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ISO 9001 Quality Management System

ISO 9001  Quality Management System

ISO is abbreviation of International Organization for standardization, is quality management standard which is occurred by ISO. ISO 9001 certificate betrays that product and services of organization is managed according to management system accepted by international and determines that assurance about quality of product and services always goes on.

 

ISO 9001 is a standard which identifies effective quality management system. When organization meets requirements of this standard, it can take ISO 9001 certificate. This certificate shows that product and services are produced suitable to standard accepted by international. Standard was developed by ISO (International Organization of standardization) which central of it is in Switzerland at Geneva. More than 150 countries are member of ISO. Power of accreditation of certification bodies were given to committees of member countries. In Turkey Accreditation power was given to TURKAK.

 

Quality Management System

         1-ISO 9001:2000  

2-History of ISO 9001:2000

3-Definitions about ISO 9001:2000 and Quality

4-ISO 9001:2000 Quality Management Principles

         5-Parts and Scope of ISO 9001:2000

 

1-ISO 9001:2000   

ISO is abbreviation of International Organization for standardization, is quality management standard which is occurred by ISO. ISO 9001 certificate betrays that product and services of organization is managed according to management system accepted by international and determines that assurance about quality of product and services always goes on.

ISO 9001 is a standard which identifies effective quality management system. When organization meets requirements of this standard, it can take ISO 9001 certificate. This certificate shows that product and services are produced suitable to standard accepted by international. Standard was developed by ISO (International Organization of standardization) which central of it is in Switzerland at Geneva. More than 150 countries are member of ISO. Power of accreditation of certification bodies were given to committees of member countries. In Turkey Accreditation power was given to TURKAK.

ISO 9001 is suitable for any organization looking to improve the way it is operated and managed, regardless of size or sector. However, the best returns on investment come from those companies that are prepared to implement it throughout their organization rather than at particular sites, departments or divisions.

Different standards which are developed for similar Technologies in different countries and different Technologies, are named as ‘’ technical obstacle for trade’’ and these standards are used against producers. Aim of ISO is to prepare recognized ISO 9000 quality management standards by international and to remove like these obstacles in front of trade.

What is the ISO 9000 Series?

The ISO 9000 series of documents was created by the International Organization for Standardization to set international requirements for quality management systems. Now adopted by over 150 countries, use of the series of standards has become commonplace in the business world.

 

The series itself is generic, and is designed to be applicable to any manufacturing or service process. The series is revised and controlled by Technical Committee (TC) 176, made up of international members from many industries and backgrounds. The series is modified periodically. The original standards were published in 1987, first revised in 1994 and the current versions were issued in 2000.
 

The previous ISO 9000 family of standards contained some 20 standards and documents.  The year 2000 ISO 9000 family of standards consists of four primary standards supported by a number of technical reports. The four primary standards are: 

 

  • ISO 9000 – Fundamentals and Vocabulary: this introduces the user to the concepts behind the management systems and specifies the terminology used.
  • ISO 9001 – Requirements: this sets out the criteria you will need to meet if you wish to operate in accordance with the standard and gain certification.
  • ISO 9004 – Guidelines for performance improvement: based upon the eight quality management principles, these are designed to be used by senior management as a framework to guide their organizations towards improved performance by considering the needs of all interested parties, not just customers.
  • ISO 10011: Guidelines for Auditing Quality Systems (watch for ISO 19011, which will merge 10011 and 14011 and, be published in the third quarter of 2001)

Customers are increasingly becoming quality-conscious shoppers. They want to know up front that your business will meet their needs. A certified Quality Management System demonstrates your commitment to quality and customer satisfaction.
 

Implementing a Quality Management System will help you enhance customer satisfaction, achieve consistency, and improve internal processes. It can minimize the risk that customer expectations are not met.

 

Each business has operational processes that are critical to its strategic objectives.  Business improvement relies on your ability to discover strengths, weaknesses, and improvement opportunities.  With our Risk Based Certification approach, ACAR Quality auditors assess how well your Quality Management System supports the areas of greatest importance to you, in addition to measuring compliance against elected standards.

On this page, we will help you understand the  what and why of a Quality Management System—what it is and why your business will benefit from implementing one.

 

Note: ISO 9001 is the most commonly used international standard that provides a framework for Quality Management Systems. It is a generic name given to a family of standards developed to provide a framework around which a quality management system can effectively be based.

