ISO 9000 ISO 9001 ISO 9001:2000 ISO 9002 Requirements Standards Regulation Consultant Certification ISO 9000 Consultancy Company in Haryana Delhi India


ISO 9000


Requirements of ISO 9001:2000 (in brief) - Introduction

The following analysis and comments on ISO 9001: 2000 are an interpretation and does not replace the Standard, which must be the prime source document. The guidance provided by notes in the clause requirements, and ISO 9004 should also be read, to ensure that the specific requirements of each clause are being met.
ISO 9000: 2000 and ISO 9004: 2000 are relevant reference standards to understand the terminology and concepts within ISO 9001: 2000, including the reference made to the importance of the "8 Quality Principles" included within it.


1.1 General
The standard is designed to apply to an organisation that needs to consistently provide product that meets customer and Regulatory requirements. It aims to "enhance" customer satisfaction through the organisation's QMS and processes for continual improvement. This emphasis differs with the ISO 9001: 1994 standard which emphasises prevention and aims to achieve customer satisfaction by preventing non-conforming product.

1.2 Application
Exclusions are permitted within clause 7 provided such exclusions do not affect the organisation's ability to provide product that fulfils both customer and regulatory requirements.

2) Normative references

Undated references to standards in ISO 9001: 2000 imply the latest versions should be applied.

3) Terms and definitions
ISO 9000 is an applicable reference for terms and definitions, the terms "Organisation" and "supplier" are defined.

4) Quality Management System

4.1 General requirements
The Quality Management System must focus on processes; their interaction, control, resourcing, monitoring and continual improvement.

4.2.1 Documentation, General
The Quality Management System documentation includes; Quality Policy, Quality Objectives, Quality Manual, Procedures, Documents for effective planning, operation and control of processes and Quality Records.

4.2.2 Quality Manual
The Quality Manual must include a description of the proposed scope and details of "exclusions" (exclusions are limited to product realisation, i.e. Clause 7 only, provided the exclusion does not affect the ability to meet customer and regulatory requirements). The Quality Manual must either include or reference documentation and must provide a description of the processes and their interaction, for example a business process overview.

4.2.3 Control of documents
Documents required by the Quality Management System must be controlled as specified in the standard, these are typically documents that describe products/services and describe how to undertake the processes e.g. procedures and support documentation. A documented procedure is required for controlling such documents.

4.2.4 Control of quality records
Quality records are also documents used to record information, these must be controlled as specified in the standard and there must be a documented procedure as an addition to the 4.2.3 requirements.

5) Management responsibility

5.1 Management commitment
Top management commitment to the development, implementation and continual improvement of the Quality Management System is required. Top management has specific responsibilities to communicate customer and Regulatory requirements within the organisation and for establishing the Quality Policy, Quality Objectives, Management Reviews and Resourcing requirements.

5.2 Customer focus
Determining customer requirements is a top management responsibility with an aim at enhancing customer satisfaction (Note: Clause 1.1 emphasis is not as final as to "satisfy" customers because of the enhancement of the "continual improvement" concept within the standard). Customer focus is also intended as a proactive process rather than just reacting to a sale or contract. Understanding customer needs will involve marketing activities.

5.3 Quality policy
The Quality Policy set by top management must include the specific requirements that provide a framework to allow appropriate quality objectives to be set. It is not to be a "vision" statement.

5.4.1 Quality objectives
Quality objectives must be set by top management at all functions and levels (including for individuals if applicable). A link with the Quality Policy should be clear and objectives must be measurable.

5.4.2 Quality management system planning
Top management planning activities for the QMS must be consistent with 4.1, i.e. must focus on processes, and ensure that integrity of the QMS is retained when changes occur.

5.5.1 Responsibility and authority
Top management must define and communicate responsibilities, authorities and their inter-relation for the whole organisation.

5.5.2 Management representative
The management representative must have responsibility and authority for the establishment, implementation and maintenance of processes needed for the QMS, reporting to top management on QMS performance and promotion of awareness of customer requirements.

5.5.3 Internal communication
Appropriate internal communication processes must be established including those related to the effectiveness of the QMS.

5.6.1 Management review, general
Management review by top management will include assessing opportunities for improvement and need for change of the QMS, Quality Policy and Quality Objectives.

5.6.2 Review input
Management review input requirements are specified and listed as regular requirements for consideration. Input may be in the form of a report or a presentation.

5.6.3 Review output
Management review decisions and actions are required on improvements for the QMS and processes, improvement of product, on resource needs and suitability of the QMS.

6) Resource Management

6.1 Provision of resources
Resources must be determined and provided to implement, maintain and continually improve the QMS and to enhance customer satisfaction.

6.2.1 Human resources
Personnel performing work affecting product quality must be competent. This means that only competent personnel must be assigned.

