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ISO 9000 Faces Complete Restructuring
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ISO/FDIS 9001:2000 requirements, which were changed in varying degrees from those in CD1, CD2 and DIS, are described below..
4 Quality Management System is compatible with ISO 14001 Element 4.1.
4.1 General Requirements, replacing ISO 9001: 1994 Element 4.2.1 and compatible with ISO 14001 Element 4.1, requires an organization to establish, document, implement, maintain and continually improve a quality management system (QMS) covering ISO 9001 requirements. The organization must identify and manage the processes necessary to achieve planned results and continual improvement.
4.2 Documentation Requirements replaces ISO 9001: 1994 Elements 4.2.1, 4.5 and 4.16.
4.2.1 General, replacing ISO 9001: 1994 Elements 4.2.1 and 4.5.1, and compatible with ISO 14001 Element 4.4.4, requires an organization to prepare a quality policy, quality manual, documented procedures, records and other documents required to ensure effective operation and control of its processes, and required by ISO 9001. The extent of QMS documentation depends on the size and type of the organization, complexity and interaction of its processes, and competence of personnel.
4.2.2 Quality Manual, replacing ISO 9001: 1994 Element 4.2.1 and compatible with ISO 14001 Element 4.4.4, requires the organization to establish and maintain a quality manual that includes the scope of the QMS, documented procedures and a description of QMS processes.
4.2.3 Control of Documents, replacing ISO 9001: 1994 Element 4.5 and compatible with ISO 14001 Element 4.4.5, requires QMS documents, including quality records, to be controlled. A documented procedure must be established to approve, review, update, and identify the current revision level of QMS documents; ensure that relevant versions are available at points of use, documents are legible, readily identifiable and retrievable, and documents of external origin are identified and controlled; and prevent unintended use of obsolete documents.
4.2.4 Control of Quality Records, replacing ISO 9001: 1994 Element 4.16 and compatible with ISO 14001 Element 4.5.3, requires the organization to control and maintain QMS records to provide evidence of conformance to requirements and of effective QMS operation. A documented procedure must be established for the identification, storage, retrieval, protection, retention time and disposition of quality records.
5 Management Responsibility is compatible with ISO 14001 Element 4.4.1.
5.1 Management Commitment, replacing ISO 9001:1994 Elements 4.1 and 4.2.1, and compatible with ISO 14001 Element 4.2, requires top management to demonstrate its commitment to the QMS by establishing the quality policy and objectives; conducting management reviews; communicating to the organization the importance of meeting customer, regulatory and legal requirements; and ensuring the availability of necessary resources.
5.2 Customer Focus, replacing ISO 9001:1994 Element 4.3,2 and compatible with ISO 14001 Elements 4.3.1 and 4.3.2, requires top management to ensure that customer requirements are determined and fulfilled with the aim of enhancing customer satisfaction.
5.3 Quality Policy, replacing ISO 9001:1994 Element 4.1.1 and compatible with ISO 14001 Element 4.2, requires top management to establish an appropriate quality policy which includes a commitment to meeting requirements and continual improvement, provides a framework for establishing and reviewing quality objectives, is communicated and understood at appropriate organizational levels, and is reviewed for continuing suitability.
5.4 Planning replaces ISO 9001: 1994 Elements 4.1.1, 4.2.1 and 4.2.3, and is compatible with ISO 14001 Element 4.3.
5.4.1 Quality Objectives, replacing ISO 9001:1994 Elements 4.1.1 and 4.2.1, and compatible with ISO 14001 Element 4.3.3, requires the organization to establish quality objectives that are measurable and consistent with the quality policy, including those needed to meet product requirements.
5.4.2 Quality Management System Planning, replacing ISO 9001:1994 Element 4.2.3 and compatible with ISO 14001 Element 4.3.4, requires top management to plan the QMS to meet Element 4.1 requirements and quality objectives, and ensure that QMS integrity is maintained when changes are planned and implemented.
