ISO 9001:2008 QMS

COURSE Materials

Introduction of the Resource Person

Engr. Bilal Haider
Lecturer
Institute of Chemical Engg. & Tech.
University of the Punjab, Lahore
Qualification:

B.Sc. Engg. (Chem.), MS (TQM), Lead Assessor ISO 17025, 9000

Professional Affiliations:

PNAC & NA

Professional Trainings:

ISO/IEC 17025 Assessor Course, Norwegian Accreditation (Norway)

IRCA Qualified ISO 9000 Auditor
National Quality Award Assessor (NQAA) Course organized by Asian Productivity
Organization (APO), Japan.
Evaluation of Measurement Uncertainty, Norwegian Accreditation (Norway)
ISO 17020 General criteria for the operation of various types of bodies performing
inspection organized by PNAC

Discussion Topics
Introduction to Quality and Standardization
Evolution of Quality Management System

(ISO 9000)
Quality Management System - Requirements

(ISO 9001:2008)

Introduction to Quality and

Standardization

What is Quality after all?

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

Customer Satisfaction
Degree to which the customers requirements have been
fulfilled

Performance
Satisfaction =
Expectation

< 1 - Dissatisfaction
= 1 - Satisfaction
> 1 - Delight

Standardization
The process of developing and agreeing upon Standards.

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

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.

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.

Attributes of a standard
A standard generally has three attributes:
1.

Level: such as at the company, national or international level.

2.

Subject: such as engineering, food, textile or management.

3.

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.

Infrastructure for Standardization in Pakistan

ILAC
IAF

ISO

Legal framework in Pakistan

Accreditation Board
PNAC

BIPM

Standards Institute
PSQCA

OIML

An institution for training and monitoring Auditors

System
auditors

System
consultants

Laboratory
accreditation
ISO 17025

HACCP

ISO14000

ISO 9000

IB

LABORATORIES

Microbe

Chemical

TESTING SERVICES

NPSL

ATION

L
CA

TIO
A
R

Textile

CALIBR

System
certifiers..

Factory
metrology
lab

ENTERPRISES

Legal
metrology

Trade
transaction

Renowned Standardization Bodies

ISO
ASTM
DIN
EN

International Organization for Standardization

American Society for Testing and Materials
Deutsches Institut fr Normung
European Norms

IEC
BSI

International Electrotechnical Commission

British Standards Institute

Certification
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 .
1.

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

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

Quality Management System

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

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

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

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)

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
organizations objectives.
This principle is reflected in ISO
9001:2008 clauses 5.3, 5.4, 5.5, 6.1, 6.2

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 organizations 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 peoples
contributions.

Quality Management Principle No.3

Involvement of people

People at all levels are essence of an organization

and their full involvement enables their abilities to be
used for the organizations benefit. This principle is
reflected in ISO 9001:2008 clauses 5.3(d) and 6.2.

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.

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.

Quality Management Principle No.4

Process Approach

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

Process Approach...

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...

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.

Quality Management Principle No.5

System approach to management

Identifying, understanding and managing interrelated processes as a system contributes to the

organizations effectiveness and efficiency in
achieving its objectives. This principle is reflected in
ISO 9001:2008clauses 4.1& 4.2.

System approach to management...

Application of this principle involves:

Structuring a system to achieve the organizations
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.

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.

Quality Management Principle No.6

Continual Improvement

Continual improvement of the organizations overall

performance should be a permanent objective of the
organization.
This principle is reflected in ISO 9001 clause 8.5.

Continual Improvement...

Application of this principle involves:

Employing a consistent organization-wide approach
to continual improvement of the organizations
performance.
Providing people with training in the methods and
tools of continual improvement.

Continual Improvement...

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.

Quality Management Principle No.7

Factual approach to decision making

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

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

Quality Management Principle No.8

Mutually beneficial supplier relationships

An organization and its suppliers are interdependent and a mutually beneficial

relationship enhances the ability of both to
create
value.
This principle is reflected in ISO 9001:2008
clause 7.4

Mutually beneficial supplier relationships

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

Sharing information and future plans.

Establishing joint development and improvement
activities.
Inspiring, encouraging and recognizing improvements
and achievements by suppliers.

