Document
The organization needs to distinguish between documents that will be controlled and documents that will not be included under the QMS. A document is:
- Plans, requirements, or specifications for realization or activities
- Input for a process
- Communication of information
- Sharing of knowledge, information, or data
Unlike a Record that is considered as evidence for performance of a process and records the output of a process, the document presents a specification or input for a process.
Types of documents in an organization include: diagrams, drawings, process charts, technical specifications, product plans, DMR, quality plans, forms, checklists, routing cards, customer’s specifications, manufacturing specifications, process flow diagrams, production plans, standard procedures, quality work procedures, bills of materials, computer files, instructions, test instructions, test protocols, agreements with suppliers, approved lists of suppliers, material specifications, regulations or directives, assembly plans, internal audit plans, corrective action forms, reports of nonconformity, and international standards.
The method will relate to external documents as well. External documents will be distinguished, registered, and controlled. The method shall first identify these external documents that are part of the realization processes of the product and thus require control, for example, a drawing or product received from a customer. This is a classic external document that must be controlled for edition or revision. Examples of external documents may be drawings, packaging instructions, diagrams of production tools, quality requirements, design files, and customer’s approvals or agreements. External documents include regulatory requirements. It is necessary to verify that the updated edition of the regulations is available. I suggest a table that will specify all the documents under the QMS. The fields of the table are:0
- Identification number
- Description or name
- Relevant process/relevant department
- Responsible for review
- Responsible for approval
- Media
- Location
- Internal/external
- Other characteristics such as public or classified
