¿Qué CAMBIA en la ISO 9001:2026? Guía completa para la gestión de calidad

Changes to ISO 9001:2026 - Overview

Introduction to ISO 9001:2026

• The video discusses the changes in the new version of ISO 9001:2026, focusing on implementing a quality management system.

• Previous videos covered organizational context, leadership, and planning stages relevant to quality management.

Chapter 8: Operational Planning and Control

• Emphasizes the need for planning, implementing, and controlling processes necessary to meet requirements as outlined in Chapter 6.

• Highlights the importance of establishing criteria for processes and ensuring documented information is available for process execution.

Quality Assurance Activities

• Stresses that organizations must control planned changes and review unintended consequences while taking actions to mitigate adverse effects.

• Organizations are required to ensure that externally supplied products or services relevant to the quality management system are considered.

Customer Communication Changes

Enhancements in Customer Interaction

• New requirements state that communication with customers should include providing product/service information, managing inquiries, contracts, feedback (including complaints), and handling customer property.

• Introduces specific requirements for contingency actions related to operational continuity.

Information Sharing Methods

• Communication can encompass training materials, website content, publications, social media interactions, and FAQs.

Product/Service Requirements Management

Defining Product/Service Requirements

• Organizations must ensure that product/service requirements are clearly defined including legal/regulatory obligations and those deemed necessary by the organization.

Review Process Adjustments

• Acknowledges situations like online sales where formal reviews may be impractical; suggests using relevant product information from websites or catalogs instead.

Design and Development Considerations

Design Planning Essentials

• Continues existing practices requiring planning of design/development activities considering nature/duration of tasks along with necessary process stages such as verification and validation.

Stakeholder Involvement

• Emphasizes involving clients/users in design/development processes; highlights expected levels of control from clients during development phases.

Implementation of New Organizational Controls

Design and Development Controls

• The organization is committed to implementing new controls to ensure that the outcomes are clearly defined and aligned with the intended purposes.

• Regular reviews are conducted to assess the capability of design and development products, ensuring compliance with input requirements through verification activities.

• Documented information must be available as evidence of design and development outputs, including specifications for product characteristics necessary for their intended purpose.

• Changes in design and development must be documented, detailing review results, updates, and actions taken to prevent adverse impacts.

Supplier Management

• The organization must ensure that externally supplied processes, products, or services meet specified requirements; this includes defining when suppliers will be included in control measures.

• It is essential to maintain control over externally provided processes within the quality management system while evaluating the effectiveness of supplier controls.

• Clear communication with suppliers regarding product delivery methods, approval processes, and release methods is crucial for maintaining quality standards.

Production and Service Provision

• Organizations should implement production and service provision under controlled conditions which include documented information defining product characteristics such as manuals and procedures.

• Adequate resources for monitoring and measurement must be available; infrastructure should support effective operations while ensuring personnel competence is maintained throughout changes.

Identification and Traceability

• Appropriate means must be utilized to identify products when necessary to ensure conformity during production; tracking status against measurement requirements is vital throughout service provision.

• Unique identification of products is required where traceability is a necessity; organizations need to safeguard customer property while it’s under their control or use.

Ensuring Documented Information and Product Preservation

Importance of Documented Evidence

• The organization must ensure that documented information is available with evidence of what has occurred, including customer property and external supplier materials.

Product Preservation During Production

• Organizations are required to preserve products during production without significant changes from previous versions.

Post-Delivery Activities Compliance

• After delivery, organizations must comply with requirements related to products and services, considering statutory regulations and potential unintended consequences.

Sustainability Considerations

• Post-delivery activities may include warranty actions, maintenance services, recycling, or final disposal, indicating a slight focus on sustainability.

Verification Before Product Release

• Products and services should not be released until planned provisions are completed satisfactorily unless approved otherwise by relevant authorities.

Documentation for Conformity Evidence

• It is essential to maintain documented information evidencing conformity with acceptance requirements and traceability of individuals who authorized the release.

Managing Non-Conforming Outputs

Identification of Non-Conformities

• Organizations must identify non-conforming outputs to prevent their unintended use or delivery, taking appropriate actions based on the nature of the non-conformance.

Actions for Non-Conformities

• Possible actions include correction, segregation, containment, return or suspension of product/service provision. Communication with customers regarding these issues is crucial.

Documentation Requirements for Non-Conformities

• Detailed documentation must describe the non-conformance, actions taken, any concessions obtained, and identify the authority responsible for deciding on corrective action.

Conclusion and Next Steps

• The session concludes with an invitation to explore further topics such as performance evaluation and corrective action in future videos. Viewers are encouraged to like the video and subscribe for updates.