ISO 9001:2000 Quality Management System Requirements

Posted on Sep 17, 2024 in Other subjects

General

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

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

Process-Based Approach

Process-Based Approach: This international standard promotes the adoption of a process approach for developing, implementing, and improving the effectiveness of a quality management system.

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

Understanding and meeting requirements
Considering processes in terms of value-added
Obtaining results of process performance and effectiveness
Continually improving processes based on objective measures

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

Plan: Establish the objectives and processes necessary to deliver results following customer requirements and organizational policies.
Do: Implement the processes.
Check: Monitor and measure processes and products against policies, objectives, and product requirements, and report results.
Act: Take action to improve process performance continually.

Relation with ISO 9004

Relation with the International Standard ISO 9004:

ISO 9001 specifies requirements for a quality management system that organizations could use for internal application, certification, or contractual purposes. It focuses on the effectiveness of quality management in complying with the quality management system requirements.

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

Compatibility with Other Management Systems

Compatibility with other management systems:

ISO 14001:1996, to improve the compatibility of the two standards for the benefit of the user community.

This International Standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, financial management, or risk management. However, this International Standard enables an organization to align or integrate its quality management system with related management system requirements. It is possible for an organization to 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

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

Needs to demonstrate its ability to provide products that consistently meet customer and applicable regulatory requirements.
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: In this International Standard, the term “product” applies only to the product intended or requested by the customer.

1.2 Application

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

2 Normative References

2 Normative references:

The International Standard quoted 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 above International Standard do not apply. However, it is recommended that parties to agreements based on this International Standard consider applying the most recent edition of the International Standard listed below. Members of IEC and ISO maintain registers of International Standards in force at the time.

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

3 Terms and Definitions

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 the vocabulary currently in use:

———————— Organization ———————— Customer
The term “organization” replaces the term “supplier organization” used in ISO 9001:1994 and refers to the unit applying this International Standard. Similarly, the term “supplier” is currently used instead of “subcontractor.”

Throughout this International Standard, wherever the term “product” appears, it can also mean “service.”

4 Quality Management System

4.1 General Requirements

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

The organization must:

Identify the 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 the methods and criteria required 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 the actions necessary to achieve planned results and the continual improvement of these processes.

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

NOTE: Processes needed for the quality management system referred to above should also consider management activities, resource provision, product realization, and measurement implementation processes.

In cases in which the organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. The control of such outsourced processes shall be identified in the quality management system.

4.2 Documentation Requirements

4.2 General 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 its processes.
Quality records required by this International Standard (see 4.2.4).

NOTE 1: Where the term “documented procedure” appears in this International Standard, it requires the procedure to be established, documented, implemented, and maintained.

NOTE 2: The extent of documentation of the quality management system can differ from one organization to another due to:

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

NOTE 3: The documentation can be in any format or media type.

4.2.1 Quality Manual

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 of and justification for any exclusions (see 1.2).
The 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

4.2.2 Document Control: Documents required by the quality management system should 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 should define the controls needed:

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

4.2.4 Control of Quality Records

4.2.4 Control of quality records: Quality records must be established and maintained 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 should define the controls needed for the identification, legibility, storage, protection, retrieval, retention time, and disposal of records.

5 Management Responsibility

5.1 Management Commitment

5.1 Management commitment: Top management shall provide evidence of its 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 that quality objectives are established.
Conducting management reviews.
Ensuring the availability of resources.

5.2 Customer Focus

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

5.3 Quality Policy: Top management shall ensure that the quality policy:

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

5.4 Planning

5.4.1 Quality Objectives

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 must be measurable and consistent with the quality policy.

5.4.2 Quality Management System Planning

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 quality management system.

5.5 Responsibility, Authority, and Communication

5.5.1 Responsibility and Authority

5.5.1 Responsibility and authority: Top management shall ensure that the responsibilities, authorities, and their interrelationships are defined, documented, and communicated within the organization.

