INTRODUCTION TO

ISO 9001:2008

AD SARWAR

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)

• ISO 9001 standards are generic standards that can be applied to any industry

ISO 9000 Family of Standards

•

•ISO 9000:2000 (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 9004:2000 (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

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.

First Edition1987

First Revision1994

Second Revision2000

Third Revision2008

Changing Scope of Quality (‘q’ to ‘Q’)

ProductQuality

“q”

OrganizationalQuality

“Q”

Focus has been shifting from product quality to Assurance

From To

Quality Control Vs Quality Assurance

Material Receiving Sorting Cutting Marking

Final Inspection Galvanizing Washing Acid

Cleansing

q q q q

Quality of each process (q) ensures that system produces the required product that meets customer requirements (Q)

q q q

Q

• Quality is:

Meeting customer expectations and satisfaction Freedom from defects

Quality and Quality Management Systems (QMS)

• QMS is:

Set of policies and procedures to ensure that desired levels of quality are met, reviewed, monitored and improved

08 quality management principles of ISO 9001:2008

THE PDCA CYCLE

PLANPolicy

Resources

Objectives

DOProcesses

Indicators

Prod. Real.

ACTCont. Impr.

Prev. Actions

Corr. Actions

CHECKAudits

Validations

Verifications

PA

C D

(The Deming Wheel)

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

4.1 General Requirements

(Process Approach)

Clause-4, Quality Management System

Determine what processes?

Sequence & Interaction of processes

Control methods for processes

Provided resources for processes

Measure and analyze processes

Improve Processes

4.2 Documentation Requirements

General- Quality Policy, Objectives, Quality Manual, Procedures, Documents

& Records

Control of Records

Quality Manual

Control of Documents

QMS Documentation Requirements

Policy &Objectives

Quality Manual

Quality System Procedures(Auditing, Document Control, Corrective Action etc.)

Records, Reports/ Logs(Test Reports, Defect Reports, Training records etc.)

Process Procedures, Plans(Operation procedures, plans, test methods, specifications etc.)

Commitment &Goals

Overall summary and system str.

Procedures related to QMS

Technical Procedures

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)

Steps to Implement ISO 9001:2008 QMS• Establish a quality policy• Set your quality objectives• Establish QMS organization• Establish communication channels• Product design and development• Purchasing & supplier management• Product monitoring & measurement• Monitoring equipment management• Customer satisfaction measurement• Internal Audit• Product Conformity• Measure performance• Analyse performance• Improve performance by corrective and preventive actions

ISO 9001 Implementation and Certification Process

ImplementationActivities

• Gap Analysis

•System Design

• Implementation & Documentation

CertificationActivities

• Audit

• Corrective Actions

• Award of Certificate

MaintenanceActivities

• Surveillance Audits

6~12 Months 1~3 Months After each year

Benefits of ISO CertificationFinancial 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

• ISO9001:2008 focuses on process improvement and better management

Documented processes & procedures (SOPs) Performance Measurement (KPIs development) Continual development (Corrective Action & Implementation) To improve internal operational efficiency to enhance quality

• What processes are required to documented and controlled??

Management Responsibility Resource Management Product Realization Measurement, Analysis & Improvement

Conclusion

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)

Queries : Questions : Concerns