ISO 13485 COMPLIANCE CERTIFICATION

This international standard establishes the specific requirements for organizations that provide or manufacture medical devices.

ISO 13485 describes the requirements for the quality management system of an organization in the field of medical devices, which includes the latest improvements in quality management, technology, and regulations. Organizations may be involved in one or more stages of the life cycle, including design and development, production, storage and distribution, as well as the installation or maintenance of a medical device, and the design and development of associated activities (like technical support).

A medical device is any product used for diagnose, prevent, or treatment of a medical condition. Medical devices can be basic health products used to cover or protect a wound, or dentist chairs, pacemakers, vital support machines, and even in-vitro diagnostic reagents.

ISO 13485:2016 requirements

4. Quality Management System
5. Management Responsibility
6. Resources Management
7. Product Manufacturing
8. Measurement, Analysis, and Improvement

ISO 13485 requirements are applicable to any organization, independently of size, type or location except where explicitly stated otherwise. When the requirements are specified as applicable for medical devices, the given associated services are equally applied by the organization.

*Exclusions are allowed in the management system with a proper justification whenever the applicable regulatory requirements allow it.

Recommendations

To have a documented system in accordance with the applicable norm.
To clearly defined the certification scope.
To have evidence of implementation of the management system for at list 3 months.

*Recommendations:

To keep internal auditors with the competence to perform internal audits.
To keep records associated with at list one internal audit.
To keep implementation evidence associated with the documented process, record control, taken actions, internal audits, and among others.
To keep records associated with the management commitment where ISO 13485 standard, compliance requirements are assured.
To keep policies and defined objectives related and documented in accordance with ISO 13485requirements.

COMPLIANCE AUDITS

Audit under GlobalSTD methodology

BENEFITS OF ISO 13485

These are some benefits:

To demonstrate the regulation requirements compliance.

To increase customers and consumers trust.

To improve process and quality in production.

To ensure medical devices in compliance with necessities and industrial needs.

27229

Certificates issued in the world

3434

Certificates in USA, leading country in ISO 13485

38503

Sites certificated worldwide

*Numbers of ISO Survey

HOW COULD I BE CERTIFIED IN ISO 13485?

Process to obtain a compliance certificate with GlobalSTD

The certification process pays attention to every detail making sure that the company duly complies with all the standard’s requirements.

Quote and signing of the contract

GlobalSTD will send you a quote that includes the cost of the certification process, considering the number of employees that are part of the system, the applicable standard, and the scope of the audited processes.

Planning and Development of Audit

GlobalSTD will plan the audit and assign auditors with demonstrated competencies to audit the industry sector that corresponds to your organization.

Closing of Non-Conformities

After the audit has ended and only when it applies, the organization will send evidence that corresponds to the closing of the detected non-conformities, which will be reviewed and approved by the auditor.

Certification Committee and Issuance of the Certificate

The Certification Committee will confer to review and approve the issuance of the certificate. Once it has been authorized, the certificate is issued and the its delivery is planned.

Medical Devices Quality Management Systems