ISO 9001:2000 Quality Management System Requirements

Posted on Sep 15, 2024 in Other subjects

General

The design and implementation of an organization’s quality management system is influenced by various needs, specific objectives, products provided, processes employed, and the organization’s size and structure.

This International Standard can be used by internal and external parties, including certification bodies, to assess an organization’s ability to meet customer requirements.

Process-Based Approach

This International Standard promotes adopting a process approach for developing, implementing, and improving a quality management system’s effectiveness.

One advantage of the process approach is the continuous monitoring of linkages between individual processes within the system and their combination and interaction. When used in a quality management system, this approach emphasizes:

  1. Understanding and meeting requirements
  2. Considering processes in terms of value-added
  3. Obtaining results of process performance and effectiveness
  4. Continually improving processes based on objective measurements

NOTE: Additionally, you can apply the “Plan-Do-Check-Act” (PDCA) methodology to all processes. PDCA can be briefly described as:

  • Plan: Establish objectives and processes necessary to deliver results according to customer requirements and organizational policies.
  • Do: Implement the processes.
  • Check: Monitor and measure processes and products against policies, objectives, and requirements. Report results.
  • Act: Take actions to continually improve process performance.

Relation with ISO 9004

ISO 9001 specifies requirements for a quality management system that organizations can use internally, for certification, or contractual purposes. It focuses on the effectiveness of quality management in meeting quality system requirements.

ISO 9004 provides guidance on a broader range of quality management system objectives than ISO 9001, particularly for continuous improvement and overall organizational effectiveness. ISO 9004 is recommended as a guide for organizations whose top management wants to go beyond ISO 9001 requirements, pursuing continuous performance improvement. However, it is not intended for certification or contractual purposes.

Compatibility with Other Management Systems

ISO 14001:1996, to enhance the compatibility of the two standards for users. This International Standard does not include requirements specific to other management systems, such as environmental management, occupational health and safety, financial management, or risk management. However, this standard enables an organization to align or integrate its quality management system with related management system requirements. An organization can adapt its existing management system(s) to establish a quality management system that meets this International Standard’s requirements.

Purpose and Scope

1.1 General

This International Standard specifies requirements for a quality management system applicable when an organization:

  1. Needs to demonstrate its ability to consistently provide products that meet customer and applicable regulatory requirements.
  2. Intends to achieve customer satisfaction through the effective implementation of the system, including processes for continual improvement and ensuring compliance with customer and applicable regulatory requirements.

NOTE: “Product” in this International Standard refers only to the product intended or requested by the customer.

1.2 Application

All requirements of this International Standard are generic and intended to apply to all organizations, regardless of type, size, or product provided. Where any requirement cannot be applied due to the organization’s nature and its product, it can be considered for exclusion.

2 Normative References

The International Standard cited below contains provisions that, by reference in this text, constitute provisions of this International Standard. As the referenced standard is dated, subsequent amendments or revisions of the International Standard do not apply. However, parties to agreements based on this International Standard are advised to consider applying the most recent edition of the International Standard listed below.

  • ISO 9000:2000, Quality Management Systems – Fundamentals and Vocabulary

3 Terms and Definitions

For this International Standard, the terms and definitions given in ISO 9000:2000 apply.

The following terms used in this edition of ISO 9001 to describe the supply chain have been changed to reflect current vocabulary:

  • Organization replaces the term supplier organization used in ISO 9001:1994 and refers to the entity applying this International Standard. Similarly, the term supplier replaces subcontractor.

Throughout this International Standard, “product” can also mean “service”.

4 Quality Management System

4.1 General Requirements

The organization shall establish, document, implement, maintain, and continually improve a quality management system’s effectiveness per this International Standard’s requirements.

The organization must:

  • Identify processes needed for the quality management system and its application throughout the organization (see 1.2).
  • Determine the sequence and interaction of these processes.
  • Determine methods and criteria to ensure effective operation and control of these processes.
  • Ensure the availability of resources and information necessary to support the operation and monitoring of these processes.
  • Measure, monitor, and analyze these processes.
  • Implement actions necessary to achieve planned results and continual improvement of these processes.

The organization must manage these processes according to this International Standard’s requirements.

NOTE: Processes needed for the quality management system should include those for management activities, resource provision, product realization, and measurement.

If the organization outsources any process affecting product conformity, it shall ensure control over such processes. Control of outsourced processes shall be identified in the quality management system.

