Process Approach
In order to maximize customer satisfaction and meet customer requirements, ISO 9001:2000 promotes the use of a process approach in developing, implementing, and improving a quality system.

For a quality system to function effectively, an organization must identify and manage a number of linked activities called a process. The implementation of ISO 9001:2000 allows companies the opportunity to control and manage the interaction of the numerous individual processes within the organization, as well as the overall system of processes.

The process approach emphasizes the need to:

a) Understand and fulfill the necessary requirements;
b) Consider processes in terms of added value;
c) Obtain results of process performance and effectiveness; and
d) Continually improve processes based on objective measurement.

In addition to the process approach, ISO 9001:2000 applies the Plan-Do-Check-Act (PDCA) methodology to enhance continual improvement of the quality system.

For more information about the process approach or the PDCA methodology, please refer to section 0.2 of ISO 9001:2000. The complete standard can be obtained by contacting the American Society for Quality.

Standard Supplements
ISO 9000:2000 - Quality Management Systems - Fundamentals and Vocabulary
ISO 9004:2000 - Quality Management Systems - Guidelines for Performance Improvements

ISO 9001:2000 - Overview and Requirements
(including correspondence between ISO 9001: 2000 and ISO 9001: 1994)

4 Quality Management System

4.1 General Requirements (ISO 9001:1994, 4.2.1)

The organization must establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements set forth in the ISO 9001:2000 standard. The requirements include identifying the processes needed, determining the sequence of their interaction, and determining the criteria and methods needed for their effective operation and control.

The organization must ensure the availability of resources and information needed for the operation and control of processes.

The organization must monitor, measure, and analyze its processes, and implement the necessary actions to achieve the planned results of the processes and to promote methods for continual improvement.

The organization must manage its processes in accordance with the requirements of the ISO 9001: 2000 standard.

The organization must identify and control outsourced processes should they affect product conformity.

4.2 Documentation Requirements

4.2.1 General (ISO 9001:1994, 4.2.1 + 4.5.1)
In accordance with the ISO 9001:2000 standard, the organization must prepare the following documentation:

a) Quality Policy and Quality Objectives
b) Quality Manual
c) Quality Procedures
d) Other documentation (i.e. work instructions, control plans, forms), as applicable
e) Records

4.2.2 Quality Manual (ISO 9001:1994, 4.2.1)
The Quality Manual must include the scope, any exclusions along with their justification, quality procedures (or reference to), and a description of process interactions.

4.2.3 Control of Documents (ISO 9001:1994, 4.5.1 + 4.5.2 + 4.5.3)
The organization must control all documents and data that are required by the quality management system to ensure that they are approved prior to use, reviewed, updated, and re-approved as necessary, legible and properly identified, and available at all points of use. The organization must identify the current revision and status of documents.

The organization must also control documents of external origin.

Obsolete documents must be removed from circulation and must be suitably identified if retained for any purpose.

4.2.4 Control of Records (ISO 9001:1994, 4.16)
The organization must retain records as objective evidence of conformance to the ISO 9001:2000 standard. The organization must prepare a documented procedure to define the control of records from their identification, to storage, protection, retrieval, retention time, and disposition.

5 Management Responsibility

5.1 Management Commitment (ISO 9001:1994, 4.1 + 4.1.2.2 + 4.2.1)

In order to demonstrate its commitment to the quality management system, top management must communicate the importance of meeting customer, statutory and regulatory requirements, establish the quality policy and the quality objectives, conduct management reviews, and provide adequate resources.

5.2 Customer Focus (ISO 9001:1994, 4.3.2)

Top management must ensure that all customer requirements are identified and fulfilled in order to attain and increase satisfaction.

5.3 Quality Policy (ISO 9001:1994, 4.1.1)

Top management must prepare a quality policy that is appropriate to its organization, include its commitment for compliance to requirements and for continual improvement, and provide a framework for establishing and reviewing quality objectives.