6.2.2 Competence
The competence required must be determined and training provided (or other action taken). This means that competence of personnel must be determined and compared with competence requirements. The effectiveness of training in achieving the competence required must be evaluated.

6.3 Infrastructure
The facilities provided must be appropriate for the achievement of product quality requirements.

6.4 Work environment
The work environment must be appropriate for the achievement of product quality requirements.

7) Product realization

7.1 Planning of product realization
Note that the whole of Clause 7 is subject to permitted exclusion but in practice Clause 7.3, design and development will normally be the main consideration for exclusion if the organisation does not have a design and development capability.

Planning for product realisation requires consideration of the processes involved. Product realisation planning must determine the product quality requirements, including inspection and testing needed, control documentation needed, resources required and records to be retained. Where design is involved, design controls must be included in the planning activity.

7.2.1 Determination of requirements related to products
Determining product requirements must include not only customer specified requirements, but also the unspecified/implied requirements expected from the known state of the art. The organisation is responsible for including Regulatory requirements in determining product requirements.

7.2.2 Review of requirements related to products
The capability to supply a product must be reviewed before submission of a tender or accepting an order. In limited cases where a review is not practical, such as internet sales, the organisation can assume that the publication of a catalogue or advertising material will cover the review requirement before acceptance of an order.

7.2.3 Customer communication
Communication arrangements with customers must be established to ensure understanding of product and contract requirements and facilitate feedback, including complaints.

7.3 Design and development
The organisation must ensure that it has defined, implemented and maintained the necessary design and development processes to respond to customer needs and expectations. The design process must consider expectations of "other interested parties" e.g. customers, suppliers, employees, society in general. All factors that contribute to meeting the expected product and process performance must be considered. These factors include life cycle, safety and health, usability and user friendliness, durability, the environment including disposability. These factors will contribute to the identification of interested parties and their expectations.

7.4.1 Purchasing process
The type and extent of control applied to suppliers must be dependent upon the effect of purchased product on the product realisation. Organisations must determine this significance. Criteria for selection, evaluation and re-evaluation of suppliers must be established and implemented. The evaluation and what product(s) have been approved for supply must be recorded.

7.4.2 Purchasing information
The adequacy of purchasing information to describe the product to be purchased must be reviewed before communication to the supplier. The approval process and technical competence of "approver" should be considered.

7.4.3 Verification of purchased product
The inspection required for incoming purchased product must be established and implemented. The extent of this should be considered together with 7.4.1, 7.4.2 and any intended inspection at the supplier's premises.

7.5.1 Control of production and service provision
The planning and provision of production should include 7.5.1 a) - f). Although "where applicable" is added to this requirement and the exclusion limitation applies to clause 7 as a whole, if the exclusion of a sub-clause requirement a) - f) would adversely affect the product it may not be excluded.

7.5.2 Validation of processes for production and service provision
Validation of processes is now a more clearly specified requirement where the resulting output cannot be monitored or measured. Typical examples include welding, soldering, sterilisation. The requirements for validation and re-validation are now clearly specified in a) - e).

7.5.3 Identification and traceability
The requirement for appropriate identification and traceability allows an understanding of the status of product and processes through monitoring, measurement and unique identification. The identification and traceability requirement for product and process activities may also arise due to the need to meet a number of additional criteria including Regulatory requirements, control of hazardous materials, mitigation of risks and product recall capability.

7.5.4 Customer property
The organisation must identify responsibilities to protect the value of the customer's property including items supplied by the customer to be subsequently included in product, product supplied for repair, packaging materials and documents such as customer specifications and drawings. Intellectual property provided by the customer is also included in this requirement.

7.5.5 Preservation of product
Processes must be defined to prevent damage, deterioration or misuse during internal processing and final delivery of the product. Suppliers must be involved with the organisation in determining effective processes to protect purchased materials.

The organisation should communicate to customers and other interested parties, the information needed to preserve the intended use of the product throughout its life cycle against damage or misuse. The information must consider any precautionary aspects arising from the nature of the product.

7.6 Control of monitoring and measuring devices
There are two main objectives for measuring and monitoring. The first is to collect data to ensure compliance, i.e. for products and for testing device calibration. The second is to collect data on processes as a means to enhance customer satisfaction.Measuring and monitoring processes must be defined and implemented to 'ensure satisfaction' of customers and interested parties. Devices used for measurement and monitoring must be fit for the intended use, including measurement accuracy, and have calibration traceable to national measurement standards.Measurement and monitoring devices must be protected against invalid adjustment and damage.If measurement and monitoring devices are not found to meet performance requirements, the organisation must take appropriate action on the product affected and preclude the use of the device. Where used in monitoring and measurement, validation of computer software is a requirement.

8) Measurement, analysis and improvement

8.1 General
Measurement, monitoring, analysis and improvement processes are required to demonstrate conformity of product, ensure conformity of the Quality Management System and continually improve the effectiveness of the Quality Management System. Applicable statistical methods and the extent of their use must be determined.

