Quality Management System Documentation Essentials
Records
Records are documents used to demonstrate compliance with requirements and the effective operation of the Quality Management System (QMS). They must be readily available for customer review as contractually agreed, serving as a form of product traceability. Data from records can be used for statistical studies, providing insights into process capability and control. Auditors rely on records to verify compliance with activities described in procedures and instructions.
Work Instructions
Work Instructions consist of technical documentation that provides specific, ordered instructions for performing a given activity or task. These documents are developed collaboratively with the personnel responsible for the activity and are approved by the relevant technical authority. They should be physically visible to the operator. Flow diagrams are often difficult to use effectively. Related technical documents, such as inspection methods, calibration methods, and plans, are also attached.
Procedures
Procedures describe how activities are performed. The organization manages its system through processes, which should be reflected in these documents. Procedures answer the questions: *who*, *what*, *when*, *where*, and *why* an activity is performed. It is also important to define, in outline form with diagrams, how to perform a certain job and its relationships, leaving specifics to the work instructions. This could include flow diagrams, process sheets, etc. These documents are written by those who perform the work, in collaboration with process owners. For training new operators, it is desirable for procedures to be simple to understand and apply. The number of procedures depends on the organization’s size and complexity. UNE-EN ISO 9001:2000 requires documented procedures for six activities:
- Document Control
- Control of Records
- Internal Audit
- Control of Non-Conforming Product
- Corrective Action
- Preventive Action
Procedures are for internal use only.
Quality Manual
Paragraph 4.2.2 of UNE-EN ISO 9000:2000 states that the organization must establish and maintain a Quality Manual. The Quality Manual outlines all activities the organization performs for its QMS to function effectively. It forms the backbone of all documentation and includes references to other system documents. Smaller organizations may include all documents within the manual, while larger, more complex organizations may only reference them. The manual should include:
- The organization’s quality policy and objectives
- Its organizational structure
- An explanation of each applicable requirement of the reference standard used
- A description of the interaction between processes
- Details and justification for any exclusions