TOTAL QUALITY MANAGEMENT QUALITY SYSTEMS

UNIT-5
QUALITY SYSTEMS
5.1 ELEMENTS OR CLAUSES OF ISO 9000
Quality system requirements:
There are twenty elements of a quality system
1. management responsibility
2. quality system
3. Contrast review
4. design control
5. document control
6. Purchasing
7. Purchaser supplied product (control of customer -supplied product)
8. Product identification and Traceability
9. Process control
10. inspection and testing
11. inspection measuring and test equipment
12. inspection and test status
13. Control of non-conforming products.
14.Corrective and preventive action
15. dandling, storage, packaging , preservation and delivery.
16. control of quality records.
17. Internal quality audit18. Training
19. servicing
20. statistical techniques
Implementation of quality system(steps to registration)
ISO 9000 quality management system generally require the following steps
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
8. Review the Present System
9. Write the Documents
10.Install the New System
11. Internal Audit
12. Management Review
13. Pre-assessment
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14. Registration
15. Award of ISO 9000 certificate
5.2 DOCUMENTATION OF QUALITY SYSTEM:
The documentation serves as reference for the management, the staffs and other
agencies whose involvement is essential for implementation of the quality system.

Figure : The documentation pyramid

Advantages:
1.Serves as a reference
2. Brings about clarity of objectives and targets.
3. provides standardization in work procedure.
4.Brings out consistency in operations.
5. Develops confidence amongst employees

7. provides a basis for continuous improvement.

Documents to be prepared:
The documents required by most organizations are,
1.Quality policy manual
2. Quality system procedures
3. Work instructions
4. Records/ Formats /forms.

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Benefits of documentation:
Documentation regularizes the method of performing the day-to-day activities.
It provides formats for standardizing practices.
It provides reference for assessing degree of enforcement in practice.
It facilitates trouble shooting for tracking back on the process.
It demonstrates the ISO quality system certification
5.3 QUALITY AUDITING:
A quality system audit is defined as a systematic and independent organization to
determine whether quality activities and related results comply with planned arrangements,
whether those arrangements are implemented effectively and whether these are suitable to
achieve objectives.
Features of quality audit:
The quality audits applies to quality systems .
Quality audits are carried by staff who are not directly responsible in the areas
being audited.
Quality audit is an information gathering activity.
Quality audits may be conducted for internal or external purposes.
Types of audits:
There are three types of audit
1.First party audit (or internal audit)
2.second party audit
3.Third party audit
Objectives or need for quality audit:
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
To meet regulatory requirements.
To permit the listing of the audited organizations quality system in a register.
To evaluate an organizations own quality system against a quality system standard.
Stages of an audit:
1.audit planning
The key elements of audit planning are,
Audit schedules
Audit personal
Notification to the audited

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Preparation of checklist.
2.Audit performance
The key elements of audit performance are,
Opening/ entry meeting
Audit process
Audit deficiencies
3. Audit reporting:
Audit reporting may contain,
Identification of the reference documents against which audit is conducted.
Observations of non-conformities
Corrective action requests.
4. audit follow up
The auditor is responsible only for identifying the non- conformity.
Corrective action and subsequent follow-up should be completed with in a time period.
5.4QS 9000 AUTOMOTIVE QUALITY MANAGEMENT SYSTEMS:
Qs 9000 is a set of quality system requirements recently adopted by members of the
automotive industry.
The objective of a QS 9000 is to develop fundamental quality systems based on
continuous improvement, direct prevention, reduction of variation and waste elimination in the
automobile supply chain.
1. QS 9000 can be applied to all internal and external suppliers of
2. Production materials
3. Production or service parts.
4. Heat treating, painting, plating services.
Structure of QS 9000
QS 9000 standards can be divided in to 3 sections.
Section 1: ISO based requirements
It includes the exact test of ISO-9001 with the addition of automotive / heavy trucking
requirements.
Section 2: Automotive sector specific requirements
1.Production
2.Continuous improvement
3. Manufacturing capabilities

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Section 3:Customer specific requirements

Each customer over and above the requirements specified in section2.
Documents required for QS9000 program
The QS 9000 quality system requirements
Advanced product quality planning & control plan
Failure mode & effects analysis
Fundamental statistical process control
Production part approval process manual
Quality system assessment manual.
5.5 ISO 14000: ENVIRONMENTAL MANAGEMENT SYSTEM STANDARDS
The ISO 14000 standards are a set of norms for Environmental management
System(EMS)either at organization and process level. The series of ISO 14000 standards
are designed to cover ,
1.environmental management systems
2. Environmental auditing
3. Environmental performance evaluation
4. Life-cycle assessment
5. Environmental aspects in product standards.
6.Terms & Definitions
ISO 14000 series of standards
The entire ISO 14000 series can be divided into two areas they are,
1.Organisation evaluation standards
2.Product evaluation standards
1.Organisation evaluation standards:
Those standards consists of the following three categories,
1.environmental management system
2.Environmental Auditing(EA)
3. environmental performance evaluation