5.5 Responsibility, Authority and Communication replaces ISO 9001: 1994 Elements 4.1.2.1 and 4.1.2.3, and is compatible with ISO 14001 Element 4.1.
5.5.1 Responsibility and Authority, replacing ISO 9001: 1994 Element 4.1.2.1 and compatible with ISO 14001 Element 4.4.1, requires top management to ensure that responsibilities, authorities and their interrelation within the organization are defined and communicated.
5.5.2 Management Representative, replacing ISO 9001: 1994 Element 4.1.2.3 and compatible with ISO 14001 Element 4.4.1, requires top management to appoint a member of the management with responsibility for ensuring that QMS processes are established, implemented and maintained, reporting QMS performance and any need for improvement to top management and promoting awareness of customer requirements throughout the organization.
5.5.3 Internal Communication, compatible with ISO 14001 Element 4.4.3, requires top management to ensure communication processes are established within the organization and that communication takes place regarding QMS effectiveness.
5.6 Management Review replaces ISO 9001: 1994 Element 4.1.3 and is compatible with ISO 14001 Element 4.6.
5.6.1 General, replacing ISO 9001: 1994 Element 4.1.3 and compatible with ISO 14001 Element 4.6, requires top management to periodically review the QMS to ensure its continuing suitability, adequacy and effectiveness, and evaluate opportunities for improvement and the need for changes, including the quality policy and objectives.
5.6.2 Review Input, replacing ISO 9001: 1994 Element 4.1.3 and compatible with ISO 14001 Element 4.6, requires management review inputs to include information on audit results, customer feedback, process performance and product conformity, preventive and corrective actions, follow-ups to previous management reviews, changes that could affect the QMS, and recommendations for improvement.
5.6.3 Review Output, replacing ISO 9001: 1994 Element 4.1.3 and compatible with ISO 14001 Element 4.6, requires management review output to include decisions and actions related to improving the effectiveness of the QMS and its processes, product improvement related to customer requirements, and resource needs.
6 Resource Management is compatible with ISO 14001 Element 4.4.1.
6.1 Provision of Resources, replacing ISO 9001: 1994 Element 4.1.2.2 and compatible with ISO 14001 Element 4.4.1., requires the organization to determine and provide the resources needed to implement and maintain the QMS, continually improve its effectiveness, and enhance customer satisfaction by meeting customer requirements.
6.2 Human Resources replaces ISO 9001: 1994 Elements 4.1.2.2, 4.2.3 and 4.18, and is compatible with ISO 14001 Element 4.4.1.
6.2.1 General, replacing ISO 9001: 1994 Elements 4.1.2.2, 4.2.3 and 4.18, and compatible with ISO 14001 Element 4.4.1, requires the organization to assign personnel to work affecting product quality who are competent on the basis of appropriate education, training, skills and experience.
6.2.2 Competence, Awareness and Training, replacing ISO 9001: 1994 Element 4.18 and compatible with ISO 14001 Element 4.4.2, requires the organization to identify competency needs and provide training for personnel performing activities affecting product quality; evaluate training effectiveness; ensure that employees are aware of the relevance and importance of their activities, and how they contribute to achieving quality objectives; and maintain appropriate education, training, skills and experience records.
6.3 Infrastructure, replacing ISO 9001: 1994 Elements 4.1.2.2 and 4.9, and compatible with ISO 14001 Element 4.4.1, requires the organization to determine, provide and maintain the infrastructure needed to achieve product conformity, including buildings, workspace and associated facilities; process equipment, both hardware and software; and supporting services, such as transport or communication.
6.4 Work Environment, replacing ISO 9001: 1994 Element 4.9 and compatible with ISO 14001 Element 4.4.1, requires the organization to determine and manage the work environment needed to achieve product conformity.
