Lecture ISO9001

DISCUSSION TOPICS
• Definition and Introduction

• History of ISO
• ISO Family & Standards in Pakistan
• Quality Management Principles of ISO 9001:2008
• ISO 9001:2008 Requirements/ Clauses
• Process Flow for Implementing ISO 9001:2008
• Benefits
• Conclusions & Take-aways
What is ISO?
• ISO is the International Organization of Standardization
• ISO is an organization that develops standards for use

worldwide to help companies better manage themselves
• ISO 9001:2008 outlines criteria for a Quality Management

System (QMS)
What is ISO 9001?
• ISO 9001 is the structural framework of a quality management
system
• ISO 9001 standards are generic standards that can be applied

to any industry
• It is important to note ISO 9000 is not a product standard; it is

rather a system standard
• It promotes standardization in processes and then measures

performance
History of ISO 9000
• ISO was formed after world war II in Geneva to write
quality standards to evaluate the quality management
systems of potential suppliers.
Third Revision
2008
Second Revision
2000
First Revision
1994
First Edition
1987
ISO 9000 Family of Standards
•ISO 9000:2008 (Quality Management Systems – Fundamentals and
Vocabulary)
•-Defines the fundamental terms & definitions used in ISO 9000
•ISO 9001:2008 (Quality Management Systems – Requirements)
-Defines the requirements for assessing the ability to meet customer and
applicable regulatory requirements and thereby address customer
satisfaction
-Only standard in the ISO 9000 family against which third-party certification
can be carried out
•ISO 9004:2008 (Quality Management Systems – Guidance for Performance
Improvement)
-Provides guidance for continual improvement of the quality management
system to benefit all parties through sustained customer satisfaction
Famous ISO Standards in Pakistan
• ISO14001 Environmental Management Standards

in production environments
• OHSAS 18001 Occupational health and safety

management system specifications
• ISO 22000 Food safety management systems

Requirements for any organization in
the food chain
• ISO27001 Information security management

systems Requirements
08 QMPs of ISO 9001:2008
08 quality management principles of ISO 9001:2008
1. Customer Focus
– What, where, how and when do your customer require?
– If you ensure it, it will ascertain in return that they would buy (or
continue to buy) from you
2. Leadership
– Leadership establishes environment, culture and direction
– Good leadership creates an environment where people can become
fully involved in achieving the organization’s objectives for quality
3. Involvement of people
– People at all levels are the essence of an organization and their full
involvement enables maximum utilization of individual abilities for the
organization’s benefit
– To educate, train and motivate employees to ensure their competence
in performing tasks affecting quality, environment, health and safety
4. Process approach
– A desired result is achieved more efficiently when activities and
related resources are managed as a process
5. System approach to management

– Identifying, understanding and managing interrelated processes
as a system contributes to the organization’s effectiveness and
efficiency in achieving its objectives
6. Continual improvement
– Continual improvement of the organization’s overall
performance should be the permanent objective of the
organization
7. Factual approach to decision making

– Effective decisions are based on the analysis of data and
information
8. Mutually beneficial supplier relationship

– An organization and its suppliers are interdependent and a
mutually beneficial relationship enhances the ability of both to
create value.
– Promote quality, environmental, health and safety principles.
– Requiring suppliers to improve their practices and encouraging
wider adoption of these principles by suppliers.
ISO 9001:2008 Structure
• Scope Section 1
• Normative References Section 2
• Terms & Definition Section 3
• Quality Management System Section 4
• Management Responsibility Section 5
• Resource Management Section 6
• Product Realisation Section 7
• Measurement, Analysis and
Improvement Section 8
QMS-Section 4
Clause-4, Quality Management System
4.1 General Requirements

4.2 Documentation Requirements
(Process Approach)
Determine what processes? General- Quality Policy, Objectives,

Quality Manual, Procedures, Documents
& Records
Sequence & Interaction of processes
Quality Manual
Control methods for processes

Control of Documents
Provided resources for processes

Control of Records
Measure and analyze processes
Improve Processes
QMS Documentation Requirements
Commitment & Policy &

Goals
Objectives
Overall summary
and system str. Quality Manual
Procedures
related to QMS Quality System Procedures
(Auditing, Document Control, Corrective Action etc.)
Technical Process Procedures, Plans

Procedures (Operation procedures, plans, test methods, specifications etc.)
Records, Reports/ Logs

(Test Reports, Defect Reports, Training records etc.)
Proofs, Evidences
Management Responsibility-Section 5
• Management commitment - evidence of commitment to the
development and improvement of QMS
• Customer focus - ensure customer needs and expectations

are understood and satisfied
• Quality policy - appropriate for company, communicated and

reviewed
• Planning - quality objectives and planning
• Administration - responsibility and authority, management

representative and internal communication
• Review - QMS to be reviewed at planned intervals

Resource Management-Section 6
• General – Required and competent resources
• Competence, Training & Awareness
• Infrastructure- Building, workspace, process equipment