5.5.2 Management Representative

5.5.2 Management representative: Top management shall appoint a member of management who, irrespective of other responsibilities, shall have the responsibility and authority that includes:

Ensuring that processes needed for the quality management system are established, implemented, and maintained.
Reporting to top management on the quality management system’s performance and any need for improvement.
Ensuring 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

5.5.3 Internal Communication: Top management shall ensure that appropriate processes are established for communication within the organization and that communication takes place regarding the effectiveness of the quality management system.

5.6 Management Review

5.6.1 General

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 reviews shall be maintained (see 4.2.4).

5.6.2 Review Input

5.6.2 Review input: The input to the management review shall include information on:

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

5.6.3 Review Output

5.6.3 Review output: The output from the 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

6.1 Provision of resources: The organization shall determine and provide the resources needed:

To implement and maintain the quality management system and continually improve its effectiveness.
To enhance customer satisfaction by meeting customer requirements.

6.2 Human Resources

6.2.1 General

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

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 its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of quality objectives.
Maintain appropriate records of education, training, skills, and experience (see 4.2.4).

6.3 Infrastructure

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

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

6.4 Work Environment

6.4 Work Environment: The organization shall determine, provide, and maintain the work environment needed to achieve conformity to product requirements.

7 Product Realization

7.1 Planning of Product Realization

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

The organization shall determine the following, as appropriate, in planning product realization:

Quality objectives and requirements for the product.
The need to establish processes, and provide resources specific to the product, and document information.
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 method of operations.

NOTE 1: A document specifying the processes of the quality management system (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

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, where known.
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

7.2.2 Review of requirements related to the product: The organization shall review the requirements related to the product. This review shall be conducted before the organization commits to supplying a product to the customer (e.g., submission of tenders, acceptance of contracts or orders, acceptance of contract or order changes) and shall ensure that:

Product requirements are defined.
Contract or order requirements differing from those previously expressed are resolved.
The organization has the ability to meet defined requirements.

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

Where the customer provides no documented statement of their requirements, the customer requirements shall be confirmed by the organization before acceptance.

Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are aware of the changed requirements.

NOTE: In some situations, such as internet sales, it is impractical to formally review each order. Instead, the review can cover relevant product information, such as catalogs or advertising material.

7.2.3 Customer Communication

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

Product information.
Inquiries, contracts, or order handling, including amendments.
Customer feedback, including customer complaints.

7.3 Design and Development

7.3.1 Design and Development Planning

7.3.1 Design and development planning: The organization shall plan and control the design and development of the product.

The organization shall determine the following in planning design and development:

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 the interfaces between different groups involved in design and development to ensure effective communication and clear responsibility assignment.

Design and development plan outputs shall be updated, as appropriate, as the design and development progresses.

7.3.2 Design and Development Inputs

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.
Where applicable, information derived from previous similar designs.
Other requirements essential for design and development.

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

7.3.3 Design and Development Outputs

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 that are essential for its safe and proper use.

7.3.4 Design and Development Review

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.
To identify any problems and propose necessary actions.

Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed.

Records of the results of reviews and any necessary actions shall be maintained (see 4.2.4).

7.3.5 Design and Development Verification

7.3.5 Design and development verification: Verification shall be performed to ensure that the design and development outputs meet the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained (see 4.2.4).

7.3.6 Design and Development Validation

7.3.6 Design and development validation: Design and development validation shall be performed, following planned arrangements (see 7.3.1), to ensure that the resulting product can meet 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 results of validation and any necessary actions shall be maintained (see 4.2.4).

7.3.7 Control of Design and Development Changes

7.3.7 Control of design and development changes: Design and development changes shall be identified and records maintained. The 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 delivered products. Records of the results of the review of changes and any necessary actions shall be maintained (see 4.2.4).

7.4 Purchasing

7.4.1 Purchasing Process

7.4.1 Purchasing process: The organization shall ensure that purchased product conforms to specified purchase requirements. The type and extent of control 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 following the organization’s requirements. Criteria for selection, evaluation, and re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see 4.2.4).

7.4.2 Purchasing Information

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 the qualification of personnel.
Quality management system requirements.

The organization shall ensure the adequacy of specified purchase requirements before being sent to the supplier.

