Understanding ISO 9000 Standards for Quality Management
ISO 9000: Quality Management Fundamentals
ISO 9000: This standard, entitled “Quality Management. Fundamentals and vocabulary,” describes the basics of quality management systems and specifies the terminology used within them. Its application can be extended to all organizations seeking to improve through the implementation of a quality assurance system, aiming to increase trust and client satisfaction in their products or services. It identifies eight principles of quality management:
- Customer focus
- Leadership
- Staff participation
- Process-based approach
- System approach to management
- Improvement
- Fact-based decision-making
- Mutually beneficial supplier relationships
The most important documents used in quality management systems according to ISO 9000 are:
- Quality manuals
- Quality plans
- Specifications
- Guides
- Documentation procedures
- Registry
ISO 9001: Quality Management System Requirements
ISO 9001: This standard, titled “Quality management systems – Requirements,” specifies the requirements for quality management systems applicable to any organization that needs to demonstrate its ability to provide products and aims to increase customer satisfaction.
ISO 9004: Guidelines for Performance Improvement
ISO 9004: This standard provides guidelines that consider both the effectiveness and efficiency of the quality management system. Its goal is to improve organizational performance and customer satisfaction, as well as the satisfaction of other stakeholders.
Key Documents in Quality Management
Quality Manual
Quality manual: This document reflects in detail the ways and means employed by a company or organization to ensure quality. It is an internal company document describing its quality system and can serve as a reference for all members of the organization. It must be constantly revised to reflect all changes occurring within the company, keeping it always updated.
Procedure Manual
Procedure Manual: This document details the procedures that enable the realization of a particular process or processes, and all activities aimed at obtaining a specific result. It clearly indicates who is responsible for conducting each step and shows the sequence of operations between different jobs.
Audits in Quality Management
Internal Audits
Internal audits are conducted to verify that processes are performed as required. They allow you to locate weaknesses in the functioning of the company, enabling corrections to be made. They are performed regularly, and documentary evidence is kept of all reports, which should contain all findings, conclusions, and corrective actions.
External Audits
External audits: These are responsible for evaluating the effectiveness of a quality assurance system. The auditor usually belongs to an organization or company that is accredited to perform this function and must be totally unrelated to the company being evaluated. A quality audit is always done at the request of a client, who usually chooses the auditing entity. The analysis of all data collected results in a final report communicated only to the client because it is strictly confidential. A favorable outcome can lead to some kind of certification. The document itself will highlight any problems identified during the audit, along with appropriate corrective or preventive actions as far as possible.