Apoyo - Cláusula 7 ISO 9001:2015
ISO 9001:2015 - Understanding Clause 7 Support
Overview of Clause 7 Support
- The video introduces the concept of support within ISO 9001:2015, emphasizing its role in continuous improvement and management processes.
- A visual representation likens this clause to a tree, with branches representing resources, competence, awareness, communication, and documented information.
Resources Required for Quality Management
- Organizations must identify and provide necessary resources for establishing, implementing, maintaining, and improving their quality management system (QMS). This includes assessing internal capabilities and determining external needs.
- Key resources outlined include:
- People: Necessary personnel must be determined for effective QMS implementation.
- Infrastructure: Essential infrastructure includes buildings, equipment (hardware/software), transport resources, and IT systems to ensure process operation and product/service conformity.
Environment for Process Operation
- The organization must maintain an appropriate environment conducive to achieving product/service conformity. Factors include:
- Social: Non-discriminatory practices and stress reduction measures.
- Physical: Control over temperature, humidity, lighting, air circulation, hygiene levels, and noise. These factors vary based on the nature of products/services provided.
Monitoring and Measurement Resources
- Organizations are required to ensure that monitoring/measurement resources are suitable for verifying product/service conformity against requirements. This involves:
- Maintaining documented evidence that these resources are fit for purpose.
- Ensuring traceability of measurements through calibration or verification against recognized standards where applicable.
- If no standards exist for calibration or verification methods used should be documented accordingly to maintain measurement integrity.
Organizational Knowledge
- Organizational knowledge is defined as specific knowledge acquired through experience that aids in achieving objectives.
- Sources can be both internal (e.g., lessons learned from projects) and external (e.g., industry standards). Organizations need to determine what knowledge is necessary for operational effectiveness while adapting to changing needs/trends.
Competence Requirements
- Competence refers to the organization's capacity to meet objectives effectively; it requires identifying necessary competencies among personnel affecting QMS performance.
- Actions may include training or mentoring current employees or recruiting competent individuals as needed while retaining documentation as proof of competence achieved through these actions.
Awareness Among Personnel
- It is crucial that all personnel understand the quality policy and relevant objectives along with their contributions towards enhancing QMS effectiveness.
Quality Management System Requirements
Importance of Communication in Quality Management
- Effective communication is crucial for the entire enterprise, particularly regarding quality management system requirements. Organizations must determine:
- What to communicate
- When to communicate
- To whom to communicate
- How to communicate
Documented Information in Quality Management Systems
- The organization's quality management system must include documented information as required by international standards and what the organization deems necessary for effectiveness.
- The extent of documented information varies based on:
- Size of the organization
- Type of activities and processes
- Complexity of processes and their interactions
- Competence of personnel involved
Creation and Protection of Documented Information
- It is essential that documented information is properly created, identified, versioned, formatted, described, reviewed, and approved.
- Additionally, this information must be accessible to all relevant personnel while being adequately protected against:
- Loss of confidentiality
- Improper use
- Loss of integrity
Key Support Elements in ISO9001:2015 Standard
- According to clause 7 of the ISO9001:2015 standard, five critical support elements should be considered in business operations:
- Resources
- People
- Competence
- Communication