4.2 Documentation Requirements

The quality management system documentation shall include:

  • Documented statements of a quality policy and quality objectives
  • A quality manual
  • Documented procedures required by this International Standard
  • Documents needed by the organization to ensure the effective planning, operation, and control of processes
  • Quality records required by this International Standard (see 4.2.4)

NOTE 1: “Documented procedure” in this International Standard requires that the procedure be established, documented, implemented, and maintained.

NOTE 2: The extent of quality management system documentation can differ between organizations due to:

  1. The size of the organization and type of activities
  2. The complexity of processes and their interactions
  3. The competence of personnel

NOTE 3: Documentation can be in any format or media.

4.2.1 Quality Manual

The organization shall establish and maintain a quality manual that includes:

  • The scope of the quality management system, including details and justification for any exclusions (see 1.2)
  • Documented procedures established for the quality management system or a reference to them
  • A description of the interaction between the quality management system processes

4.2.2 Document Control

Documents required by the quality management system shall be controlled. Quality records are a special document type and shall be controlled according to the requirements given in 4.2.4. A documented procedure shall define the controls needed to:

  • Approve documents for adequacy before issue
  • Review and update documents as necessary and re-approve them
  • Ensure changes and the current revision status of documents are identified
  • Ensure relevant versions of applicable documents are available at the point of use
  • Ensure documents remain legible and readily identifiable
  • Ensure external documents and their distribution are identified and controlled
  • Prevent the unintended use of obsolete documents and apply suitable identification if retained for any reason

4.2.4 Control of Quality Records

The organization shall establish and maintain quality records to provide evidence of conformity to requirements and the effective operation of the quality management system. Quality records shall remain legible, readily identifiable, and retrievable. A documented procedure shall define the controls needed for the identification, legibility, storage, protection, retrieval, retention time, and disposal of records.

5 Management Responsibility

5.1 Management Commitment

Top management shall provide evidence of their commitment to developing, implementing, and continually improving the quality management system’s effectiveness by:

  • Communicating to the organization the importance of meeting customer, statutory, and regulatory requirements
  • Establishing the quality policy
  • Ensuring quality objectives are established
  • Conducting management reviews
  • Ensuring the availability of resources

5.2 Customer Focus

Top management shall ensure that customer requirements are determined and met to achieve customer satisfaction (see 7.2.1 and 8.2.1).

5.3 Quality Policy

Top management shall ensure that the quality policy:

  1. Is appropriate to the organization’s purpose
  2. Includes a commitment to meet requirements and continually improve the quality management system’s effectiveness
  3. Provides a framework for establishing and reviewing quality objectives
  4. Is communicated and understood within the organization
  5. Is reviewed for continuing suitability

5.4 Planning

5.4.1 Quality Objectives

Top management shall ensure that quality objectives, including those needed to meet product requirements (see 7.1 a)), are established at relevant functions and levels within the organization. Quality objectives shall be measurable and consistent with the quality policy.

5.4.2 Quality Management System Planning

Top management shall ensure that:

  • Quality management system planning is performed to meet the requirements given in 4.1 and the quality objectives.
  • The integrity of the quality management system is maintained when planning and implementing changes to the system.

5.5 Responsibility, Authority, and Communication

5.5.1 Responsibility and Authority

Top management shall ensure that responsibilities and authorities are defined, communicated, and understood within the organization.

5.5.2 Management Representative

Top management shall appoint a management member who, irrespective of other responsibilities, shall have the responsibility and authority to:

  • Ensure processes needed for the quality management system are established, implemented, and maintained
  • Report to top management on the quality management system’s performance and any need for improvement
  • Ensure the promotion of awareness of customer requirements throughout the organization

NOTE: The management representative’s responsibility can include liaison with external parties on matters relating to the quality management system.

5.5.3 Internal Communication

Top management shall ensure that appropriate processes are established for internal communication and that communication occurs regarding the quality management system’s effectiveness.

5.6 Management Review

5.6.1 General

Top management shall review the organization’s quality management system at planned intervals to ensure its continuing suitability, adequacy, and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. Records of management review shall be maintained (see 4.2.4).

