|ISO 13485:2016 Section||Document Section|
The Quality Manual describes the scope of the Quality Management System, its documented procedures and a description of their interactions.
The QMS described in this Quality Manual applies to all products of <your company name>.
Other roles besides manufacturer are: Authorized representative, distributor.
<your company name> is a manufacturer of Medical Devices.
The following table only gives an overview of the most relevant regulation and standards. For a comprehensive overview, see the list of applicable standards (reference here).
|Standard / Regulation / Law||Why Applicable?|
|MDR (2017/745)||Regulation for all Medical Device Manufacturers in the EU|
|EN ISO 13485:2016||QMS required by essential requirements of MDD/MDR|
|EN ISO 14971:2019||Risk management for medical devices|
|IEC 62304:2006||Software development for medical devices|
|IEC 62366-1:2015||Usability evaluation for medical devices|
The following sections of ISO 13485:2016 will be excluded due to the product being stand-alone software:
Describe what your company is about, specifically, its mission and things which are important for it. Maybe you’re developing software for patients with a certain disease and your goal is to improve their lives.
In addition, the policy should include a commitment to meet legal requirements, keep the QMS up to date and define quality objectives to work towards.
Whatever policy you outlined above, now you need to make it measurable by defining objectives which can be tracked. Those objectives should not (only) refer to the quality of your devices but the quality of your QMS and the overall work of your organization. Typical examples are: hiring excellence in staff, providing, best-of-class device performance, high standards of customer satisfaction, etc.
Implementation Option 1: You define measurable, yet still abstract quality objectives here. In a next step (see short-term goals below), those are narrowed down to very concrete measures (for example: monthly number of user complaints). The advantage of that: you don’t need to update your quality manual and objectives a lot. And you can re-use a system that you already have, combining QMS with your regular business goals.
Implementation Option 2: As part of your management review, you will have to review all QMS processes plus your quality policy and objectives at least annually. You can use that opportunity to define process-related KPIs which serve at the same time as your quality objectives.
How does your team track its goals? Your auditors want to see how your quality objectives translate into your daily work. You should formulate strategic goals for your company that are somewhat related to your quality goals and which are tracked at least on an annual basis. Do you already have a goal-oriented system in place to track your team’s work? Even better: align business and quality goals and describe your system here.
Describe the roles of the people in your company. Typically this is done by drawing an organigram (you could use draw.io for that). Or, you just use a table like below.
Minimum requirement information: required qualification and description of tasks related to QMS process involvement If applicable, add: report / authority, access rights, etc.
|Product Manager||Ada Lovelace|
All C-level roles (CEO, CTO, CMO) are referred to as the Management. Management is generally responsible to define responsibilities and authorities, to define and communicate Quality Policy and Goals and to ensure that the whole organization is oriented towards them.
See ISO 13485, para. 5.1, para. 5.5.1
The Quality Management Officer (QMO) is responsible for:
Required qualification for this role:
See ISO 13485, para. 5.1, para. 5.5.2
Person Responsible for Regulatory Compliance (PRRC) Responsibilities of the PRRC are in accordance with Art. 15 MDR as follows:
The PRRC shall not be subjected to Management instructions while carrying out his/her responsibilities specified above. His/her tasks may be delegated to other roles as long as it is ensured that final responsibility stays with the PRRC. She or he has the power and authority to represent the company in the scope of his/her responsibilities, e.g. in communicating with state authorities.
Required qualification for this role:
List all your SOPs here. This list is highly company-specific and might therefore be currently incomplete.
Also mention if one of these processes is outsourced to a third party (typical examples: internal auditing or clinical evaluation done by a regulatory consultant, software development done by an external agency; see ISO 13485:2016, para. 4.1.5 for more context).
|SOP||Process Category||Internal / Outsourced|
|SOP Corrective and Preventive Action||Management||Internal|
|SOP Clinical Evaluation||Core||Outsourced (?)|
|SOP Product Certification and Registration||Core||Internal|
|SOP Change Management||Core||Internal|
|SOP Document and Record Control||Support||Internal|
|SOP Integrated Software Development||Core||Internal|
|SOP Feedback Management||Core||Internal|
|SOP Internal Auditing||Management||Outsourced (?)|
|SOP Management Review||Management||Internal|
|SOP Post-Market Surveillance||Management||Internal|
|SOP Problem Resolution||Core||Internal|
|SOP Software Validation||Support||Internal|
|SOP Update of Regulations||Support||Internal|
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