ISO 9001:2000 Quality Management Systems Requirements

Posted on Sep 17, 2024 in Other subjects

General

The design and implementation of system quality management of an organization 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

This international standard promotes the adoption of a process approach for the development, implementation and improvement of the effectiveness of a system of quality management.

One advantage of the process approach is providing continuous monitoring of the binding sites between the individual processes within the system of processes as well as over their combination and interaction.

When used in a system of quality management, this approach emphasizes the importance of:

Understanding and meeting the requirements.
The need to consider processes in terms of value added.
Obtaining results of the performance and effectiveness of processes, and
Continual improvement of processes based on objective measures.

NOTE:

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

Plan: Establish the objectives and processes necessary to deliver results in accordance with customer requirements and policies of the organization.
Do: Implement the processes.
Check: Monitor and measure processes and product against policies, objectives and product requirements and report results.
Act: Take actions to continually improve process performance.

Relation with the International Standard ISO 9004

ISO 9001 specifies requirements for a system of quality management that could be used for internal application by organizations, for certification or contractual purposes. It focuses on the effectiveness of quality management to comply with the requirements of the system of quality management.

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

Compatibility with Other Management Systems

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

This International Standard does not include requirements specific to other management systems such as those particular to environmental management, management of health and safety at work, financial management or risk management. However, this International Standard enables an organization to align or integrate its own system of quality management requirements related management systems. It is possible for an organization to adapt its existing management system(s) with the aim of establishing a system of quality management that meets the requirements of this International Standard.

Purpose and Scope

1.1 General

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

Needs to demonstrate its ability to consistently provide product that meets 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 requirements and regulatory requirements that apply.

NOTE:

In this International Standard, the term “product” applies only to the product intended or requested by the customer.

1.2 Aplicación

All the requirements of this International Standard are generic and are intended to be applicable to all organizations regardless of type, size or product provided. Where any requirement of this International Standard can not be applied due to the nature of the organization and its product, it can be taken into account to their exclusion.

2 Normative References

International Standard quoted below, contains provisions which, through reference in this text, constitute provisions of this International Standard. As the standard of reference is dated, subsequent amendments, or revisions of the above International Standard does not apply. However, it is recommended that parties to agreements based on this International Standard to 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, Systems Quality Management – Principles and vocabulary.

3 Terms and Definitions

For the purpose of this International Standard are applicable to the terms and definitions given in ISO 9000:2000.

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.

———————— ———————— provider organization customer
The term replaces the term provider organization that was used in ISO 9001:1994, and refers to the unit which applies this International Standard. Similarly, the term provider is currently used in place of the term subcontractor.

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

4 System of Quality Management

4.1 General Requirements

The organization shall establish, document, implement, maintain and continually improve the effectiveness of a system of quality management in accordance with the requirements of this International Standard.

The organization must:

Identify the processes needed for the system of quality management 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 process control.
Ensure the availability of resources and information necessary to support the operation and monitoring processes.
Measure, track and analyze these processes, and
Implement the actions necessary to achieve planned results and continual improvement of these processes.

The organization must manage these processes in accordance with the requirements of this International Standard.

NOTE

Processes needed for the system of quality management that have been referred to above should also consider the processes for management activities, provision of resources, product realization and implementation of measures.

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

4.2 General Documentation Requirements

The documentation system of quality management should include:

Documented statements of a quality policy and quality objectives.
A quality manual.
Documented procedures required by this International Standard.
Documents required by the organization to ensure the control, operation and effective planning processes, and
The 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 that the procedure is established, documented, implemented and maintained.

NOTE 2:

The extent of documentation of the management system of quality 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, and
The competence of staff.

NOTE 3

The documentation can be in any format or media type.

4.2.1 Quality Manual

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

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

4.2.2 Document Control

Documents required by the system of quality management should be monitored. The quality records are a special type of document and shall be controlled according to the requirements given in 4.2.4.