5.6.2 Review Input

Input to management review shall include information on:

  • Audit results
  • Customer feedback
  • Process performance and product conformity
  • The status of corrective and preventive actions
  • Follow-up actions from previous management reviews
  • Planned changes that could affect the quality management system
  • Recommendations for improvement

5.6.3 Review Output

Output from management review shall include decisions and actions related to:

  • Improving the effectiveness of the quality management system and its processes
  • Improving product related to customer requirements
  • Resource needs

6 Resource Management

6.1 Provision of Resources

The organization shall determine and provide resources needed to:

  1. Implement, maintain, and continually improve the quality management system’s effectiveness
  2. Enhance customer satisfaction

6.2 Human Resources

6.2.1 General

Personnel performing work affecting product quality shall be competent based on appropriate education, training, skills, and experience.

6.2.2 Competence, Awareness, and Training

The organization shall:

  • Determine the necessary competence for personnel performing work affecting product quality
  • Provide training or take other actions to satisfy these needs
  • Evaluate the effectiveness of the actions taken
  • Ensure that personnel are aware of the relevance and importance of their activities and how they contribute to achieving quality objectives
  • Maintain appropriate records of education, training, skills, and experience (see 4.2.4)

6.3 Infrastructure

The organization shall determine, provide, and maintain the infrastructure needed to achieve product conformity. Infrastructure includes, for example:

  • Buildings, workspace, and associated utilities
  • Process equipment (hardware and software)
  • Supporting services such as transport or communication

6.4 Work Environment

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

7 Product Realization

7.1 Planning of Product Realization

The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of other quality management system processes (see 4.1).

When planning product realization, the organization shall determine, as appropriate:

  • Quality objectives and requirements for the product
  • The need to establish product-specific processes and documentation and provide resources
  • Required verification, validation, monitoring, inspection, and testing activities specific to the product and the criteria for product acceptance
  • Records needed to provide evidence that the realization processes and the resulting product meet requirements (see 4.2.4)

The output of this planning shall be in a form suitable for the organization’s operations method.

NOTE 1: A document specifying the quality management system processes (including the product realization processes) and the resources to be applied to a specific product, project, or contract can be called a quality plan.

NOTE 2: The organization may also apply the requirements given in 7.3 to the development of product realization processes.

7.2 Customer-Related Processes

7.2.1 Determination of Requirements Related to the Product

The organization shall determine:

  • Requirements specified by the customer, including the requirements for delivery and post-delivery activities
  • Requirements not specified by the customer but necessary for the product’s specified or intended use
  • Statutory and regulatory requirements related to the product
  • Any additional requirements determined by the organization

7.2.2 Review of Requirements Related to the Product

The organization shall review product requirements before committing to supply a product to the customer (e.g., submitting tenders, accepting contracts or orders, accepting contract or order changes). This review shall ensure that:

  • Product requirements are defined
  • Differences between the contract or order requirements and those previously expressed are resolved
  • The organization has the ability to meet defined requirements

Records of the results of the review and any actions arising from it shall be maintained (see 4.2.4).

If the customer does not provide a documented statement of requirements, the organization shall confirm the requirements with the customer before acceptance.

If product requirements are changed, the organization shall ensure that relevant documentation is amended and that relevant personnel are aware of the changed requirements.

NOTE: In some situations, such as internet sales, a formal review of individual orders is impractical. Instead, the review may cover relevant product information, such as catalogs or advertising material.

7.2.3 Customer Communication

The organization shall determine and implement effective arrangements for communicating with customers regarding:

  • Product information
  • Inquiries, contract or order handling, including amendments
  • Customer feedback, including customer complaints

7.3 Design and Development

7.3.1 Design and Development Planning

The organization shall plan and control product design and development.

When planning design and development, the organization shall determine:

  • The design and development stages
  • The review, verification, and validation activities appropriate to each design and development stage
  • The responsibilities and authorities for design and development

The organization shall manage interfaces between different groups involved in design and development to ensure effective communication and a clear assignment of responsibility. Design and development planning results shall be updated, as appropriate, as the design and development progresses.

7.3.2 Design and Development Inputs

Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These inputs shall include:

  • Functional and performance requirements
  • Applicable statutory and regulatory requirements
  • Information from previous designs, where appropriate
  • Other requirements essential for design and development

These inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous, and not in conflict.

7.3.3 Design and Development Outputs

Design and development outputs shall be provided in a form that enables verification against design and development inputs and shall be approved before release. Design and development outputs shall:

  • Meet the input requirements for design and development
  • Provide appropriate information for purchasing, production, and service provision
  • Contain or reference product acceptance criteria
  • Specify the product characteristics essential for its safe and proper use

7.3.4 Design and Development Review

At suitable stages, systematic reviews of design and development shall be performed to:

  • Evaluate the ability of the design and development results to meet requirements
  • Identify any problems and propose necessary actions

Representatives of functions involved in the design and development stage(s) under review shall participate in such reviews. Records of the reviews’ results and any actions arising from them shall be maintained (see 4.2.4).

