International Organization for Standardization ISO 9000

Table of Contents:-

  • International Organization for Standardization
  • Meaning of International Organization for Standardization – ISO 9000
  • Objectives of International Organization for Standardization – ISO 9000
  • International Organization for Standardization – ISO Standards for Quality System
  • Factors for Selecting an International Organization for Standardization – ISO Model
  • Clauses in International Organization for Standardization – ISO 9000

International Organization for Standardization

The International Organization for Standardization – ISO 9000 quality standard is a widely employed international standard and was developed by the International Standards Organisation (ISO). The British quality standard (BS 5750) influenced the standard and was originally published as a standard in 1987 and revised in 1994. The standard is revised approximately every five years to ensure that it continues to meet the needs of the international community, and submissions for improvements are welcomed. The ISO 9000 standards may be applied to various types of organisations including manufacturing, software and service organisations.The achievement of ISO 9000 by a company typically indicates that the company has a sound quality system in place and that quality and customer satisfaction are the company’s core values. ISO 9000 is regarded as a minimal standard that an organisation which takes quality seriously should satisfy, and many organisations require that their subcontractors be ISO 9000 certified.

Evolution and Enhancement: A Comparative Analysis of the International Organization for Standardization ISO 9000 Standards (1994 vs. 2000)

The International Organization for Standardization – ISO 9000 standard was developed owing to a need by organisations to assess the capability or maturity of their sub-contractors. The approach taken before the definition of the standard was that organisations who wished to have confidence in the capability of contractors developed their internal quality standard, and before the selection of a particular sub-contractor, a quality representative from the organization visited the proposed sub-contractor, and assessed the maturity of the sub-contractor concerning the prime contractor’s or subcontractor’s quality system.

The latest revision of ISO 9000 is termed ISO 9000:2000, and it is a significant enhancement over the 1994 version of the standard. It emphasizes customer satisfaction and continual improvement and includes a process model. The old 1994 version of the standard emphasized defining procedures for doing the work, whereas the new standard the emphasis on processes. It is a simpler standard and is effective from December 2000. The older 1994 ISO 9000 standard is first discussed and then the new ISO 9000:2000 standard and its implementation in an organisation.

Meaning of International Organization for Standardization – ISO 9000

The International Organization for Standardization (ISO) is the specialized international agency for standardization and at present comprises the national standards bodies of 91 countries. ISO is the acronym for International Organization for Standardization, located in Geneva, Switzerland.

ISO 9000 is a set of five Worldwide standards that establish requirements for quality  management. Unlike Product Standards, these measures are for Quality Management System. They are being used by the twelve-nation European Economic Community to provide a universal framework for quality assurance – primarily through a system of internal and external audits. The purpose is to ensure that a certified company has a quality system in place that will enable it to meet its published quality standards. The ISO standards are generic in that they supply all functions and all industries, from banking to chemical manufacturing. They are often referred to as “one-size-fits-all standards.”

Objectives of International Organization for Standardization – ISO 9000

The basic objectives of ISO-9000 are:

1) To encourage international trade of goods and services.

2) To obtain competitiveness by cost-effectively obtaining the required quality.

The following points mean to achieve the above objectives.

1) Promoting a single third-party assessment of quality standards.

2) Becoming part of a national/regional/international quality standard.

3) Encouraging bilateral and multinational agreements in trade, technology and manufacturing.

4) Helping industries improve their quality standards.

5) Promoting Total Quality Control (TQC) systems.

International Organization for Standardization – ISO Standards for Quality System

ISO 9000 series of standards on quality systems was formulated by the International Organization for Standards to meet the requirements of the internationally uniform quality system. The European Nation trade has reached an understanding that the post-1992 trade transaction would be dealt only with those companies who have registered ISO: 9000 quality system.

The developed countries started producing their standards for specifying the variety of products manufactured. In 1972, the British Standards Institution, United Kingdom published BS 4891-a guide to quality assurance. This standard was used to guide companies willing to set up quality systems.

It covered the following points:

  1. Management involvement and objective,
  2. Programming and planning.
  3. Principles of quality control,
  4. Design and specification control,
  5. Purchasing control and vendor appraisal,
  6. Production control,
  7. Marketing and service quality function,
  8. Documentation,
  9. Defects and failure analysis, and
  10. Non-conformance control.

MIL standards were introduced in 1974. In 1975 BSI published BS 5179 in three parts drawn from the contents of the Defiance Standard 05-21 series. This standard was not written in the mandatory terms but used by major purchasers for the evaluation and selection of their vendors. To meet growing awareness of quality in the industries BS 5750 standard was developed by BSI in 1979. In 1981, further guides were published for the usage of BS 5750.

