Quality Management System


A Quality Management System (QMS) can be understood as a set of processes, controls, and policies which govern particular tasks within a pre-determined scope for an organisation. Article 10 of the EU Medical Device Regulation 2017/745 (MDR) and the EU IVD Regulation 2017/746 (IVDR) make it obligatory for manufacturers to set up and maintain a QMS for their organisation, regardless of risk classification. With that said, manufacturers of only Class I medical devices or Class A IVDs are not required to have this QMS evaluated by a third-party Notified Body (NB).

The industry standard for operating a Quality Management System for medical devices is EN ISO 13485:2016. More specifically, the recent A11:2021 harmonisation amendment to this standard adds Annexes ZA and ZB which cross-reference QMS requirements from the EU MDR and IVDR, respectively, with the clauses covered by ISO 13485:2016. Even though low-risk classifications do not require additional assessment, the standard is still certainly worth consideration.

Internal audits are an integral part of maintaining a compliant Quality Management System to ensure it is functioning as intended and is fit for purpose. Apart from this, ISO 13485:2016 makes conducting an internal audit a requirement, and therefore compliance with this standard will require organisations to conduct internal audits of the system.


Specculo's QMS Services

We provide the following relevant services to help you build and maintain a healthy system:

Quality Management System Setup

Complete setup of your QMS to fit the scope and role of your organisation. As a minimum, this service includes the Quality Manual and major quality procedures which may be used as a foundation to develop the system further.

For Class I or Class A manufacturers looking for a quality system setup to meet the requirements of the MDR/IVDR, we offer a “bare bones”, paper-based option to simplify your compliance strategy.

We may also be retained to maintain and keep your system up to date to ensure that you continually meet your regulatory requirements.

Internal Audit & Gap Assessment

Our trained consultants will conduct either a remote or onsite internal audit of your system to identify any deficiencies against specified requirements. 

Although these can be performed by the Quality Department within your organisation, it is advantageous to hire a third-party auditor to conduct an objective internal audit. 

If you are only looking to have your quality documentation reviewed, we also offer a deep-dive “paper-review” gap assessment.

Specculo Process

In all cases, we would schedule an initial consultation in order to determine your needs and to identify which of our services will be the most relevant to you.

Quality Management System Setup

For full-scale QMS setups, we will schedule a number of in-depth meetings to determine the specifications of the system you will need. This depends on whether you have any existing protocols in place, as well as the scope, role, and size of your organisation. We will then be able to create a robust foundation that will include, as a minimum, the Quality Manual, Quality Policy, and all major procedures as required by EN ISO 13485:2016 and the EU Regulations. Training can also be provided to the relevant staff, as appropriate.

Internal Audits

Organisations are required to conduct internal audits as part of their quality management system according to ISO 13485. Internal audits are a systematic and documented process for evaluating the compliance and effectiveness of the QMS.

The frequency of internal audits should be determined by the manufacturer based on the risk profile of their products and processes. However, internal audits are generally conducted at least once a year.

Find out more about our internal audit services and processes below.

ISO 13485

ISO 13485 Internal Audit

Find out more about our ISO 13485 Internal Audit services.

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MDSAP Internal Audit

Find out more about our MDSAP Internal Audit services.

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What you get with Specculo

We have years of experience in handling large and small projects alike on a vast range of medical devices and IVD technology.


As your regulatory consultant, you get our full attention throughout the project.


You can expect high quality, state of the art procedures and documentation.

Fast lead times

We give you our time and take you through the created documentation, and how to maintain it.​

Simplify your compliance workflow.