7 Product Realization is compatible with ISO 14001 Elements 4.4 and 4.4.6.
7.1 Planning of Product Realization, replacing ISO 9001: 1994 Elements 4.2.3, 4.9 and 4.10.1, and compatible with ISO 14001 Element 4.4.6, requires the organization to plan and develop the processes needed for product realization, which must be consistent with other QMS process requirements and be documented in a form suitable for the organization's method of operations. The organization must determine the product's quality objectives and requirements; the need to establish processes and document, and provide resources specific to the product; required product verification, validation, monitoring, inspection and test activities, and acceptance criteria; and necessary records to provide evidence that the realization processes and resulting product fulfill requirements.
7.2 Customer-Related Processes replaces ISO 9001:1994 Elements 4.3 and 4.4.4, and is compatible with ISO 14001 Element 4.4.6.
7.2.1 Determination of Requirements Related to the Product, replacing ISO 9001: 1994 Elements 4.3.2 and 4.4.4, and compatible with ISO 14001 Elements 4.3.1, 4.3.2 and 4.4.6, requires the organization to determine customer-specified requirements, including requirements for delivery and post-delivery activities; requirements not specified by the customer, but necessary for specified or known and intended use; statutory and regulatory requirements related to the product; and any additional requirements.
7.2.2 Review of Requirements Related to the Product, replacing ISO 9001: 1994 Element 4.3 and compatible with ISO 14001 Elements 4.3.1 and 4.4.6, requires the organization to review requirements related to the product before committing to supply it. This review must ensure that product requirements are defined, changes in contract or order requirements are resolved, and the organization is able to meet the requirements. Records of review results and follow-up actions must be maintained. Customer requirements must be confirmed by the organization before acceptance if not previously documented by the customer. When product requirements are changed, relevant documentation must be amended and relevant personnel must be made aware of the changes.
7.2.3 Customer Communication, replacing ISO 9001: 1994 Element 4.3.2 and compatible with ISO 14001 Element 4.4.3, requires the organization to identify and implement effective communication arrangements with customers relating to product information; inquiries, contracts or order handling, including amendments; and customer feedback, including complaints.
7.3 Design and Development replaces ISO 9001:1994 Element 4.4.
7.3.1 Design and Development Planning, replacing ISO 9001: 1994 Elements 4.4.2, 4.4.3, 4.4.6, 4.4.7 and 4.4.8, and compatible with ISO 14001 Element 4.4.6, requires the organization to plan and control design and development of product. This planning determines the design and development stages; appropriate review, verification and validation activities; and responsibilities and authorities for design and development activities. Interfaces between different groups involved in design and development must be managed to ensure effective communication and clarify assignment of responsibilities. Planning output must be appropriately updated as the design and development progresses.
7.3.2 Design and Development Inputs, replacing ISO 9001: 1994 Element 4.4.4 and compatible with ISO 14001 Element 4.4.6, requires inputs relating to product requirements to be determined and reviewed for adequacy, with records maintained. These include functional, performance, and applicable statutory and regulatory requirements; applicable information derived from previous similar designs; and other essential design and development requirements. Requirements must be complete, unambiguous and not in conflict with each other.
7.3.3 Design and Development Outputs, replacing ISO 9001: 1994 Element 4.4.5 and compatible with ISO 14001 Element 4.4.6, requires design and development outputs to be provided in a form that enables verification against input requirements, and to be approved before release. Outputs must meet input requirements; provide appropriate information for purchasing, production and service provision; contain or reference product acceptance criteria; and specify product characteristics that are essential for its safe and proper use.
7.3.4 Design and Development Review, replacing ISO 9001: 1994 Element 4.4.6 and compatible with ISO 14001 Element 4.4.6, requires systematic reviews of design and development at suitable stages to evaluate the ability of design and development results to fulfill requirements, identify problems and propose necessary actions. Representatives of functions concerned with the design and development stage(s) being reviewed must participate, and records of review results and any necessary actions must be maintained.
