Anyone who outsources regulatory consulting, warehousing, or fulfillment services for medical devices to a service provider must be able to rely on that provider’s processes meeting the same quality requirements as their own. This reliability must be demonstrated regularly and independently.
WQS Management Consultants GmbH has completed the recertification audit conducted by TÜV NORD Polska Sp. z o.o. and has once again been certified to ISO 13485:2016 (PN-EN ISO 13485:2016-04). The certification covers our entire range of services. These include consulting on quality management systems and regulatory affairs, as well as the storage, packaging, and shipping of medical devices on behalf of clients. The certificates are valid until 2029 and are maintained through regular surveillance audits.
Our Certificates
The scope of certification is divided between two certificates. Both certificates are based on the same audit and quality management system.
ISO 13485 Certificate for Consulting, Storage, and Packaging
Scope: Consulting on quality management systems and regulatory affairs for medical devices; storage and packaging of medical devices on behalf of clients
Registration No.: AC090 MD/0048/5083/2026
Valid: 23 October 2026 to 22 October 2029
Accreditation: PCA (AC 090), IAF MLA
ISO 13485 Shipping Certificate
Scope: Contract-based shipping of medical devices
Registration No.: TNP MD/0074/5083/2026
Valid: 1 October 2026 to 30 September 2029
Accreditation: outside the scope of accreditation of the certification body
We operate according to an externally audited quality management system, from regulatory strategy to the delivery of your products. This provides you with consulting and logistics services from a single source, complete with documentation for your supplier file.
What is ISO 13485, and what does certification demonstrate?
ISO 13485 specifies the requirements for the quality management systems of organisations involved in one or more phases of a medical device’s life cycle. The standard is therefore not limited to manufacturers; it also applies to suppliers and service providers, such as those involved in warehousing, packaging, distribution, or regulatory consulting.
Certification demonstrates that an independent certification body has audited the QMS and confirmed compliance with the standard’s requirements for a defined scope. The certificate is generally valid for three years and is maintained through annual surveillance audits.
What role does ISO 13485 play under the MDR?
According to Article 10(9) of Regulation (EU) 2017/745 (MDR), manufacturers must establish, document, implement, and maintain a quality management system. EN ISO 13485:2016, including Amendment A11:2021, has been published as a harmonized standard under the MDR via Implementing Decision (EU) 2021/1182. Its application establishes a presumption of conformity for the covered requirements in accordance with Article 8 of the MDR.
In practice, this means that ISO 13485 forms the basis of the QMS. MDR-specific requirements such as post-market surveillance (PMS and PMCF), risk management according to EN ISO 14971, and technical documentation must also be integrated into the system.
QMS ISO 13485
Establishing an ISO 13485 QMS or bringing It into Compliance with the MDR
We review your existing QMS against the requirements of ISO 13485 and the MDR and derive the specific steps needed to achieve certification.
What factors should manufacturers consider when evaluating suppliers?
Section 4.1.5 of ISO 13485 requires manufacturers to monitor and control outsourced processes. Section 7.4.1 specifies criteria for the evaluation and selection of suppliers based on the risk associated with the supplied product or service. The validity of the certificate depends on the following points:
- Scope: Does it precisely cover the activity being outsourced?
- Accreditation: Is the certification accredited? By which accreditation body?
- Validity and authenticity: Is the certificate current and verifiable in the certification body’s reference list?
The manufacturer determines in its own evaluation criteria whether an accredited certificate is required for a specific activity.
For your supplier evaluation, we provide both certificates as PDF files.
What does recertification under ISO 13485 mean?
An ISO 13485 certificate is generally valid for three years. During this period, the certification body reviews the QMS through annual surveillance audits. At the end of the cycle, a recertification audit is conducted, during which the entire system is reevaluated.
Recertification demonstrates that the QMS has been effectively implemented, maintained, and further developed over a full certification cycle. Changes to standards, regulations, and internal processes are taken into account.
What does recertification mean for WQS customers?
Since 1993, we have been supporting manufacturers of medical devices and in vitro diagnostic devices in establishing and further developing their quality management systems. Our own QM system is subject to the same requirements that we implement in customer projects and is also audited externally.
For our collaboration, this means that our consulting, warehousing, packaging, and shipping follow documented processes whose effectiveness has been independently verified. Our customers receive documentation for their supplier records valid through 2029.
We describe in detail how a QMS is established and implemented within a company on our page on Quality Management for Medical Devices.
Quality Management • ISO 13485
We Assess Your QM System
Whether it’s setup, a gap analysis, or preparation for the next audit: We evaluate the status of your QM system and support you through the implementation process all the way to certification.
Frequently Asked Questions About ISO 13485 Recertification by WQS
For which services is WQS certified under ISO 13485?
The certification covers consulting on quality management systems and regulatory affairs for medical devices, as well as the storage, packaging, and shipping of medical devices on behalf of clients.
How long are the certificates valid?
Both certificates are valid through 2029. The certificate for shipping is valid through September 30, 2029, and the certificate for consulting, storage, and packaging is valid through October 22, 2029. Both are maintained through annual surveillance audits.
Does a consulting firm have to be certified to ISO 13485?
There is no legal requirement. However, for manufacturers who outsource regulatory or logistical services, a certified quality management system at the service provider simplifies the supplier evaluation in accordance with Section 7.4 of ISO 13485.
How do I obtain the certificates for my supplier evaluation?
Über unser Kontaktformular oder per E-Mail an info@wqs.de. Wir senden Ihnen beide Zertifikate als PDF. Die Echtheit können Sie zusätzlich über die Registriernummer in der Referenzliste von TÜV NORD Polska prüfen.
Weiterführende Links
- European Parliament & Council of the EU: Regulation (EU) 2017/745 on Medical Devices (MDR), Official Journal of the European Union, May 5, 2017 – eur-lex.europa.eu
- Commission: Implementing Decision (EU) 2021/1182 on harmonized standards for medical devices, July 16, 2021 – eur-lex.europa.eu
- TÜV NORD Polska: TÜV NORD Polska Reference List – TÜV NORD Polska
