Understanding Quality Systems: ISO 9000 Standards
Item 12: The Quality System
The quality system in the company. (Test)
A company ensures quality when it can always meet the agreed requirements of its customers.
The ISO 9001, 9002, and 9003 describe the contents of a quality system for a company to ensure the quality of their products. In Spain, it is called UNE-EN-ISO 9001, 9002, 9003.
Each of the three standards describes a model in the following areas:
- UNE-EN-ISO 9001: activities of product design, production, installation, and after-sales service.
- UNE-EN-ISO 9002: production, installation, and after-sales service.
- UNE-EN-ISO 9003: final inspection product.
Documents of a Quality System
(Development)
One of the principles of quality assurance is that all business activities that affect product quality should be put in writing.
The quality system of a company has many documents. The main ones are: quality manual, procedures, work instructions, and records. The latter are the documentary evidence of the implementation of procedures and work instructions. Besides these, there may be plans (training plan, control plan) and specifications of both products sold by the company and those who purchase.
The Quality Manual
(Development)
The quality manual of a company is the document describing its quality system. In the quality manual, the organization of the company, its business (products manufactured, services provided), and the measures taken to ensure the quality of their products are explained.
Structure of a Quality Manual
Purpose and Scope
This chapter explains what is written in the quality manual as part of the company affected.
Reference Documents and Definitions
This chapter includes a list of documents relating to the company’s quality system, procedures, work instructions, standards, etc.
Presentation of the Company
This chapter explains the activity of the company, its organization, and means.
Objectives and Quality Policy of the Company
The quality objectives and policies are set by the company management.
Description of the Quality System
This is the main chapter of the quality manual. It describes the processes and activities the company performs to ensure the quality of their products and services. Usually divided into subchapters or sections.
Procedures and Work Instructions
(Test)
These are documents that describe the specific way of carrying out an activity. The procedures are used for those activities that string together several operations and involve different people or departments within the company (e.g., procurement process). Work instructions are used to describe a specific operation, usually associated with a job.
A summary-type of a procedure or instruction has the following sections:
- Purpose and scope.
- Reference documents.
- Specific definitions.
- Annexes.
The procedures should include flow charts explaining in a graphic way the different operations. Flow diagrams are schematic representations of an activity in which the different operations are carried out and those responsible take them out.