ISO 13485 Procedure Templates

Core QMS

Quality Manual

The foundational document of your ISO 13485 QMS. Defines quality policy, objectives, organizational structure, and how your quality system meets each clause of the standard.

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Core QMS

Document Control SOP

Defines how quality documents are created, reviewed, approved, distributed, and retired. Ensures only current, approved documents are in use throughout your organization.

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Corrective Actions

CAPA Procedure

Systematic approach to investigating root causes, implementing corrective and preventive actions, and verifying effectiveness. A critical procedure for any ISO 13485 QMS.

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Human Resources

Training Management SOP

Ensures all personnel performing quality-affecting work are competent through documented training, education, skills assessment, and ongoing qualification records.

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Corrective Actions

NCR Procedure

Governs the identification, segregation, investigation, and disposition of nonconforming materials and products. Includes use-as-is, rework, return-to-supplier, and scrap dispositions.

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Post-Market

Complaint Handling SOP

End-to-end process for receiving, evaluating, investigating, and resolving customer complaints, including regulatory reporting triggers for MDR, MedWatch, and Vigilance reports.

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Core QMS

Internal Audit Procedure

Structured approach to planning, conducting, and following up on internal quality audits. Ensures your QMS is effective and identifies opportunities for improvement before external auditors do.

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Supply Chain

Supplier Management SOP

Controls the evaluation, qualification, monitoring, and re-evaluation of suppliers providing materials, components, and services that affect medical device quality.

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Core QMS

Change Control Procedure

Manages changes to products, processes, materials, and documents. Ensures all changes are evaluated for regulatory impact, validated where necessary, and properly documented before implementation.

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Infrastructure

Equipment & Calibration SOP

Controls the qualification, calibration, maintenance, and monitoring of production and inspection equipment. Ensures measurement results are valid and traceable to national/international standards.

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Risk Management

Risk Management Procedure (ISO 14971)

Comprehensive risk management process aligned with ISO 14971:2019. Covers hazard identification, risk estimation, risk evaluation, risk control, and overall residual risk assessment throughout the product lifecycle.

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Core QMS

Management Review Procedure

Structures the periodic review of the QMS by top management. Defines required inputs, expected outputs, and frequency to ensure the system remains suitable, adequate, and effective.

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