Data must be collected as the basis for factual decision making on the performance of products, capability of processes, achievement of objectives and level of customer satisfaction and of other interested parties.The analysis of relevant data must be used at management review.

A list of considerations for measurement, analysis and improvement are indicated in ISO 9004: 2000 with the objective of benefiting the organisation, establishing priorities, improving product/process performance and effectiveness and for measuring customer satisfaction.

8.2.1 Customer satisfaction
Monitoring and measurement must include a measure of customer perception of the fulfilled customer requirements and a method for obtaining and using this information must be determined.

8.2.2 Internal audit
Planned internal audits must be carried out to demonstrate conformity to planned arrangements (clause 7.1), ISO 9001: 2000 and the Quality Management System. The audit scope, frequency and method must be defined. An audit procedure is required. Action to eliminate the cause of
non-conformity must be taken without undue delay and verification action recorded.

ISO 10011/1 and 10011/2 apply for audit/auditor guidance. The audit procedure must therefore include a requirement for the collection of objective evidence and auditors must be competent to determine the strengths and weaknesses of the quality management system.
Improvement action must be taken in response to internal audit results. Internal audit planning should consider a wide range of subjects, ref. ISO 9004: 2000.

8.2.3 Monitoring and measurement of processes
Monitoring and measurement of processes must be carried out to demonstrate the ability of processes to achieve planned results. This should provide information for continual improvement and for achieving strategic objectives and the needs of customers and interested parties.

8.2.4 Monitoring and measurement of product
Monitoring and measurement of product characteristics must be carried out in accordance with clause 7.1.
Evidence of conformity to acceptance criteria is required before release of the product by authorised personnel. When selecting measurement methods for products, the organisation must consider customer needs and expectations, needs of interested parties and also opportunities for performance improvement, including from inspection and test reports.
Interested parties may include the people in the organisation, investors, suppliers and partners, regulators and the public.

8.3 Control of non-conforming product
Non-conforming product must be identified, segregated, and controlled to prevent misuse. The organisation must deal with non-conforming product by taking action to eliminate the non-conformity and either obtain authorisation for its use from the customer, or remove it from the possibility of use.
Review of the extent of non-conforming product should be part of management review to consider reduction goals and resource needs.
People carrying out the product non-conformity review and making the decision on disposition must have the competence to evaluate the total effects and the authority to agree the outcome and corrective action.
When non-conforming product is corrected for subsequent use it must be subjected to re-verification to demonstrate conformity.
When non-conforming product is detected after delivery, appropriate action must be taken dependent on the effects, e.g. recall. A procedure is required to describe the process for controlling non-conforming product.

8.4 Analysis of data
The organisation must determine, collect and analyse appropriate data to demonstrate the suitability and effectiveness of the quality management system. This must give information relating to customer satisfaction, product conformity, trends in processes and suppliers. Other data may be collected, such as success of performance improvement objectives, economics of quality, market related performance, benchmarking and competitiveness.

8.5.1 Continual improvement
Continual improvement of the Quality Management System must be demonstrated through the use of the Quality Policy, Quality Objectives, audit results, analysis of data, corrective and preventive action and management review.

8.5.2 Corrective action
A procedure is required to define requirements for reviewing non-conformities, determining their cause, evaluating the need for action to eliminate recurrence, determining and implementing action needed, recording the results of action taken and reviewing corrective action taken. Sources of potential information for corrective action are listed in ISO 9004: 2000. Note that prevention of recurrence of non-conformity may involve competence assessment and training.

8.5.3 Preventive action
A procedure is required to define requirements for determining potential non-conformities and their causes, evaluating the need for action, determining and implementing action, record results of action taken and review of its effectiveness.

Quality Management Principles

These eight principles have been identified for use by top management in order to lead an organisation toward improved performance, and have been integrated in the contents of ISO 9001:2000. They should, in particular, be taken into account by Senior Management when developing/reviewing Quality Policy and Objectives.

a) Customer Focus
Organisations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.

b) Leadership
Leaders establish unity of purpose and direction of the organisation. They should create and maintain the internal environment in which people can become fully involved in achieving the organisation's objectives.

c) Involvement of people
People at all levels are the essence of an organisation and their full involvement enables their abilities to be used for the organisation's benefit.

d) Process approach
A desired result is achieved more efficiently when activities and related resources are managed as a process.

e) System approach to management
Identifying, understanding and managing interrelated processes as a system contributes to the organisation's effectiveness and efficiency in achieving its objectives.

f) Continual improvement
Continual improvement of the organisation's overall performance should be a permanent objective of the organisation.

g) Factual approach to decision making
Effective decisions are based on the analysis of data and information.

h) Mutually beneficial supplier relationships
An organisation and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.
Successful use of the eight management principles by an organisation should result in benefits to interested parties, such as improved monetary returns, the creation of value and increased stability.


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