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Process Validation: All about Process Validation, Regulatory Requirements for Process Validation and what to look out for.
Supplier management: The purchasing controls inclusively supplier evaluation, supplier selection and supplier audits are FDA and ISO 13485 requirements. How to act compliant ~
Electronic signatures: The FDA's requirements with respect to electronic signatures and records are known: 21 CFR part 11. But what are the European (e.g. MDR) requirements?
Risk Based Approach: Overview of what a “risk-based approach” is and concrete advice on how companies can meet these regulatory requirements.
Quality Policy & Objectives: Quality Objectives and Quality Policy, KPIs and Target Values - the focus lies on the QM-Systems's conformity with ISO 9001 and ISO 13485, and above all the respective certificate.
Unannounced Audit: Notified bodies have to perform unannounced audits of quality management systems at least every five years. Find out when you might expect an unannounced audit...
Corrective and Preventive Actions: Corrective and Preventive Actions, CAPA, MDR, 21 CFR part 820 – QSR, ISO 13485, FDA, non-significant changes, deviations in audits
Management Reviews: Management Reviews, 5 Reasons Why Bosses Should Love Them, FDA 21 CFR part 820, MDR and IVDR, ISO 13485, process for the management review

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