PROCESO DE AUDITORIA AL SISTEMA DE GESTIÓN

Summary

This educational video covers the essential aspects of quality management system (QMS) audits, explaining their importance in ensuring compliance and continuous improvement. It highlights key standards like ISO 9000, 9001, and ISO 19011, outlining the purpose, classification, and frequency of audits. Audits, both internal and external, are crucial for verifying that an organization meets required criteria and regulations. The video also discusses the roles of auditors and auditees, the need for evidence, and how audits lead to certification, with a focus on improving product, service, and process quality for organizational success.

Takeaways

• 😀 The audit of a quality management system is crucial for verifying compliance with standards and identifying areas for improvement in processes and products.
• 😀 A quality audit is defined as a systematic, independent, and documented process to obtain and evaluate evidence to determine whether criteria are met (ISO 9000:2015).
• 😀 Objective evidence in an audit refers to information that can be verified, such as documents or physical proof, which demonstrates compliance with requirements.
• 😀 Criteria for audits include policies, work instructions, and legal requirements, all of which organizations must meet and demonstrate through objective evidence.
• 😀 Non-conformities, or failures to meet criteria, are identified during audits, enabling companies to correct and improve their processes.
• 😀 The ISO 19011:2018 standard provides guidance on managing audit programs but does not set requirements like ISO 9001, which sets the minimum requirements for quality management systems.
• 😀 Audits help organizations demonstrate the effectiveness of their quality management systems and the ability to meet customer requirements.
• 😀 Certification of a quality management system (such as ISO 9001) requires passing audits, but certification is valid for only three years, after which a renewal audit is needed.
• 😀 Audits can be internal (first-party audits), where an organization audits its own system, or external (second-party and third-party audits), where external auditors assess the system.
• 😀 Internal audits help companies prepare for certification or identify internal issues, while external audits are typically conducted by clients (second-party) or certifying bodies (third-party).
• 😀 The frequency of audits depends on scheduling, requested necessity, significant system changes, or the detection of non-conformities. There is no fixed timeline for audits.

Q & A

What is the purpose of auditing in a quality management system?

The purpose of auditing in a quality management system is to verify that an organization meets the established standards, identify areas for improvement, and ensure compliance with regulations. This process helps in maintaining product and service quality, as well as improving organizational efficiency.

How does ISO define an audit?

According to ISO 9000:2015, an audit is a systematic, independent, and documented process to obtain objective evidence and evaluate it to determine whether audit criteria are being met.

What is meant by 'objective evidence' in an audit?

Objective evidence refers to factual, verifiable information that can demonstrate compliance. For example, clean dishes or a completed shopping list can serve as objective evidence to show that a task was completed as per the requirement.

What are 'audit criteria' and how are they used?

Audit criteria are the requirements or standards against which an organization’s processes are evaluated. These can include company policies, legal requirements, and customer or product specifications. They serve as the reference point for auditing the organization’s systems.

What are non-conformities in the context of an audit?

Non-conformities occur when an organization fails to meet one or more of the audit criteria. These are identified during an audit and indicate areas where corrective actions are needed.

What is the difference between internal and external audits?

Internal audits are conducted by members within the organization to assess the effectiveness of the internal quality management system. External audits are conducted by third parties, such as customers, suppliers, or certification bodies, to assess compliance with external standards or certification requirements.

What role does an auditor play in the audit process?

An auditor, or audit team, is responsible for conducting the audit by gathering evidence, evaluating compliance with audit criteria, and providing conclusions regarding the effectiveness of the quality management system.

Who is considered the 'auditee' in an audit?

The auditee is the organization or individual being audited. They are responsible for providing the necessary evidence and documents to the auditor during the audit process.

What is the difference between second-party and third-party audits?

A second-party audit is conducted by an external party with a vested interest in the organization, such as a customer or supplier. A third-party audit is performed by an independent external entity, often a certification body, to assess compliance for certification purposes.

How often should audits be conducted in a quality management system?

Audits should be conducted regularly, depending on the organization’s needs and any changes to its system. Internal audits are often scheduled periodically, while external audits are typically conducted when requested, usually for certification renewal or after significant changes in the organization.