The International Organization for Standards (ISO) revised and issued BS: 5750 in 1987 as ISO 9000 series of standards on quality systems. Since then, many countries have produced their standards in replicas of the ISO: 9000 series. More than forty countries have adopted them under the designation EN 29000. In India BIS (Bureau of Indian Standards) published the ISO: 14000 series as a quality system standard.

ISO 9000 quality standards stipulate certain management practices as guidelines and minimum requirements for making quality products and services conforming to the needs of customers. These are developed to facilitate the international exchange of goods and services. All these systems are essentially self-disciplined standards based on the principles of harmonization of specification and continuous surveillance of the third party.

Factors for Selecting an International Organization for Standardization – ISO Model

International Organization for Standardization – ISO 9000 is a series of guidelines for the selection and use of the appropriate systems standards of ISO 9001, ISO 9002 or ISO 9003. Thus, ISO 9000 is the road map to the entire series. ISO 9004 helps to build up a quality system that can fit a specific situation. It offers guidelines for interpreting the elements required in ISO 9001, ISO 9002 or ISO 9003. The contents of ISO 9000 are as follows:

1) Management Responsibility

i) The quality policy shall be defined, documented, understood, implemented, and maintained.

ii) Responsibilities and authorities for all personnel specifying, achieving and monitoring quality shall be defined. In-house verification resources shall be defined, trained and funded. A designated management person sees that the Q91 program is implemented and maintained.

2) Quality System

i) Procedure shall be prepared.

ii) Procedure shall be implemented.

3) Contract Review

Incoming contracts (and purchase orders) shall be reviewed to see whether the requirements are adequately defined, agree with the bid, and can be implemented.

4) Design Control

i) The design project shall be planned.

ii) Design input parameters shall be defined.

iii) Design output and essential product characteristics shall be documented.

iv) Design output shall be verified to meet input requirements.

v) Design changes shall be controlled.

5) Document Control

i) Generation of documents shall be controlled.

ii) Distribution of documents shall be controlled.

iii) Changes to documents shall be controlled.

6) Purchasing

i) Potential subcontractors and sub-suppliers shall be evaluated for their ability to provide stated requirements.

ii) Requirements shall be clearly defined in contracting data.

iii) The effectiveness of the subcontractor’s quality assurance system shall be assessed.

7) Customer Supplied Material

Any customer-supplied material shall be protected against loss or damage.

8) Product Identification and Traceability

The product shall be identified and traceable by item, batch, or lot during all production, delivery, and installation stages.

9) Process Control

i) Production and installation processes shall be planned and defined.

ii) Production shall be carried out under controlled conditions documented instructions, in-process controls, approval of processes and equipment, and criteria for workmanship.

iii) Special processes that cannot be verified after the fact shall be monitored and controlled throughout the processes.

10) Inspection and Testing

i) Incoming materials shall undergo inspection or verification before use.

ii) In-process inspection and testing shall be performed.

iii) Final inspection and testing shall be performed before the release of the finished product.

iv) Records of inspection and test shall be kept.

11) Inspection, Measuring, and Test Equipment

i) Equipment used to demonstrate conformance shall be controlled, calibrated and maintained:

  1. Identify measurements to be made.
  2. Identify affected instruments.
  3. Calibrate instruments (procedures and status indicators).
  4. Periodically check calibration.
  5. Assess measurement validity if found out of calibration.
  6. Control environmental conditions in the metrology lab.

ii) Knowledge of measurement uncertainty and equipment capability is essential.

iii) Where test hardware or software is used, it shall be checked before use and rechecked during use.

12) Inspection and Test Status

i) Status of inspections and tests shall be maintained for items as they progress through various processing steps.

ii) Records shall show who released the conforming product.

13) Control of Non-conforming Products

i) Non-conforming products shall be controlled to prevent inadvertent use of the installation.

ii) Review and disposition of non-conforming products shall be accomplished formally.

14) Corrective Action

i) Problem causes shall be identified.

ii) Typical problems and their reasons shall be corrected.

iii) The effectiveness of corrective actions shall be assessed.

15) Handling, Storage, Packaging, Delivery

i) Procedures for handling, storage, packaging and delivery shall be developed and maintained.

ii) Handling controls shall prevent damage and deterioration.

iii) Secure storage shall be provided. Products in stock shall be checked for deterioration.

iv) Packing, preservation, and marking processes shall be controlled

v) Quality of the product after final inspection shall be maintained. This might include delivery controls.

16) Quality Records

Quality records shall be identified, collected, indexed, filed, stored, maintained and disposed of.

17) Internal Quality Audits

i) Audits shall be planned and performed.

ii) The outcomes of audits shall be communicated to management.

iii) Any deficiencies found shall be corrected.

18) Training

i) Training needs shall be identified.

ii) Training shall be provided.

iii) Selected tasks might require qualified individuals.

iv) Records of training shall be maintained.

