necessary for
operation & monitoring of processes
28

4.1 General Requirements (Contd.)

Implement QMS by (Contd.)

monitoring, measuring and analyzing these processes, and

implementing actions necessary to achieve planned results and
Continual Improvement of these processes

Manage the processes in accordance with requirements of

this standard
Note : Processes referred above should include processes for
management activities, provision of resources, product realization
and measurement.

29

4.1 General Requirements (Contd)

Identify any outsource processes that affects

product conformity with requirements and
ensure control over such processes within
QMS

30

QMS focuses towards importance of an organization to

identify
implement
manage
continually improve

Manage interrelations to achieve objectives and performance

improvements
Focuses on Process effectiveness and efficiency which can be

assessed through internal / external review processes

evaluated on maturity scale

maturity tables are available in ISO 9004:2000 which may be adopted

31

 Some

guidance on questions for an organization may

choose to ask itself in order to address the requirements:
a) Identify the processes needed for the quality management
system, and their application throughout the organization
What are the processes needed for quality management system?
Who are the customers of each process (internal and/or external
customers)?
What are the requirements of these customers?
Who is the owner of the process?
Are any of these processes outsourced?
What are the inputs and outputs of each process?

32

b) Determine the sequence and interaction of these processes

What is the overall flow of the processes?
How can it be described ? ( I.e. Process maps or flow charts?)
What are the interfaces between the processes?
What documentation's are needed?

33

c) Determine criteria and methods required to ensure that both the

operation and control of these processes are effective

What are the characteristics of intended and unintended results of the

process?
What are the criteria for monitoring, measurement and analysis?
How can this be incorporated into the planning of QMS and product
realization processes?
What are the economic issues (cost, time, waste, etc.)?
What methods are appropriate for data gathering?

34

d) Ensure the availability of resources and information necessary to

support the operation and monitoring of these processes

What are the resources needed for each process?

What are the communication channels?
How can external and internal information about the process be
provided ?
How feedback be obtained ?
What data need to be collected ?
What records needed to be kept?

35

e) Measure, monitor and analyze these processes

How can process performance (Process capability, customer

satisfaction) be monitored ?
What measurements are necessary?
How can gathered information (Statistical techniques) be best
analyzed ?
What does the result of this analysis tell ?

36

f) Implement action necessary to achieve planned results and continual

improvement of these processes

How can the process be improved ?

What corrective and/or preventive actions are necessary?
Have these corrective / preventive actions been implemented?
Are these effective?

37

4.2 Documentation Requirements

4.2.1 General : QMS documentation to include

documented Statement of Quality Policy & Quality Objectives
a Quality Manual
documented procedures required in this standard
documents needed by organization to ensure effective planning, operation
and control of its processes
quality records required by this standard (see 4.2.4)

38

4.2 Documentation Requirements (Contd)

NOTE 1:- Term Documented Procedure implies procedure to
be established, documented, implemented and
maintained
NOTE 2:The Extent of QMS documentation to depend upon
the size of organization & type of the activities
the complexity of the processes and their interaction, &
the competence of personnel
NOTE 3:- The documentation can be in any form or type of medium
39

4.2 Documentation Requirements (Contd)

4.2.2 Quality Manual
Establish & maintain Quality Manual that includes
the scope of QMS, including details of, and justification for any exclusions
referred at 1.2,
documented procedures established for QMS or their reference
a description of the interaction between the processes of QMS

40

4.2 Documentation Requirements (Contd)

4.2.3 Control of Documents

Establish a procedure defining the controls
to approve documents for adequacy prior to issue
to review & update as necessary and re-approve documents
to ensure that changes and their current revision status are identified
to ensure that relevant versions of applicable documents are available
at the point of use
41

4.2 Documentation Requirements (Contd)

4.2.3 Control of Documents (Contd)

Establish a procedure defining the controls (contd)
to ensure that documents remain legible and readily identifiable
to ensure that documents of external origin are identified and their
distribution controlled
to prevent unintended use of obsolete documents
to apply suitable identification to obsolete documents, if retained for
any purposes
42

4.2 Documentation Requirements (Contd)

4.2.4 Control of Quality Records

Records required for providing evidence of conformity to QMS shall be

established
Records to be legible, readily identifiable and retrievable
Establish Procedure defining controls of records related to
Identification, Storage
Protection , Retrieval
Retention Time & Disposal

Note: Quality records include specified records

43

MANAGEMENT COMMITMENT - 5.1

Top management to provide evidence of its commitment to development

and implementation of QMS & continually improving its effectiveness by
Communicating to organization the importance of meeting customer and
statutory / regulatory requirements
Establishing Quality Policy
Ensuring that Quality Objectives are established
Conducting Management Reviews; &
Ensuring the availability of necessary resources