Top management must also ensure that the quality policy is communicated to all members of the organization, and is reviewed for continuing suitability.

5.4 Planning

5.4.1 Quality Objectives (ISO 9001:1994, 4.1.1 + 4.2.1)
Top management must identify quality objectives at relevant functions and levels of the organization. Quality objectives must be measurable and consistent with the quality policy.

5.4.2 Quality Management System Planning (ISO 9001:1994, 4.2.3)
While planning the quality management system, top management must ensure that the system is consistent with the requirements defined in the general requirements of section 4.1 of the ISO 9001:2000 standard as well as the quality objectives.

Top management must also ensure that the integrity of the quality management systems is maintained when changes to the quality management system are planned and implemented.

5.5 Responsibility, Authority and Communication

5.5.1 Responsibility and Authority (ISO 9001:1994, 4.1.2.1)
Top management is responsible for defining and communicating the responsibilities, authorities and interrelation of personnel within the organization (i.e. job descriptions, organization chart).

5.5.2 Management Representative (ISO 9001:1994, 4.1.2.3)
Top management must appoint a member of the organization as its Management Representative (MR).

The Management Representative is responsible for the proper functioning (i.e. establishing, implementing, and maintaining) of the entire quality management system and reporting to top management on its performance. The Management Representative's job also includes ensuring that customer requirements are communicated throughout the organization.

5.5.3 Internal Communication
Top management must ensure that effective communication processes are established within the organization.

5.6 Management Review

5.6.1 General (ISO 9001:1994, 4.1.3)
Top management must review the quality management system at planned intervals to determine its continuing suitability and effectiveness. Top management must also examine opportunities for improvement and implement changes to the quality management system (including the quality policy and the quality objectives) accordingly.

Records of management review meetings must be maintained.

5.6.2 Review Input (ISO 9001:1994, 4.1.3)
When conducting management reviews, information such as results of audits, customer feedback, process performance and product conformity, the status of preventive and corrective actions, follow-up on actions taken during previous management review meetings, planned changes that may affect the quality management system, and suggestions for improvement must be taken into consideration.

5.6.3 Review Output (ISO 9001:1994, 4.1.3)
Decisions and actions with regards to the improvement of the effectiveness of the quality management system and its processes, improvement of product related to customer requirements, and resource needs must be included in the management review output.

6 Resource Management

6.1 Provision of Resources (ISO 9001:1994, 4.1.2.2)

The organization must provide adequate resources to implement and maintain the quality management system, continually improve its effectiveness, and enhance customer satisfaction by meeting customer requirements.

6.2 Human Resources

6.2.1 General (ISO 9001:1994, 4.1.2.2 + 4.2.3 + 4.18)
The organization's personnel performing work that can affect the quality of the product or service must be qualified based on appropriate education, training, skills and experience.

6.2.2 Competence and Awareness and Training (ISO 9001:1994, 4.18)
The organization must determine the level of competence required to perform work affecting quality, provide the proper training and/or other action to ensure that the personnel performing the work are properly qualified, and that they are aware of the relevance of their activities and how they contribute to the achievement of the organization's quality objectives.

The organization is responsible for maintaining records (training, education, skills, and experience) to demonstrate that personnel are qualified to perform their work.

6.3 Infrastructure (ISO 9001:1994, 4.1.2.2 + 4.9)

The organization must determine, provide and maintain the proper infrastructure (i.e. buildings, workspace, process equipment, supporting services) in order to achieve product conformity.

6.4 Work Environment (ISO 9001:1994, 4.9)

The organization must ensure that the work environment is suitable for the achievement of product conformity.

7 Product Realization

7.1 Planning of Product Realization (ISO 9001:1994, 4.2.3 + 4.9 + 4.10.1)

The organization must plan and develop processes for product realization consistent with the requirements of the other processes of the quality management system. Planning product realization must take into account several factors such as quality objectives, product requirements, the need to establish processes or documents, availability of resources, required verification, validation, monitoring, inspection and test activities, and the criteria for product acceptance.

