ISO 9001 Quality Management System: Requirements & Registration
To secure registration, organizations must develop and use quality management systems conforming to the requirements of ISO 9001. The first question asked by someone unfamiliar with ISO 9000 is, “What is a quality management system?”
The following definition is provided:
The quality management system is composed of all the organization’s policies, procedures, plans, resources, processes, and delineation of responsibility and authority, all deliberately aimed at achieving product or service quality levels consistent with customer satisfaction and the organization’s objectives.
When these policies, procedures, plans, and so forth are taken together, they define how the organization works and how quality is managed.
Quality Management System Documentation
The quality management system will include this documentation:
- A quality policy: This statement describes how the organization approaches quality.
- The quality manual: This must address each clause of the ISO 9001 standard. It will also typically include an organization chart, or some such device, illustrating management responsibility for operating the quality system. Quality procedures may be part of this manual, or they may be referenced.
- Quality objectives: These are the goals related to quality and must be in harmony with the quality policy. Quality objectives are assigned to the relevant organizational functions and levels and are tracked by top management.
- Quality procedures: These describe step-by-step what the company does to meet the quality policy. As a minimum, there will be a procedure for each of the ISO 9001 clauses outlining requirements. There may also be procedures for any processes that can impact quality.
- Forms, records, etc.: These provide proof of activities for the firm and for the auditors.
Organizational Registration to ISO 9001: What Are the Steps?
- Develop (or upgrade) a quality manual that describes how the organization will assure the quality of its products or services.
- Document procedures (or upgrade existing documentation) that describe how the various processes for design, production, continual improvement, and so on, will be operated. This must include procedures for management reviews and audits.
- The organization must secure (and provide evidence of, if registering) top management’s commitment to the QMS and continual improvement.
- The organization’s top management must ensure that customer requirements are determined and met.
- If registering, the organization must hire an accredited registrar company to examine its systems, processes, procedures, quality manual, records, and related items. If everything is in order and if the registrar is satisfied that the organization is effectively using the QMS, registration will be granted. Otherwise, the registrar will inform the organization of the areas requiring work (but will not tell the company specifically what must be done), and another audit will be scheduled.
- Whether registered or not, the organization must conduct its own internal audits to ensure that the systems, processes, and procedures are working effectively.
- Once registered, the outside registrar will make periodic audits for the same purpose. These audits must be passed to retain registration.