R-001-001 Control of documents 2023_003

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

Quality management and others

Name	Code	Approval date	Impact?	Version
Quality Manual	QM	20231024	FALSE	c529e20
Quality policy	Annex-001	20230912	TRUE	21f1072
Process map	Annex-002	20230919	FALSE	e2d5076
Organization Chart	Annex-003	20230919	TRUE	e2d5076
Substitution table	Annex-004	20231026	FALSE	a0acf14

Quality policy

The implementation of the change in the procedure has led to the distribution to all the employees, and their signature on a document copy stored in their corresponding file within the HR tool as evidence.

Organization Chart

The implementation of the change in the Annex means that the new chart is updated at the HR tool and will be updated within this tool when required. The old document was properly archived within the QMS deprecate corresponding folder.

General and Specific Procedures (GP and SP)

Name	Code	Approval date	Impact?	Version
Documents and records control	GP-001	20230918	FALSE	80b635e
Quality planning	GP-002	20231026	FALSE	a0acf14
Audits	GP-003	20230912	FALSE	3a1e517
Vigilance system	GP-004	20231014	FALSE	7f3306b
Product Withdrawal	SP-004-001	20231014	FALSE	7f3306b
Human resources and training	GP-005	20231026	FALSE	a0acf14
Anti-corruption and anti-bribery	SP-005-001	20220923	TRUE	2
Non-conformity. Corrective and preventive actions	GP-006	20230912	FALSE	0b8c5d6
Post-market surveillance	GP-007	20231014	FALSE	d607f6b
Product requirements	GP-008	20230912	FALSE	67972ba
Sales	GP-009	20230914	FALSE	49b8dc9
Purchases and suppliers evaluation	GP-010	20230912	FALSE	397ebb7
Provision of service	GP-011	20230912	FALSE	b192e93
Design, re-design and development	GP-012	20231014	FALSE	91956cc
Cybersecurity Requirements of AI/ML Models	SP-012-001		TRUE	Under review
Risk management	GP-013	20230918	FALSE	8a62e98
Feedback and complaints	GP-014	20230912	FALSE	10c38e8
Clinical evaluation	GP-015	20230912	FALSE	f40fac7
Traceability and identification	GP-016	20230912	FALSE	e1e41a4
Technical Assistance Service	GP-017	20230912	FALSE	3ff316f
Infraestructure and facilities	GP-018	20230912	FALSE	9fcb037
Remote infrastructure control access policy	SP-018-001	20230912	FALSE	9fcb037
Software validation	GP-019	20230919	FALSE	61d0dc4
QMS Data analysis	GP-020	20231014	FALSE	909f03c
Communications	GP-021	20230912	FALSE	e8a194b
Document translation	GP-022	20231015	FALSE	439cb65
Design change management	GP-023	20230912	FALSE	e534eea
Data protection	GP-050	20230912	FALSE	213901b
First layer of information in digital environments	Annex DP-050	20230912	FALSE	213901b
Data protection officer manual	SP-050-001	20230912	FALSE	213901b
Manual of functions and obligations of the staff	SP-050-002	20230912	FALSE	213901b
Security violations	GP-051	20230912	FALSE	09ac78c
Data Privacy Impact Assesment (DPIA)	GP-052	20230912	FALSE	495f715
Business continuity and disaster recovery plans	GP-100	20230912	FALSE	2ce89fe
Information security	GP-101	20230912	FALSE	631379f

Cybersecurity Requirements of AI/ML Models

The implementation of the new procedure entailed the revision of the risk analysis and the incorporation of new risks related to cybersecurity into the risk analysis.