44

5.2 CUSTOMER FOCUS

Top Management to ensure

Customer requirements (i.e. Needs and Expectation) are

determined and fulfilled with an aim of enhancing customer
satisfaction (Refer 7.2.1 & 8.2.1)

Ref ISO 9004 : Needs and Expectations can include product

conformity, dependability, availability, delivery, post-realization
activities, price, life cycle costs, product safety and product liability

45

5.3 Quality Policy

Top Management to ensure that Quality Policy

Is appropriate to purpose of the organization
Includes a commitment to comply with requirements and
continually improve the effectiveness of QMS
Provides a frame-work for establishing and reviewing Quality
Objectives
Is communicated and understood within the organization, and
Is reviewed for continuing suitability

46

5.4.1 Quality Objectives

Top Management to ensure that :
Quality objectives, including those needed to meet product
requirements (see 7.1 a), at relevant functions and levels within the
organization are established.
Quality Objectives shall be measurable and consistent with Quality
Policy (including commitment to continual improvement)

47

5.4.2 Quality Management System Planning

Top Management to ensure that :

the planning of QMS is carried out to meet requirements given in

4.1 and quality objectives
the integrity of QMS is maintained when changes to quality
management systems are planned and implemented.

48

5.5 Responsibility, Authority & Communication

5.5.1 Responsibility & Authority

Top Management to ensure that :
Responsibilities & authorities and their inter-relations are defined
and communicated within the organization.

49

5.5.2 Management Representative

Appoint member of the Management as Management
Representative (MR). MR to have responsibility and
authority for :
Establishing processes needed for QMS, implemented and maintained
Reporting on performance of QMS and any needs for improvement to
Top Management
Promotion of awareness of customer requirements throughout the
organization
Note : MR can have on QMS issues
50

5.5.3 Internal Communication

Top Management to ensure that :
Communication processes are established between various levels
and functions and takes place regarding effectiveness of QMS

ISO 9004 Guidelines

Consider Processes of Communication for upward, downward & across

within the organization
System to define processes of communication w.r.t
Quality Policy, Requirements
Objectives & Accomplishments
51

5.6 Management Review

5.6.1 General

Top Management to review QMS at planned interval & ensure its

continuing suitability, adequacy and effectiveness

Review to include assessing opportunities for improvements

Review to evaluate need for change in QMS, Quality Policy and

Quality Objectives

Records from Management Reviews to be maintained.

52

5.6 Management Review (Contd)

5.6.2 Review Input

Shall include information on :

Audit results
Customer feedback
Process performance and product conformity
Status of preventive and corrective actions
Follow up actions of previous management reviews
Planned changes that could affect QMS
Recommendations for improvement

53

5.6 Management Review (Contd)

5.6.3 Review Output

To include any decisions and actions related to :
improvement of the effectiveness of QMS and its processes
improvement of product related to customer requirements
resource needs

54

6.1 Provision of Resources (ISO 9001)

Determine

and provide resources needed :

to implement, maintain and continually improve effectiveness of

QMS and
to enhance customer satisfaction by meeting customer requirement
Resources

means :

Human Resources (i.e. Competent Man-power)

Infra-structure
Work Environment

55

 Refer

General Requirements of QMS 4.1 (d) which

requires :
to ensure the availability of resources (i.e. Human Resources, Infrastructure & Work Environment) necessary to support the operation and
monitoring of these processes.

Refer

also Management Review Output Clause 5.6.3 (c)

which requires . any decisions & actions related to :
Resource Needs (i.e. for improvements)

56

6.2 Human Resources (ISO 9001)

6.2.1 General

Personnel whose work affect product quality to be

COMPETENT on the basis of appropriate education,
training, skills and experience

57

6.2 Human Resources (Contd.)

6.2.2 Competence, Awareness and Training ( ISO 9001)

The organization to

Determine necessary competence for personnel performing work affecting

product quality,
Provide training or take any other actions to satisfy these needs,
Evaluate effectiveness of the actions taken.
Ensure that its personnel are aware of
relevance and importance of their activities
how they contribute to the achievement of the Quality Objectives

Maintain records of education, training, skills & experience,

58

6.2 Human Resources (Contd.)

Skill and Competence Evaluation

Name: Mr. RAM

Dept: Electrical

First Aid
Cable

Motors

Safety

Transformer

VFD
First Skill Evaluation
- June 99
Second Skill Evaluation
- Dec 00
Third Skill Evaluation
- June 01

Relays

TPM

C.B.S.
Battery
Charger

Fuses

Contractor

59

6.2 Human Resources (Contd.)

Questionnaire for Evaluation of Skill & Competence for Electrical Techniques

Sl. No.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.

