Introduction to ISO 9001 by ShahMuhammad


More Info
 ISO 9001:2008

•   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 good 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
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

                                  Second Revision

                 First Revision

 First Edition
ISO 9000 Family of Standards
•ISO 9000:2000 (Quality Management Systems – Fundamentals and
-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
-Only standard in the ISO 9000 family against which third-party certification
can be carried out
•ISO 9004:2000 (Quality Management Systems – Guidance for Performance
-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
Process Improvement

• When process outcome is in trouble, there could possibly be
  three factors:

    70% of processes/ systems not followed (Process Control)
    20% processes are ineffective (Process Improvement)
    10% processes not suitable (Process Re-engineering)

• Level 1 analysis is finding incidences &
• Level 2 analysis is finding factors/ reasons
        ISO 9001:2008
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 unity of purpose 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
08 quality management principles of ISO 9001:2008
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
08 quality management principles of ISO 9001:2008

7. Factual approach to decision making
    – Effective decisions are based on the analysis of data and

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.

• Formalize                                 • Establish Expectation
  Improvement                               • Define processes &
• Corrective Actions     Act       Plan       procedures

                       Check       Do
        • Evaluate &                        • Establish
        • Compare                             Implementation

                       (The Deming Wheel)
ISO 9001:2008 CLAUSES
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 &
    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 &

              Overall summary
              and system str.           Quality Manual

     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

• 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

•   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 &
                                                          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

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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