There should be a documented procedure to define the controls needed:

To approve documents for adequacy prior to issue.
To review and update documents as necessary and to carry out its re-approval.
To ensure that identifies the changes and current revision status of documents.
To ensure that relevant versions of applicable documents are available at point of use.
To ensure that documents remain legible and readily identifiable.
To ensure that identifies the external documents and their distribution controlled, and
To prevent the unintended use of obsolete documents and apply suitable identification to them if they are retained for some reason either.

4.2.4 Control of Quality Records

Must establish and maintain quality records to provide evidence of compliance with the requirements and the effective operation of quality management. Quality records shall remain legible, readily identifiable and retrievable. There should be a documented procedure to define the controls needed for 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 the development and implementation of the system of quality management and continuous improvement of its effectiveness by:

Communicate to the organization the importance of meeting customer requirements as well as statutory and regulatory requirements.
Establishing the quality policy.
Ensure that they establish quality objectives.
Conducting management reviews and
Ensure the availability of resources.

5.2 Customer Focus

Top management shall ensure that customer requirements are determined and met with the aim of achieving customer satisfaction (see 7.2.1 and 8.2.1).

5.3 Quality Policy

Top management shall ensure that the quality policy:

Is appropriate to the purpose of the organization.
Includes a commitment to meet the requirements and continually improve the effectiveness of quality management.
Provides a framework for establishing and reviewing quality objectives.
Is communicated and understood within the organization.
Is revised to ensure adequate continuity is maintained.

5.4 Planning

5.4.1 Quality Objectives

Top management shall ensure that quality objectives, including those needed to meet the requirements of the product [see 7.1 a)] provides in relevant functions and levels within the organization. The quality objectives must be measurable and consistent with the quality policy.

5.4.2 Quality Management System Planning

Top management shall ensure that:

System planning, quality management is performed in order to meet the requirements given in paragraph 4.1, as well as the quality objectives, and
Maintaining the integrity of the system of quality management when planning and implementing changes in the system of quality management.

5.5 Responsibility, Authority and Communication

5.5.1 Responsibility and Authority

Top management shall ensure the definition and communication of responsibilities, authorities and their interrelationships within the organization.

5.5.2 Management Representative

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

Ensure that they establish, implement and maintain processes to the system of quality management.
Inform senior management of the operation of quality management, including needs for improvement.
Promote awareness of customer requirements at all levels of the organization.

NOTE

– The responsibility of the management representative can include liaison with external parties on matters relating to the system of quality management.

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 system of quality management.

5.6 Management Review

5.6.1 General

Top management shall, at planned intervals, review the system of quality management of the organization to ensure its continued consistency, adequacy and effectiveness. The review shall include assessing opportunities for improvement and the need for changes in the system of quality management, including quality policy and quality objectives.

Records of the revisions made by management (see 4.2.4).

5.6.2 Review Input

The information for management review should include information on:

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

5.6.3 Review Output

The results of the management review should include the decisions and actions associated with:

Improving the effectiveness of quality management and processes.
Improvement of product related to customer requirements.
Resource needs.

6 Resource Management

6.1 Provision of Resources

The organization shall determine and provide the resources needed to:

Implement and maintain the system of quality management and continually improve its effectiveness, and
Achieve customer satisfaction.

6.2 Human Resources

6.2.1 General

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

6.2.2 Competence, Awareness and Training

The organization must:

Determine the needs of competence for personnel performing activities affecting product quality.
Provide training or take other actions to meet those needs.
Evaluate the effectiveness of actions taken.
Ensure employees are aware of the relevance and importance of their activities and how they contribute to the achievement of quality objectives, and
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 conformity to product requirements. Infrastructure includes, for example:

Buildings, workspace and associated infrastructure.
Process equipment, both hardware and software, and
Supporting services such as transportation and communication.

6.4 Work Environment

The organization must identify and manage workplace conditions needed to achieve conformity to product requirements.

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 system processes quality management (see 4.1).

In planning product realization, the organization must determine, when appropriate, the following:

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

The result of this planning should be presented in a form suitable for the method of operation of the organization.

