1. UNIT V QUALITY SYSTEMS

2. ISO (International organisation for standardisation)
Definition:
“The quality system is the organisation structure, responsibilities, procedures, process and resources for implementing quality management.”

3. In short a quality system involves:
The quality system should function in such a manner as to provide proper confidence that :
The system is well understood and effective
The products or services actually do satisfy customers expectations.
In short a quality system involves:
How- Methods and process description
Who- Responsibilities and authorities
When- Records and evidence
Where- identification and traceability

4. ISO 9000
The ISO 9000 family is primary concerned “ quality management”. This means what the organisation does to fulfill.
The customers quality requirement
Applicable regulatory requirements
Enhance customers satisfaction
Continuous improvement

5. Need For ISO 9000
Every organisation is concerned with the quality of its product or service.
Reasons for implementing a quality system:
Improved employee involvement
Improved housekeeping
Improved decision making
Improved customers satisfaction
Improved safe working
Reduced customer complaints
Reduced quality cost

6. ISO 9000 Quality system
The ISO 9000 standards are a collection of formal international standards, technical reports, had books and web based documents on quality management and quality assurance ISO technical committee and it sub committees are responsible for the development of the standards

7. ELEMENTS OR CAUSES OF ISO 9000
Management responsibility
Contract review
Design control
Document control
Purchasing
Purchaser supplied product
Product identification and traceability
Process control

8. Inspection and testing
Measuring and test equipment
Inspection and test status
Control of non- conforming products
Corrective and preventive action
Handling, storage, packaging and delivery
Control of quality records
Internal quality audits
Servicing
Stastical techniques

9. Steps To Registration Of Quality System
Top management commitment
Appoint the management representative
Awareness
Appoint an implementation team
Training
Time schedule
Select element owners

10. Review the present system
Write the documents
Install the new system
Internal audit
Management review
Registration
Award of ISO 9000 certificate

11. Documentation Of Quality System
The documents required by most organisations are:
Quality policy manual
Quality system procedures
Work instructions
Record/Formats/Forms

13. Quality Auditing
Quality auditing should be carried out in order to verify whether a quality system is effective and suitable
Definition:
A quality system audit is define as “ a systematic and in dependent examination to determine whether quality activities and related results comply with planned arrangements, whether these arrangement are implemented effectively and whether these are suitable to achieve objectives.”

14. Features Of Quality Audits
The quality audit typically applies to quality system or elements such as process, products or service.
Quality audits are carried by staff who are not directly responsible in the areas being audited

15. Types Of Audits
First party audit or internal audit: Where the auditee is its own client
Second party audit: This refers to audit by one organisation on another organisation
Third party audit: This refers to audit by an independent organisation on a supplier, for accreditation assessment purpose

16. Objectives Of Quality Audits
To determine the conformity or non- conformity of the quality system elements with regard to specified requirements.
To determine the effectiveness of the implemented quality system in meeting specified quality objective
To meet regulatory, if applicable
To evaluate an organisation’s own quality system against a quality system standard

17. Stages Of Audit Audit planning Audit performance Audit reporting
Audit follow-up

18. ISO 14000
The ISO standards are a set of norms for environmental management system either at organisation and process level or product level
The series of ISO14000 standards are designed to cover:
Environmental management system
Environmental auditing
Environmental performance evaluation
Life- cycle assessment
Environmental aspects in product standards

19. Organisation Evaluation Standards

20. Concepts Of ISO14000

21. Requirements Of ISO14000 General requirements Environmental policy
Environmental aspects
Legal aspects
Objective and targets
Environmental management program
Structure and responsibility

22. Training and awareness program
Communications
Document control
Operational control
Monitoring and measuring
Recording
Environmental management system audit
Management review

23. Benefits of ISO14000
The benefits of ISo14000 quality system can be viewed in two categories
Global benefits
To facilitate trade and remove trade barriers
To improve environmental performance of plant earth
Organizational benefits
Satisfying customers requirement
Improving team work
Improving industry/ government relations
Maintaining a good relationship with public /community /
society

24. Case study