7.3.5 Design and Development Verification, replacing ISO 9001: 1994 Element 4.4.7 and compatible with ISO 14001 Element 4.4.6, requires performing design and development verification to ensure the outputs meet the input requirements. Records of verification results and any necessary actions must be maintained.
7.3.6 Design and Development Validation, replacing ISO 9001: 1994 Element 4.4.8 and compatible with ISO 14001 Element 4.4.6, requires performing design and development validation in accordance with planned arrangements to ensure that the resulting product is capable of fulfilling specified or known intended use requirements. Validation must be completed before product delivery or implementation wherever practicable. Records of validation results and any necessary actions must be maintained.
7.3.7 Control of Design and Development Changes, replacing ISO 9001: 1994 Element 4.4.9 and compatible with ISO 14001 Element 4.4.6, requires design and development changes to be identified, documented and controlled; verified and validated, as appropriate; and approved before implementation. This includes evaluation of the effect of changes on constituent parts and delivered product. Records of changes, along with review results and any necessary actions must be maintained.
7.4 Purchasing replaces ISO 9001:1994 Elements 4.6, 4.10.2, 4.10.3 and 4.10.4, and is compatible with ISO 14001 Element 4.4.6.
7.4.1 Purchasing Process, replacing ISO 9001: 1994 Element 4.6.2 and compatible with ISO 14001 Element 4.4.6, requires the organization to ensure that purchased product conforms to specified requirements, with the type and extent of control applied to the supplier and the purchased product dependent upon the effect on subsequent product realization or the final product. Suppliers must be evaluated and selected based on their ability to supply product in accordance with the organization's requirements, with the criteria for selection, evaluation and re-evaluation established. Records of evaluation results and any necessary actions must be maintained.
7.4.2 Purchasing Information, replacing ISO 9001: 1994 Element 4.6.3 and compatible with ISO 14001 Element 4.4.6, requires purchasing information describing the product to be purchased, including where appropriate, requirements for approval of product, procedures, processes and equipment; qualification of personnel; and the QMS. The organization must ensure the adequacy of specified purchase requirements before communicating them to the supplier.
7.4.3 Verification of Purchased Product, replacing ISO 9001: 1994 Elements 4.6.4, 4.10.2, 4.10.3 and 4.10.4, and compatible with ISO 14001 Element 4.4.6, requires the organization to establish and implement the inspection or other activities necessary to ensure that purchased product meets specified purchase requirements. Where the organization or its customer proposes to perform verification at the supplier's premises, the organization must state the intended verification arrangements and product release method in the purchasing information.
7.5 Production and Service Provision replaces ISO 9001: 1994 Elements 4.7, 4.8, 4.9, 4.10.3, 4.10.5, 4.12, 4.15 and 4.19, and is compatible with ISO 14001 Element 4.4.6.
7.5.1 Control of Production and Service Provision, replacing ISO 9001: 1994 Elements 4.9, 4.10.3, 4.15.6 and 4.19, and compatible with ISO 14001 Element 4.4.6, requires the organization to plan and carry out production and service provision under controlled conditions, which include, as applicable, the availability of product characteristics information; the availability of work instructions; using suitable equipment; the availability and use of monitoring and measuring devices; the implementation of monitoring and measurement; and the implementation of release, delivery and post-delivery activities.
7.5.2 Validation of Processes for Production and Service Provision, replacing ISO 9001: 1994 Element 4.9 and compatible with ISO 14001 Element 4.4.6, requires the organization to validate production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement, including any processes where deficiencies become apparent only after the product is in use or the service has been delivered. Validation must demonstrate the ability of these processes to achieve planned results, and must include, as applicable, defined criteria for process review and approval, approval of equipment and qualification of personnel, use of specific methods and procedures, requirements for records, and revalidation.
7.5.3 Identification and Traceability, replacing ISO 9001: 1994 Elements 4.8, 4.10.5 and 4.12, and compatible with ISO 14001 Element 4.4.6, requires the organization, where appropriate, to identify the product by suitable means throughout product realization, and the product status with respect to monitoring and measurement requirements. The organization must control and record the product's unique identification where traceability is required.