Question
What are the motor specifications?
What are main parts of the motor?
What is the bearing? What type of bearing used in the motoring?
What is lubrication? What type of lubricants are used for motor bearing lubrication?
How to maintain the motor bearing?
What is the importance of motor fan cover and cooling fins?
What is the importance of earthing in the motor body?
What is the relationship between KW and current rating in case of 3ph-380V motors,
3ph-220V motors, single phase 220 motors?
What will happen if the motor not aligned with the driven machine properly?
(Disadvantage of misalignment).
What are the protective elements which must be found in the motor starter circuit?
How to control the motor starting current?
How to control the induction motors speed?
What happens if 3ph motor runs with two phases?
In induction motors, what is the relation between the number of pole-pairs & speed?
What are the tools required for the motor over hauling?

Marks
5
5
5
5
5
5
5

Obtained

10
10
10
10
10
5
5
5
60

6.3 Infrastructure (ISO 9001)

Determine, provide and maintain infra-structure needed to
achieve the conformity to product requirements

Infra-structure includes, as applicable :

buildings, workspace and associated utilities
process equipment (both hardware and software)
supporting services (such as transport or communication)

61

6.4 Work Environment (ISO 9001)

Determine and manage work environment needed to

achieve the conformity to product requirements
Based on Human Factors & Physical Factors
These may include :

safety, rules and guidance, use of PPE

Ergonomics (a science of space requirement)
special facilities for employees
noise, light, temperature, humidity, vibration
hygiene, pollution, cleanliness

62

7.1 Planning of Product Realization

Plan and develop product realization processes
Product realization process must be compatible with all the other
process of quality management system e.g. Documentation,
resources identification and provision, human resource development
Determine the following as appropriate
Product specific Quality Objective and system requirements;
Product specific processes, documents and resources;
Product specific verification, validation, monitoring, inspection testing and
acceptance criteria;
Records required to demonstrate the compliance of product and processes
to the requirements
Use suitable form(s) for documenting / recording planning output

63

7.1 Planning of Product Realization

NOTE 1: A document covering QMS process (including product
realization processes & resources required can be referred as Quality
Plan
NOTE 2: Requirements given in 7.3 may be applied for development of
product realization processes

64

7.2.2 Review of Requirements Related to Product

Review the requirements related product before giving
commitment for supply (e.g. submission of tenders, acceptance
of contract / order, acceptance of changes) to ensure
Product requirements are completely defined
Differing requirements of contract / order are resolved
Organization have the ability to meet the requirements

Maintain the records of review and subsequent action planned

and taken
When customer does not provide documented requirements
confirm the requirements before acceptance

65

7.2.2 Review of Requirements Related to Product

When the product requirements change ensure

Updation of affect documents

Provide information about the change to the concerned personnel
NOTE 1: In same situations such as internet sales, a formal review
is impractical for each order. Instead, the review can cover relevant
product information such as catalogues or advertising material

66

7.2.3 Customer Communication

Determine and implement effective arrangements for communicating
about,
Product information
Enquiry, contract / order handling including amendments
Customer feedback and customer complaints

67

7.3 Design and Development

NOTE: This requirements include product and manufacturing process design &
development and focus on error prevention than detection

7.3.1 Design and Development Planning

Plan and control design and development by determining

Design and development stages

Review, verification and validation of design & development activities required at
different stages
Responsibility and authority for design and development

Manage interfaces between different groups involved in design and

development activities to ensure
Effective communication
Clear assignment of responsibility

Update planning output as design and development activities progress

68

7.3.2 Design and Development Inputs

Determine the following inputs related to product and maintain records

Functional and performance requirements

Applicable statutory and regulatory requirements
Informations derived from previous similar design (where required)
Other requirements necessary for design and development

Review the inputs for adequacy

Ensure the requirements are complete, unambiguous and do not
conflict with each other

69

7.3.3 Design and Development Output

Define design and development output using units or measurables

which can be verified and validated to meet design input
requirements
Ensure Design and Development output
Meets the input requirements
Provide appropriate informations for purchasing, production and service
provision
Contain or reference product acceptance criteria
Specify the characteristics of product that are essential for its safe and
proper use
70

7.3.4 Design and Development Review

Plan & perform systematic review of design and development at

different of stages,
To evaluate the ability of the results of design and development to
meet requirements
To identify any problem and propose necessary actions

Include representatives from the relevant stages of design and

development in review

Prepare and maintain records of review and subsequent actions

71

7.3.5 Design and Development Verification

Plan and perform design and development verification

To ensure design and development output meets the input requirements
Maintain the records of verification and subsequent actions

