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Updated September 30, 2021

Template: Quality Manual, Policy, Objectives

Dr. Oliver Eidel
ISO 13485

This is a free template, provided by OpenRegulatory.

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Related Documents

The following templates are Documents or SOPs related to this template. That means that they mention this template somewhere and (most likely) contain instructions on how and when to fill it out.
Beginning of template

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).

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  
IEC 62304:2006  
IEC 62366-1:2015  
ISO 15233-1:2012 Labeling requirements for Medical Devices
GDPR (25.05.2018)  

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. So, let’s say if you’re creating software for patients with a certain disease, maybe you’d want to measure the number of complaints they have. Or, better, you have some metric for how much you improve their lives.

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. 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
Developers Ada Lovelace, Alan Turing

4. Processes

List all your SOPs here.

This list is currently incomplete as I still have to create some QMS templates :) you will complete it yourself.. right?

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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Please don’t remove this notice even if you’ve modified contents of this template.

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Questions?

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