DOCUMENTATION

“ Document what you practice and practice what you document.”

The company’s controlled documents and data sheets must be formatted in a standard way with the format designed to make it readable information easy to use. Periodic review of documents must be done. Every new or revised controlled document or data sheet must undergo a standard and systematize approval process by a authorized personnel who are considered expert or responsible subject matter documentation. These reviewers and approves must have access to supporting reference material if necessary. Revised documents must include description of all previous changes to the documents in a continuous trail. A changes notice must be issued to affected parties every time when a document is revised if necessary. Few obsolete documents that needed to be retained for reference should be retained as quality record. The obsolete document to be disposed must be removed from the system to prevent accidental use.

Basic ISO documentation

1. ·        Management system documentation – The management system manual briefly describe how it meets the requirements of the standard using the system implemented. The manual must also include references and procedure.
2. ·        Procedure - Procedure describes how to perform a task in general, outline of key steps and order. Procedure should be reference related work instruction.
3. ·        Work instruction – Work instruction provide detailed step by step description of a task and not just a outline.
4. ·        Records – Records are the documents you keep to show that you follow your quality system.

Additional documentation for ISO 13485

·        Responsibility of Authorities

·        Training procedures

·        Health, Cleanliness and Clothing

·        Environmental conditions

·        Control of Contaminated products

·        Risk managements

·        Customers requirements

·        Design and developments

·        Purchase control, including purchase traceability and verification

·        Records of sterilization and servicing

·        Preserving products includes self life

·        Reference material

·        Labeling and packaging

·        Installation and verification

·        Preservation of product

·        Measurement and Monitoring