 

 

2-History of ISO 9001:2000  

 

  • 1963 MIL/Q/9858 (USA defense technology)
  • 1968 AQAP standards (NATO member countries)
  • 1979 BS 5750(in England)
  • 1987 ISO 9000 serial (by ISO)
  • 1988 EN 29000 standards (by CEN )
  • 1988 TS 6000 issued as quality assurance system standard
  • 1991 TS-EN-ISO 9000
  • 1994 revision by ISO .(9001:1994 / 9002:1994 /9003:1994)
  • 1996 EN 29000 serial EN-ISO 9000 as issued.
  • 2000 revision by ISO and 9001:2000 as issued.

Firstly standard was issued as quality assurance system in 1987 year. In this level, standard was occurred 3 sub-standards: ISO9001, ISO9002, ISO9003. Organizations applied one of these 3 standards according to scopes. Version of this standard was focused to find correct production and to catch false.

Firstly revision was done in 1994 year and standard was issued as quality assurance system. In this level, standard was occurred 3 sub-standards: ISO9001, ISO9002, ISO9003. Organizations applied one of these 3 standards according to scopes. This version of standard, it focused to prevent false as addition.

Last revision of standard was done in 2000 year and standard was issued as quality management system. There is only ISO 9001: 2000. There are no actual standards like ISO 9002 and ISO 9003. But ISO issued ISO 9000, ISO 9004, ISO 19011 supporting ISO 9001:2000. Foundations take only ISO 9001:2000 standard regardless scope. But to certification dependency being to actions, excluded matters of standard are determined on the certificate. This version of standard, as addition to previous version provides to increase continual improvement and productivity in basic of process, it presents management model which holds costumer focusing foreground.

New version of ISO 9001 will come in 2008 year called as ISO 9001:2008.

 

 

3-Definitions about ISO 9001:2000 and Quality  

 

 

Process: Inputs turning to outputs each other related or interacting action team.

Product: Result of process.

System: Related each other or interacting element team.

Management System: Occurring of policy and objectives and succeeding these objectives.

Quality Policy: All aims and management about quality which means formal by organization management.

Quality Management: Actions which are coordinated to control and management of organisation about qualtiy

Continual Improvement: To increase ability of meeting requirements of actions which are repeated.

Productivity: Relations which is between got result with used resources

Definition of Quality: Despite being in use for nearly 50 years, the term TQM still poses problems of definition for writers on quality, and consequently often remain a rather abstract term. There are a number of well-known quality definitions. ISO 8402 [ISO, 1986] defines quality as "the totality of features and characteristics of a product or service that bears on its ability to meet a stated or implied need". [Crosby, 1979] defines quality as "conformance to requirement". [Juran, 1988] defines quality as "fitness for use". Japanese companies found the old definition of quality "the degree of conformance to a standard" too narrow and consequently have started to use a new definition of quality as "user satisfaction" [Wayne, 1983]. Table below defines quality from the view point of different quality professionals and to provide a conceptual scheme for the discussion of TQM. This can be classified in three sections: Customer-base, Service and Manufacturing-base, and Value-based definition.

Customer-based Definitions

  • Edwards [1968] Quality consists of the capacity to satisfy wants...
  • Gilmore [1974] Quality is the degree to which a specific product satisfies the wants of a specific consumer. ·
  • Kuehn & Day [1962] In the final analysis of the marketplace, the quality of a product depends on how well it fits patterns of consumer preferences.
  • Juran [1988] Quality is fitness for use.
  • Oakland [1989] The core of a total quality approach is to identify and meet the requirements of both internal and external customers.
  • Manufacturing & Service-based definitions
  • Crosby [1979] Quality [means] conformance to requirements
  • Price [1985] Do it right first time
  • Value-based definitions
  • Broh [1982] Quality is the degree of excellence at an acceptable price and the control of variability at an acceptable cost.
  • Feigenbaum [1983] Quality is the degree to which a specific product conforms to a design or specification
  • Newell & Dale [1991] Quality must be achieved in five basic areas: people, equipment, methods, materials and the environment to ensure customer’s need are met.
  • Kanji [1990] Quality is to satisfy customers’ requirements continually; TQM is to achieve quality at low cost by involving everyone’s daily commitment

4-ISO 9001:2000 Quality Management Principles 

 

ISO 9001:2000 principles

 

1. Costumer focused: Organizations depend on customers, therefore organization should understand needs of customers now and in the future, adjust to customer requirements and meet customer requirements and endeavor to pass over customer expectations.

2. Leadership: leaders provide union of aim and administrative. Leaders should occur internal ambient to attendances as whole to succeeded objectives of organization.

3. Involvement of people: All level of people is compact of organization, involvement is provided to use their abilities to benefit for the organization.

4. Process Approach: When actions and related resources are managed as a process, successful results are realized as efficiency.

 

P Plan.. Determine objectives & processes 
U Apply. Apply processes 
K Control.. Monitor & measure
I Improve.. Provide continual improvement 



5. System approach to management:  When each other related processes are determined, understood and managed, it provides efficiency and increases productivity of organization for succeeding of objectives.