72

7.3.6 Design and Development Validation

Plan & perform design and development validation to ensure

Resulting product is capable of meeting the requirements for application
or intended use where known
Whenever practicable, complete validation before delivery or implementation
of product
Prepare and maintain records of validation and subsequent actions

73

7.3.7 Control of Design and Development Changes

Identify and maintain records of design and development changes

Review, verify, validate and approve changes before implementation
Evaluate the effects of changes on
Constituent parts
Already delivered product
Prepare and maintain records of review of changes and subsequent
actions

74

7.4 Purchasing

7.4.1 Purchasing Process

Ensure purchased product conforms to specified purchase

requirements
Apply controls on suppliers considering the
effect of purchased product on the subsequent products
realization processes or finished products
Establish criteria for selection, evaluation and re-evaluation of
suppliers
Evaluate and select suppliers based on their ability to meet the
requirements
Maintain records of suppliers evaluation and actions arising from
evaluation
75

7.4.2 Purchasing Information

Describe clearly all the purchasing informations /
requirements including

Requirements for approval of product, procedure, processes and

equipment
Requirement for qualification of personnel
Quality Management System requirements

Ensure adequacy of specified purchase requirements before

communication to the suppliers

76

7.4.3 Verification of Purchased Product

Establish and implement inspection or other similar activity
to ensure the conformance specified purchasing
requirements
When verification is desired at suppliers premises (by the
organization or customer) define in purchase information
The intended verification arrangements
Method of product release

77

7.5.1 Control of Production and Service Provision

Plan and carry out production & service provisions under
controlled conditions which include, as applicable

availability of information that describes product characteristics

availability of work instructions , as necessary
use of suitable equipment
availability and use of monitoring and measuring devices
implementation of monitoring and measurement
implementation of release, delivery and post-delivery activities

78

7.5.2 Validation of Processes for Production and Service

Provision

Validate any processes for production and service provision where

resulting output can not be verified by subsequent monitoring /
measurement.
Include any process where deficiencies become apparent only after
the product is in use or service has been delivered
Validate the ability of process to demonstrate achievement of
planned results

79

7.5.2 Validation of Processes for Production and

Service
Provision (Contd.)

Establish arrangements for these processes including the

following, as applicable :

Defined criteria for review and approval of the processes

Approval of equipment and qualification of personnel
Use of specific methods and procedures
Requirements for records
Revalidation

80

7.5.3 Identification and Traceability

Where appropriate, identify the product by suitable means
throughout product realization
Identify the product status w.r.t. monitoring and
measurement requirements
Where traceability is a requirement, control and record the
unique identification of the product
NOTE: In some sectors, the above is met by configuration
management

81

7.5.4 Customer Property

Exercise care with customer property while under organization control

or being used in the organization
Identify, verify, protect and safeguard customer property, provided for
use or incorporation into the product
Record and report the following details of customer property to the
customer
Loss
Damage
Any other unsuitability for use

Note: Customer property can include intellectual property

82

7.5.5 Preservation of Product

Ensure product conformity is preserved
During internal processing
Delivery to the intended destination

This include

Identification
Handling
Packaging
Storage
Protection

This also apply to constituent parts of a product

83

Determine
the monitoring & measurements to be undertaken
Monitoring & Measuring devices needed to provide evidence of
conformity of product to determined requirements

Establish processes to ensure that monitoring & measurement

Can be carried out
Are carried out

in a manner that is consistent with the monitoring &

measurement requirements

84

Where necessary to ensure valid results, measuring

equipment be

Calibrated or verified at specified interval or prior to use with

- a reference traceable to National / International Standards
- where no such standards exists, basis used for calibration or
verification to be recorded
Adjusted or re-adjusted as necessary
Identified to enable calibration status to be determined
Safeguarded from adjustments that would invalidate measurement
results
Protected from damage and deterioration during handling,
maintenance and storage

85

Assess and record the validity of previous measuring results

if equipment is found not conforming to the requirements
take appropriate actions on equipment and products affected

Maintain records of the results of calibration and verification

Verify the ability of Computer Software to satisfy the intended
application when used for monitoring or measurement of specified
requirements
To be undertaken prior to initial use and re-confirmed as necessary
NOTE: See ISO 10012-1 & ISO 10012-2 for guidance

86

8.1 General

Plan and implement monitoring, measurement, analysis and

improvement processes needed
to demonstrate conformity of the product
to ensure conformity of the Quality Management System
to continually improve the effectiveness of QMS

