Understanding ISO 9000 Quality Management Systems
UNE EN ISO 9000
With the publication in 1987 of the ISO 9000 series of international standards, unification was initiated in the field of management and quality assurance, covering three types of situations:
- Unification of concepts: UNE-EN ISO 8402
- Unification of business activities: Regulated activities
Objectives: Quality improvement so that the organization can meet the specifications of products and services determined by both the quality system and the customer. Improving the image for the performance of quality requirements in front of customers and their own organization.
ISO 9000
Quality management system fundamentals and vocabulary describe the basics of quality management systems. The application of this rule can be extended to all organizations seeking improvement through the implementation of a quality assurance system. These principles are:
- Customer Focus: Be taken into account and their expectations must be met.
- Leadership: The directive sets the direction and is responsible for the general launch.
- Participation of the parties.
- Process-Based Focus.
- System Management Focus.
- Continuous improvement.
- Fact-Based Focus for decision making.
- Mutually beneficial supplier relationships.
Most Important Documents:
- Quality manual
- Quality plans
- Specifications
- Guidelines
- Documentation of procedures
- Records
ISO 9001
Replaces and cancels ISO 9001, 9002, and 9003 of 1994 and takes into account the principles of ISO 9000 and 9004:2000. ISO 9001 specifies requirements for quality management systems for any organization that needs to show its ability to provide products that meet quality requirements:
- Identify the processes needed for the quality management system and its application through the organization.
- Determine the sequence and interaction of the processes.
- Determine the criteria and methods needed to ensure that both processes and controls are effective.
- Assure resource availability and information.
- Perform follow-up measurements.
- Implement needed actions.
The address is responsible for appropriate Quality Management so that improvements are carried out.
Quality Management System
Documents that could be used to implement the quality system:
- Quality manual
- Procedures manual
Quality Manual
This document reflects in detail the ways and means employed in a company or organization to ensure quality. The quality manual is a generic type and should not be too extensive. It is recommended to focus on quality according to ISO 9000. The quality manual is the document that should include the scope of the quality management system.
Contents:
- Policy and quality objectives
- Organizational structure: Organizational charts, function, and responsibility of each member
- Organization of the quality system
- Management approval
Page layout:
- Name
- Object
- Responsible
- Visa
- Date
- Numbering
- Managed copy number
- Chapter number
Procedures Manual
The sequence of actions that would continue to produce a certain result. It should appear in detail the procedures that allow the realization of a certain process. To clearly explain a particular procedure, the following points or paragraphs may be included:
- Object
- Scope
- Detailed description of the actions to perform
- Associated human and material resources for each task
- A flowchart (very useful in many cases)
- Information in and out of the process