meeting applicable regulatory requirements. New requirements added related to monitoring and — of suppliers, and action to be when purchasing requirements are not met. Provides addition details related to the content of the — records. New requirement added to include notification of changes — 7.4.2 Purchasing information in purchased product. New requirements added on the extent of verification — activities and action to be taken 7.4.3 Verification of purchased product when the organization becomes of any changes to the purchased product. 7.5.1 Control of production and service Adds details related to the controls for carrying out — provision production and service provision. 7.5.2 Cleanliness of product Added a requirement to the list. — New requirement for analysis of records for servicing — 7.5.4 Servicing activities activities. Added requirements to the list — Adds details related to situations requiring procedures. — 7.5.6 Validation of processes for production Relates the specific approach to software validation to the — and service provision risk associated with the use of the software. Adds requirements related to the validation records. — 7.5.7 Particular requirements for validation of processes for sterilization and Added requirements for sterile barrier systems. — sterile barrier systems 7.5.8 Identification Added requirement for unique device — identification. 7.5.8 Identification New requirement for a documented procedure for — product identification and regarding identification and product status during production 7.5.11 Preservation of product Adds details as to how preservation can be accomplished. — Indicates that feedback should come from production and — post-production activities. 8.2.1 Feedback Adds a requirement to utilize feedback in risk — management processes in order to monitor and maintain product requirements. 8.2.2 Complaint handling New sub-clause. — 8.2.3 Reporting to regulatory authorities New sub-clause. — 8.2.6 Monitoring and measurement of Adds requirement to identify the test equipment used to — product perform measurement activities. Added details related to kinds of controls that shall be — documented. Generalized the requirement to include any investigation — 8.3 Control of nonconforming product and the rationale for decisions. Adds requirements related to concessions. — Separated requirements for nonconformities detected — before delivery, detected after
meeting applicable regulatory requirements. — New requirements added related to monitoring and of suppliers, and action to be when purchasing requirements are not met. — Provides addition details related to the content of the records. 7.4.2 Purchasing information — New requirement added to include notification of changes in purchased product. 7.4.3 Verification of purchased product — New requirements added on the extent of verification activities and action to be taken when the organization becomes of any changes to the purchased product. 7.5.1 Control of production and service provision — Adds details related to the controls for carrying out production and service provision. 7.5.2 Cleanliness of product — Added a requirement to the list. 7.5.4 Servicing activities — New requirement for analysis of records for servicing activities. 7.5.6 Validation of processes for production and service provision — Added requirements to the list — Adds details related to situations requiring procedures. — Relates the specific approach to software validation to the risk associated with the use of the software. — Adds requirements related to the validation records. 7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier systems — Added requirements for sterile barrier systems. 7.5.8 Identification 7.5.8 Identification — Added requirement for unique device identification. — New requirement for a documented procedure for product identification and regarding identification and product status during production 7.5.11 Preservation of product — Adds details as to how preservation can be accomplished. 8.2.1 Feedback — Indicates that feedback should come from production and post-production activities. — Adds a requirement to utilize feedback in risk management processes in order to monitor and maintain product requirements. 8.2.2 Complaint handling — New sub-clause. 8.2.3 Reporting to regulatory authorities — New sub-clause. 8.2.6 Monitoring and measurement of product — Adds requirement to identify the test equipment used to perform measurement activities. 8.3 Control of nonconforming product — Added details related to kinds of controls that shall be documented. — Generalized the requirement to include any investigation and the rationale for decisions. — Adds requirements related to concessions. — Separated requirements for nonconformities detected before delivery, detected after
isr_13485_delta_checklist.docx