Templates ISO 13485 Templates

Updated September 29, 2022

Template: Quality Manual, Policy, Objectives

Dr. Oliver Eidel

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Quality Manual, Policy and Objectives

ISO 13485:2016 Section Document Section
4.1.1 1.
4.1.2 4.
4.2.1 b) (All)
4.2.2 (All)
5.3 2.
5.4.1 2.

Summary

The Quality Manual describes the scope of the Quality Management System, its documented procedures and a description of their interactions.

1. Scope

The QMS described in this Quality Manual applies to all products of <your company name>.

Role of Company

Other roles besides manufacturer are: Authorized representative, distributor.

<your company name> is a manufacturer of Medical Devices.

Applicable Standards

Remove either the MDD or MDR entry, depending on which you’re complying with (MDD will only be possible until May 2021, afterwards it’s only MDR).

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?
MDD (93/42/EEC) Directive for all Medical Device Manufacturers in the EU
MDR (2017/745/ Regulation for all Medical Device Manufacturers in the EU
ISO 13485:2016 QMS required by essential requirements of MDD/MDR
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

Exclusions

The following sections of ISO 13485:2016 will be excluded due to the product being stand-alone software:

2. Quality Policy & Objectives

Quality Policy

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.

Quality Objectives

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. In a next step (see short-term goals), those are narrowed down to concrete measures like for example the monthly number of user complaints.

Short-Term Goals

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.

3. Roles

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.

Role People
CEO Steve Jobs
CTO Steve Wozniak
Product Manager Ada Lovelace
QMO Oliver Eidel

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 to:

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:

4. Processes

List all your SOPs here. This list is currently incomplete as many SOPs are company-specific. You will have to complete it yourself - good luck!

SOP Process Category
SOP Corrective and Preventive Action Core
SOP Document and Record Control Core
SOP Integrated Software Development Core
SOP Post-Market Surveillance Support
SOP Software Validation Support

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