ISO 9000
The International Organisation for Standardisation (ISO) is an international federation of national standards involving more than 140 countries. ISO 9000 is a well-known family of guidelines and standards developed by the ISO. It has become popular worldwide for its role insetting up quality management systems within organisations.
Understanding > Introduction to ISOWhat are Standards?
Today great emphasis is being laid on organisations following predefined levels of standards in their processes andoperation. But what are standards? How are they useful to an organisations business performance?Standards are documented technical specifications and other defined benchmarks. These specifications are applied as a setof regulations and procedures to ensure that the materials, products, operations and services conform to predefinedrequirements. Standards contribute to the enhancement of the product parameters such as quality, safety, reliability,effectiveness and interchangeability at an optimum cost.
The ISO:
The International Organisation for Standardisation (ISO) is an international federation of national standards involving morethan 140 countries. A non-governmental organisation it was set up in 1947. The motto of ISO is to endorse the growth of standardisation worldwide to promote international trade and services. ISO promotes mutual collaboration between variousorganisations in the scientific, technology and economic related activities.
Advantages of ISO standards:
ISO sets up technical standards (that are voluntary) that help in enhancing various types of organisational processes. Theyaid in the development, production and delivery of products and services in a more effective, secure and cleaner way. ISOstandards also seek to safeguard customer interests.ISO Standards are acknowledged worldwide as the means for manufacturers and service providers to bring about utmostease and effectiveness in trading their products and services. These International Standards provide a benchmark to makethe transfer of technology between suppliers and their customers possible.
The evolution of ISO:
International standardisation was first initiated in the electro technical area. The International Electro TechnicalCommission (IEC) was established in 1906. The International Federation of the National Standardising Associations (ISA),established in 1926, put in groundbreaking efforts in other areas. ISA focused mainly on mechanical engineering. Itsactivities came to an end in 1942.In 1946, representatives from 25 countries convened in London and decided to form a new international organisation, inorder to “make possible the international coordination and integration of organisational standards". The new organisation,ISO, formally became operative on 23 February 1947.
ISO standards -The process:
ISO has a well-defined process for incorporating standards.
First phase:
In any country a business segment puts forward the need for a standard before its national standards institute. The lattersuggests this to the ISO. Once the necessity for an International standard has been acknowledged and officially approved,the technological feasibility of the standard is defined. This stage is usually performed in teams consisting of professionalsfrom those countries that are interested in the particular standard.
Second phase:
Once the experts reach a conclusion on the technical parameters to be covered in the standard, the participating countriesdiscuss in detail the specifics pertaining to the standard. This is the consensus-building phase.
Final phase:
The final phase comprises of the endorsement of the final draft of the International Standard. This report is subsequentlymade available in print as an ISO International Standard.Many of the standards need regular reviews. Various factors contribute to make a standard obsolete: scientificadvancement, new techniques and equipment, changing trends in quality and safety procedures. To consider these issues,ISO has stipulated that all ISO standards should be evaluated every five years.
The goal of any organisation is to constantly accrue benefits through product innovation and efficiency in the use of resources. The critical aspect to achieve this is to attain all round quality performance. Quality is a basic consumerrequirement. A customer prefers organisations reliable as far as its quality performance is concerned. Consistently
manufacturing products and offering services of superior quality is the need of the hour worldwide. This is a critical aspectin sustaining customer loyalty and retaining the market base.In order to attain this, organisations have to comply with a set of procedures that are not only acknowledged and acceptedwithin a country but also internationally. ISO 9000 standards serve this purpose.ISO 9000 is a well-known family of guidelines and standards developed by the ISO. ISO 9000 standards for a QualityManagement System handles the processes concerned with the design, development and delivery of a product or service.The standard stipulates specifications for the control and assessment of a process for attaining quality performance.The 1987 version of ISO 9000 standard, (originally published as BS5750 by the British Standards Institute) emphasised onquality control by means of effective checking and corrective actions. Quality control (QC) is a management function thatcontrols the quality of raw materials, products, components, and services concerned with production and inspectionactivities. It aims to prevent defects in the products or services.The 1994 version of the ISO 9000 standard focused on quality assurance via preventive actions, and stipulated the needfor documented procedures. Quality assurance (QA) comprises all measures taken to ascertain that the standards andprocedures are in conformity and that the products or services meet the performance requirements.An ISO 9000 certification indicates that the management is effectively controlling the processes that are ‘critical to quality’ with respect to the customer. ISO 9000 is not just about service or product quality; it's about quality in management.These standards address aspects related to process management. This requires organisations to identify, document andcontrol processes ranging from executive management to the production of different items.An organisation could be successfully certified to ISO 9000 if it adhered to the specifications of the standard. In order to becertified, an organisation must submit to an accredited assessor’s examination. The assessor interviews staff members toensure that they are aware of their roles and responsibilities in complying with the ISO 9000 standard. The assessor alsoexamines the organisation's paperwork to check on ISO 9000 compliance. When all issues are addressed, the organisationis deemed for certification.
ISO 9000:94 family is a set of international quality standards and guidelines that have become popular worldwide for theirrole in setting up quality management systems within organisations.In the past, organisations preferred to implement any of the three ISO 9000:94 requirement standards i.e. the ISO 9001,ISO 9002 and ISO 9003. Moreover, there was a notion that ISO standards are applicable only in the manufacturing sector.ISO in a move to change this perception drafted some more guidelines that cater to the requirements of the service sector,small and medium scale industries and software companies. Given below is a list of ISO 9000:94 guidelines and standards.
