ISO 13485 FDA Medical Device Regulation For QMS (Part 2 / 2)

Apply ISO 13485 controls for purchasing by evaluating, selecting, and monitoring suppliers with a risk-based approach and written quality agreements.

Explains the requirements for purchased products from suppliers, including product specs, acceptance criteria, supplier qualifications, and the role of quality agreements and change notifications to ensure QMS compliance.

Establish and implement verification activities to ensure purchased products meet specifications and QMS requirements, based on supplier evaluation and risk, with documentation and handling of changes and non-conformities.

Explore supplier products and services under ISO 13485 for QMS, covering off-the-shelf and customized components, software, finished devices, and services like sterilization, design, packaging, and calibration.

Learn how to monitor supplier performance to manage risk in medical device quality, including audits, testing, certificates, regulatory requirements, KPIs, traceability, and changes within the QMS.

Implement production controls aligned with risk management to ensure device quality and regulatory compliance, including monitoring, labeling, packaging, external-provider controls, and batch records for traceability and release.

Document product cleanliness per ISO 13485, establish cleaning procedures, provide resources, and ensure environment to maintain hygienic products, with verification, validation, inspection, and testing for traceability before sterilization or use.

Define ISO 13485 acceptance criteria and installation plans, verify installation and testing with electrical, plumbing, and waste systems, provide user-site instructions and safety controls, and audit performance under a QMS.

Learn ISO 13485 servicing requirements for medical devices, including documenting procedures, reference materials, and records, planning and validation, and feedback to improve servicing quality within the QMS.

Learn iso 13485 requirements for sterile medical devices, including batch sterilization records, traceability, sterile barrier systems, validated processes, aseptic techniques, material microbiological status, and regulatory standards.

Validate processes to provide objective evidence that outputs meet specifications, covering seven procedures, IQ/OQ/PQ, software validation, and risk-based sampling with revalidation.

Identify and trace medical devices and materials through unique device identification, lot/serial tracking, and status updates to ensure safety, regulatory compliance, and rapid issue resolution across production and supply chains.

Identify, verify, protect, and safeguard customer property and confidential health information, report loss, and protect intellectual property and personal data with storage, password protection, multi-factor authentication, encryption, and restricted access.

ISO 13485 requires preserving medical devices across life cycles and documenting preservation procedures, including packaging, to protect against alteration, contamination, and damage during processing, storage, handling, and distribution.

Learn how ISO 13485 requires calibration and validation of monitoring and measuring equipment and its software, with documented procedures, traceability, and records to ensure product conformity.

The video outlines four phases of measurement, analysis and improvement in a QMS: planning, data source selection, acceptance criteria, and management review, linking to regulatory requirements and the business plan.

Monitor data and feedback from production and post-production to meet customer requirements, and follow the 8.2.2 complaint process to drive risk management and improvement.

Learn how ISO 13485 requires identifying and controlling non-conforming products through documented procedures, segregation, evaluation, and disposition, with a risk-based approach to prevent recurrence.

Analyze data to assess the QMS's adequacy, suitability, and effectiveness using documented procedures, statistical and non-statistical methods, and horizontal analysis to identify non-conformities and support regulatory and customer requirements.

Improve processes with corrective and preventive actions (CAPA) by thoroughly investigating non-conformities, analyzing causes, implementing and documenting actions, verifying and validating effectiveness, and preventing recurrence.