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ISO 13485 Consulting
Consulting for medical devices
ISO 13485 Consulting for QM System Implementation
Our quality management (QM) team provides ISO 13485 consulting and QM support specifically for medical device manufacturers.
With our ISO 13485 consulting for the implementation of the QM system for medical devices, our QM team covers all the necessary tasks for medical device manufacturers and thus relieves them as much as possible.
Together with medical device manufacturers, we identify all relevant processes, create the necessary documents, such as quality management manuals or process instructions, and ensure that manufacturers receive their ISO 13485 certificate from the notified body within the agreed period.
Overview of ISO 13485 Consulting & Support for a QM System
- ISO 13485 consulting and support in setting up the QM system for medical devices
- Analysis of the integration needs for a QM system according to ISO 13485
- Preparation and revision of documentation based on ISO 13485 standards for medical devices, such as quality management manual, process instructions, work instructions
- Identification of quality and regulatory processes to be documented in process instructions
- Risk analysis consultation as a foundation for process assessment
- Support for internal audits and management reviews to identify and correct QM system weaknesses
- Assistance in obtaining certification offers from accredited bodies and support during the selection process
- Preparation for certification audits and guidance for external certification or recertification
- Continuous improvement guidance for further development of the quality management system as per ISO 13485, including corrective and preventive actions (CAPAs)
7 Steps to Initial Certification with ISO 13485 Consulting
Below is a seven-step guide to successfully achieving ISO 13485 certification for medical devices. Our QM team can offer practical support and provide tailored ISO 13485 consulting for medical devices.
The notified body for the initial certification can be selected from the German Accreditation Body GmbH (DaKKs - Deutsche Akkreditierungsstelle GmbH). It publishes on its website the notified bodies or certifiers that are accredited for ISO 13485 certification.
To establish a quality management system, a quality management manual must be drawn up, depending on the requirements of the medical device manufacturer. After an initial draft, the quality management manual may need to be improved.
Employees must be trained to work according to the processes described in the quality management manual.
It may be helpful to conduct an internal test audit before the final audit with the notified body.
Finally, the notified body is invited to audit the QM system. If the audit is passed, the notified body issues an ISO 13485 certificate to the medical device manufacturer. This means that medical device manufacturers are authorized to bring medical devices to market. In addition, the notified body issues an audit report to the manufacturer.
In the 2nd and 3rd year after the first audit (certification audit), surveillance audits follow to ensure compliance with ISO 13485.
In the fourth year following the initial audit, the company undergoes recertification to renew its ISO 13485 certification.
ISO 13485 Quality Management Requirements
The current version of ISO 13485 (ISO 13485:2016) outlines the following quality management requirements:
- A documented quality policy and quality goals, which are usually documented in the QM manual..
- Control of documents and quality management processes.
- Risk management: A risk-based approach in QM to focus efforts according to risk levels, reducing unnecessary tasks and bureaucracy. This helps improve product safety and legal compliance while optimizing resource use.
- Ensuring appropriate personnel qualifications and competence.
- Evaluation of the effectiveness of training or similar measures.
- Provision of suitable work equipment (e.g. measuring equipment and validation of software), infrastructure (information systems) and working environment.
- Product safety of medical software and security precautions for the storage of patient-related electronic data.
- Appropriate supplier selection and procurement process: monitoring of suppliers and their evaluation, requirements for procurement information and verification of procured products.
- Development, Production, and Delivery Processes: Including validation, identification, and product maintenance, with regulatory communication as required.
Management Review
Finally, quality management must be regularly evaluated regarding measurement, analysis and improvement of quality or target achievement. This is done in a management review, which must include the following aspects:
- Feedback and complaint handling,
- Reporting to regulators,
- Audits,
- Monitoring and measurement of processes,
- Corrective measures,
- Preventive measures,
- Follow-up to previous evaluations,
- Changes affecting the quality management system,
- Recommendations for improvements,
- Applicable new or revised regulatory requirements,
- Necessary improvements to maintain the suitability, adequacy and effectiveness of the QM system and its processes,
- Product improvements in relation to customer requirements,
- Need for resources.
Mandatory QM System for Medical Device Manufacturers: ISO 13485
A QM system in compliance with ISO 13485 is mandatory for medical device manufacturers. Why is this the case and what is ISO 13485? ISO 13485 is a standard that specifies the requirements for quality management or quality management systems of medical device manufacturers. It supports manufacturers in complying with the extensive requirements for a quality management system. In this way, it helps them ensure their commitment to the quality and safety of their medical devices.
Companies that place medical devices on the market as manufacturers are legally obliged to set up (initial certification) a QM system (quality management system) and maintain it (surveillance audit) for the manufacture of their products, such as medical apps or medical software.
Except for class I medical devices, i.e. with the lowest risk potential, manufacturers must have their quality management system audited and certified by a notified body, such as TÜV, before placing their medical apps or medical software on the market.