6. Continual improvement:  permanently objective of organization always should be to improve the whole performance of organization.

Improvement:  It means, increasing the features and characteristic of product and/or increasing of efficiency and productivity of the processes to produce and to distribute them.

7. Realistic approach to make decision:  Efficiency decisions are reliant to data analysis and knowledge's.

8. Each other benefit is reliant on supplier relations:  An organization and its supplier are independent of each other and each other benefit relations contribute plus worth.

 

5-Parts and Scope of ISO 9001:2000 

1. General

        1.1. Index and revision status
        1.2. Purpose and scope
        1.3. Exclusions

2. Company Background

       2.1. Company background and history
       2.2. Activities

3. Definitions And Conventions

       3.1. Definitions and conventions
       3.2. Abbreviations

4. Quality Management System

      4.1. General requirements
      4.2. Documentation and records

5. Management Responsibility

     5.1. Management commitment
     5.2. Customer focus
     5.3. Quality policy
     5.4. Quality system planning
     5.5. Organization and communication
     5.6. Management review

6. Resource Management

     6.1. Provision of resources
     6.2. Human resources and trainings
     6.3. Infrastructure
     6.4. Work environment

7. Product Realisation

      7.1. Planning of product realization
      7.2. Customer related processes
      7.3. Design control
      7.4. Purchasing
      7.5. Operations
      7.6. Measuring and monitoring equipment

8. Measurement, Analysis And Improvement

      8.1. Planning of monitoring and measurement
      8.2. Monitoring and measurement
      8.3. Control of non-conforming product
      8.4. Analysis of data
      8.5. Continual improvement


      8.1 General 
      8.2 Monitoring and measurement 
      8.3 Control of non-conformity product 
      8.4 Data analysis
      8.5 Improvement 


TS EN ISO 9000:2000 Serial 
 

TS EN ISO 9000 standard are occurred from 4 standards. These are;

TS EN ISO 9000:2000 Quality management systems – basic concepts, terms

TS EN ISO 9001:2000 Quality management system – requirements

TS EN ISO 9004:2000 Quality management system – guide to improve

TS EN ISO 19011:2000 guide for inspection of quality and environment

Benefits of ISO 9001

  • - Better management of core business processes.
  • - Increased awareness of quality among staff.
  • - Improved productivity and quality.
  • - Improved internal communications.
  • - Costumer satisfaction
  • - Increasing of costumer,
  • - Better supplier relations
  • - Stiffening of organization image ,
  • - Reduced wastage and cost per unit/service
  • - An important step in the road to Total Quality Management.
  • - Improves Customer Demand: 33.4% of corporations with ISO 9001:2000 report improved customer demand.  This means they are winning more business.  (Source – Dun and Bradstreet Survey)
  • - Protect Your Business: 69.3% of surveyed businesses that do not have ISO 9001:2000 say they have lost a customer bid or proposal to an ISO 9001:2000 certified competitor.  Many of these companies said they didn’t know why they were losing the business until it was too late.
  • - Your Competitors Are Doing It: In many industries, 35 to 40% of your competitors are ISO 9001:2000 Registered or in the process.  The longer you wait to start, the greater is their competitive advantage.
  • - Easy & Cost Effective : Getting ISO 9001:2000 is no longer the costly, time consuming proposition that it once was.
  • - Using our system to become ISO 9001:2000 compliant is very simple and inexpensive.  It will put you way ahead of your competition and will enable you to improve your systems and operations.
  • - Qualify for Government Contracts: The Department of Defense, Food and Drug Administration, Railways, Department of Energy and the General Services Administration have all approved the use of ISO 9001:2000 in contracts and bids.
  • - A template for the creation of a sound quality system and a foundation to develop future quality initiatives.
  • - ISO 9001:2000 Help to identify best practice and ensure everyone in the organization is moving in the right direction
  • - Providing of different from rivals in market actions
  • - Doing as effective of input, production and final control
  • - Providing easily in determining and distribution of powers and responsibilities inside operation
  • - A powerful management tool that complements other key management other key management functions such as financial and strategic planning.
  • - Provide instant dashboard visibility of enterprise-wide quality compliance
  • - Increased Credibility : You can generate a significant increase in business, as many corporations will only deal with
  • - Occurring of documentation (infrastructure) which makes standard of operation actions
  • - Occurring of infrastructure which keeps regularly records in the past
  • - Operation from benefit of certificate which is available in international (demonstrating of quality for export)
  • - Decrease of fault ratio, wastage, repeat operating
  • - Stepping important in institutional way
  • - Certification to internationally recognized standards