ISO 13485 & Quality Management Systems

Specialist ISO 13485 consulting and quality management system services for medical device and IVD manufacturers, importers and distributors, from QMS implementation to internal audits and certification readiness.

Quality Management & Compliance

Quality Systems Built for Medical Device Operations.

ISO 13485 provides an internationally recognised framework for managing quality across medical device and IVD operations. An effective quality management system establishes clear responsibilities, documented procedures and controls that support product safety, regulatory compliance and consistent operations.

Verion Medical supports medical device and IVD companies with QMS development, implementation, compliance assessments and ISO 13485 certification readiness.

Our ISO 13485 & Quality Management Services

QMS Gap Assessment

Comprehensive reviews of existing quality management systems against ISO 13485:2016 and applicable regulatory requirements, with documented findings and prioritised corrective actions.

QMS Development & Implementation

Design and implementation of ISO 13485-aligned quality management systems tailored to the organisation’s activities, operational risks and regulatory responsibilities.

SOP Development & Document Control

Development and review of standard operating procedures, quality manuals, work instructions, forms and document control systems to support consistent operations and regulatory compliance.

CAPA & Risk Management

Establishment and improvement of corrective and preventive action (CAPA), nonconformity management, complaint handling and risk-based quality processes.

Supplier & Outsourced Process Management

Development of supplier qualification, performance monitoring and outsourced activity controls, including quality agreements and oversight of contracted service providers.

Internal Audits & Certification Readiness

ISO 13485 internal audits, management review preparation, compliance assessments and corrective action support ahead of independent certification or surveillance audits.

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Why Verion Medical?

1

A Quality System That Fits Your Business

Avoid unnecessary complexity with a QMS designed around your products, activities and operational responsibilities.
2

Identify Compliance Gaps Early

Address weaknesses in procedures, records and quality controls before they become significant audit findings.
3

Maintain Compliance Beyond Certification

Keep your quality system current through effective internal audits, corrective actions and ongoing process reviews.

Is Your QMS Ready for Certification?
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Before You Get Started

FREQUENTLY ASKED QUESTIONS

1. Does ISO 13485 apply to medical device importers and distributors, or only manufacturers?
ISO 13485 is not limited to medical device manufacturers. The standard applies to organisations involved in relevant stages of the medical device lifecycle, including design, production, storage, distribution, installation, servicing and associated activities.

Importers and distributors may therefore require an ISO 13485-aligned quality management system covering their activities, including supplier controls, traceability, complaint handling and outsourced operations.

Verion Medical supports the implementation of quality systems appropriate to manufacturers, importers, distributors and other medical device organisations.
Yes. Organisations with an established ISO 9001 quality management system can use their existing processes and documentation as a foundation for ISO 13485 implementation.

However, ISO 9001 certification does not replace ISO 13485 certification. Additional requirements specific to medical devices must be addressed, including applicable regulatory controls, risk management, process validation, traceability and medical device-related documentation.

Verion Medical provides QMS gap assessments and implementation support to help organisations align existing systems with ISO 13485 requirements.
An ISO 13485 gap assessment evaluates the existing quality management system against the applicable requirements of ISO 13485:2016 and the organisation’s regulatory obligations.

The assessment typically covers document control, management responsibilities, training, supplier qualification, risk management, CAPA, complaint handling, internal audits and operational records.

Verion Medical provides documented findings and practical recommendations to address identified gaps and support quality management system implementation or certification readiness.
ISO 13485 requires organisations to maintain appropriate controls over outsourced processes that affect product quality or regulatory compliance.

Depending on the activities involved, these controls may include supplier qualification, documented agreements, defined responsibilities, performance monitoring, storage requirements and product traceability.

Outsourcing an activity does not automatically remove the organisation’s responsibility for its compliance. Verion Medical assists with developing supplier management procedures and quality controls for contracted activities.
Yes. Verion Medical provides ISO 13485 certification readiness support, including QMS implementation, gap assessments, internal audits, management review preparation and corrective action support.

ISO 13485 certificates are issued by independent certification bodies, not by Verion Medical. For certification used to meet applicable SAHPRA requirements, the certification body must be recognised by SAHPRA.

Our role is to help organisations prepare their systems, personnel and quality records for an independent certification assessment.

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Get Your Facility Ready for ISO Certification

Identify compliance gaps and prepare for your ISO 13485 assessment.

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