Top 6 ISO 13485 Requirements Every Medical Company Must Follow

One of the most essential core procedures that must be documented and implemented in medical companies according to ISO 13485 requirements for medical device management:
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Written Traceability Procedures (Traceability SOP)

1. Aimed at ensuring the ability to trace the medical product from the moment it is received until it reaches the end-user.
2. Required to identify any affected product in case a problem or defect is discovered.
3. Implemented by recording supplier data, batch numbers, and customer information.
4. During inspections, the authority requests proof of actual traceability and updated records.

Written Transportation Procedures (Transportation SOP)

1. Ensure the transport of medical products under conditions that preserve their safety and quality (such as temperature and humidity).
2. Include packaging requirements, documentation, and handling procedures in case of incidents during transportation.
3. Necessary to present these procedures and transportation records during authority visits.

Written Storage Procedures (Storage SOP)

1. To ensure proper storage of products in accordance with company, supplier, and regulatory requirements (e.g., specific temperature, protection from humidity).
2. Implemented through daily monitoring of conditions and documentation in approved records (such as temperature logs).
3. The authority verifies the compliance of storage conditions with specifications and related records.

Written Complaint Handling Procedures (Complaints SOP)

1. To ensure the recording, investigation, and resolution of customer complaints related to medical products.
2. Required to demonstrate an integrated system for monitoring issues and taking corrective actions.
3. During inspection visits, the authority requests access to the complaint records and how they were handled.

Written Safety Alert Procedures (Safety Alert SOP)

1. Concerned with how to manage safety alerts, product recalls, or warning notices related to product safety.
2. The procedure explains the communication process with relevant authorities and customers, along with corrective steps taken.
3. Considered a core requirement by the authority, and evidence is requested during inspection.

Product Traceability System

1. An integrated system that consolidates traceability, complaints, and product recalls under one frame work to ensure full control over the product lifecycle.
2. Aids in quick decision-making during issues and protects patients and users.
3. The authority audits this system during visits as a fundamental part of the evaluation.

Why are these procedures essential during authority visits?

Because they represent the true guarantee of the safety and security of medical products in the Saudi market and demonstrate the company's commitment to quality and regulatory compliance. The absence or weak implementation of any of these procedures is considered a critical point during evaluation.

For consultation regarding ISO 13485 Quality Management systems, contact us at info@bio-standards.com

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