7.5.4 Customer Property, replacing ISO 9001: 1994 Element 4.7 and compatible with ISO 14001 Element 4.4.6, requires the organization to exercise care with customer property while it is under the organization's control or being used by the organization. Customer property provided for use or incorporation into the product must be identified, verified, protected and safeguarded. Lost, damaged or otherwise unsuitable customer property must be recorded and reported to the customer.
7.5.5 Preservation of Product, replacing ISO 9001: 1994 Element 4.15 and compatible with ISO 14001 Element 4.4.6, requires the organization to preserve product conformity to customer requirements during internal processing and delivery to the intended destination, including identification, handling, packaging, storage and protection. Preservation also applies to a product's constituent parts.
7.6 Control of Monitoring and Measuring Devices, replacing ISO 9001: 1994 Element 4.11 and compatible with ISO 14001 Element 4.5.1, requires the organization to determine the monitoring and measurements to be undertaken, and the monitoring and measuring devices needed to provide evidence of product conformity to determined requirements. The organization must establish processes to ensure that monitoring and measurement can be carried out and in a manner that is consistent with monitoring and measurement requirements. Where necessary to ensure valid results, measuring equipment must be calibrated or verified at specified intervals, or prior to use, against international or national measurement standards, or under a recorded basis where no such standards exist; adjusted or re-adjusted as necessary; identified to enable the calibration status to be determined; safeguarded from adjustments that would invalidate the measurement result; and protected from damage and deterioration during handling, maintenance and storage. The organization must re-assess and record the validity of previous measuring results when the equipment is found not to conform to requirements, with appropriate action taken on the affected equipment and product. Records of calibration and verification results must be maintained. The ability of computer software to satisfy monitoring and measuring of specified requirements must be confirmed prior to initial use and reconfirmed as necessary.
8 Measurement, Analysis and Improvement is compatible with ISO 14001 Element 4.5.
8.1 General, replacing ISO 9001: 1994 Elements 4.10, 4.17 and 4.20.1, and compatible with ISO 14001 Element 4.5.1, requires the organization to plan and implement the monitoring, measurement, analysis and improvement processes needed to demonstrate product conformity, ensure QMS conformity and continually improve QMS effectiveness, including determining applicable methods, such as statistical techniques, and the extent of their use.
8.2 Monitoring and Measurement replaces ISO 9001: 1994 Elements 4.9, 4.10, 4.17 and 4.20.1, and compatible with ISO 14001 Element 4.5.1
8.2.1 Customer Satisfaction, compatible with ISO 14001 Element 4.5.1, requires the organization to monitor information relating to customer perception of the organization fulfilling customer requirements as one of the QMS performance measurements, while determining methods for obtaining and using this information.
8.2.2 Internal Audit, replacing ISO 9001: 1994 Element 4.17 and compatible with ISO 14001 Element 4.5.4, requires the organization to conduct periodic internal audits to determine if the QMS conforms to planned arrangements, ISO 9001 requirements and the organization's QMS requirements; and has been effectively implemented and maintained. Audit program planning must take into consideration the status and importance of processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods must be defined. Auditor selection and audit conduct must ensure that the audit process is objective and impartial. Auditors must not audit their own work. A documented procedure must define responsibilities and requirements for planning and conducting audits, reporting results and maintaining records. The management responsible for the area being audited must ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities must include verification of actions take and the reporting of verification results.
8.2.3 Monitoring and Measurement of Processes, replacing ISO 9001: 1994 Elements 4.9, 4.17 and 4.20.1, and compatible with ISO 14001 Element 4.5.1, requires the organization to apply suitable methods to monitor and, where applicable, measure the QMS processes. These methods must demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action must be taken, as appropriate, to ensure product conformity.