19) Servicing

i) Servicing activities shall be performed according to written procedures:

ii) Servicing activities shall meet requirements.

20) Statistical Techniques

i) Statistical techniques shall be identified.

ii) Statistical techniques shall be used to verify the acceptability of process capability and product characteristics.

Clauses in International Organization for Standardization – ISO 9000

The clauses in ISO are as follows:

Clause 1: Scope

Scope of the total quality management system, areas covered and any exclusion identified.

Clause 2: Normative Reference

The ISO 9000:2000 standard (Fundamentals/Vocabulary) must be used in conjunction with the standard.

Clause 3: Terms and Definitions

The terms and definitions provided by the International Organization for Standardization – ISO 9000.

Clause 4.1: General Requirements

This clause covers the requirement of the organization to set up a quality management system and broadly sets out the activities associated with this. The organization shall document, implement, and maintain a Quality Management System (QMS) and continually improve its effectiveness by the requirements of the standard.

Clause 5: Management Responsibility

Specifically identifies the responsibility of top management and the necessity for effective leadership.

Clause 5.1: Management Commitment

Top management must provide evidence of its commitment to developing and implementing the QMS and continually improving its effectiveness.

Clause 5.2: Customer Focus

Top management ensures that customer requirements are determined and met to enhance customer satisfaction.

Clause 5.3: Quality Policy

A Quality Policy establishes a commitment to quality and continuous improvement, provides the context for quality objectives and outlines how the goals relate to customer requirements.

Clause 5.4: Planning

Top management is responsible for ensuring that the planning of the QMS is carried out to meet the requirements of the standard as well as the quality objectives. The integrity of the QMS is sustained when changes to the QMS are designed and implemented.

Clause 5.5: Responsibility, Authority, and Communication

Top management must ensure that responsibility and authority are clearly defined and communicated within the organization. Everyone should know their expected duties (guilt) and permissible actions (controls). They should comprehend the interrelation between these responsibilities and authorities. A management representative should be appointed with the responsibility for the QMS. Additionally, an effective process of communication needs to be established, and the effectiveness of the QMS must be communicated to the organization.

Clause 6: Resource Management

To ensure that the resources needed to both maintain and improve the QMS are available and also to carry out the work required in a manner that will satisfy customer requirements.

Clause 6.1: Provision of Resources

The organization shall determine and provide the resources needed to continually improve the QMS’s effectiveness and enhance customer satisfaction by meeting customer requirements.

Clause 6.2: Human Resources

Personnel performing work affecting the quality of service shall be competent based on appropriate education, training, skills, and experience. The organization must determine the necessary competence and provide training to meet these requirements. They must evaluate the effectiveness of the training and maintain suitable records. Additionally, they must ensure that their personnel know the relevance and importance of their activities and how they contribute to achieving the quality objectives.

Clause 6.3: Jofrastructure

The organization shall determine, provide, and maintain the infrastructure needed micans and include buildings, workspace, in infrastructure This means determining and providing for current infrastructure requirements and planning for expected future needs.

Clause 6.4: Work Environment

The organization shall determine and manage the work environment needed to achieve conformity of service.

Clause 7.1: Planning of Product Realization

The organization shall plan and develop the processes needed for service realization. This includes the need to establish processes, and documents, and provide resources specific to the service, required verification, validation, monitoring, inspection and test activities specific to the service and also the records needed to provide evidence that the realization processes and resulting service meet the requirements

Clause 7.2: Customer-Related Processes

The organization shall determine customer requirements, statutory and regulatory needs, and any additional requirements specified by the organization and review these requirements. Records resulting from the review and actions taken should be maintained. This clause primarily focuses on the services provided but can also encompass additional factors such as regulatory or legal requirements and unspecified customer expectations.

Clause 7.3: Design and Development

The organization shall plan and control the design and development of its service. This involves determining the design and development stages, reviewing, verifying, and validating each step, and defining the responsibilities and authorities for design and development. This clause necessitates having controls for the design processes and establishing a disciplined approach to the design process. The design process should include inputs, outputs, reviews, verification, and validation. Changes in design and development also need to be identified, and records must be maintained.

Clause 7.4: Purchasing

The organization shall ensure that the purchased product conforms to specified purchase requirements. The organization shall evaluate and select suppliers based on their ability to supply products by these requirements. Criteria for evaluation, selection, and re-evaluation shall be established. Records of the outcomes of the review shall be maintained. The organization shall also establish and implement the inspection or other activities necessary (verification) to ensure that the purchased product meets specified requirements.

Clause 7.5.1: Control of Production and Service Provision

This clause describes the various types of controls we need to have to deliver the service. These include the availability of information that represents the service, the availability of work instructions, the use of suitable equipment, and the availability of monitoring and measuring devices. Additionally, it addresses the implementation of monitoring and measurement.