7.3.5 Design and Development Verification

Verification shall be performed to ensure that design and development outputs meet the design and development input requirements. Records of the verification results and any actions arising from them shall be maintained (see 4.2.4).

7.3.6 Design and Development Validation

Design and development shall be validated according to planned arrangements (see 7.3.1) to ensure that the resulting product meets the requirements for the specified or intended use or application. Validation shall be completed before the product’s delivery or implementation, where practicable. Records of the validation results and any actions arising from them shall be maintained (see 4.2.4).

7.3.7 Control of Design and Development Changes

Design and development changes shall be identified and records maintained. Changes shall be reviewed, verified, and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluating the effect of the changes on constituent parts and previously delivered products. Records of the results of the review of changes and any actions arising from them shall be maintained (see 4.2.4).

7.4 Purchasing

7.4.1 Purchasing Process

The organization shall ensure that purchased products conform to specified purchase requirements. The control type and extent applied to the supplier and the purchased product shall depend on the effect of the purchased product on subsequent product realization or the final product.

The organization shall evaluate and select suppliers based on their ability to supply products according to the organization’s requirements. Criteria for selection, evaluation, and re-evaluation shall be established. Records of the evaluation results and any necessary actions arising from them shall be maintained (see 4.2.4).

7.4.2 Purchasing Information

Purchasing information shall describe the product to be purchased, including, where appropriate:

  • Requirements for the approval of product, procedures, processes, and equipment
  • Requirements for personnel qualification
  • Quality management system requirements

The organization shall ensure the adequacy of specified purchase requirements before submitting them to the supplier.

7.4.3 Verification of Purchased Product

The organization shall establish and implement inspection or other activities necessary to ensure that the purchased product meets specified purchase requirements.

If the organization or its customer intends to perform verification at the supplier’s premises, the organization shall state the intended verification arrangements and the product release method in the purchasing information.

7.5 Production and Service Provision

7.5.1 Control of Production and Service Provision

The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable:

  • The availability of information that describes the product characteristics
  • The availability of work instructions, as necessary
  • The use of suitable equipment
  • The availability and use of monitoring and measuring devices
  • The implementation of monitoring and measurement
  • The implementation of product release, delivery, and post-delivery activities

7.5.2 Validation of Processes for Production and Service Provision

The organization shall validate any production and service provision processes where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been performed. Validation shall demonstrate the ability of these processes to achieve planned results.

The organization shall establish arrangements for these processes, including, 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 (see 4.2.4)
  • Revalidation

7.5.3 Identification and Traceability

Where appropriate, the organization shall identify the product by suitable means throughout product realization.

The organization shall identify the product status with respect to monitoring and measurement requirements.

Where traceability is a requirement, the organization shall control the product’s unique identification and maintain records (see 4.2.4).

NOTE: Configuration management is a means of maintaining identification and traceability in some industry sectors.

7.5.4 Property Belonging to the Customer

The organization shall exercise care with the customer’s property while it is under the organization’s control or being used by the organization. The organization shall identify, verify, protect, and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged, or otherwise found unsuitable for use, this shall be recorded (see 4.2.4) and reported to the customer.

NOTE: Customer property can include intellectual property.

7.5.5 Preservation of Product

The organization shall preserve the product’s conformity during internal processing and delivery to the intended destination. This preservation shall include identification, handling, packaging, storage, and protection. Preservation shall also apply to the product’s constituent parts.

7.6 Control of Monitoring and Measuring Devices

The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of product conformity to determined requirements (see 7.2.1).

The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements.

Where necessary to ensure valid results, measuring equipment shall be:

  • Calibrated or verified at specified intervals, or before use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded
  • Adjusted or re-adjusted as necessary
  • Identified to enable the calibration status to be determined
  • Safeguarded from adjustments that would invalidate the measurement result
  • Protected from damage and deterioration during handling, maintenance, and storage

In addition, the organization shall assess and record the validity of previous measurement results when it finds that the equipment does not conform to requirements. The organization shall take appropriate action on the equipment and any affected product. Records of the results of calibration and verification shall be maintained.

