My analysis of the standard produced the following results
Required Procedures
The six standard sections that require documented procedures in ISO 9001:2000 also require documented procedures under ISO 13485:2003. These are:
4.2.3 Control of Documents
4.2.4 Control of Records
8.2.2 Internal Audits
8.3 Control of Nonconforming Product
8.5.2 Corrective Actions
8.5.3 Preventive Actions
In addition, the following standard sections of ISO 13485:2003 require the establishment of documented procedures to define and control the requirements and practices of these operational areas:
7.3.1 Design & Development – to ensure a controlled, consistent design and development process
7.4.1 Purchasing Process –to ensure the purchased product conforms to specified purchase requirements
7.5.2.2 Particular Requirements for Sterile Medical Devices – to ensure validation of sterilization processes.
7.5.3.1 Identification –to ensure that devices returned are identified and distinguished from conforming product
7.5.3.2.1 Traceability –to define the extent of product traceability and the records that must be kept
7.5.5 Preservation of Product – to ensure the conformity of product during internal processing and delivery to the intended destination
7.6 Control of Monitoring and Measuring Devices – to ensure that monitoring and measurement can be and is carried out consistently with the monitoring and measurement requirements
8.2.1 Feedback – to ensure an adequate system to provide early warning of quality problems and for input into the CAR/PAR processes
8.4 Analysis of Data – to ensure that data demonstrating the suitability and effectiveness of the quality management system is determined, collected and analyzed and to evaluate any improvements to QMS effectiveness
8.5.1 Improvement, General – to address the issuance and implementation of advisory notices and notification to regulatory authorities, as required. Such procedures must be capable of implementation at any time.
In addition, there are certain clauses that require documented procedures only under specific conditions as well as requirements that require documentation, but not necessarily a 'documented procedure'. These are:
6.3 Infrastructure – When maintenance activities, or their lack, may affect product quality, documented requirement for such activities will be defined
6.4 Work Environment – When contact between personnel and the product or work environment may adversely affect product quality:
• documented requirements for health, cleanliness and clothing of personnel will be defined
If work environment conditions may adversely affect product quality:
• documented requirements for work environment conditions and
• documented procedures/work instructions to monitor and control work environment conditions
Document any special arrangements to control contaminated or potentially contaminated product so that other product, personnel or the work environment are not contaminated.
7.1 Planning of Product Realization – Requirements for risk management throughout product realization will be documented.
7.2.2 Review of Requirements Related to the Product – Customer product requirements are defined and documented
7.5.1.1 Control of Production & Service Provision – The documented procedures, requirements, work instructions and reference materials required to complete production and service activities in a controlled manner must be identified.
7.5.1.2.1 – Cleanliness of Product and Contamination Control – Documented requirements for cleanliness of product, under the conditions defined in the standard. Please review for applicability.
7.5.1.2.2 – Installation Activities – Compare your product requirements to standard for applicability. For example, the application of a bandage would not be considered installation; however, if its application must be effected in a particular fashion in order to work properly, documented requirements may be needed.
7.5.2.1 Validation of processes for Production and Service Provision – Is computer software used that might affect product conformance to specified requirements? If so, documented procedures for software validation are required.
My summary list, developed for a customer who was beginning a 13485 QMS implementation, was specific to documentary requirements and did not address records requirements.
