Examples for SOP content for Infrastructure and Work Environment in ISO 13485 QMS for software

Question

Our company is establishing a QMS according to ISO 13485, and I have been asked to identify procedures, assign them to the standard's clauses, and draft SOPs. My background is mostly hardware-related, so I am looking for guidance on what should be included in an SOP for Infrastructure and Work Environment, specifically referencing clauses 6.3, 6.4.1 (with 6.4.2 excluded since stand-alone software cannot experience physical contamination), and considering whether clause 7.5.11 (Preservation of product) should be included. Any examples or advice would be appreciated.

Dr. Oliver Eidel · Accepted Answer

The infrastructure topic really depends on your business setup, especially your IT infrastructure. There's no single generic description, but you should address the specific bullet points mentioned in the relevant clauses. Typically, an SOP would start with scope, responsibilities, process owner, and KPIs. For IT infrastructure, you might include physical environment (number and type of rooms, any special conditions), IT environment (network, security management, internet access, mobile terminals, home office rules, restoration, monitoring, etc.), and onboarding/offboarding of employees. Make sure to cross-reference HR processes where appropriate, and to document access rights management for departing employees.

Answer

For software-focused companies, you might want to include business computers, cell phones (with backup and security), software updates, internet/intranet services, site computer services, maintenance, fire control equipment (if relevant), electrical system maintenance, environmental permits, access rules, authentication, etc. Automated software development tools are often considered equipment, so you could describe them in the Equipment Maintenance SOP (clause 7.6) or under infrastructure, depending on their use. If these tools are part of your QM process, make sure to validate their actual use according to computerized system validation requirements. You don't always have to validate the whole system, but at least ensure the key functionalities are tested and work as intended in your specific context.

Examples for SOP content for Infrastructure and Work Environment in ISO 13485 QMS for software

3 Answers

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