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:
- 6.4.2 Contamination control
- 7.5.2 Cleanliness of product
- 7.5.5 Particular requirements for sterile medical devices
- 7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier systems
- 7.5.9.2 Particular requirements for implantable medical devices
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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