02 QMS Documentation

Quality System Procedure
Quality Management System Documentation

Procedure Code: Initial Issue Date: Last Revision Date:
Atomica/QSP02 20/05/2024 -
Page 1 of 3 Issue No.: 1 Revision No.: 0
1.0 PURPOSE
To establish a documented procedure to define the documentary Structure of Atomica’s Quality
Management System and the method used for coding the quality documents.
2.0 SCOPE
This procedure covers all quality system documents, which consists of:
 Quality Policy
 Quality Objectives
 Quality Manual
 Operating Procedures
 Work instruction
 Specifications and Standards ( Internal & International )
 Quality Records
 Technical File ( Device Master Record DMR)
3.0 RESPONSIBILITY
MR
QA Manager
4.0 PROCEDURE
4.1 Definitions:
 Quality Manual
The Quality Manual is a document describes the policy of Atomica to meet requirements of EN ISO
13485:2016 Standard and the customer needs and expectations
 Procedures
The Procedure is a document describes the steps to cover each quality process/activity related EN
ISO 13485:2016 standard and answers the question who, what, where and when?
 Work Instructions/SOP
The Work Instructions is a document describes the steps to cover each quality process / activity
related EN ISO 13485:2016 standard and answers the question how to perform this activity.
 Formats
Forms are tabulated for implementing the quality activities within STS.
 Quality Records
Quality Records is evidence of compliance with requirements, records shouldn't be changed, since
they contain "event" data (facts or history).
This document contains confidential information that belongs to Atomica. The document cannot be fully or
Warning partially copied without the prior written approval of the designated Directors of the organization. The content in
this document is intended only for the internal stakeholders.
Document Control, Approval and Issue Register maintained by Management Representative.

Atomica/QSP02 20/05/2024 -
 Technical File (Device Master Record DMR)

A Device Master Record (DMR) file is created and maintained for each type/model of medical device.
The DMR for each type of device shall include or refer to the location of the following information:
- Device specifications including appropriate drawings, composition, formulation, component
specifications, and software specifications;
- Production process specifications including the appropriate equipment specifications,
production methods, production procedures, and production environment specifications;
- Quality assurance procedures and specifications including acceptance criteria and the quality
assurance equipment to be used;
- Packaging and labeling specifications, including methods and processes used; and
- Installation, maintenance, and servicing procedures and methods.
- All documents are technically correct, contain and/or reflect the approved device and
process designs, are under change control, contain the release or other control date, contain
an approval signature, and are directed toward the intended user.
4.2 Method:
a) The Quality Manager shall ensure that the Quality System Documents are prepared in a logical
format.
b) The Quality Documents are prepared to meet the EN ISO 13485:2016 Requirements and to assure
meeting Atomica customer requirements.
c) Documents Coding System
To easily identify and retrieve the documents, all the documents prepared are numbered/named as
per the system mentioned below:
Table 2: Identification of Documents
Level of
Document Name Description
Document
Xxxxxxx – Atomica ai (Atomica)
I Quality System Manual YYY – Quality System Manual (QSM)
ZZ – Number which starts from 01
II Mandatory Procedures YYY – Quality System Procedure (QSP)
ZZ – Number which starts from 01
III WI/ SOP AAA –Work Instruction (WI)/ Standard Operating Procedure (SOP)
BB – Letters of the department which it belongs
CC- Letters of the Section which it belongs

Atomica/QSP02 20/05/2024 -
DDD – Number which starts from 001

Xxxxxxx –Atomica
IV Technical File XX – Medical Device
XX - number of files
BBB – Quality System Procedure (QSP)
CC – Number of QSP which it belongs
V Formats/Forms
D – Format (F)
XX – Number which starts from 01
XX – Revision starting from R1
Product Identification
VI Label/
XXX – document Name
Product Data Sheet
5.0 REFERENCE
EN ISO 13485:2016 Clause 4.2 Documentation Requirements
6.0 FORMS
Nil
7.0 REVISION HISTORY
Issue No. Revision No. Release Date Reason Next Review Date
01 R0 20/05/2024 Initial Release NA
……………………………………………………………..End of the Document………………………………………………………………………
Prepared by Reviewed by Approved by
Sign : Sign: Sign:

Quality Assurance Manager Management Representative CEO

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Quality System Procedure

Quality Management System Documentation

Document Control, Approval and Issue Register maintained by Management Representative.

 Technical File (Device Master Record DMR)

Document Control, Approval and Issue Register maintained by Management Representative.

DDD – Number which starts from 001

……………………………………………………………..End of the Document………………………………………………………………………

Prepared by Reviewed by Approved by

Sign : Sign: Sign:

Document Control, Approval and Issue Register maintained by Management Representative.

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