ISO 13485 audit checklist about validation of processes for production and service provision
ISO 13485 audit checklist about validation of processes for production and service provision
Clause 7.5.2
7.5.2.1 General requirements
• Do you have any production or service processes where the resulting output cannot be verified later?
• If so, how to you validate them?
• Can you show me records that demonstrate that the validation done has met the requirements?
• How are these special processes reviewed and approved?
• Can you show me records of personnel and equipment qualification?
• Where are specific methods and procedures defined?
• Can you show me records for these processes?
• When changes are made to processes, how do you revalidate them?
• Documented procedures for validation of computer software?
• Records of validation?
7.5.2.2 Particular requirements for sterile medical devices
• Documented procedures for the validation of sterilization processes?
• Records of validation of each sterilization process?
Clause 7.5.2
7.5.2.1 General requirements
• Do you have any production or service processes where the resulting output cannot be verified later?
• If so, how to you validate them?
• Can you show me records that demonstrate that the validation done has met the requirements?
• How are these special processes reviewed and approved?
• Can you show me records of personnel and equipment qualification?
• Where are specific methods and procedures defined?
• Can you show me records for these processes?
• When changes are made to processes, how do you revalidate them?
• Documented procedures for validation of computer software?
• Records of validation?
7.5.2.2 Particular requirements for sterile medical devices
• Documented procedures for the validation of sterilization processes?
• Records of validation of each sterilization process?
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