NOTE 1

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

NOTE 2

The organization may also apply the requirements given in paragraph 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 must determine:

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

7.2.2 Review of Requirements Related to the Product

The organization shall review the requirements related to the product. This review should take place before the organization’s commitment to providing a product to the customer (e.g., submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that:

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

Records of the results of the review and actions arising from it (see 4.2.4).

When the customer provides no documented statement of requirements, the organization must confirm the customer’s requirements before acceptance.

When changing product requirements, the organization must ensure that relevant documentation is amended and that appropriate staff is aware of the changed requirements.

NOTE

In some situations, such as internet sales, it is impractical for a formal review of each order. Instead, the review can cover relevant information for the product, such as catalogs or advertising material.

7.2.3 Customer Communication

The organization shall identify and implement effective arrangements for communicating with customers in relation to:

Information about the product.
Treatment of questions and orders, including amendments, and
Customer feedback, including customer complaints.

7.3 Design and Development

7.3.1 Design and Development Planning

The organization shall plan and control the design and product development.

When planning the design and development organization must determine:

Stages of design and development.
The review, verification and validation appropriate to each stage of design and development, and
Responsibilities and authorities for design and development.

The organization shall manage the interfaces between the different groups involved in the design and development to ensure effective communication and a clear designation of responsibilities.

The results of the planning should be updated, as appropriate, as the design and development progresses.

7.3.2 Design and Development Inputs

Should be identified inputs related to product requirements and records maintained (see 4.2.4). These should include:

Functional requirements and performance.
The applicable statutory and regulatory requirements.
Applicable information from previous similar designs, where applicable, and
Other requirements essential for design and development.

These items should be reviewed for adequacy. The requirements must be complete, unambiguous and should not be in conflict with each other.

7.3.3 Design and Development Outputs

The results of the design and development shall be provided so as to allow verification in relation to the design and development input and shall be approved prior to release.

The outputs of design and development should:

Meet the elements of design and development input.
Provide appropriate information for purchasing operations, production and service.
Contain or reference acceptance criteria for the product, and
Specific product features that are essential for safe and proper use.

7.3.4 Design and Development Review

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

Assess the ability of the results of design and development to meet requirements, and
Identify problems and propose necessary actions.

Participants in such reviews shall include representatives of the functions involved with the phase(s) of design and development that is (are) being reviewed.

Records of the results of reviews and subsequent action must be maintained (see 4.2.4).

7.3.5 Design and Development Verification

Verification should be performed to ensure that results meet the design and development inputs. Records of the results of the verification and subsequent action (see 4.2.4).

7.3.6 Design and Development Validation

You must validate the design and development in accordance with planned arrangements (see 7.3.1) to confirm that the resulting product is capable of meeting the requirements for specified or intended use or application. Whenever possible, validation must be completed before delivery or implantation of the device. Records of the validation results and subsequent action (see 4.2.4).

7.3.7 Control of Design and Development Changes

The design and development changes shall be identified and records maintained. Changes must be reviewed, verified and validated, when appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and the product delivered.

Records of the results of the review of changes and subsequent action (see 4.2.4).

7.4 Purchasing

7.4.1 Purchasing Process

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

The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the requirements of the organization. Should establish the criteria for selection and periodic evaluation. Records of the results of the evaluation and subsequent actions required arising from it (see 4.2.4).

7.4.2 Purchasing Information

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

Requirements for approval of product, procedures, processes and equipment.
Requirements for qualification of personnel, and
System requirements for quality management.

The organization shall ensure the adequacy of specified purchase requirements prior to its submission to the provider.

7.4.3 Verification of Purchased Product

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

When the organization or its customer intends to conduct verification activities at the supplier’s premises, the organization must specify in the purchase information on arrangements for verification and the method for the introduction of the product.

7.5 Production and Service Operations

7.5.1 Control of Production and Service Operations

The organization shall plan and carry out operations and service production under controlled conditions. Controlled conditions shall include, as appropriate either:

The availability of information describing the product characteristics.
The availability of work instructions.
The use of appropriate equipment.
The availability and use of measuring and monitoring equipment.
The implementation of monitoring and measurement, and
The implementation of release, delivery and post-sale.

