ISO 9001-2000 Clause

ISO 9001:2000 Cross Reference MapISO 9001:2000

ClausesDescription Related ITD Procedure

1. Scope Scope of the QMS, areas covered and any exclusions identified Quality Manual2. Normative

ReferenceThe normative reference ISO 9000:2000 (fundamentals/vocabulary) must be used in conjunction with the standard itself

Quality Manual

3. Terms & Definitions

The terms and definitions given in ISO 9000 apply. Quality Manual

4.1 General Requirements 4.1 a)4.1 b)4.1 c)

4.1 d)4.1 e)

4.1 f)

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

Quality Manual (Section 1.2 & 6)Quality Manual (Section 6)Each procedure under Effectiveness Review sectionQuality Manual (Section 4)Quality Manual (Section 5) and Management ReviewITD Corrective & Preventive Action Procedure and Management Review

4.2 Documentation Requirements

The important issue here is that people must have the information they need to do their job. The QMS must include quality policy, quality objectives, quality manual, documented procedures, documents to ensure the effective planning, operation and control of its processes, and records. All documents are required to be controlled. Also required is the control of records, i.e. identification, storage, protection, retrieval, retention time and disposition of records.

Document Control Procedure

5. Management Responsibility

Specifically identifies the responsibility of top management and the need for effective leadership

Quality Manual (Section 3)

5.1 Management Commitment

Top management shall provide evidence of its commitment to the development and implementation of the QMS and continually improving its effectiveness

Quality Policy

5.2 Customer Focus Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction

Quality Policy

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

Quality Policy

5.4 Planning Top management shall ensure that the planning of the QMS is carried out in order to meet the requirements of the standard as well as the quality objectives. The integrity of the QMS is maintained when changes to the QMS are planned and implemented.

Quality Manual (Sections 3.1 & 4)

5.5 Responsibility, Authority &

Top management shall ensure that responsibility and authorities are defined and communicated within the organisation. Everybody should know what they are expected to do


ISO 9001:2000 Cross Reference Map Revision Date: 1 July ‘05 of 6

ISO 9001:2000 Clauses

Description Related ITD Procedure

Communication (responsibilities) and what they are allowed to do (authorities). They should understand how these responsibilities and authorities relate to each other. A Management representative needs to be appointed who has responsibility for the QMS. Appropriate communication processes need to be established, and the effectiveness of the QMS must be communicated to the organisation.

5.6 Management Review

The QMS must be reviewed at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. Records from the review must be maintained. The review inputs and outputs must be clearly stated.





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.


6.1 Provision of Resources

The organisation shall determine and provide resources needed to implement and maintain the QMS and continually improve its effectiveness, and to enhance customer satisfaction by meeting customer requirements

Quality Manual (Section 3.1, 3.4 & 4)

6.2 Human Resources

Personnel performing work affecting quality of service, shall be competent on the basis of appropriate education, training, skill and experience. The organisation must determine the necessary competence and provide training to satisfy these. They must evaluate the effectiveness of the training and maintain appropriate records. They must also ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives

Quality Manual (Section 4) & Training Procedure.

6.3 Infrastructure The organisation shall determine, provide and maintain the infrastructure needed to perform work. Infrastructure includes buildings, workspace, utilities, equipment and supporting services. This means determining and providing for current infrastructure requirements and planning for expected future needs.


6.4 Work Environment

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


7.1 Planning of Product Realisation

The organisation shall plan and develop the processes needed for service realisation. This includes the need to establish processes, 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 realisation processes and resulting service meet the requirements

ITD Service Provision Procedure

7.2 Customer Related Processes

The organisation shall determine customer requirements, statutory and regulatory requirements and any additional requirements determined by the organisation, and review these requirements. Records resulting from the review and actions arising should be maintained. This clause focuses mainly on the service provided, but can cover additional factors such as regulatory or legal requirements, and unspecified customer expectations.

ITD Service Provision Procedure & Quality Manual (Section 2). ITD Project Management & System Development Procedure

7.3 Design & Development

The organisation shall plan and control the design and development of its service. This requires determining the design and development stages, the review, verification and validation of each stage, and the responsibilities and authorities for design and development. This clause requires you to have controls for the design processes and to establish a disciplined approach to the design process. The design process should include inputs, outputs, review, verification and validation. Design and development changes also need to be identified and records maintained.