Clause 7.5.2: Validation of Processes for Production and Service Provision

ITD has no processes where the resulting outputs cannot be verified by subsequent monitoring and measuring; therefore, this clause is excluded.

Clause 7.5.3: Identification and Traceability

Where appropriate, the organization shall identify the product/service by suitable means. Where traceability is a requirement, the organization shall control and record the unique identification of the product/service. Identification involves understanding the product or service resulting from a particular process. When it is necessary to identify a product or service, the methods used and the records to be kept need to be defined. Traceability knows where a product or service came from.

Clause 7.5.4: Customer Property

The organization shall identify, verify, protect, and safeguard customer property provided for use or incorporation into the product/service.

Clause 7.5.5: Preservation of Product

The organization shall preserve the conformity of the product or service during internal processing and delivery to the intended destination. This preservation shall include handling, identification, storage, packaging and protection.

Clause 7.6: Control of Monitoring and Measuring Devices

This means having confidence in the equipment used to check your work. This clause applies to organizations where monitoring devices and measuring equipment are used to verify that what we are providing, meets your customer requirements. Monitoring implies observation and supervision activities. Measurement considers the determination of a magnitude, quantity or dimension. Where necessary to ensure valid results, measuring equipment shall be calibrated, safeguarded, adjusted, and protected from deterioration and damage.

Clause 8.1: Measurement Analysis and Improvement

This clause covers the wider measurement, monitoring, analysis, and improvement of the quality management system. The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed to demonstrate conformity with the product/service, to ensure conformity with the QMS and to continually improve the effectiveness of the QMS. This shall include determining applicable methods, including statistical techniques, and the extent of their use.

Clause 8.2.1: Customer Satisfaction

The organization shall monitor information relating to consumer perception as to whether they have met customer requirements. The methods for acquiring and employing this information shall be determined. Monitoring of customer satisfaction should be performed on an ongoing basis, as customers’ perceptions of performance change over time. The results of customer satisfaction monitoring should be addressed in the management review and continual improvement activities to identify and implement changes to improve customer relationships.

Clause 8.2.2: Internal Audit

The organization shall conduct internal audits at planned intervals to determine whether the QMS conforms to the standard and the QMS requirements established by the organization and is effectively implemented and maintained. The responsibilities and requirements for planning and conducting audits, reporting results, and keeping records shall be defined in a documented procedure. Management must ensure that actions are taken immediately to eliminate detected non-conformities and their causes. Follow-up activities shall include the verification of the actions taken and reporting verification results.

Clause 8.2.3: Monitoring and Measurement of Processes

The organization shall apply suitable methods for monitoring and measuring the QMS processes. These methods shall demonstrate the processes’ ability to achieve planned results. When planned results are not achieved, corrective action shall be taken, as appropriate to ensure conformity of the service.

Clause 8.2.4: Monitoring and Measurement of Product

There is considerable overlap between this clause and the previous one. In many cases, the same monitoring or measurement procedures will be adequate for monitoring or measuring both processes and products/services.

Clause 8.3: Control of Non-Conforming Product

The standard requires having ways to identify a product or service non-conformity and to decide what to do about it. We need to have a documented procedure describing how we comply with the requirements and to record any such activities. When a non-conforming product is corrected, it shall be subject to re-verification to demonstrate conformity to the requirements.

Clause 8.4: Analysis of Data

Analyzing data is essential for any potential improvement in the quality management system, processes, and product/service. The organization shall determine, collect, and analyze appropriate data to demonstrate the suitability and effectiveness of the QMS and to evaluate where continual improvement of the QMS’s effectiveness can be made. This shall include data generated from monitoring and measurement and other relevant sources. Data analysis shall provide information on customer satisfaction, product/service requirements conformity, characteristics and trends of processes and products, including opportunities for preventive action, and suppliers.

Clause 8.5.1: Continual Improvement

Continual improvement is taking regular actions to implement agreed-upon solutions that should bring positive benefits. The organization shall continually improve the effectiveness of the QMS through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions, and management review.

Clause 8.5.2: Corrective Action

Corrective action is an important improvement activity. Corrective action identifies measures needed to correct identified problems. It seeks to eliminate permanently the causes and consequent effects of problems that could hurt business results, the organization’s products/services, processes and QMS, and the satisfaction of customers. Corrective action involves identifying the cause of a particular problem and then implementing the necessary steps to prevent it from recurring.

Clause 8.5.3: Preventive Action

Preventive action seeks to prevent potential problems that could adversely affect business results, products/services, processes, the QMS, or customer satisfaction. A documented procedure shall define requirements for determining potential non-conformities and their causes, evaluating the need for action to prevent the occurrence of non-conformities, selecting and implementing action needed, records of the results of action taken, and reviewing preventive measures taken.

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