MG1401 – Total Quality Management

Unit – V: QUALITY SYSTEMS (#1)

Prepared by N.Shanmuga Sundaram, AP/ECE. K.K.Senthil Kumar, Lect./ECE.
MAHENDRA ENGINEERING COLLEGE, Namakkal Dt.

Contents
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History of Quality ISO – An introduction What is ISO 9000? ISO 9000 – Series of Standards Major Elements of ISO 9001:2000 Principles of QMS ISO 9001:2000 Requirements ISO Implementation ISO Documentation ISO Auditing

History of Quality

Before Industrial revolution, the quality was heavily relied on craftsman & workmanship. After Industrial revolution, the concept of mass production, inspection and standards were set. Later, the concept of Quality Control (QC) came into existence, by using Statistical Process Control (SPC) techniques. Then came the concept of Quality Assurance (QA). Quality improvement finally took a new dimension identifying and eliminating problems at source itself. by

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Quality Management System (QMS) has now become vital for the survival of an organization.

ISO – An Introduction

ISO means International Organization for Standardization. It is the world's largest developer of International Standards. ISO is a network of the national standards institutes of 162 countries, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. ISO is a non-governmental organization that forms a bridge between the public and private sectors. ISO standards are voluntary. ISO itself does not regulate or legislate. ISO standards are based on international consensus among the experts in the field, by making a periodic review of its standards at least every five years to decide whether they should be maintained, updated or withdrawn.

What is ISO 9000?

ISO Technical committee developed a series of international standards for Quality Systems in 1987 and interim revision was carried out in the year 1994, 2000 and 2008. ISO 9000 is a series of Quality Assurance methods, designed and intended to apply to any product or services made by an organization. ISO ensures Continual improvement and satisfaction to all stake holders in an organization.

ISO 9000 series of standards
ISO 9000 ISO 9001 ISO 9002 ISO 9003 ISO 9004 ISO 9004 -2 QS 9000 TS 9000 FDA-CGMP Quality management & QA Standards guidance Model for QA in design / Dev. / Prod. / Install. Model for QA in Prod / Installation Model for QA in final inspection & Test Generic guidance for QM and systems Guidelines for services. Encompasses ISO 9000 Establishes QS requirements for worldwide telecom. Networks (based on ISO 9001) Medical devices (includes ISO 9001)

Major elements in ISO 9000:2000

Principles of Quality Management

Customer Focus Leadership Involvement of People Process approach Continual improvement Factual approach to decision making Mutually beneficial supplier relationships

ISO 9001:2000 QMS Requirements

ISO 9001:2000 is generic in nature and concentrates on following three areas. # Focus on customer # Process oriented approach # Continual improvement

Since it is generic in nature, any clauses that are not suitable to any organization can be excluded.

ISO 9001:2000 QMS Requirements (contd..)

1. 2. 3. 4.

Scope Normative reference Terms and Definitions Quality Management System Management responsibility Resource management Product realization Measurement, Analysis and Improvement

The standards contain 8 clauses, of which first three give information about the organization and remaining five clauses are the requirements that the company has to meet.

5. 6. 7. 8.

ISO 9001:2000 QMS Requirements (contd..)

1. Scope: Requirement of the organization to develop QMS. 2. Normative reference: The required concepts and related definitions can be obtained from ISO 9000:2000 standards. 3. Terms and Definitions: Terms and Definitions given in ISO 9000:2000 can be applied. 4. Quality Management System: * General requirements The organization has to identify the customer requirements and accordingly has to establish, document, implement and maintain QMS. * Documentation Quality statements, Quality manuals, Quality system procedures, work instructions, etc in standard format.

ISO 9001:2000 QMS Requirements (contd..)

5. Management Responsibility: a) Management commitment b) Customer focus c) Quality policy d) Planning e) Responsibility, Authority and Communication f) Management Review

6. Resource Management: a) Processing of resources b) Human resources c) Infrastructure d) Work environment

ISO 9001:2000 QMS Requirements (contd..)

7. Product realization: a) Planning for Product realization b) Customer related processes c) Design and Development d) Purchasing e) Production and Service provision f) Control of monitoring and measuring devices 6. Measurement, Analysis and Improvement: a) General b) Monitoring and Measurement c) Control of Non-conforming product d) Analysis of Data e) Improvement

Implementation of ISO 9001:2000
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Top management commitment Appointment of Management Representative Awareness program Appointment of care team for implementation Training Time schedule Selection of Process owners Review of the Existing system Writing Documents Installation of New system Internal audit Management Review Pre-Assessment Registration

Registration of ISO 9001:2000

The registration process includes three parts, namely:

Identifying a system / certifying agency
(by assessing the reputation of agency, cost and lead time)

Submitting an Application along with Quality manual for review Registration / agency certification audit.
(Duration of audit will take 1 ~ 3 days).

Drawbacks in Successful implementation

Using a Generic document / copying documents from other organization. Over documentation / complex in nature Using external agency / consultants (without involving employees) Continuing documentation to text (not using other media) Neglecting top management Developing a system that does not represent reality

ISO Documentation

ISO Auditing

Purpose: The auditing is done to check whether the System (QMS) is followed and expected results are obtained. Frequency: The audit is done once in every six months / at least once in a year. Objectives of Audit: 1) To apply corrective action to avoid repetition of mistakes. 2) To follow-up on Non-conformities from previous audits. 3) To determine whether organization follows documented QMS. 4) Steps for Continual improvement in QMS. 5) Provide opportunity to improve Quality system.

ISO Auditing (contd..)

Auditor: A Qualified person who looks for objective evidence through verification of records, files, etc., and finds out the strengths and weakness in implementing the QMS. Procedure for Audit: 1) Planning: Selection of auditors, dept., time duration, required documents, etc. 2) Audit has 3 parts: Pre-audit meeting, audit and closing meeting. 3) Review of documents, questioning the members of audited dept., to find out the factual evidence. (3 types of questions are asked. They are open, closed and clarifying questions). 4) Auditing is done with mutual trust existing between auditor and auditee. 5) Non-conformity Report (NCR) is developed. 6) In closing meeting, Audited information, Details of NCR and Suggestions for Corrective actions will be discussed.

Remaining part of the Quality systems (ISO 14000) will be continued in the next presentation…

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