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Figure: Organizational evaluation standards

2. Product Evaluation standards

Figure:The product evaluation standards

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The product evaluation standards consists of 3 categories,

1.environmental aspects in product standards
2. Environmental Labels and declarations
3. Life cycle assessment
Terminologies used in ISO 14000 standards
The concept and requirements of ISO 14000 have the following terms,
1.Environment
2. Environmental aspects
3. Environmental impact
4. environmental objective
5. Environmental target
5.6CONCEPT OF ISO 14000(EMS MODEL)
The EMS model consists of 5 stages. They are
1. Environmental policy
2. Planning
3. Implementation and operation
4. Checking and corrective action
5. Management review

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5.7 REQUIREMENTs OF ISO 14000(Major elements of EMS)

The major elements are:
1. General requirements
2. Environmental policy
3. Planning
4. Implementation and operation
5. Checking and corrective action
6. Management review
1. General requirements
General requirements state the general requirements of ISO 14000 to the organization.
It requires that an organization should establish and maintain an EMS.
The EMS include policy, planning, implementation operation, checking correction
2. Environmental policy
Environmental policy explains the contents that are to be included in the
environmental policy
Hence the following issue are stated in the environmental policy
1. Management commitment to continuous improvement
2. Prevention of pollution
3. Creating a frame work for setting objectives
4. Education and training for environment
3. Planning
i. Environmental aspect
Environmental aspect explains about the environmental aspect and its relation
with the environmental impart any environmental aspect is identify using FMEA
analysis.
ii. Legal aspects
Legal aspects explain about the organization to have a procedure to identify and
have a procedure to identify and have access to all legal requirement.
Legal requirements include the industry code of practice contracts, agreement
with public authority and other regulatory action.
iii. Objectives and target
This element describes the organization to establish and maintain the objective and
target at each level.
The procedure should also prevent such accident and emergency situation.
iv. Environmental management programs

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4. Implementation and operation

i. Resources, Roles, Responsibility and authority
ii. Training, awareness, and competency
iii. Communication
iv. Environmental management system documentation
v. Document control
vi. Operational control
vii. Emergency preparedness and response
5.Checking and corrective action
i. Monitoring and measuring
Establish and maintain procedures to regularly monitor, and measure key
characteristics of operations and activities
ii. Non conformance corrective and preventive action
This element describes the procedure to define responsibility and authority for
handling and investigating non conformance.
iii. Records
Establish and maintain procedures for identifying, maintaining and disposing
environmental records.
iv. EMS audit
Establish and maintain procedures for periodic EMS audits to ensure
Conformance to EMS standards
Proper implementation and maintenance
Proper availability of audit results to management.
6.Management review
The organizations top management shall periodically overview the EMS ensure its
suitability and effectiveness.
The review shall address the need for changes in policies, objectives and so on.
5.8BENEFITS OF ISO 14000 (EMS)
The benefit by adopting EMS can be put under two categories namely
a) Global benefit
b) Organizational benefit
a. Global
1. Facilitate trade and remove trade barriers
2. Improve environmental performance of planet earth

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3. Build consensus that there is a need for environment management and a common
terminology for EMS.
b. Organizational
1. Assuring customers of a commitment to environmental management
2. Meeting customer requirements
3. Maintaining a good public / community relations image
4. Satisfying investor criteria and improving access to capital
5. Obtaining insurance at reasonable cost
6. Increasing market share that results from a competitive advantage
7. Reducing incidents that result in liability
8. Improving defense posture in litigation
9. Conserving input materials and energy
10. Facilitating the attainment of permits and authorization
11. Improving industry/government relations
2MARK QUESTION ANSWERS
1. Give the ISO 9000 Series of Standards?
1. for

2. Model for Quality Assurance in Design, Development,

3.

4. Inspection and

5. ISO 9004-
2. What is the need for ISO 9000?
ISO 9000 is needed to unify the quality terms and definitions used by industrialized
nations and use terms to demonstrate a supplier s capability of controlling its processes.
3. Give some other quality systems?
i. QS-9000
ii. TE-9000
iii. AS9000
4.What are the three sections of QS-9000?
i. Common requirements, which include the exact text of ISO 9001 and the addition of
automotive/heavy trucking requirements.
ii. Additional requirements covering production part approval process, continuous
improvement and manufacturing capabilities.

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