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

organizations overall performance

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)

PDCA Methodology
Plan
Act

Do

check

Model of Process based Quality Management System

Continual Improvement of the quality
management system

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Management
responsibility

Measurement,
analysis &
improvement

Resource
management

Product
realization

Product

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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

Quality Management System - 1

4.1 General Requirements
a)
b)
c)

Identification of the processes for the QMS

Determine the sequence of these processes
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 - 2

4.2

Documentation Requirements - 1

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

Quality Management System - 3

4.2

Documentation Requirements - 2

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

Quality Management System - 4

4.2 Documentation Requirements - 3
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

Quality Management System - 5

4.2

Documentation Requirements - 4

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

Documentation Requirements
Clause 4
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

Management Responsibility - 1
5.1 Management Commitment
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
5.2 Customer Focus
Determine and meet the customer requirements
for enhancing customer satisfaction

Management Responsibility - 2
5.3 Quality Policy
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

Management Responsibility - 3
5.4

Planning - 1

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

Management Responsibility - 4
SMART Objectives

Specific
Measurable
Achievable
Results orientated
Time bound

Management Responsibility - 5
5.4 Planning - 2
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 - 6
5.5 Responsibility, Authority and Communication - 1
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

Management Responsibility - 7
5.5 Responsibility, Authority and Communication - 2

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 - 8
5.6

Management Review - 1

5.6.1 General
The management shall review the QMS at
planned intervals to ensure its 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

Management Responsibility - 9
5.6

Management Review - 2

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 - 10
5.6

Management Review - 3

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

Documentation Requirements
Clause 5
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

Resource Management - 1
6.1

Provision of Resources

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 - 2
6.2

Human Resources

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

Resource Management - 3
6.3

Infrastructure

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)

Resource Management - 4
6.4

Work Environment

The organization shall determine and manage

the work environment needed to achieve
conformity to product requirements

Documentation Requirements
Clause 6
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

Product Realization - 1
7.1

Planning of Product Realization

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)

Product Realization - 2
7.2

Customer Related Processes - 1

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

Product Realization - 3
7.2

Customer Related Processes - 2

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

Product Realization - 4
7.2

Customer Related Processes - 3

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

Product Realization - 5
7.3

Design and Development - 1

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

Product Realization - 6
7.3

Design and Development - 2

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

Product Realization - 7
7.3

Design and Development - 3

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

Product Realization - 8
7.3

Design and Development - 4

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

Product Realization - 9
7.3

Design and Development - 5

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.

Product Realization - 10
7.3

Design and Development - 6

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.

Product Realization - 11
7.3

Design and Development - 7

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.

Product Realization - 12
7.4

Purchasing - 1

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

Product Realization - 13
7.4

Purchasing - 2

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

Product Realization - 14
7.4

Purchasing - 3

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 suppliers premises
is required by organization / customer, it
shall be indicated so in the purchase
information.

Product Realization - 15
7.5

Production and Service Provision - 1

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.

Product Realization - 16
7.5

Production and Service Provision - 2

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

Product Realization - 17
7.5

Production and Service Provision - 3

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

Product Realization - 18
7.5

Production and Service Provision - 4

7.5.4Customer Property

The organization shall

a)

Identify, verify, protect

customer property

and

safeguard

b) In case of loss, damage or unsuitable for use

customer must be informed
c)

Records must be maintained

Product Realization - 19
7.5

Production and Service Provision - 5

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

Product Realization - 20
7.6

Control of Monitoring and Measuring Equipments

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

Documentation Requirements
Clause 7
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 customers requirements
Specifications for companys products
Procedure for design and development
Specifications for purchased materials

Documentation Requirements
Clause 7 contnd..
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.

Documentation Requirements
Clause 7 contd
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.

Documentation Requirements
Clause 7
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).

Measurement, Analysis and Improvement - 1

8.1

General

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

Measurement, Analysis and Improvement - 2

8.2

Monitoring & Measurement - 1

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

Measurement, Analysis and Improvement - 3

8.2

Monitoring & Measurement - 2

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

Measurement, Analysis and Improvement - 4

8.2

Monitoring & Measurement - 3

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.

Measurement, Analysis and Improvement - 5

8.2

Monitoring & Measurement - 4

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.

Measurement, Analysis and Improvement - 6

8.3 Control of Nonconforming Product - 1
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.

Measurement, Analysis and Improvement - 7

8.3 Control of Nonconforming Product - 2
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

Measurement, Analysis and Improvement - 8

8.4

a)
b)
c)

d)

Analysis of Data

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:
Customer Satisfaction (see 8.2.1)
Conformity of product requirements (see 7.2.1)
Characteristics and trends of processes and
and products including opportunities of
Corrective action
Suppliers

Measurement, Analysis and Improvement - 9

8.5

Improvement - 1

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

Measurement, Analysis and Improvement - 10

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 - 11

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 - 12

8.5

Improvement - 4

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

Measurement, Analysis and Improvement - 13

8.5

Improvement - 5

d) Records of results action taken

e) Reviewing preventive action taken

Documentation Requirements
Clause 8
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.

Documentation Requirements
Clause 8 contnd..
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.

Documentation Requirements
Clause 8 contnd..
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.

No body
Can Achieve

QUALITY
Without

Thank you !!!