Introduction There are many companies in the world have already adopted to ISO 9000,Why? Because it controls quality. It saves money. Customers expect it. And competitors use it. ISO 9000 applies to all types of organizations. It doesn't matter what size they are or what they do. It can help both product and service oriented organizations achieve standards of quality that are recognized and respected throughout the world.
All organizations have an established way or system of doing things These systems may be effective, but are often informal, inconsistent, & not documented The purpose of quality management is to identify those systems & processes that can help an organization meet its customers’ expectations ISO 9001:2008 is helpful because it defines basic quality processes that have proven to be effective in successful organizations over the past 50 years Introduction
What is ISO ISO is the International Organization for Standardization Established in 1947 and located in Switzerland Its members come from over 120 national standards bodies
What is ISO 9000:2008 ISO 9000 refers to a set of quality management standards Present guidelines Establishes a start point for understanding the standards Defines the fundamental terms and definition used in the ISO 9000 family
What is ISO 9000:2008 The ISO 9000:2008 Standards apply to all kinds of organizations in all kinds of areas. E.g. computing, financial services, accounting, banking, telecommunications, education
Objectives of ISO 9000:2008 Enable integration of management system Reach stakeholders’ requirements Enable implementation of continuous improvement Simple to use and easy to interpret ISO's purpose is to facilitate international trade by providing a single set of standards that people everywhere would recognize and respect.
Benefits of ISO 9000:2008 Improved customer satisfaction Reduced costs of quality Improved productivity and quality Improved internal communication Improved working efficiency Increase the competitive power Transparency of process Motivate the staff of the companies Increase the credibility of the customer Reduce the probability of error in the working process
8 principles of ISO 9000 ： 2008 Customer focusSystem approach Leadership Involvement of people Process approach Continuous Improvement Factual Improvement Supplier Relationship
Principle 6 : Continuous Improvement Continual improvement should be a permanent objectives of the organization. Continually improving the efficiency of all process Increase competitive power
Model of ISO 9000:2008 Customer requirements Principle 6 : Continuous Improvement Management Responsibility （ 5 ） Resource management （ 6 ） Measurement, analysis and improvement （ 8 ） Product Realization （ 7 ） product input output Satisfaction customer
Use of ISO 9000 as Continuous Improvement Deming’s wheel (P.D.C.A)
The ISO 9000 Quality Management System: A Definition To secure registration, organizations must develop and use quality management systems conforming to the requirements of ISO 9001. As stated in ISO 9000, a QMS is a management system to direct and control an organization with regard to quality. The quality management system will include this documentation: A quality policy. This statement describes how the organization approaches quality. The quality manual. This must address each clause of the ISO 9001 standard. It will also typically include an organization chart, or some such device, illustrating management responsibility for operating the quality system. Quality procedures may be part of this manual, or they may be referenced. Total Quality Management 14
The ISO 9000 Quality Management System: A Definition Quality objectives. These are the goals related to quality and must be in harmony with the quality policy. Quality objectives are assigned to the relevant organizational functions and levels and are tracked by top management. Quality procedures. These describe step by step what the company does to meet the quality policy. As a minimum, there will be a procedure for each of the ISO 9001 clauses outlining requirements. There may also be procedures for any processes that can impact quality. Forms, records, and so on. These provide proof of activities for the firm and for the auditors. Total Quality Management 15
Certification Process 1.Develop a quality manual & procedures addressing ISO 9001:2008 requirements 2.Train personnel and implement processes based on the quality manual & procedures 3.Carry out & document internal audits to verify that processes are carried out according to defined processes 4.Contact 2 or 3 registrars 5.The lead auditor will evaluate your quality manual & procedures about 2 months before the certification audit