& other services
• Facilities - workspace, equipment and supporting

services
• Work environment
Product Realization-Section 7
• Product realisation is the sequence of processes and

sub-processes required to achieve the product - must
be planned
• Customer-related processes - identification of
requirements, product obligations and communication
• Design and/or development - planning, inputs and
outputs, review, verification and changes control
• Purchasing - control and purchasing information
• Production and service operations - operations
control, traceability, preservation and verification
• Control of measuring and monitoring devices
Measurement, Analysis & Improvement-
Section 8
• Measurement, analysis and improvement

(Processes, Customer satisfaction, Product &
Equipment)
- Planning
- Customer satisfaction
- Internal audit
- Control of nonconformity
- Analysis of data
- Improvement (CA & PA)
Conclusion (Sequencing & Interaction)
Continual Improvement
• Effectiveness of QMS must continually be improved by:
 Quality Policy
 Objectives (KPIs)
 Audit Results
 Analysis of data
 Corrective Actions
 Preventive Actions
 Management Reviews
ISO 9001 Implementation –Flow Chart
Selection of External QA Consultants for ISO9001
training and advisory Implement corrective actions to meet
ISO9001:2008 requirements
ISO9001 High level Training / Awareness Sessions

Mock Audit
Gap Analysis between Existing systems & ISO9001

External 3rd Party Audit &
standards
ISO9001:2008 Certification
System Development and Document Processes, SOPs Surveillance Audits

and Work Instructions
System implementation according to the documented

Processes, SOPs and Work Instructions
Perform Internal Audits

Steps to Implement ISO 9001:2008 QMS
• Management Decision and Commitment

• Establishment of Quality Council
• Appoint your Management Representative
• Establish Quality Policy and Objectives
• Establish QMS Organization
• Provide Infrastructure and other Resources
• Review of Current QMS (Gap Analysis)
• Documentation Process (Technical & QA)
• Implementation of Processes and Monitoring through KPIs
• Perform Internal Audit
• Improve performance by corrective and preventive actions
• Perform Assessment
• External Audit and Certification
ISO 9001 Implementation and Certification Process
Implementation Certification Maintenance

Activities Activities Activities
• Gap Analysis • Audit • Surveillance Audits
•System Design • Corrective Actions
• Implementation • Award of Certificate

& Documentation
6~12 Months 1~3 Months After each year

Some Reasons of Failure
• Over Documentation
• Emphasis on adherence and not adequacy
• Just get the certificate!
• Loss of direction and credibility
• Short term Corrective/ Preventive Actions
• Weak auditing system

Benefits of ISO Certification
Financial benefits:
• Profits are enhanced because of increased acceptability
• More work is done in less time thus increasing production rate
• Cost of quality comes down as a whole
For the Organization:

• Products are of consistent quality
• Production is more efficient with less reworks
• Export marketing is easier
• Increased market share
• Customer confidence is enhanced as they expect products of consistent
quality
For Employees:
• Better understanding of their work.
• Reduced stress level because of an efficient management system
• New staff learns their job quickly because it's written down
Quality is the result of a carefully
constructed cultural environment. It has
to be the fabric of the organization, not
part of the fabric
(Philip B. Crosby)

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What is ISO?

What is ISO?

What are the eight quality management principles of ISO 9001:2008?

What are the eight quality management principles of ISO 9001:2008?

DISCUSSION TOPICS

• Definition and Introduction

• ISO is an organization that develops standards for use

• ISO 9001:2008 outlines criteria for a Quality Management

• ISO 9001 standards are generic standards that can be applied

• It is important to note ISO 9000 is not a product standard; it is

• It promotes standardization in processes and then measures

• ISO14001 Environmental Management Standards

• OHSAS 18001 Occupational health and safety

• ISO 22000 Food safety management systems

• ISO27001 Information security management

5. System approach to management

7. Factual approach to decision making

8. Mutually beneficial supplier relationship

4.1 General Requirements

Determine what processes? General- Quality Policy, Objectives,

Control methods for processes

Provided resources for processes

Measure and analyze processes

Commitment & Policy &

Technical Process Procedures, Plans

Records, Reports/ Logs

• Customer focus - ensure customer needs and expectations

• Quality policy - appropriate for company, communicated and

• Planning - quality objectives and planning

• Administration - responsibility and authority, management

• Review - QMS to be reviewed at planned intervals

• Competence, Training & Awareness

• Infrastructure- Building, workspace, process equipment

• Facilities - workspace, equipment and supporting

• Product realisation is the sequence of processes and

• Measurement, analysis and improvement

ISO9001 High level Training / Awareness Sessions

Gap Analysis between Existing systems & ISO9001

System Development and Document Processes, SOPs Surveillance Audits

System implementation according to the documented

Perform Internal Audits

• Management Decision and Commitment

Implementation Certification Maintenance

• Gap Analysis • Audit • Surveillance Audits

•System Design • Corrective Actions

• Implementation • Award of Certificate

6~12 Months 1~3 Months After each year

• Emphasis on adherence and not adequacy

• Just get the certificate!

• Loss of direction and credibility

• Short term Corrective/ Preventive Actions

• Weak auditing system

For the Organization:

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