The organization shall confirm that the software used for monitoring and measurement of specified requirements is suitable for its intended application before its initial use and reconfirmed as necessary.

NOTE: See ISO 10012 for guidance.

8 Measurement, Analysis, and Improvement

8.1 General

The organization shall plan and implement the monitoring, measurement, analysis, and improvement processes needed to:

  • Demonstrate product conformity
  • Ensure the quality management system’s conformity
  • Continually improve the quality management system’s effectiveness

This shall include determining the applicable methods, including statistical techniques, and the extent to which they are used.

8.2 Monitoring and Measurement

8.2.1 Customer Satisfaction

As a measure of the quality management system’s performance, the organization shall monitor information relating to customer perception of the degree to which the organization has met customer requirements. The methods for obtaining and using this information shall be determined.

8.2.2 Internal Audit

The organization shall conduct internal audits at planned intervals to determine whether the quality management system:

  • Conforms to the planned arrangements (see 7.1), the requirements of this International Standard, and the quality management system requirements established by the organization
  • Is effectively implemented and maintained

An audit program shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency, and methods shall be defined. The selection of auditors and conduct of audits shall ensure the audit process’s objectivity and impartiality. Auditors shall not audit their work.

A documented procedure shall define the responsibilities and requirements for planning and conducting audits, reporting results, and maintaining records (see 4.2.4).

The management responsible for the area being audited shall ensure that any nonconformity and its cause are corrected without undue delay. Follow-up activities shall include the verification of the actions taken and the verification results’ reporting.

NOTE: See ISO 19011 for guidance.

8.2.3 Monitoring and Measurement of Processes

The organization shall apply suitable methods for monitoring and, where applicable, measuring the quality management system processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to ensure product conformity.

8.2.4 Monitoring and Measurement of Product

The organization shall monitor and measure the product’s characteristics to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process according to planned arrangements (see 7.1). Evidence of conformity with acceptance criteria shall be maintained. Records shall indicate the person(s) authorizing the product release for delivery (see 4.2.4).

Product release or delivery shall not proceed until all planned arrangements (see 7.1) have been satisfactorily completed unless otherwise authorized by a relevant authority and, where applicable, by the customer.

8.3 Control of Nonconforming Product

The organization shall ensure that any product that does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The procedures for controlling nonconforming products shall be defined in a documented procedure.

The organization shall deal with nonconforming products by one or more of the following ways:

  • Taking action to eliminate the detected nonconformity
  • Authorizing its use, release, or acceptance under concession by a relevant authority and, where applicable, by the customer
  • Taking action to prevent its originally intended use or application

Records of the nature of nonconformities and any subsequent actions taken, including any concessions obtained, shall be maintained (see 4.2.4).

When nonconforming products are corrected, they shall be re-verified to demonstrate conformity to the requirements.

When nonconforming products are detected after delivery or use has started, the organization shall take action appropriate to the nonconformity’s effects or potential effects.

8.4 Analysis of Data

The organization shall determine, collect, and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the quality management system can be made. This shall include data generated as a result of monitoring and measurement activities and from other relevant sources. The analysis of data shall provide information relating to:

  • Customer satisfaction (see 8.2.1)
  • Conformity to product requirements (see 7.1)
  • The characteristics and trends of processes and products, including opportunities for preventive action
  • Suppliers

8.5 Improvement

8.5.1 Continual Improvement

The organization shall continually improve the quality management system’s effectiveness using the quality policy, quality objectives, audit results, data analysis, corrective and preventive actions, and management review.

8.5.2 Corrective Action

The organization shall take action to eliminate the causes of nonconformities to prevent recurrence. Corrective actions shall be appropriate to the nonconformities’ effects encountered. A documented procedure shall define requirements for:

  • Reviewing nonconformities (including customer complaints)
  • Determining the causes of nonconformities
  • Evaluating the need for action to ensure that nonconformities do not recur
  • Determining and implementing the action needed
  • Recording the results of action taken (see 4.2.4)
  • Reviewing corrective action taken

8.5.3 Preventive Action

The organization shall determine action to eliminate the causes of potential nonconformities to prevent their occurrence. Preventive actions shall be appropriate to the potential problems’ effects. A documented procedure shall define requirements for:

  • Determining potential nonconformities and their causes
  • Evaluating the need for action to prevent the occurrence of nonconformities
  • Determining and implementing the action needed
  • Recording the results of action taken (see 4.2.4)
  • Reviewing preventive action taken