8.2.4 Monitoring and Measurement of Product, replacing ISO 9001: 1994 Elements 4.10 and 4.20.1, and compatible with ISO 14001 Element 4.5.1, requires the organization to monitor and measure product characteristics at appropriate product realization process stages, in accordance with planned arrangements, to verify that product requirements are fulfilled. Evidence of conformity to the acceptance criteria must be maintained, with records indicating the person(s) authorizing product release. Product release and service delivery cannot proceed until all the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, the customer.
8.3 Control of Nonconforming Product, replacing ISO 9001: 1994 Element 4.13 and compatible with ISO 14001 Elements 4.5.2 and 4.4.7, requires the organization to ensure that product which does not conform to requirements is identified and controlled to prevent its unintended use or delivery. A documented procedure must define the controls and authorities for dealing with nonconforming product. The organization must deal with nonconforming product by either taking action to eliminate the detected nonconformity; authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, the customer; taking action to preclude its original intended use or application; or some combination of these methods. Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, must be maintained. When nonconforming product is corrected, it must be subject to re-verification to demonstrate conformity to requirements. When nonconforming product is detected after delivery or use has started, the organization must take action appropriate to the effects, or potential effects, of the nonconformity.
8.4 Analysis of Data, replacing ISO 9001: 1994 Elements 4.14 and 4.20, and compatible with ISO 14001 Element 4.5.1, requires the organization to determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the QMS, and to evaluate where continual improvement of the QMS can be made. This includes data generated by monitoring and measuring, and from other relevant sources. The data analysis must provide information relating to customer satisfaction; conformance to product requirements; characteristics and trends of processes and products, including opportunities for preventive action; and suppliers.
8.5 Improvement replaces ISO 9001: 1994 Elements 4.1.3 and 4.14, and is compatible with ISO 14001 Element 4.2.
8.5.1 Continual Improvement, replacing ISO 9001: 1994 Element 4.1.3 and compatible with ISO 14001 Element 4.3.4, requires the organization to continually improve the effectiveness of the QMS through the use of the quality policy, objectives, audit results, analysis of data, corrective and preventive actions, and management review.
8.5.2 Corrective Action, replacing ISO 9001: 1994 Elements 4.14.1 and 4.14.2, and compatible with ISO 14001 Element 4.5.2, requires the organization to take action to eliminate the causes of nonconformities in order to prevent recurrence. Corrective actions must be appropriate to the effects of the encountered nonconformities. A documented procedure must be established to define requirements for reviewing nonconformities, including customer complaints; determining the causes of nonconformities; evaluating the need for action to prevent the recurrence of nonconformities; determining and implementing needed actions; recording the results of actions taken; and reviewing corrective actions taken.
8.5.3 Preventive Action, replacing ISO 9001: 1994 Elements 4.14.1 and 4.14.3, and compatible with ISO 14001 Element 4.5.2, requires the organization to determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions must be appropriate to the effects of the potential problems. A documented procedure must be established to define requirements for determining potential nonconformities and their causes, evaluating the need for action to prevent nonconformity occurrence, determining and implementing needed action, recording the results of actions taken, and reviewing preventive actions taken.
ISO member balloting on Final Draft International Standard (FDIS) versions of the ISO 9000 standards will end November 14. If the FDIS is approved, as expected, the new ISO 9000 standards will be published in mid to late November or early December.
Under transitional planning by the International Accreditation Forum (IAF), ISO/TC 176 and the ISO Committee on Conformity Assessment (CASCO), registrars will not be able to issue ISO 9001: 2000 registration certificates before the revised standard is published.
