¡Es oficial! La nueva ISO 9001:2026 está aquí. Te contamos por qué importa

Support in Quality Management Systems

Overview of Changes in the New Version

• The speaker introduces the topic of support within the new version, referencing previous videos on chapters 4 and 5 related to quality management system planning.

• Emphasis is placed on moving from planning to execution, highlighting the need for resources and controls to ensure effective quality management.

Resource Determination

• Organizations must identify and provide necessary resources for establishing, implementing, maintaining, and improving their quality management systems.

• Understanding current resource capabilities is crucial for determining additional needs from external suppliers.

Infrastructure Requirements

• The organization must determine and provide infrastructure essential for process operation and product/service conformity.

• Infrastructure includes buildings, equipment (hardware/software), transportation resources, and information technology.

Environmental Considerations

• Requirement 7.14 emphasizes that an appropriate operational environment must be determined, provided, and maintained.

• Factors influencing a suitable environment include social aspects (non-discrimination), psychological factors (stress reduction), physical conditions (temperature/light/noise), and technological advancements.

Cultural Aspects of Quality Management

• The discussion touches on organizational culture regarding quality and ethical behavior as part of leadership responsibilities.

• Resources for monitoring and measurement are critical to ensure valid results when verifying product or service conformity.

Measurement Traceability

• Organizations need to ensure that measurement tools are calibrated or verified regularly to maintain accuracy in results.

• It’s important to protect measurement equipment from damage that could compromise data validity.

Knowledge Management in Organizations

• Chapter 7.16 discusses the necessity for organizations to identify required knowledge for process operations aimed at achieving desired outcomes.

• This knowledge should be maintained, updated as needed, addressing changing requirements through experience or additional training.

Objectives of the Organization

Competence and Training

• The importance of determining necessary competencies for individuals performing tasks that impact quality management system performance and efficiency is emphasized.

• Ensuring personnel are competent involves education, training, and relevant experience; actions may include providing training or hiring qualified individuals.

Awareness and Contribution

• Individuals under organizational control must be aware of the quality policy, their contributions to the effectiveness of the quality management system, and implications of non-compliance with quality requirements.

Support and Communication in Quality Management

Strategic Alignment

• There needs to be congruence between strategy and operations within a quality management system, reinforcing planning as a critical component.

Internal and External Communication

• A quality management system must define relevant internal and external communications essential for its outcomes, including what will be communicated, when, by whom, how, and to whom.

Documented Information Requirements

Documentation Necessities

• The quality management system should include documented information required by standards as well as any additional documentation deemed necessary for effective operation.

Audit Criteria Clarification

• The extent of documented information depends on factors like organization size, activity types, process complexity, product/service nature, and staff competence.

Control of Documented Information

Creation and Update Protocol

• When creating or updating documented information, it’s crucial to ensure appropriateness in content description, format (e.g., language or software version), and clarity regarding its use.

Protection Against Misuse

• Documented information must be controlled to ensure availability for use while protecting against loss of confidentiality or integrity issues.

Management Activities Related to Document Control

Key Management Activities

• Organizations need to manage activities related to distribution, access/retrieval, usage/storage/conservation of documented information effectively.

Evidence Protection Measures

• External information identified as part of the quality management system must be protected from unintentional alterations. Access permissions should clarify whether users can view only or also modify documents.

Conclusion & Future Learning Resources

Summary Insights

• The discussion highlights improvements in understanding the standard's usability concerning quality management culture.

Additional Resources

• Viewers are encouraged to engage with supplementary videos aimed at enhancing competencies related to these topics.