Procedure for product identification (clause 7.5.8).Procedure and records for validation of process for sterilization and sterile barriers systems (clause 7.5.7).Procedure and records of production and service provision process validation (clause 7.5.6).Records of sterilization process (clause 7.5.5).Procedure and records for servicing of the medical device (clause 7.5.4).Records for medical device installation and verification of installation (clause 7.5.3).Requirements for medical device installation and acceptance criteria for verification of installation (clause 7.5.3).Requirements for cleanliness of product (clause 7.5.2).Record for each medical device or batch that provides traceability (clause 7.5.1).Record of verification of purchased product (clause 7.4.3).Criteria and records for evaluation and selection of suppliers (clause 7.4.1).Procedure for purchasing (clause 7.4.1).Design and development file (clause 7.3.10).
Records of design and development review (clause 7.3.5).Design and development outputs (clause 7.3.4).Design and development planning (clause 7.3.2).Procedure for design and development (clause 7.3.1).Arrangements for communication with customers (clause 7.2.3).Records of the results of the customer requirements review and actions arising from it (clause 7.2.2).Outputs of product realization planning (clause 7.1).Process for risk management in product realization (clause 7.1).Arrangements for control of contaminated or potentially contaminated products (clause 6.4.2).Requirements for work environment (clause 6.4.1).Requirements for infrastructure and maintenance activities (clause 6.3).Procedure and records for management review (clause 5.6.1).Responsibilities and authorities (clause 5.5.1).Procedure for record control (clause 4.2.5).Procedure for document control (clause 4.2.4).Procedure and records for the validation of the application of computer software (clause 4.1.6).Roles undertaken by the organization under applicable regulatory requirements (clause 4.1.1).(Please note that some of the documents will not be mandatory if the company does not perform relevant processes related to ISO 13485 documentation requirements): Here are the required ISO 13485 documents, categorized according to the clauses of the standard.