ISO 9000 SERIES OF

STANDARDS

 ISO 9000:2000-Quality Management

System-fundamentals and vocabulary
 ISO 9001:2000-Quality Management
System-requirements
 ISO 9004:2000-Quality Management
System-guidelines for performance
improvement
SECTOR-SPECIFIC
STANDARDS

 AS 9100: Quality system for aerospace

industry
 ISO/TS 16949: Quality system for
automotive suppliers
 TL 9000: Quality system for supplier of
telecommunications
ISO 9001 REQUIREMENTS
Application of a quality management system
shows the importance of:
Understanding and fulfilling the
requirements
The need to consider processes (value-added)
Obtaining results of process performance and
effectiveness
Continual improvement of process based on
objective measure
ISO 9001 REQUIREMENTS
1. Scope
2. Normative Reference
3. Terms and Definitions
Supplier => Organization => Customer
4. Quality Management System
4.1. General Requirements
4.2. Documentation: General, Quality
Manual, Control of Documents, and
Control of Records
ISO 9001 REQ. (Cont.)
5. Management Responsibility
5.1. Management Commitment
5.2. Customer Focus
5.3. Quality Policy
5.4. Planning: Quality Objectives, Quality
Management System Planning
5.5. Responsibility, Authority, and
Communication: Responsibility and Authority,
Management Representative, Internal
Communication
5.6. Management Review: General, Review Input,
Review Output.
ISO 9001 REQ. (Cont.)

6. Resource Management
6.1. Provision of Resources
6.2. Human Resources: General,
Competence, Awareness and Training
6.3. Infrastructure
6.4. Work Environment
ISO 9001 REQ. (Cont.)
7. Product Realization
7.1. Planning of Product Realization
7.2. Customer-Related Processes:
Determination of Requirements
Related to the Product, Review of
Requirements Related to the Product,
Customer Communication
7.3. Design and Development: D&D
Planning, D&D Inputs, D&D Outputs,
D&D Review, D&D Verification, D&D
Validation, Control D&D Changes
ISO 9001 REQ. (Cont.)
7.4. Purchasing: Purchasing Process,
Purchasing Information, Verification
of Purchased Product
7.5. Production and Service Provision:
Control of PSP, Validation of
Processes for PSP, Identification and
Traceability, Customer Property,
Preservation of Product
7.6. Control of Monitoring and Measuring
Devices
ISO 9001 REQ. (Cont.)
8. Measurement, Analysis, and Improvement
8.1. General
8.2. Monitoring and Measurement: Customer
Satisfaction, Internal Audit, Monitoring and
Measurement of Processes, Monitoring and
Measurement of Product and Service
8.3. Control of Nonconforming Product
8.4. Analysis of Data
8.5. Improvement: Continual Improvement,
Corrective Action, Preventive Action
IMPLEMENTATION

1. Top Management Commitment

2. Appoint the Management Representative
3. Awareness
4. Appoint an Implementation Team
5. Training
6. Time Schedule
7. Select Element Owners
IMPLEMENTATION (Cont.)

8. Review the Present System

9. Write the Documents
10. Install the New System
11. Internal Audit
12. Management Review
13. Preassessment
14. Registration
DOCUMENTATION

 Policy: WHY-WHAT
 Procedure: WHO-WHEN-WHERE
 Work Instructions: HOW
 Records: EVIDENCE
INTERNAL AUDITS
Objectives:
 Determine that actual performance conforms to
the documented QMS
 Initiate corrective action activities in response to
deficiencies
 Follow up on noncompliance items from previous
audits
 Provide continued improvement in the system
through feedback to management
 Cause the auditee to think about the process,
thereby encouraging possible improvements
INTERNAL AUDITS
 Auditor : qualified person to check the
QMS.
 Techniques: examination of documents,
observation of activities, and interviews.
 Procedure: an audit planning. Includes
identify the activity or departments to be
audited, list the procedures and documents,
and etc.
REGISTRATION
Selecting a Registrar:
1. Qualifications and Experiences
2. Certificate Recognition
3. The Registration Process
4. Time and Cost Constraints
5. Auditor Qualifications
REGISTRATION
Registration Process
1. Application for registration
2. Document review
3. Preassessment
4. Assessment
5. Registration
6. Follow-up surveillance (investigation)
ENVIRONMENTAL
MANAGEMENT SYSTEM
ISO 14001 provides organizations to achieve
environmental and economic goals by
integrating into other management systems

Benefits of EMS (Global)

Facilitate trade and remove trade barriers
Improve environmental performance of
planet earth
Build a consensus for environmental
management and common terminology for
EMS (Cont.)
Benefits of EMS (Organizational)
 Assuring customers of a commitment to environmental
management
 Meeting customer requirements
 Maintaining a good public/community relations image
 Satisfying the investor criteria and improving access to
capital
 Obtaining insurance at reasonable cost
 Increasing market share
 Improving defense position in litigation
 Conserving input materials and energy
 Improving industry/government relations