7.5.2 Validation of Processes for Production and Service Operations

The organization shall validate any processes for production operations and service in those areas where the resulting output can not be verified through monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is being used or has the service performed.

Validation shall demonstrate the ability of these processes to achieve planned results.

The organization shall establish the necessary preparations for these processes including, as appropriate:

Defined criteria for review and approval processes.
Approval of equipment and qualification of personnel.
Use of specific methods and procedures.
Requirements for records (see 4.2.4), and
Re-validation.

7.5.3 Identification and Traceability

When appropriate, the organization must identify the product by suitable means throughout product realization.

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

Where traceability is a requirement, the organization shall control and record the unique identification of the product (see 4.2.4).

NOTE

In some industry sectors, configuration management is a means to maintain identification and traceability.

7.5.4 Customer Property

The organization shall exercise care with customer property while under the control of the organization or being used by the organization. The organization shall identify, verify, protect and maintain the customer’s property provided for use or incorporation into the product. Any good customer is lost, damaged or otherwise deemed it unsuitable for use should be recorded (see 4.2.4) and communicated to the customer.

NOTE:

The property of the client may include intellectual property.

7.5.5 Preservation of Product

The organization shall preserve the conformity of product during internal processing and final delivery to the destination. This should include identification, handling, packaging, storage and protection. This shall also apply to the constituent parts of a product.

7.6 Control of Measuring and Monitoring Equipment

The organization must determine the measurement and monitoring activities to be undertaken and related equipment required to ensure product conformity to specified requirements (see 7.2.1).

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

Where necessary to ensure the achievement of valid results, measuring equipment must:

Calibrated or verified at specified intervals prior to use, against national or international standards, where no such patterns should record the basis used for calibration or verification.
Adjusted or re-adjusted as necessary.
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 the results of the above measures when it detects that the computer does not comply with the requirements. The organization shall take appropriate action on the equipment and any product affected. Records of the results of calibration and verification.

You must confirm the ability of software to satisfy the intended application when they are used in monitoring and measurement of specified requirements. This must be done before initial use and reconfirmed as necessary.

NOTE:

See ISO 10012 standard for recommendations.

8 Measurement, Analysis and Improvement

8.1 General

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

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

This should include determination of applicable methods, including statistical techniques, and the extent of its use.

8.2 Measurement and Monitoring

8.2.1 Customer Satisfaction

As a measure of system performance quality management, the organization shall monitor information on customer perception of the degree to which the organization has met its requirements. Should be identified and methods for obtaining and using this information.

8.2.2 Internal Audit

The organization must conduct internal audits periodically to determine whether the system of quality management:

Conforms to planned arrangements (see 7.1), with the requirements of this International Standard and the requirements of the management system of quality set by the organization, and
Has been implemented and maintained effectively.

You need to plan the audit program taking into consideration the status and importance of the processes and areas to be audited, and the results of previous audits. It should define the audit criteria, scope of, frequency and methodology. Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors should not audit their own work.

Should be defined in a documented procedure the responsibilities and requirements for planning and conducting audits, and for the presentation of results and maintaining records (see 4.2.4).

The management with responsibility for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes.

Monitoring activities should include verification of the actions taken and the reporting of verification results.

NOTE:

See ISO 10011 Standard as a guide.

8.2.3 Monitoring and Measurement of Processes

The organization shall apply suitable methods for monitoring and, where applicable, measurement of processes of the management system of quality. These methods shall demonstrate the ability of processes to achieve planned results. When not achieve the desired results, should be carried out corrections and corrective actions, as appropriate, to ensure product conformity.

8.2.4 Monitoring and Measurement of Product

The organization must measure and monitor the characteristics of the product to verify compliance with product requirements. This should be done at appropriate stages of product realization process in accordance with planned arrangements (see 7.1).

You must keep evidence of conformity with acceptance criteria. The records must indicate the authority responsible for placing the product in use (see 4.2.4).

Do not proceed to put to use the product or service delivery until they have successfully completed all planned arrangements (see 7.1), unless the competent authority, or where appropriate the client, otherwise.

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 Data Analysis

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.