Documentation requirements ISO 13485:2003
The following definitions from ISO 9000 apply:Procedure: specified way to carry out an activity or a process
Record: document stating results achieved or providing evidence of activities performed.
Overview of required procedures
| paragraph | standard element |
| 4.2.3 | Document control |
| 4.2.4 | Record control |
| 6.3 | Maintenance activities |
| 6.4 | Health, cleanliness and clothing of personnel as they come into contact with the product |
| 6.4 | Work environment conditions |
| 6.4 | Control of contaminated or potentially contaminated product |
| 7.1 | Risk Management |
| 7.3.1 | Design and development |
| 7.4.1 | Purchasing process |
| 7.5.1.2.1 | Cleanliness of the product |
| 7.5.1.2.2 | Installation activities |
| 7.5.1.2.3 | Servicing activities |
| 7.5.2.1 | Validation of the application of computer software |
| 7.5.2.2 | Validation of sterilization processes |
| 7.5.3.1 | Product Identification |
| 7.5.3.1 | Identification of returned goods |
| 7.5.3.2 | Traceability |
| 7.5.5 | Preservation of product |
| 7.5.5 | Control of products with a limited shelf life |
| 7.6 | Control of monitoring and measuring devices |
| 8.2.1 | Customer
Feedback system |
| 8.2.2 | Internal audits |
| 8.2.4.1 | Monitoring and measurement of products |
| 8.3 | Control of noconforming product |
| 8.4 | Analyis of data |
| 8.5.1 | Advisory notice |
| 8.5.1 | Notification of adverse events |
| 8.5.2 | Corrective actions |
| 8.5.3 | Preventive actions |
Overview of required documented statements
| paragraph | standard element |
| 4.2.1 | Quality Policy and objectives |
| 5.5.1 | Responsibilities and authorities |
| 7.2.2 | Product Requirements |
| 7.3.1 | Design and development |
| 7.3.3 | Output of the design planning |
| 7.4.1 | Assessment criteria for suppliers |
| 7.5.2.1 | Defined criteria for review and approval of the processes |
Overview of required registrations
| paragraph | standard element |
| 5.6.1 | Management review |
| 6.2.2 | Education, training, skills and experience |
| 6.3 | Maintenance activities |
| 7.1 (d) | Proof that realization processes and the resulting product meet the requirements |
| 7.1 | Risk management |
| 7.2.2 | Results of the assessment of product requirements and measures resulting |
| 7.3.2 | Design and development inputs |
| 7.3.3 | Design and development outputs |
| 7.3.4 | Results of design reviews |
| 7.3.5 | Results of design verification |
| 7.3.6 | Results
of design validation |
| 7.3.7 | Results of design changes |
| 7.4.1 | Supplier evaluations |
| 7.4.3 | Verification of purchased products |
| 7.5.1.1 | Batch records for each batch of medical devices |
| 7.5.1.2.2 | Installation and verification |
| 7.5.1.2.3 | Service activities |
| 7.5.1.3 | Parameters of the sterilization process |
| 7.5.2 (d) | Registrations of validations |
| 7.5.2.1 | Software validation |
| 7.5.2.2 | Sterilization validation |
| 7.5.3 | Unique identification of a product |
| 7.5.3.2 | Traceability |
| 7.5.4 | Customer property lost, damaged or otherwise deemed unsuitable for use |
| 7.5.5 | Storage conditions of products with a limited shelf life |
| 7.6 | Calibration and verification |
| 8.2.2 | Internal audits |
| 8.2.4.1 | Meet acceptance criteria |
| 8.2.4.1 | Persons responsible for release of the product |
| 8.3 | The nature of nonconformities and any subsequent actions taken |
| 8.4 | Analysis of data |
| 8.5.1 | Customer complaints |
| 8.5.2 | Results of corrective actions |
| 8.5.3 | Results
of preventive actions |
|
Health, cleanliness and clothing of personnel as they come into contact with the product |