The purpose of the documentation in the QMS is to ensure that critical processes, where you need to make sure that all employees consistently do the same thing, are understood and repeatable. Procedure and records for preventive action (clause 8.5.3).Procedure and records for corrective action (clause 8.5.2).Procedure and records for data analysis (clause 8.4).Procedure and record of control of the nonconforming product (clause 8.3.1).Identity of the person authorizing the release of the product (clause 8.2.6).Records of audits and their results (clause 8.2.4).Procedure for internal audit (clause 8.2.4).Records of reporting to regulatory authorities (clause 8.2.3).Procedure and records for complaint handling (clause 8.2.2).Procedure for customer feedback (clause 8.2.1).Procedure and records for validation of the application of computer software used for monitoring and measuring (clause 7.6).Procedure for monitoring and measuring (clause 7.6).Procedure for preserving the conformity of the product (clause 7.5.11).Report on changes on customer property (clause 7.5.10).Records of traceability and name and address of the shipping package consignee (clause 7.5.9.2).Procedure for traceability (clause 7.5.9.1).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).Procedure and records for control of design and development changes (clause 7.3.9).Procedure for transfer of design and development outputs to manufacturing (clause 7.3.8).Design validation plans, results and conclusions (clause 7.3.6).Design verification plans, results and conclusions (clause 7.3.6).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.
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