The above includes determination of applicable methods

including statistical techniques, and the extent of their use

87

8.2 Monitoring and Measurement (M & M)

8.2.1 Customer Satisfaction

One of the measure of the performance of QMS

Monitor information relating to customer perception (satisfaction /
dissatisfaction) as to organization has fulfilled customer requirements
Establish methods for obtaining and using the information
Customer Satisfaction Survey can be based on following indicators
Quality
Cost
Delivery
Development Capability / Technical Assistance
Management Approach

88

8.2 Monitoring and Measurement (M & M) (Contd)

8.2.2 Internal Audit

Conduct at planned intervals Internal Audit to determine
whether QMS
Conforms to the planned arrangements (see 7.1),
Requirements of this standard and QMS established by the
organization
Has been effectively implemented and maintained

Plan the audit programme considering

Status & importance of the processes and area being audited

Results of previous audits
89

8.2 Monitoring and Measurement (M & M) (Contd)

8.2.2 Internal Audit (Contd.)

Define Audit Criteria, Scope, Frequency and Methodology
Ensure objectivity and impartiality of audit process during
selection of auditors and conduct of audits
Auditor not to audit their own work (i.e. Audit to be
performed by personnel other than those who perform
activities being audited)
90

8.2 Monitoring and Measurement (M & M) (Contd)

8.2.2 Internal Audit (Contd.)

Document Procedure covering

responsibilities and requirements for

planning and conducting audits

reporting results and maintaining records

Management of audited activity (auditee) to take corrective

actions without undue delay to eliminate detected nonconformities and their causes
Follow up activities to include

verification of the actions taken

reporting of verification results (see 8.5.2)

91

8.2 Monitoring and Measurement (M & M) (Contd)

8.2.3 Monitoring and Measurement of Processes

Apply suitable methods for Monitoring & where applicable for

Measurement of QMS processes
to demonstrate ability of processes to achieve planned results

If planned results are not achieved, correction and corrective actions

to be taken as appropriate for ensuring conformity of product

92

8.2 Monitoring and Measurement (M & M) (Contd)

8.2.4 Monitoring and Measurement of Product

At appropriate stages of product realization processes (see 7.1),

monitor and measure product requirements to verify that same are
fulfilled
Evidence of conformity with acceptance criteria be maintained
Records to indicate person(s) authorizing release of product
Product release and service delivery shall not proceed until all the
planned arrangements (see 7.1) are satisfactorily completed, unless
otherwise approved by a relevant authority, and where applicable by
the customer
93

8.3 Control of Non-Conforming Product

Establish documented procedure to identify and control nonconforming product to prevent unintended use or delivery
Controls and related responsibilities & authorities dealing with
non-conforming product be defined in procedure
Deal with non-conforming product by one or more of the
following :
Taking actions to eliminate the detected non-conformity
Authorizing its use, release or acceptance under concession by
relevant authority, and where applicable by the customer
By taking action to preclude its original intended use or application

94

8.3 Control of Non-Conforming Product (Contd)

Maintain records of nature of non-conformities and

subsequent actions taken, including concessions obtained
As and when non-conforming product is corrected,
demonstrate conformity to the requirements by re-verification
When non-conformity is detected after delivery or use has
started, take actions appropriate to the effects or potential
effects of non-conformity

95

8.4 Analysis of Data

Determine, collect and analyze appropriate data to

demonstrate suitability and effectiveness of QMS
evaluate to identify areas of continual improvement

Analyze the data to provide information on

customer satisfaction
conformance to product requirements and
characteristics and trends of processes and products including
opportunities for preventive action
suppliers

96

8.5 Improvement

8.5.1 Continual Improvement

Continually improve the effectiveness of QMS
Facilitate Continual Improvement through use of

Quality Policy
Quality Objectives
Audit (Internal & External) Results
Analysis of Data
Corrective and Preventive Action and
Management Review

97

8.5 Improvement (Contd)

8.5.2 Corrective Action

Take corrective action to eliminate the cause of nonconformities to prevent recurrence
Documented procedure to define requirements for

Reviewing non-conformities (including customer complaints)

Determining the causes of non-conformities
Evaluating the need for action to ensure the non-conformities do not
recur
Determining and implementing action needed
Records of the results of actions taken
Reviewing corrective action taken
98

8.5 Improvement (Contd)

8.5.3 Preventive Action

Determine action to eliminate the causes of potential nonconformities to prevent their occurrence
Preventive Actions to be appropriate to impact of potential
problems
Documented procedure to define requirements for

determining potential non-conformities and their causes

evaluating the need for action to prevent occurrence of non-conformities
determining and implementing the actions needed
records of results of action taken
reviewing preventive action taken

99