Management System Standards
ISO/IEC 42001 Artificial Intelligence Management System
ISO/IEC 42001 concerns management systems for organisations developing or using artificial intelligence.
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Internal auditor and awareness training across the ISO family
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Medical-device quality systems in manufacturing
ISO 13485 concerns quality management systems for medical devices. A manufacturing-focused enquiry should identify the products, operations and responsibilities involved, with particular attention to controlled processes, records and product traceability.
Device type, intended market and the organisation’s role affect the discussion. Training can explain a system and its evidence needs, while product approvals, regulatory submissions and technical compliance decisions require their own qualified review. Avoid treating a quality-system course as product authorization.
Practical discussion topics
- Quality-system scope and documented responsibilities
- Controlled manufacturing and change records
- Supplier and purchased-product controls
- Identification, traceability and nonconforming product
- Audit evidence and corrective-action follow-up
Who should discuss this subject
Medical-device quality teams, manufacturing supervisors and document or process owners.
Prepare a useful enquiry
- Device family and manufacturing activities
- Applicable market requirements and existing system maturity
ISO management-systems programme guide · Management-systems consulting
Official subject resources
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