ISO 13485 audit checklist about control of production and service provision
ISO 13485 audit checklist about control of production and service provision
Clause 7.5.1
7.5.1.1 General requirements
When carrying out production (or service) are all of the following controlled conditions in place?
a) Is information that describes the characteristics of the product available?
b) Are appropriate documented procedures, documented requirements, work instructions, reference materials and reference measurement procedures available (if needed)?
c) Is suitable equipment used for carrying out production (or service)?
d) Are appropriate gages, etc. used in production (or service)? (See 7.6)
e) Are appropriate kinds of monitoring and measurement done? (See 8.2.4)
f) Are proper release, delivery and post-delivery activities in place?
g) Are packaging and labeling operations defined and implemented?
record
7.5.1.2 Control of production and service provision — Specific requirements
7.5.1.2.1 Cleanliness of product and contamination control
• Documented requirements for cleanliness of product?
7.5.1.2.2 Installation activities
• Documented requirements with acceptance criteria for installing and verifying the installation
• Documented requirements for installation and verification if installation is performed by outside org.
• Records of installation and verification
7.5.1.2.3 Servicing activities
• Documented procedures, work instructions and reference materials and reference measurement procedures
• Records of servicing activities
7.5.1.3 Particular requirements for sterile medical devices
• Records of the process parameters for the sterilization process
• Sterilization traceability records
Related documents:
Advertisement
Sponsor sites:
1. Phrases For Performance Appraisals.
2. Interview questions and answers.
This entry was posted
on Sunday, November 22nd, 2009 at 3:58 am and is filed under ISO 13485 checklist.
You can leave a response, or trackback from your own site.
