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Lecture 14
Outline
Introduction of ISO and its standards ISO 9000 Quality Management System
What is ISO?
International Organization for Standardization Objective to develop standards and not to certify companies Around 148 countries members Around 18000 standards produced Technical committees formed for devising standards, TC 176 for ISO 9001
What is ISO?
First Pakistani company certified in 1994 More than 3,000 companies certified to ISO 9001 in Pakistan More than 220 Certification (Auditing) Agencies throughout the world of which around 15 have offices in Pakistan
ISO 26000 Social responsibility ISO 31000 Risk Management ISO 9000 Quality Management ISO 14000 Environmental Management
ISO 9000
The ISO 9000 family addresses "Quality management". This means what the organization does to fulfill:
the customer's quality requirements, and applicable regulatory requirements, while aiming to enhance customer satisfaction, and achieve continual improvement of its performance in pursuit of these objective.
ISO 9001
ISO 9001 is a series of standards describing the requirements for establishing and maintaining a quality management system in an organization
ISO 9001
ISO 9001 is the document that contains the requirements. The other documents are very important and helpful in developing and improving quality management systems. The family of documents include:
ISO 9000: Quality Management Systems-Vocabulary ISO 9001:Quality Management Systems-Requirements ISO 9004:Quality Management Systems-Guidelines for Improvements
In the past, ISO 9002 and ISO 9003 also existed but became obsolete when the 2000 revision of the standard was released.
2008
2000
First revision named as ISO 9001:1994
1994
Originally released as ISO 9001:1987
1987
CORE STANDARDS
ISO 9000:2000 ISO 9001:2000 ISO 9004:2000 ISO 10005:1995 ISO 10006:2003 ISO 10007:2003 ISO 10012 ISO 10013:2001 ISO/TR 10014:1999 ISO/TR 10015:2000 ISO/TR 10017:2003 ISO 19011:2003 ISO 10002:2004 ISO 10001 ISO 10003
Fundamentals and Vocabulary QMS Requirements Guidelines for Performance Improvement Guidelines for Quality Plans Guidelines for Project Management Guidelines for Configuration Mgt Measurement Management System Documentation Economics Of Quality Training Statistics Auditing Complaint handling Market based Code of Conduct External Dispute Resolution System
SUPPORTING STANDARDS
It is not an industry specific or product specific standard an independent auditing agency audits the organization against the requirements of the standard and issues certificate on successful compliance initial certification audit yearly or half-yearly surveillance audits
Staff gets a better understanding of their role and objectives, by having a documented management system. They benefit from reduced stress levels, because they are using an efficient management system and because they know what is expected of them. They get increased morale and a sense of pride through achieving the goals of registration and customer satisfaction. New staff can immediately learn their job, because the details are in writing.
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Your products will be of a more consistent quality, and you will produce fewer rejects. You gain cost savings, because your production will be more efficient. There are economies in production (because your systems are controlled from start to finish), and economies in time that was formerly spend re-doing work. You can improve the quality of your raw materials by requiring your suppliers to have a ISO 9001 system. Export marketing is easier, because some foreign buyers recognize ISO 9001 (BS 5750).
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You can expect preferential treatment from potential customers who have ISO 9001 certification. This means an increase in new business. You secure greater customer loyalty, because you continuously satisfy their needs and give them no cause to seek another supplier. That means you suffer fewer customer losses. You can use ISO 9001 in your publicity to win more sales. ISO 9001 helps you minimize the risk of producing unsafe products. It may also give you some protection law against product liability claims. Being first in your area or industry may put you ahead of your rivals by 18 months to two years.
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Your customers get a known level of quality that is independently audited. They get a means of choosing between competing suppliers. They can have more confidence in your goods. ISO 9001 minimize their risk, by publishing responsibility on to their supplier (i.e. you). They can manage you, their supplier, better by specifying that you must have a ISO 9001 system. They can assess your quality system, and thus check your ability to produce satisfactory goods and services.
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ISO 9001:2008 is the standard that provides a set of standardized requirements for a quality management system, regardless of what the user organization does, its size, or whether it is in the private, or public sector. It is the only standard in the family against which organizations can be certified although certification is not a compulsory requirement of the standard. The other standards in the family cover specific aspects such as fundamentals and vocabulary, performance improvements, documentation, training, and financial and economic aspects.
from
Organizational Quality
Dept.Dept.-Wise Performance
Only
Product Quality
Involvement of People
Process Approach
1. Customer Focused
2. Leadership
Leaders should:
establish unity of purpose (vision and mission) provide direction to the organization (policy and objectives) provide resources to achieve organizations objectives
Corporate Goal
3. Involvement Of People
4. Process Approach
Organizations need to do more than simply monitor process outputs, (typically through
inspection activities)
they must also control all process inputs, (people, facilities/equipment, material and methods) and, they must establish appropriate controls over the transformation activities, (if desired results are to be achieved consistently and efficiently)
Resources Inputs
Transformation
Outputs
6. Continual Improvement
COLLECTION OF DATA
ANALYSIS
DECISION
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ORGANIZATION
PRODUCT OR SERVICE
Without satisfied customers, an organization is in peril! To keep customers satisfied, the organization needs to meet their requirements. The ISO 9001:2008 standard provides a tried and tested framework for taking a systematic approach to managing the organization's processes so that they consistently turn out product that satisfies customers' expectations.
The requirements for a quality system have been standardized - but many organizations like to think of themselves as unique. So how does ISO 9001:2008 allow for the diversity of say, on the one hand, a "Mr. and Mrs." enterprise, and on the other, to a multinational manufacturing company with service components, or a public utility, or a government administration? The answer is that ISO 9001:2008 lays down what requirements your quality system must meet, but does not dictate how they should be met in any particular organization. This leaves great scope and flexibility for implementation in different business sectors and business cultures, as well as in different national cultures.
Checking that it works The standard requires the organization itself to audit its ISO 9001:2008based quality system to verify that it is managing its processes effectively - or, to put it another way, to check that it is fully in control of its activities. In addition, the organization may invite its clients to audit the quality system in order to give them confidence that the organization is capable of delivering products or services that will meet their requirements. Lastly, the organization may engage the services of an independent quality system certification body to obtain an ISO 9001:2008 certificate of conformity. This last option has proved extremely popular in the market-place because of the perceived credibility of an independent assessment. The organization may thus avoid multiple audits by its clients, or reduce the frequency or duration of client audits. The certificate can also serve as a business reference between the organization and potential clients, especially when supplier and client are new to each other, or far removed geographically, as in an export context.