7.4.3 Verification of Purchased Product

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

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

7.5 Production and Service Provision

7.5.1 Control of 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 appropriate:

The availability of information that describes the characteristics of the product.
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

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 used or the service has been delivered.

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 the review and approval of processes.
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

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: In some industry sectors, configuration management is a means of maintaining identification and traceability.

7.5.4 Customer Property

7.5.4 Customer property: The organization shall exercise care with customer 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 and reported to the customer (see 4.2.4).

NOTE: Customer property can include intellectual property.

7.5.5 Preservation of Product

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 constituent parts of a product.

7.6 Control of Monitoring and Measuring Devices

7.6 Control of monitoring and measuring equipment: 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.
Be adjusted or re-adjusted as necessary.
Be identified to enable the calibration status to be determined.
Be safeguarded from adjustments that would invalidate the measurement result.
Be protected from damage and deterioration during handling, maintenance, and storage.

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

When computer software is used to monitor and measure specified requirements, the organization shall confirm the software’s ability to satisfy the intended application before initial use and reconfirm it as necessary.

NOTE: See ISO 10012 for guidance.

8 Measurement, Analysis, and Improvement

8.1 General

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

To demonstrate the conformity of the product.
To ensure the conformity of the quality management system.
To continually improve the effectiveness of the quality management system.

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

8.2.1 Customer satisfaction: As one of the measurements of the quality management system’s performance, the organization shall monitor information relating to customer perception as to whether the organization has met customer requirements. The methods for obtaining and using this information shall be determined.

8.2.2 Internal Audit

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 objectivity and impartiality of the audit process. Auditors shall not audit their work.

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

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 reporting of verification results.

NOTE: See ISO 19011 for guidance.

8.2.3 Monitoring and Measurement of Processes

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 the conformity of the product.

8.2.4 Monitoring and Measurement of Product

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

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

8.3 Control of Nonconforming Product

The organization shall ensure that the product does not comply with the requirements is identified and controlled to prevent unintended use or delivery. The controls and related responsibilities to them, and authorities for dealing with nonconforming product shall be defined in a documented procedure.
The organization shall deal with nonconforming product by one or more of the following ways;
acting to eliminate the detected nonconformity;
authorizing their use, shipment or acceptance under concession by the competent authority and, where appropriate, the client;
acting to resume their original use or application.

Records maintained (see 4.2.4) the nature of nonconformities and any subsequent actions taken, including concessions obtained.
When correcting a nonconforming product must undergo re-verification to demonstrate conformity with the requirements.
When nonconforming product detected after delivery or use has started, the organization must take appropriate action regarding the consequences, or potential effects of the nonconformity.
8.4 Analysis of data

The organization shall determine, collect and analyze appropriate data to demonstrate the adequacy and effectiveness of quality management and to evaluate where continual improvement of quality management. This should include data generated by measuring and monitoring activities and any other relevant source.
Analysis of these data should provide information on:
customer satisfaction (see 8.2.1);
conformity to product requirements (see 7.2.1);
characteristics and trends of processes and products including opportunities to take preventive action, and
suppliers

8.5 Improvement

8.5.1 Continuous Improvement

The organization shall continually improve the effectiveness of quality management through the use of quality policy, quality objectives, audit results, analysis, corrective and preventive actions and management review .
8.5.2 Corrective Actions

The organization shall take action to eliminate the cause of nonconformities in order to prevent their recurrence. Corrective actions must be appropriate to the effects of the nonconformities encountered.
There should be a documented procedure to define requirements for:
reviewing nonconformities (including customer complaints);
determine causes of nonconformity;
assess the need for action to ensure that nonconformities do not recur;
determine and implement the necessary actions;
record the results of action taken (see 4.2.4), and
reviewing corrective action taken.

8.5.3 Preventive Action

The organization shall determine action to eliminate causes of potential nonconformities to prevent their occurrence. Preventive actions taken shall be appropriate to the effects of potential problems.
There should be a documented procedure to define requirements for:
determining potential nonconformities and their causes;
assess the need for action to prevent occurrence of nonconformities;
determine and implement the necessary actions;
record the results of action taken (see 4.2.4), and
reviewing preventive action taken.