R-001-001 Control of documents 2023_003

• Governed by GP-001 Document and Registry Control
• Comes from template T-001-001

Version control

Reason for review	Date	Version id
First version	20220910	1
Document adapted to new QMS	20230116	2
Data protection section included	20230118	3
Data protection documents codification updated and included within the other documents	20230307	4

Written by	Reviewed by
E-Signature (Appfire integration): María Diez D810830658F3B445FB634F7F8A7581CB Signer name: María Diez Signing time: Mon, 06 Mar 2023 08:10:50 GMT Reason: Creation of document	E-Signature (Appfire integration): Alfonso Medela F828436F64D417F854A46D0B5A9DB449 Signer name: Alfonso Medela Signing time: Tue, 07 Mar 2023 08:09:58 GMT Reason: Reviewed
Quality manager (QM)	Technical manager (PRRC)

Quality management and others

Name	Code	Approval date	Impact?	Version
Quality Manual	QM	20230417	✖️	7
Quality policy	Annex-001	20230217	✖️	3
Process map	Annex-002	20221123	✖️	1
Organization Chart	Annex-003	20230331	✖️	6

General and Specific Procedures (GP and SP)

Name	Code	Approval date	Impact?	Version
Documents and records control	GP-001	20230424	✖️	11
Quality planning	GP-002	20221228	✅ *	3
Audits	GP-003	20221227	✖️	3
Vigilance system	GP-004	20230102	✖️	3
Human resources and training	GP-005	20221222	✖️	3
Anti-corruption and anti-bribery	SP-005-001	20220923	✖️	2
Non-conformity. Corrective and preventive actions	GP-006	20221222	✖️	3
Post-market surveillance	GP-007	20230103	✖️	3
Product requirements	GP-008	20230316	✖️	3
Sales	GP-009	20230329	✖️	4
Purchases and suppliers evaluation	GP-010	20230321	✖️	3
Provision of service	GP-011	20230330	✖️	3
Design, re-design and development	GP-012	20230412	✅ **	5
Risk management	GP-013	20230203	✖️	3
Feedback and complaints	GP-014	20230306	✖️	4
Clinical evaluation	GP-015	20230509	✖️	4
Infraestructure and facilities	GP-018	20220911	✖️	3
Remote infrastructure control access policy	SP-018-001	20220911	✖️	2
Design change management	GP-023	20230503	✖️	1
Data protection	GP-050	20220911	✖️	1
Data protection officer manual	SP-050-001	20220911	✖️	1
Manual of functions and obligations of the staff	SP-050-002	20230911	✖️	1
Security violations	GP-051-001	20230118	✅ $	3
Data Privacy Impact Assessment (DPIA)	GP-052-001	20220911	✖️	1

* The implementation of the change in the procedure has led to the creation of new templates and records to ensure compliance and registration of the new activities described above.

** The implementation of the change in the GP-012 procedure has led to the creation of 3 new templates (T-012-006, T-012-007 and T-012-008) to ensure compliance with the corresponding standards ISO 62304:2007/A1:2016 and UNE-EN 62366-1:2015/A1:2020.

$ The implementation of the change in the DP-003 procedure has led to the creation of 3 new templates and records to ensure compliance and registration of the new activities described above.

Templates

Name	Code	Approval date	Impact?	Version
Control of documents and records	T-001-001	20230307	✖️	4
Manufacturer declaration of conformity_MDD	T-001-002	20230306	✖️	8
Backup copies control	T-001-003	20230116	✖️	2
Backup integrity verification	T-001-004	20230116	✖️	2
List of external documents	T-001-005	20230125	✖️	1
IFU and label validation	T-001-006	20230314	✖️	1
Manufacturer declaration of conformity_MDR	T-001-007	20230417	✖️	1
Quality objectives list	T-002-001	20221228	✖️	2
Quality objectives	T-002-002	20221228	✖️	2
Quality indicators	T-002-003	20230214	✖️	3
Management review report	T-002-004	20221228	✖️	2
Process validation card	T-002-007	20230308	✖️	1
Quality calendar	T-002-005	NA	✖️
SWOT and CAME analysis	T-002-006	20221229	✖️	1
Audits program	T-003-001	20221219	✖️	1
Internal auditor qualification	T-003-002	20221227	✖️	2
Internal audit plan	T-003-003	20221227	✖️	2
Internal audit checklist	T-003-004	20221228	✖️	2
Internal audit report	T-003-005	20221228	✖️	2
Job description	T-005-001	20221219	✖️	2
Non conformity report	T-006-001	DHF	✖️	1
List of non-conformities, claims and communications	T-006-002	DHF	✖️	1
PMS plan	T-007-001	20230104	✖️	1
PMCF plan	T-007-002	20230104	✖️	1
PSUR	T-007-003	20230105	✖️	1
PMS evaluation report	T-007-004	20230109	✖️	1
PMCF evaluation report	T-007-005	20230104	✖️	1
Sanitary alerts databases	T-007-006	20230104	✖️	1
GSPR	T-008-001	20230316	✖️	1
Implementation plan	T-009-001	20230306	✖️	1
Suppliers evaluation	T-010-001	20230321	✖️	1
API key order	T-011-001	20230330	✖️	1
API key delivery	T-011-002	20230330	✖️	3
Requirements	T-012-001	DHF	✖️
Activities	T-012-002	DHF	✖️
Tests	T-012-003	DHF	✖️
Version release	T-012-004	DHF	✖️
Design change control	T-012-005	DHF	✖️
Life cycle plan and report	T-012-006	20230413	✖️	1
Software usability plan	T-012-007	20230411	✖️	1
Software usability report	T-012-008	20230412	✖️	1
Customers product version control	T-012-012	20230306	✖️	2
Risk Management Plan	T-013-001	20230207	✖️	1
Risk Management Record	T-013-002	20230207	✖️	1
Risk Management Report	T-013-003	20230207	✖️	1
Customer Satisfaction Survey	T-014-001	20230310	✖️	1
Clinical Evaluation Plan	T-015-001	20230227	✖️	1
Clinical Evaluation Report CER	T-015-003	20230227	✖️	1
Clinical investigation plan	T-015-004	20230508	✖️	1
Investigator's brochure	T-015-005	20230508	✖️	1
Clinical investigation report	T-015-006	20230508	✖️	1
Declaration of interest Clinical evaluation team	T-015-007	20230307	✖️	1
Infrastructure and facilities incidents log	T-018-002	20230118	✖️	1
Processing activities (ROPA)	T-DP-050-001	20220911	✖️	1
API events logs	T-DP-051-001	20230117	✖️	1
Security groups	T-DP-051-002	20230118	✖️	1
EC2 instances	T-DP-051-003	20230117	✖️	1
Information clause on the processing of personal data in contracts (processors)	T-DP		✖️	1
Information clause on the processing of personal data in contracts (controllers)	T-DP		✖️	1
Employee data modification	T-DP		✖️	1
Employee recruitment	T-DP		✖️	1
Footer for email	T-DP		✖️	1
Email footer for advertising purposes	T-DP		✖️	1
Privacy policy	T-DP		✖️	1
Release of image rights	T-DP		✖️	1