Templates

Name	Code	Approval date	Impact?	Version
Control of documents	T-001-001	20230918	FALSE	80b635e
Manufacturer declaration of conformity_MDD	T-001-002	20231004	FALSE	fbc0fd3
List of external documents	T-001-005	20230918	FALSE	80b635e
IFU and label validation	T-001-006	20230918	FALSE	18163e5
Manufacturer declaration of conformity_MDR	T-001-007	20231018	FALSE	cb9ea49
Device name labeling	T-001-008	20231016	FALSE	d45f580
Quality objectives list	T-002-001	20230912	FALSE	cb17804
Quality objectives	T-002-002	20230912	FALSE	7058d3e
Quality indicators	T-002-003	20230912	FALSE	52672ff
Management review report	T-002-004	20230912	FALSE	a3ff563
Quality calendar	T-002-005	20230912	FALSE	180c2004
SWOT and CAME analysis	T-002-006	20230912	FALSE	b97f496
Process validation card	T-002-007	20230914	FALSE	d28e41d
Audits program	T-003-001	20230912	FALSE	9eadf26
Internal auditor qualification	T-003-002	20230912	FALSE	9eadf26
Internal audit plan	T-003-003	20230912	FALSE	9eadf26
Internal audit checklist	T-003-004	20230912	FALSE	9eadf26
Internal audit report	T-003-005	20230912	FALSE	9eadf26
Withdrawal record	T-004-001	20230918	FALSE	ccb09d0
Job description	T-005-001	20230919	FALSE	8c71f79
Personnel card	T-005-002		TRUE	Under review
Training plan	T-005-003		TRUE	Under review
Training evaluation and record	T-005-004		TRUE	Under review
Certification that the Legit.health onboarding training has been completed	T-005-005		TRUE	Under review
GDPR training	T-005-006		TRUE	Under review
Non conformity report	T-006-001	20231017	FALSE	fb4ddd3
List of non-conformities, claims and communications	T-006-002	20231017	FALSE	fb4ddd3
PMS plan	T-007-001	20231014	FALSE	d607f6b
PMCF plan	T-007-002	20231014	FALSE	d607f6b
PSUR	T-007-003	20231014	FALSE	d607f6b
PMS evaluation report	T-007-004	20231014	FALSE	d607f6b
PMCF evaluation report	T-007-005	20231014	FALSE	d607f6b
Sanitary alerts databases	T-007-006	20231014	FALSE	d607f6b
GSPR	T-008-001	20230912	FALSE	67972ba
Implementation plan	T-009-001	20230914	FALSE	49b8dc9
Suppliers evaluation	T-010-001	20230912	FALSE	9e5c09d
API key order	T-011-001	20230912	FALSE	b192e93
API key delivery	T-011-002	20230912	FALSE	b192e93
Requirements	T-012-001	20231017		fb4ddd3
Activities	T-012-002	20231017		fb4ddd3
Tests	T-012-003	20231017		fb4ddd3
Version release	T-012-004	20231017		fb4ddd3
Design change control	T-012-005	20230919		5a03f59
Life cycle plan and report	T-012-006	20230912		2b9ee1f
Software usability plan	T-012-007	20230912		2b9ee1f
Software usability report	T-012-008	20230912	FALSE	2b9ee1f
Validation and testing of machine learning models	T-012-009	20231018	FALSE	8547e10
Device back up verification	T-012-010	20231014	FALSE	91956cc
Customers product version control	T-012-012	20230912	FALSE	2b9ee1f
Risk Management Plan	T-013-001	20230918	FALSE	8a62e98
Risk Management Record	T-013-002	20230918		8a62e98
Risk Management Report	T-013-003	20230918	FALSE	8a62e98
Customer Satisfaction Survey	T-014-001	20230912	FALSE	10c38e8
Clinical Evaluation Plan	T-015-001	20230912	FALSE	f40fac7
Preclinical and clinical evaluation record	T-015-002	20231124		ddd7b5e
Clinical Evaluation Report CER	T-015-003	20230912	FALSE	f40fac7
Clinical investigation plan	T-015-004	20230912	FALSE	f40fac7
Investigator's brochure	T-015-005	20230912	FALSE	f40fac7
Clinical investigation report	T-015-006	20230912	FALSE	f40fac7
Declaration of interest Clinical evaluation team	T-015-007	20230912	FALSE	f40fac7
Clinical development plan	T-015-008	20230912	FALSE	f40fac7
Infrastructure list and control plan	T-018-001	20230912		9fcb037
Infrastructure and facilities incidents log	T-018-002	20231018	FALSE	cb9ea49
Software validation report	T-019-001	20230919	FALSE	61d0dc4
External software list	T-019-002	20231018	FALSE	c9485a8
Trend report	T-020-001	20231014	FALSE	909f03c
DPIA	T-052-001	20230912	FALSE	495f715
Information clause on the processing of personal data in contracts (processors)	T-DP-050	20230912	FALSE	213901b
Information clause on the processing of personal data in contracts (controllers)	T-DP-050	20230912	FALSE	213901b
Employee data modification	T-DP-050	20230912	FALSE	213901b
Employee recruitment	T-DP-050	20230912	FALSE	213901b
Footer for email	T-DP-050	20230912	FALSE	213901b
Email footer for advertising purposes	T-DP-050	20230912	FALSE	213901b
Privacy policy	T-DP-050	20230912	FALSE	213901b
Release of image rights	T-DP-050	20230912	FALSE	213901b
Processing activities (ROPA)	T-DP-050-001	20230912	FALSE	213901b
API events logs	T-DP-051-001	20230912	FALSE	09ac78c
Security groups	T-DP-051-002	20230912	FALSE	09ac78c
EC2 instances	T-DP-051-003	20230912	FALSE	09ac78c

HR templates (T-005)

The folling templates are being improved and transferred to the HR tool. All of them, along with the new version of the GP-005 HR and training procedure, will be released when the complete revision of all of them was completed:

• T-005-006 GDPR training
• T-005-005 Certification that the Legit.health onboarding training has been completed
• T-005-004 Training evaluation and record
• T-005-003 Training plan
• T-005-002 Personnel card

Record signature meaning

• Author: JD-004 María Diez
• Reviewer: JD-003 Taig Mac Carthy
• Approval: JD-001 Andy Aguilar