ISO 9000 Implementation Imran Hussain

ISO 9000: 1994 Clauses Management Responsibility Quality System Contract Review Design Control Document Control Purchasing Purchaser Supplied Product Product Identification and Traceability Process Control Inspection and Testing

ISO 9000: 1994 Clauses Inspection Measuring and Test Equipment Inspection and Test Status Control of Non-Conforming Product Corrective Action Handling, Storage, Packaging and Delivery Quality Records Internal Quality Audits Training Servicing Statistical Techniques

ISO 9000:2000 Clauses Quality Management System Resource Management Product or Service Realization Management Responsibility Measurement, Analysis and Improvement

ISO 9000: 2000 Quality Management System

Quality Management System Documentation Standard ISO 9000 Quality Manual Policy Statement, Commitment, Organisation, Responsibilities LEVEL 1 Quality System Procedures Company Practices, Interfaces LEVEL 2 Work Instructions Written Instructions to Control Tasks LEVEL 3 Forms Quality Records LEVEL 4 Sales Design Purchasing Manufacturing Accounts Personnel After Sales

Why have a Quality Policy?

Need for Quality Policy All organizations have in mind some principles, beliefs which are their broad guides to managerial conduct These guides rest on a philosophical and ethical base They concern important issues and are intended to have a long life, i.e. to act as a stabilizer Such principles and beliefs are referred to as a Quality Policy

Need for Quality Policy When organizations grow, there are different managers working under which various employees are working Things need to be defined at that stage as things start becoming ambiguous As the unwelcome incidents accumulate, there arises a growing urge to think through, write out, and publish quality policies to serve as guides to managerial action

Advantages of Policies It provides insiders and outsiders with a new, superior form of predictability, i.e. a written guide to managerial action It forces the organization to think about quality problems to a depth never before achieved. “before you write it down, you must think it out” It establishes legitimacy and can be communicated in an authoritative, uniform manner It permits practices to be audited against that policy

Disadvantages of Policies Major disadvantage is work involved Some managers think that written policies tend to restrict innovation and to narrow the range of action available to adapt to changing conditions

Corporate Quality Policies As a company grows, it becomes evident that no one set of quality policies can fit all company activities This problem is solved by creating several levels of quality policy out of which one is corporate policy which usually consists of The purpose of writing and publishing quality policies A brief statement of corporate intent The minimal actions to be taken by the company divisions with respect to quality Interdivisional relationships concerning quality Relationship of quality policies to other company policies

Corporate Quality Policies A delegation of authority to subordinate company organization units to establish subsidiary quality policies appropriate to their needs Summary statement It is the policy of the company to provide products and services of a quality that meet the initial and continuing needs and expectations of customers in relation to the price paid and to the nature of competitive offerings, and in doing so, to be the leader in product quality reputation

Corporate Quality Policies Importance of quality Leadership in quality has top priority Quality shall be given equal priority to costs and delivery Quality competitiveness Equal or exceed competitive quality Be of the highest quality Customer relations Provide customer satisfaction Meet customer perception of good quality

Corporate Quality Policies Internal Customers We regard the receivers of our work results as “customers” whose needs are important to understand and satisfy Work Force Involvement Our policy is to foster a spirit of pride among employees regarding the company’s quality performance Quality improvement Resources will be allocated primarily to the prevention of defects and corrective action will be focused on rot-cause identification and elimination

Divisional Quality Policies The same design shall be used in all factories making a specific product. Quality of design shall be used in all factories making a specific product

Quality Policies for Functional Areas Many of the policies are prepared to provide guidance to managers in specific functional departments such as product development, manufacturing and marketing New product introduction Design reviews shall be conducted with customer, market and regulatory bodies in order to ensure the compliance of the design for quality Suppliers We seek to establish long-term, open relations with our suppliers

Quality Policies for Functional Areas Manufacturing Manufacturing process capability must be verified during the product development cycle Production Involvement and a spirit of pride will be fostered among employees by encouraging ideas and resolutions regarding the company’s quality performance Customer service Service operations shall be conducted so as to minimize customers’ shutdowns

Quality Objectives An objective is an aimed-at-target– an achievement toward which effort is extended. Quality objective is an aimed-at-quality target Quality objectives should be quantifiable in nature (measurable) - SMART

Objectives vs. Policies

Objectives vs. Standards

Implementing ISO 9000:2000 Awareness Training Establish a Team Establish ISO 9000 Status Prepare Action Plan Track Action Plan Present Status of Action Plan ISO 9000 Readiness Assessment Contact Registrar (Certification Body) Official ISO 9000 Audit Continuous Improvement Celebrate!

ISO 9000:2000 Clauses Quality Management System Resource Management Product or Service Realization Management Responsibility Measurement, Analysis and Improvement

Quality Management System (QMS) Concerned with the documentation and management of the QMS Sub-clauses: Quality Manual Control of documents Control of records

Management Responsibility Concerned with the responsibility of management in the implementation of the quality system Sub-clauses: Management commitment Customer focus Quality policy Planning Responsibility, authority, and communication Management review

Resource Management Concerned with the provision of resources needed to implement the QMS Sub-clauses: Provision of resources Human resources Infrastructure Work environment

Product or Service Realization Concerned with the provision of processes to implement the product or service Sub-clauses: Planning of product realization Customer related processes Customer requirements Customer communication Design and development Control of changes Purchasing process Production and service provision Validation of processes Identification and traceability Customer property Preservation of product Control of measuring and monitoring devices

Measurement, Analysis and Improvement Concerned with the establishment of a measurement program to measure QMS performance and to identify problems Sub-clauses: Measurement of customer satisfaction Internal audits Measurement and monitoring of processes Measurement and monitoring of product Control of nonconformity Analysis of data Continual improvement Corrective action Preventive action

References Software Quality Management and ISO 9001, by Michael Jenner, Ch. 1, 2 A Practical Approach to Software Quality, by Gerard O’Regan, Ch. 3