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Quality Manual Policy Objectives

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227 views

Quality Manual Policy Objectives

Uploaded by

Memories & Moments Payel & Swastik
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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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:
• 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. 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
Role People
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:
• ensure that processes needed for the company’s quality management system are
documented
• report to top management on the effectiveness of the quality management system
and any need for improvement
• ensure the promotion of awareness of applicable regulatory requirements and QMS
requirements throughout the organization.
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: * Ensure (review / release) the conformity of the
devices is appropriately checked in accordance with the QMS before a device is released
(also see Art. 10 Para. 9 MDR) * Ensure (review / release) that the technical documentation
and the EU declaration of conformity are drawn up and kept up-to-date for all medical
devices (also see Art. 10 Para. 4 and Art. 6 MDR) * Ensure (review / release) that
obligations for post-market surveillance are complied with in accordance with Art. 10 Para.
10 MDR * Ensure (review / release) that the reporting obligations of Articles 87 to 91 MDR
are fulfilled (FSCA / incidents, also see Art. 10 Para. 13 MDR) * Ensure that, in the case of
investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV
MDR is issued.
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: * Fluent in English language * Knowledge of the role
and responsibilities of a ‘Person Responsible for Regulatory Compliance’ according to Art.
15 MDR * Higher education degree in law, medicine, pharmacology or engineering OR: four
years of professional experience in the fields of quality management and regulatory affairs
* At minimum one year of professional experience in the fields of quality management and
regulatory affairs
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 Core
Action
SOP Document and Record Control Core
SOP Integrated Software Core
Development
SOP Post-Market Surveillance Support
SOP Software Validation Support

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