ITD Project Management & System Development Procedure




7.4 Purchasing The organisation shall ensure that purchased product conforms to specified purchase requirements. The organisation shall evaluate and select suppliers based on their ability to supply product in accordance with these requirements. Criteria for selection, evaluation and re-evaluation shall be established. Records of results of evaluation shall be maintained. The organisation shall also establish and implement the inspection or other activities necessary (verification) for ensuring that purchased product meets specified requirements.

Purchasing Procedure

7.5.1 Control of production & service provision

This clause describes the various types of controls that you might need to have in place for the delivery of service. These include the availability of information that describes the service, the availability of work instructions, the use of suitable equipment, the availability of monitoring and measuring devices and the implementation of monitoring and measurement.

Quality Manual (Section 6) and related procedures

7.5.2 Validation of processes for production and service provision

ITD do not have any processes where the resulting outputs cannot be verified by subsequent monitoring and measuring, therefore this clause is excluded

Excluded

7.5.3 Identification & Traceability

Where appropriate, the organisation shall identify the product/service by suitable means. Where traceability is a requirement, the organisation shall control and record the unique identification of the product / service. Identification is knowing what the product or service resulting from a particular process is. Where you need to identify a product/service, the methods used and the records to be kept need to be defined. Traceability is knowing where a product/service came from.

Equipment Management Procedure

7.5.4 Customer Property

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


7.5.5 Preservation of Product

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

Equipment Management Procedure; Print Room Procedure and Post Room Procedure

7.6 Control of monitoring & measuring devices

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





8.1 Measurement Analysis & Improvement

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


8.2.1 Customer Satisfaction

The organisation shall monitor information relating to customer perception as to whether they have met customer requirements. The methods for obtaining and using 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 the customer satisfaction monitoring should be addressed in the management review and continual improvement activities, to identify and implement those changes which will improve the relationship with customers. Note: Satisfaction is not the opposite of dissatisfaction. Satisfaction can produce a neutral response whereas dissatisfaction can produce a strong negative response!


8.2.2 Internal Audit The organisation shall conduct internal audits at planned intervals to determine whether the QMS conforms to the standard and to the QMS requirements established by the organisation, and is effectively implemented and maintained. The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records shall be defined in a documented procedure. Management must ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities shall include the verification of the actions taken and the reporting of verification results.

Internal Audit Procedure

8.2.3 Monitoring & Measurement of Processes

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


8.2.4 Monitoring & 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 the purposes of monitoring or measuring both processes and products / services.


8.3 Control of Nonconforming product

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

Quality Manual (Section 7), Print Room Procedure, Equipment Management Procedure




8.4 Analysis of Data Analysing data is an essential activity for any possible improvement in the quality management system, in the processes and in the product/service. The organisation shall determine, collect and analyse appropriate data to demonstrate the suitability and effectiveness of the QMS and to evaluate where continual improvement of the effectiveness of the QMS can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources. The analysis of data shall provide information on customer satisfaction; conformity of product/service requirements; characteristics and trends of processes and products including opportunities for preventive action; and suppliers.


8.5.1 Continual Improvement

Continual improvement is the process of taking actions on a recurring basis to implement agreed solutions that should bring positive benefits. The organisation 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.

Quality Manual, Quality Policy, Quality Objectives, Management Review and Corrective & Preventive Action Procedure

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 have a negative impact on business results; the organisation’s products/services, processes and QMS; and the satisfaction of customers. Corrective action involves finding the cause of a particular problem and then putting in place the necessary actions to prevent it from recurring.

Corrective & Preventive Action Procedure

8.5.3 Preventive Action

Preventive action seeks to prevent the occurrence of potential problems that could have a negative effect on business results, products/services, processes, QMS or customer satisfaction. A documented procedure shall define requirements for determining potential nonconformities and their causes; evaluating the need for action to prevent occurrence of nonconformities; determining and implementing action needed; records of the results of action taken; and reviewing preventive action taken.

Corrective & Preventive Action Procedure


ISO 9001-2000 Clause

Documents

Transcript of ISO 9001-2000 Clause