The organization must maintain records to provide evidence that the realization processes and resulting product fulfill requirements.

The output for the planning of product realization must be in a form suitable for the organization.

7.2 Customer-related Processes

7.2.1 Determination of Requirements Related to the Product (ISO 9001:1994, 4.3.2 + 4.4.4)
The organization must take into consideration any requirements set forth by the customer, including delivery and post-delivery activities, requirements necessary for specified use or known and intended use, statutory and regulatory requirements related to the product, and any other requirements determined by the organization.

7.2.2 Review of Requirements Related to the Product (ISO 9001:1994, 4.3.2 + 4.3.3 + 4.3.4)
The organization must review all requirements related to the product prior to making a commitment to the customer to supply the product. The organization must ensure that the product requirements are defined, any differences between the contract/order with requirements previously discussed are resolved, and that the organization is capable of meeting the defined requirements.

The organization is responsible for maintaining records of results and actions arising from product requirement reviews.

In the case of no documented contract or order requirements, the organization must confirm the customer requirements prior to acceptance.

In the event of a change in the product requirements, the organization must ensure that all relevant documents are amended and relevant personnel are made aware of the change.

7.2.3 Customer Communication (ISO 9001: 1994, 4.3.2)
The organization must determine and implement the appropriate methods to communicate with customers with regards to product information, inquiries, contracts, order, and handling of amendments, and customer feedback (including customer complaints).

7.3 Design and Development

7.3.1 Design and Development Planning (ISO 9001:1994, 4.4.2 + 4.4.3 + 4.4.6 + 4.4.7 + 4.4.8)
The organization must plan and control the design and development of product, including the planning of the design and development stages, appropriate review, verification and validation, and the design's responsibilities and authorities.

7.3.2 Design and Development Inputs (ISO 9001:1994, 4.4.4)
During product design and development, the organization must take into account inputs in relation to functional and performance requirements, applicable statutory and regulatory requirements, information derived from previous similar designs (where applicable), and other essential requirements.

The organization must review input requirements for adequacy and completeness, and ensure that they are not in conflict with each other.

The organization is responsible for maintaining adequate records to evidence design and development input, as well as, their review.

7.3.3 Design and Development Outputs (ISO 9001:1994, 4.4.5)
Design and development outputs must be in a form that enables verification against the input requirements and must be approved prior to release. Design and development outputs must meet input requirements, provide appropriate information for purchasing, production and for service provision, contain or reference product acceptance criteria, and specify the characteristics of the product that are essential for its safe and proper use.

7.3.4 Design and Development Review (ISO 9001:1994, 4.4.6)
The organization must ensure that systematic design and development reviews are conducted at appropriate stages in order to evaluate the results of design and development to the requirements, and to identify any problems and propose necessary actions.

Participants must include representatives of functions, internal and external (as applicable), concerned with the stage of the design and development being reviewed.

Records of the reviews and any actions taken must be maintained.

7.3.5 Design and Development Verification (ISO 9001:1994, 4.4.7)
In order to ensure that design and development outputs have satisfied the input requirements, design verification must be performed and the results documented.

7.3.6 Design and Development Validation (ISO 9001:1994, 4.4.8)
In order to ensure that the resulting product is capable of fulfilling the requirements for the specified or intended use, design validation must be performed according to planned arrangements and the results documented. Wherever practical, design validation must be performed prior to the delivery or implementation of the product.

7.3.7 Control of Design and Development Changes (ISO 9001:1994, 4.4.9)
Design and development changes must be identified and recorded.

Changes in relation to design and development must be reviewed, verified, validated (as appropriate), and approved prior to being implemented.

The review of design and development changes must take into consideration the effect they have on constituent parts and delivered product.

The records of change reviews and the actions taken must be maintained.

7.4 Purchasing

7.4.1 Purchasing Process (ISO 9001:1994, 4.6.2)
The organization must ensure that purchased product conforms to specified purchase requirements. The organization must determine the level of control exercised over its suppliers and the purchased product. The level of control is dependent upon the effect of the purchased product on the final product.

