Basic Principles & Methodology
The ISO 9001 standard is intended for use in any organisation which designs, develops, manufactures, installs and/or services any product or provides any form of service. ISO 9001 provides a number of requirements which an organisation needs to fulfil if it is to achieve customer satisfaction through consistent products and services which meet customer expectations. While there are other standards in the ISO 9000 series of standards (see below), ISO 9001:2008 is the only one for which third-party auditors may grant certifications.
The ISO 9001:2008 standard is divided into the following five sections:
- 1. Quality Management System
This ISO 9001:2008 section outlines the necessary steps to implement the ISO 9001 quality system:
- Identify the business activities (processes) that are needed for the quality management system,
- Determine the sequence and interaction of these processes,
- Determine how these processes are effectively operated and controlled,
- Ensure that all information is available to support the operation and monitoring of these processes,
- Measure, monitor and analyse these processes, and implement action necessary to correct the processes and achieve continual improvement.
Necessary documentation includes a quality manual, quality procedures, work instructions and quality records. The quality procedures include a document control procedure that ensures that all documentation is effectively controlled. Also in this section, ISO 9001 emphasizes the need for continuous improvement.
- 2. Management Responsibility
Top management’s commitment to quality is crucial to the success of the ISO 9001 quality system. This ISO 9001:2008 section requires a corporate quality policy and quality objectives, and it reinforces the involvement of top management with customer requirements.
Top management is required to clearly define responsibilities and authorities within the company, including the position of the ISO 9001 management representative.
- 3. Resource Management
This section of ISO 9001:2008 contains requirements for a company to identify and to provide necessary resources (equipment, facilities, etc) and to address customer satisfaction. This ISO 9001:2008 section also includes requirements for employee training, as well as for the physical facilities and the work environment.
- 4. Product Realisation
Product Realisation is defined as “that sequence of processes and sub processes required to achieve the product.” This is how a company’s products (or services!) are designed, produced, tested, handled, shipped, etc. Emphasis is placed on how the company understands, communicates and actually meets their customers’ requirements. This ISO 9001:2008 section also contains various requirements for the design of products and for the planning of processes, projects and services.
- 5. Measurement, Analysis and Improvement
The last section of ISO 9001:2008 closes the loop by requiring the implementation of systems that provide feedback on all key processes, so that the company can immediately identify when not on track and implement corrective action. Measurement and monitoring activities include internal audits and the monitoring of customer satisfaction. All of these activities must be defined, planned and implemented. Measuring and monitoring allows the company to manage by fact, not by guess.