1 Quality Management System

American Academy of Project Management

PRODUCTIVITY ACADEMY www.prodemyasia.com

What’s ISO?

 International Organization for

Standardization
 Provide international standards for
products and services Facilitates worldwide
exchange of goods and services

PRODUCTIVITY ACADEMY www.prodemyasia.com

1
  What We Need to Know
1. Basics of ISO
2. Benefits
3. Requirements
4. Documentation Procedures
5. How to Implement ISO
6. How to do an Internal Audit
7. How to Register

PRODUCTIVITY ACADEMY www.prodemyasia.com

Getting to Know ISO

 Found in 1946 Geneva, Switzerland

–

 90 Member Countries
 ANSI USA Representative
–

 ISO Technical Committee (TC) 176

Developed the International Standards for Quality
in 1987 ISO 9000, 9001 & 9004

PRODUCTIVITY ACADEMY www.prodemyasia.com

2
  Benefits of ISO Registration

 Global competitiveness
 Maintain or increase market shares
 Secondary benefits for the supplier
 Decrease in scrap, rework and nonconformities at
final inspection
 Increase in product reliability
 Improved time to market, on-time delivery and
throughput
 Decrease in the cost of poor quality measured but
external forces

PRODUCTIVITY ACADEMY www.prodemyasia.com

Requirements

 Scope
 Normative References
 Terms and Definitions
 Quality Management System (QMS)
 Management Responsibilities
 Resource Management
 Product or Service Realization
 Measurement, Analysis and Improvement

PRODUCTIVITY ACADEMY www.prodemyasia.com

3
 1 Three Requirements
 st

INFORMATION ONLY
 Scope
 Normative Reference
 Terms and Definitions

PRODUCTIVITY ACADEMY www.prodemyasia.com

PRODUCTIVITY ACADEMY www.prodemyasia.com

4
 4 – Quality Management System
(QMS)

 Identify the process

 Determine the process sequence
 Set methods for effective operation and control of
process
 Ensure availability of resources and information for the
process
 Monitor, measure and analyze the process
 Continually improve the process
 Document Quality policies, manuals, procedures...Set
controls for documents and maintain records of conformance

MODEL OF A PROCESS-BASED QUALITY MANAGEMENT SYSTEM



PRODUCTIVITY ACADEMY www.prodemyasia.com

5 – Management Responsibility

 Commitment
 Customer Focus
 Quality Policy
 Planning Quality Objectives and QMS
–

 Define Responsibilities, Authorities and

Communication

 Review

PRODUCTIVITY ACADEMY www.prodemyasia.com

5
 6 – Resource Management

 Provision of Resources
 Human Resources
 Infrastructure
 Work Environment

PRODUCTIVITY ACADEMY www.prodemyasia.com

7 Product Realization
–

 Plan
 Customer Related
 Design and Develop
 Purchasing
 Production and Service Provision
 Control of Monitoring and Measuring
Devices

PRODUCTIVITY ACADEMY www.prodemyasia.com

6
 8 Measure, Analyze and Improve
–

 Monitor and Measure

 Control of Nonconforming Product
 Analysis of Data
 Improvement

PRODUCTIVITY ACADEMY www.prodemyasia.com

 Documentation

PRODUCTIVITY ACADEMY www.prodemyasia.com

7
 Implementation
 Top Management Commitment
 Appoint the Management Representative
 Awareness
 Appoint an Implementation Team
 Training
 Time Schedule
 Select Element Owners
 Review the Present System
 Write the Documentation
 Install the New System
 Internal Audit
 Management Review
 Pre-Assessment
 Registration

PRODUCTIVITY ACADEMY www.prodemyasia.com

Implementation Activivities

PRODUCTIVITY ACADEMY www.prodemyasia.com

8
 Internal Audits

•
 Objectives
1. Does actual performance conform to documented
Q MS ?
2. Initiate corrective action to deficiencies
• 3.Follow up on noncompliance items from previous
• audits
4.Provide continued improvement through feedback
Encourage possible improvements by thinking about the
system

PRODUCTIVITY ACADEMY www.prodemyasia.com

 How To Do An Internal Audit

 Auditor
 n Trained in auditing principles and procedures n Objective, honest and impartial
 n Good communicator, listener and observer
 Techniques
 n Examination of documents n Observation of activities
 n Interviews
 Procedure
 n Pre-Audit Meeting
 Timetables, what is being audited, review requirements
 n Audit
 Determine how well the system has been implemented and maintained
 n Closing Meeting
 Present a summary including nonconformities, corrective action and decide on follow-up

PRODUCTIVITY ACADEMY www.prodemyasia.com

9
Two Ways to be ISO Certified

 2-Party System Customer audits the supplier’s

quality system
 3-Party System
Registrar audits and certifies a supplier’s quality
system

PRODUCTIVITY ACADEMY www.prodemyasia.com

 Registration

•
 Select a Registrar
Qualifications and experience
Certificate recognition
Registration process
Time and cost constraints
Auditor qualifications

PRODUCTIVITY ACADEMY www.prodemyasia.com

10
  Registration Process
 Application for Registration
 Document Review
 Pre-Assessment
 Assessment
 Registration
 Follow-up Surveillance

PRODUCTIVITY ACADEMY www.prodemyasia.com

What We Now Know

1. Basics of ISO
2. Benefits
3. Requirements
4. Documentation Procedures
5. How to Implement ISO
6. How to do an Internal Audit
7. How to Register

PRODUCTIVITY ACADEMY www.prodemyasia.com

11