ISO 8402
, Quality management and quality assurance – Vocabulary. Defines the essential terms used in the ISO 9000family, which is necessary for avoiding misinterpretations.
ISO 9000-1
, Quality management and quality assurance standards – Part 1: Sets the guidelines for selection and use of specific standards. Provides the scope for understanding and selecting the appropriate standards.
ISO 9000-2
, Quality management and quality assurance standards –Part 2: Provides basic guidelines for the applicationof ISO 9001, ISO 9002 and ISO 9003. Helps in interpreting ISO 9001, ISO 9002 and ISO 9003.
ISO 9000-3
, Quality management and quality assurance standards –Part 3: Sets guidelines for the application of ISO9001 1994 in the development, delivery, installation, and maintenance of computer software. Also provides a specificinterpretation of the requirements of ISO 9001 for computer software development applications.
ISO 9000-4
, Quality management and quality assurance standards –Part 4: Provides guidance on how to plan, organiseand control resources to produce reliable and sustainable products.
ISO 9001
, Quality systems – Model for quality assurance in design, development, production, installation and servicing.This is a requirement standard used to ascertain the process capabilities for the design and development of the product orservice, as well as for installation and servicing.
ISO 9002
, Quality systems – Model for quality assurance in production, installation and servicing.This standard is used to ascertain process capabilities for production, installation and servicing (identical to ISO9001except for design control requirement).
ISO 9003
, Quality systems – Model for quality assurance in final inspection and testing. This is a requirement standardused to control product or service through final inspection and testing.
ISO 9004-1
, Quality management and quality system elements –Part 1: Guidelines for implementation. This optionalstandard provides guidelines to implement a quality system to satisfy the customers’ and organisational requirements.
ISO 9004-2
, Quality management and quality system elements –Part 2: Sets guidelines for services. This standard isanalogous to ISO 9004-1, but the guidelines are designed specifically to suit the requirements of the service sector.
ISO 9004-3
, Quality management and quality system elements –Part 3: Sets guidelines for processed materials.
ISO 9004-4
, Quality management and quality system elements –Part 4: Sets guidelines for quality improvement. Providesguidelines for implementing continual quality improvement within the organisation using tools and techniques based oninformation compilation and evaluation.
ISO 10005
, Quality management –Sets guidelines for quality plans. This standard provides guidance on how to preparequality plans for the control of specific products, and projects.
ISO 10006
, Sets guidelines to quality in project management
ISO 10007
, Quality management –Sets guidelines for configuration management. Provides guidelines to ensure that acomplex product continues to work in the desired manner even when certain parts are modified.
ISO 10011-1
, Sets guidelines for auditing quality systems – Part 1: Provides guidelines for auditing a quality system, andverifying the system’s capability to achieve set quality goals. It can be used within the organisation or for auditing thesuppliers.
ISO 10011-2
, Sets guidelines for auditing quality systems – Part 2: Qualification criteria for quality systems: auditors.Provides guidance on the education, training, know-how, personal traits and management capabilities needed to carry outan audit.
ISO 10011-3
, Sets guidelines for auditing quality systems – Part 3: Management of audit programmes. Provides basicguidelines for managing quality system audit programmes.
ISO 10012-1
, Quality assurance requirements for measuring equipment – Part 1: It is a metrological confirmation systemfor measuring equipment. Provides guidelines on the key characteristics of a calibration system to ensure thatmeasurements are done with the projected accuracy.
ISO 10012-2
, Quality assurance for measuring equipment – Part 2:Sets guidelines for control of measurement processes. Provides additional guidance on the application of statistical processcontrol whenever it is apt for achieving the objectives of Part 1.
ISO 10013
, Sets guidelines for developing quality manuals. Provides guidelines for the setting up, organising andcontrolling quality manuals customised to specific needs.
Continue the tour:The ISO 9000:94 Quality System ElementsUnderstanding > The ISO 9000:94 Quality System ElementsThe ISO 9000 Quality system elements:
An ISO 9000 compliant quality assurance system includes 20 system elements. Of the three system models (ISO 9001,9002, and ISO 9003), ISO 9001 requires all 20-system elements whereas certain sub clauses have been omitted in ISO9002 and 9003. The 20 system elements that ISO 9001 requires are listed below:4.1 Management Responsibility.4.2 Quality System.4.3 Contract Review.4.4 Design Control.4.5 Document and Data Control.4.6 Purchasing.4.7 Control of Customer – Supplied Product.4.8 Product Identification and Traceability.4.9 Process Control.4.10 Inspection and Testing4.11 Control of Inspection, Measuring and Test Equipment.4.12 Inspection and Test status.4.13 Control of Non-Conforming Product.4.14 Corrective and Preventive Action.4.15 Handling Storage, Packaging, Preservation, and Delivery.4.16 Control of Quality Records.4.17 Internal Quality Audits.4.18 Training.4.19 Servicing.4.20 Statistical Techniques.The ISO 9002 standard comprises of all the twenty clauses except Design control (clause 4.4)The ISO 9003 standard comprises all the twenty clauses as in ISO 9000 barring Design control (4.4), Process control (4.9),Preventive action (4.14) and Servicing (4. 19)The ISO 9000 Standard’s twenty system elements are explained in detail below.
4.1. Management Responsibility:4.1.1. Quality policy:
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The organisation should establish a quality policy and properly document it.
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ISO 9000
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