The organization must establish criteria for selection, evaluation and re-evaluation of its suppliers.

The organization must maintain records of the results of evaluations and actions taken.

7.4.2 Purchasing Information (ISO 9001:1994, 4.6.3)
The organization must ensure that purchasing information describes the product to be purchased including requirements for approval, procedures, processes, equipment, qualified personnel, and quality management system requirements, as appropriate.

The organization must ensure the adequacy of purchase requirements prior to their communication to the supplier.

7.4.3 Verification of Purchased Product (ISO 9001:1994, 4.6.4 + 4.10.2 + 4.10.3 + 4.10.4)
The organization must establish and implement the inspection or other appropriate activities to verify that the purchased product meets the specified requirements.

If the organization or its customer intend on verifying the purchased product at the supplier's premises, the organization must state the arrangements and method of product release in the purchasing documents.

7.5 Production and Service Provision

7.5.1 Control of Production and Service Provision (ISO 9001:1994, 4.9 + 4.10.3 + 4.15.6 + 4.19)
The organization must plan and implement production and service activities under controlled conditions which include, as applicable, the availability of information that describes the characteristics of the product, availability of work instructions, the use of 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 (ISO 9001:1994, 4.9)
The organization must validate any processes for production and service activities where the resulting output cannot be adequately verified until after the product is in use or the service has been delivered.

As applicable, the organization must establish arrangements for these processes, including defined criteria for review and approval of the processes, approval of equipment and qualification of employees, use of methods and procedures, requirements of records, and revalidation.

7.5.3 Identification and Traceability (ISO 9001:1994, 4.8 + 4.10.5 + 4.12)
Where appropriate, the organization must suitably identify the product throughout the realization process.

The organization must also identify the status of the product to monitoring and measurement requirements.

Where traceability is a requirement, the organization must control and record the unique identification of the product.

7.5.4 Customer Property (ISO 9001:1994, 4.7)
The organization is responsible for customer property while in its care. The organization must ensure that customer property is properly identified, verified, and protected. If customer property is damaged, lost, or otherwise unsuitable for use, the organization must report it to the customer and maintain records.

7.5.5 Preservation of Product (ISO 9001:1994, 4.15.2 + 4.15.3 + 4.15.4 + 4.15.5 + 4.15.6)
The organization is responsible for properly identifying, handling, packaging, storing and protecting product in order to preserve its conformity and integrity. Preservation applies to product during internal processing until delivery.

7.6 Control of Monitoring and Measuring Devices (ISO 9001:1994, 4.11.1 + 4.11.2)

The organization is responsible for determining the monitoring and measurement needed, and the appropriate equipment required to evidence conformity of product to specified requirements. Hence, the organization must establish processes to ensure that the monitoring and measurements can be carried out consistently.

In order to ensure valid results, the organization must ensure that measuring equipment is properly calibrated or verified at specified interval against standards traceable to international or national measurement standards. Where no such standards exist, the basis for calibration or verification must be recorded.

Measuring equipment must be adjusted or re-adjusted as necessary, properly identified to show its status, safeguarded against adjustments that would invalidate the measurement, and protected from damage and deterioration.

When measuring equipment is found to be out of tolerance, the organization must assess the previous measuring results, and takes the appropriate action on equipment and product affected.

The organization must maintain the results of calibration and verification records.

The organization must also ensure the ability of computer software to satisfy the intended application when used in the monitoring and measurement of specified requirements. This must be done prior to initial use and reconfirmed as needed.

8 Measurement, Analysis and Improvement

8.1 General (ISO 9001:1994, 4.10 + 4.17 + 4.20.1)

The organization must plan and implement processes for monitoring, measurement, analysis and improvement in order to demonstrate product conformity, conformity to the quality management system, and continually improve the effectiveness of the quality management system.

