1. Quality Management Systems
Anurag Sharma
Alfred Borget Anoye

2. Introduction

3. Why develop quality standard?
To increase quality oriented customers
To generalize norms of quality
To prepare credible benchmarking

4. Most prevalent standards
ISO 9000: specifies necessary components of a quality management system
ISO 14001: manages environment processes and impacts
QS 9000: supplement of IS0 9000:1994 for continuous improvement, prevention of nonconformance, and scrap and rework reduction
ISO/TS 16949: specific to the Automotive industry

5. Most prevalent standards (cont’d)
AS 9100: specific to aerospace industry
TL 9000: specific to telecommunications industry
ISO & 88: specific to medical devices
TE Supplement: specific to US automotive suppliers

6. History of ISO
Found in 1946
International standards for quality systems published in 1987
Republished and updated version in 1994

7. Benefits of ISO regulation
Significant improvement on:
Internal quality
Production reliability
External quality
Time performance
Cost of poor quality

8. ISO 9000 series of Standards
ISO 9000: 2000 –focus on fundamentals and vocabulary
ISO 9001: 2000—focus on requirements
ISO 9004: 2000—focus on guidelines for performance improvement

9. ISO 2001 Requirements
It is the standard used for registration by acquiring conformity of the quality management system
More details of IS found in

10. Implementing ISO Management Interest Management representation
Awareness and communication
Assigning a team
Training and practices
Time Frame
Element ownership

11. Implementing ISO (cont’d)
Revision of the current system
Documentation
Identifying flaws
Installing new system
Auditing
Management assessment
Registration

12. Documentation (why is it needed?)
Records or proofs
Future references
Planning and updating
Traceability

13. Cascading documentation
Policy
Procedure
Work Instructions
Document Development

14. Document development
Policies, procedures and work instruction brought together
Revision
Discarding irrelevant documents
Changes and amendments
Updating
Reader friendly format

15. Documentation Simplicity Brevity and Conciseness Attractive format
Good fonts and designs
Relevant information
Traceability
Underscoring important issues

16. Creating Manuals Statement of purpose Company’s policy
Making controlled copies
Inclusion of ISO 9001
Flow diagrams and figures instead of verbiage
Procedure manuals (refer to flow diagram in text)

17. Auditing
One of the key elements of ISO standard, audit is performed in order to make sure if the system is being followed and the expected results are obtained.
It is done by the qualified individuals who are trained in auditing principles and procedures.

18. Objectives of Auditing
Conformance of actual performance
Identifying deficiencies and implementing corrective actions
Improvising the system
Inculcating flawless process to employees

19. Auditing techniques Examining documentation Observing activities
Listening to employees
Identifying significant issues from trivial
Generating appropriate questionnaire

20. Auditing procedure
Auditing procedure comprises of making audit plan and checklist first. The plan should contain department, its activity, list of procedures and regulatory requirement. The checklist on the other hand is a form of questions based on procedures, records and work instruction to ensure the well running of system.

21. Registration
Quality systems registration is an assessment and audit of a quality system by a third party; a registrar. Selecting a registrar is based upon the qualifications, recognition, process of registration and time limits.

22. Registration process Application Review Preassessment Assessment
Follow-up surveillance

23. Questions
What is more important, implementation of an ISO or its registration?
Case study
Company A has an ISO 9001 registration, all its processes are well governed and follow ISO regulations. It delivers excellent products to customers.
Company B does not have ISO registration, but it still manufactures products as good as Company A.
How can we prove company A superior to company B?