Prior to publication, registrars can conduct third party audits to ISO/FDIS 9001: 2000. Registration certificates issued to the ISO 9000: 1994 standards will remain valid for a maximum of three years after the revised standards are published. Auditors and other relevant registrar personnel will be required to demonstrate knowledge and understanding of ISO 9001: 2000 requirements, the eight quality management principles on which the revised standards are based, and the concepts and terminology of ISO 9000: 2000.
| ISO 9001: 1994 | ISO 9001: 2000 |
| 4.1 Management Responsibility | 5.1, 5.3, 5.4.1, 5.5.1, 5.5.2, 5.6, 6.1, 6.2.1, 6.3, 8.5.1 |
| 4.2 Quality System | 4.1, 4.2.1, 4.2.2, 5.1, 5.4.1, 5.4.2, 6.2.1, 7.1 |
| 4.3 Contract Review | 5.2, 7.2 |
| 4.4 Design Control | 7.2.1, 7.3 |
| 4.5 Document and Data Control | 4.2.1, 4.2.3 |
| 4.6 Purchasing | 7.4 |
| 4.7 Control of Customer-Supplied Product | 7.5.4 |
| 4.8 Product Identification and Traceability | 7.5.3 |
| 4.9 Process Control | 6.3, 6.4, 7.1. 7.5.1, 7.5.2, 8.2.3 |
| 4.10 Inspection and Testing | 7.1, 7.4.3, 7.5.1, 7.5.3, 8.1, 8.2.4 |
| 4.11 Control of Inspection, Measuring and Test Equipment | 7.6 |
| 4.12 Inspection and Test Status | 7.5.3 |
| 4.13 Control of Nonconforming Product | 8.3 |
| 4.14 Corrective and Preventive Action | 8.4, 8.5.2, 8.5.3 |
| 4.15 Handling, Storage, Packaging, Preservation and Delivery | 7.1, 7.5.5 |
| 4.16 Control of Quality Records | 4.2.4 |
| 4.17 Internal Quality Audits | 8.2.2, 8.2.3 |
| 4.18 Training | 6.2 |
| 4.19 Servicing | 7.1, 7.5.1 |
| 4.20 Statistical Techniques | 8.1, 8.2.3, 8.2.4, 8.4 |
| ISO 9001: 2000 | ISO 9001: 1994 |
| 4 Quality Management System | |
| 4.1 General Requirements | 4.2.1 |
| 4.2 Documentation Requirements | 4.2.1, 4.2.1, 4.5, 4.16 |
| 5 Management Responsibility | |
| 5.1 Management Commitment | 4.1, 4.2.1 |
| 5.2 Customer Focus | 4.3.2 |
| 5.3 Quality Policy | 4.1.1 |
| 5.4 Planning | 4.1.1, 4.2.1, 4.2.3 |
| 5.5 Responsibility, Authority and Communication | 4.1.2.1, 4.1.2.3 |
| 5.6 Management Review | 4.1.3 |
| 6 Resource Management | |
| 6.1 Provision of Resources | 4.1.2.2 |
| 6.2 Human Resources | 4.1.2.1, 4.2.3, 4.18 |
| 6.3 Infrastructure | 4.1.2.2, 4.9 |
| 6.4 Work Environment | 4.9 |
| 7 Product Realization | |
| 7.1 Planning of Product Realization | 4.2.3, 4.9, 4.10.1 |
| 7.2 Customer-Related Processes | 4.3, 4.4.4 |
| 7.3 Design and Development | 4.4 |
| 7.4 Purchasing | 4.6, 4.10.2, 4.10.3, 4.10.4 |
| 7.5 Production and Service Provision | 4.7, 4.8, 4.9, 4.10.3, 4.10.5, 4.12, 4.15, 4.19 |
| 7.6 Control of Monitoring and Measuring Devices | 4.11 |
| 8 Measurement, Analysis and Improvement | |
| 8.1 Planning | 4.10, 4.17, 4.20.1 |
| 8.2 Monitoring and Measurement | 4.9, 4.10, 4.17, 4.20.1 |
| 8.3 Control of Nonconforming Product | 4.13 |
| 8.4 Analysis of Data | 4.14, 4.20 |
| 8.5 Improvement | 4.1.3, 4.14 |
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