8.2 Monitoring and Measurement

8.2.1 Customer Satisfaction
The organization must develop a method to obtain, monitor, and measure customer satisfaction.

8.2.2 Internal Audit (ISO 9001:1994, 4.17)
The organization must plan and conduct periodic internal audits in order to ensure that the quality management system conforms to the company's documented system and the ISO 9001: 2000 standard, and to ensure that it is effectively implemented.

The audits must be planned according to the status and importance of the areas being audited and the results of previous audits.

The organization is responsible for defining the audit criteria, scope, frequency and methods used to perform the audits.

In order to ensure objectivity, internal auditors must be independent from the area being audited.

The personnel responsible for the area being audited must ensure that appropriate actions are taken to eliminate nonconformances.

Actions taken to correct audit nonconformances must be verified and reported through follow-up activities.

8.2.3 Monitoring and Measurement of Processes (ISO 9001:1994, 4.9 + 4.17 + 4.20.1)
The organization is responsible for monitoring planned processes to ensure that they are effective. If the planned processes are found to be ineffective, the organization must take the appropriate corrective action to ensure product conformity.

8.2.4 Monitoring and Measurement of Product (ISO 9001:1994, 4.10.2 + 4.10.3 + 4.10.4 + 4.10.5 + 4.20.1)
In order to ensure conformity with specified requirements, the organization must monitor and measure the characteristics of the product throughout the various stages of product realization . The organization must maintain records of product conformity, including the indication of the personnel that authorized the release of the product.

No product or service shall be delivered to the customer until all necessary planned arrangements (i.e. inspections) have been completed, unless otherwise approved by the relevant authority, and, where appropriate, by the customer.

8.3 Control of Nonconforming Product (ISO 9001:1994, 4.13.1 + 4.13.2)

The organization must ensure that product that does not conform to specified requirements is properly identified and controlled from unintended use or delivery. The organization must define and document the controls to be exercised and the authorities responsible for dealing with the nonconforming product.

The organization must determine the disposition of the nonconforming product in order to eliminate the detected nonconformity, and to authorize its use, release or acceptance under relevant authority or customer (as applicable), or to preclude its original intended use or application.

The organization must maintain records of the nature of nonconformities, including actions taken and concessions made.

When nonconformities are corrected, they must be subject to re-verification to ensure conformity to specified requirements.

When nonconforming product is detected after delivery or use has started, the organization must take the appropriate actions to the effects or potential effects of the nonconformity.

8.4 Analysis of Data (ISO 9001:1994, 4.14.2 + 4.14.3 + 4.20)

In order to demonstrate the suitability and effectiveness of the quality management system and to promote continual improvement, the organization is responsible for determining, collecting and analyzing appropriate data relating to customer satisfaction, conformance to product requirements, characteristics and trends of processes and products, opportunities for preventive action, and suppliers.

8.5 Improvement

8.5.1 Continual Improvement (ISO 9001:1994, 4.1.3)
The organization must continually improve the effectiveness of the quality management system by use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management reviews.

8.5.2 Corrective Action (ISO 9001:1994, 4.14.1 + 4.14.2)
The organization is responsible for taking action to eliminate the cause of nonconformities in order to prevent them from recurring.

The organization must prepare a documented procedure to define the requirements for reviewing nonconformities (including customer complaints), identifying the causes of nonconformities, evaluating the need for actions to ensure that nonconformities do not recur, determining and implementing the necessary actions, and recording and reviewing the results of actions taken.

8.5.3 Preventive Action (ISO 9001:1994, 4.14.1 + 4.14.3)
The organization is responsible for determining appropriate actions to eliminate the causes of potential nonconformities in order to prevent them from occurring.

The nature of preventive actions must be appropriate to the effects of the potential problems.

The organization must prepare a documented procedure to define the requirements for identifying potential nonconformities and their causes, evaluating the need for actions to prevent occurrence of nonconformities, determining and implementing necessary actions, and recording and reviewing the results of actions taken.