GP-005 Human Resources and Training

Purpose

Define the methodology for human resources (HR) activities to ensure personnel performing work affecting product quality are competent on the basis of appropriate education, training, skills and experience, as required by ISO 13485:2016 clause 6.2.

This procedure covers:

• Recruitment and onboarding of qualified personnel
• Determination of competence requirements through job descriptions
• Training planning, execution and effectiveness evaluation
• Annual performance and competency evaluation
• Maintenance of training and competency records

Scope

All our team members.

Responsibilities

JD-001

• Approve new hires and training plans
• Evaluate training effectiveness together with department managers

JD-004

• Oversee and coordinate the training and development plan together with JD-006
• Ensure training, onboarding and offboarding records are properly archived

JD-006

• Identify competencies and training needs
• Manage recruitment, onboarding and offboarding processes
• Ensure all HR procedures are followed and records properly archived

Department managers

• Identify training needs of their personnel
• Evaluate effectiveness of training for their team members

All team members

• Request and attend training
• Suggest the need for hiring new personnel

Inputs

• Personnel recruitment needs
• Personnel training needs

Outputs

• Improvement of personnel competencies
• T-005-001 Job description
• Organisation chart
• T-005-002 Personnel card
• T-005-003 Training plan
• T-005-004 Training evaluation and record
• T-005-005 Certification that the onboarding training has been completed
• T-005-006 GDPR training
• T-005-007 Technical responsible designation
• T-005-008 PRRC designation
• T-005-009 QMS procedures training
• T-005-012 Annual performance and competency evaluation

Development

HR tools

We use the following validated tools (see corresponding R-002-007 Process validation card for each):

• FactorialHR: Employee data management, time tracking, leave management, document management, and performance management
• Planka: Kanban-style task management for HR processes and onboarding coordination
• Slack: Team communication and collaboration platform

Record working hours

Working hours are recorded using FactorialHR in accordance with Spanish labor law (Real Decreto 8/2019). Employees must record effective working hours daily. Breaks are mandatory (15 min for >6h/day part-time; 30 min for 8h/day full-time). Additional working hours require prior manager approval.

Job descriptions and organizational chart

Each position has an assigned job description (T-005-001) detailing education, experience, skills and responsibilities. Job descriptions are stored in FactorialHR, signed by the employee and their direct manager.

The organization chart shows hierarchic relationships and is maintained in FactorialHR. Substitution arrangements are described in Annex-4 Substitution table of the Quality Manual.

Statutory roles required by applicable regulations (ISO 13485:2016, Real Decreto 1591/2009, Real Decreto 192/2023, MDR 2017/745) are formalized in T-005-007 Technical Responsible designation and T-005-008 PRRC designation.

Recruitment and onboarding

Recruitment procedure

The recruitment process is owned by JD-006 in collaboration with JD-001 and the hiring manager:

1. Identify the need to hire and define job description requirements (education, experience, skills)
2. Publish job post and screen candidates (CVs stored in Google Drive: Human Resources > Hiring)
3. Conduct screening interviews (JD-006) and technical assessments if required
4. Interview with hiring manager to evaluate competencies and team fit
5. Final interview with JD-001 and collective decision
6. Offer negotiation and acceptance

Onboarding procedure

The onboarding process ensures new hires receive the training needed to perform their duties competently.

Onboarding steps:

1. Documentation: JD-006 requests employee documentation to create T-005-002 Personnel card in FactorialHR and process the contract
2. Contract and policies: Employee signs contract, job description, occupational risk prevention documents and company policies in FactorialHR
3. Access setup: JD-012 creates corporate email and grants platform access
4. Onboarding training: Employee completes personalized training via Planka board (20-24 hours) covering:
   • Company introduction and product knowledge
   • Tools training (FactorialHR, Google Workspace, Slack)
   • Cybersecurity and GDPR basics
   • QMS introduction and applicable procedures (T-005-009 QMS procedures training)
   • Role-specific training (e.g., Hubspot for Business Development)
5. Certification: Employee signs T-005-005 Certification that the onboarding training has been completed
6. Feedback meeting: Employee meets with direct manager and JD-006 to discuss responsibilities and provide feedback

Training

Training ensures personnel maintain and improve the competencies required for their roles, as required by ISO 13485:2016 clause 6.2.

Training plan

The T-005-003 Training plan is structured in three parts:

1. General and regulatory mandatory training: Mandatory training applicable to all personnel (occupational risk prevention, GDPR, cybersecurity, GCP, QMS fundamentals) with specified re-training frequency.

2. QMS procedures training: Training requirements for each General Procedure (GP) according to job description. When a GP is applicable, all its Specific Procedures (SP) are automatically applicable.

3. Annual specific training plan: Specific training activities planned for each calendar year, updated annually (e.g., R-005-003 Training plan 2026).

Training needs identification:

Training needs are identified from:

• New employee onboarding
• Job description requirements
• Regulatory changes (identified during Annual Management Review per GP-002)
• Performance gaps identified in annual appraisals
• New procedures or process changes

When training needs are identified, they are communicated to the area manager, who requests approval from JD-001. The JD-004 and JD-006 register approved training in the T-005-003 Training plan.

Execution

Training can be conducted through workshops, on-the-job training, e-learning, external courses, or seminars. Trainers shall be qualified and competent in the subject matter.

Competency verification

All training includes competency verification appropriate to the training type:

Training Type	Assessment Method	Passing Criteria
Theoretical/Knowledge-based	Written test or quiz	80%
Procedure/Process-based	Visual observation during task performance and review during Annual Performance Evaluation (T-005-012)	Pass/Fail
Software/Tool-based	Practical exercises	80% or Pass/Fail
External certifications	Certificate from provider	As defined by provider

The T-005-004 Training evaluation and record template can be used to document the assessments for Theoretical/Knowledge-based and Software/Tool-based training types (first and third rows in the table above). This template is available but not mandatory; an alternative format specifically adapted to the training content may be used if preferred. If assessment fails, re-training is scheduled within 30 days.

Records storage

note

The T-005-003 Training plan is maintained in the QMS. All individual training records (T-005-004, certificates) are stored in each employee's folder in FactorialHR.

Annual performance and competency evaluation

In compliance with ISO 13485:2016 clause 6.2, an annual performance and competency evaluation is conducted during Q4 for all personnel.

Annual appraisal process:

1. Preparation: Manager and employee review job description, previous objectives, and training completed
2. Competency evaluation: Evaluate whether employee meets competency requirements (education, experience, skills, QMS procedures)
3. Performance review: Review objectives achievement (Exceeded / Met / Partially met / Did not meet expectations)
4. Gap identification: Document gaps and include required training in the Training Plan
5. New objectives: Establish SMART objectives for the upcoming period
6. Employee feedback: Gather input on work environment, training, and career development
7. Documentation: Complete and sign T-005-012 Annual performance and competency evaluation
8. CV update: Update CV to reflect current education and experience
9. Archiving: Archive in employee's folder in FactorialHR

A summary of appraisal results is provided as input to the Annual Management Review (GP-002).

Offboarding

When an employee leaves the company:

1. JD-006 updates T-005-002 Personnel card and the Organization chart in FactorialHR
2. Direct manager or JD-001 evaluates the need for replacement
3. If replacement is required, start recruitment procedure
4. If not, reassign responsibilities to other team members

Work leave coordination

When a team member goes on a planned leave of absence exceeding five consecutive working days, they must prepare a structured handover document detailing their ongoing projects, responsibilities, expected milestones, and contingency guidance. This ensures continuity and prevents critical milestones from being missed during the absence.

The full procedure is described in SP-005-003 Work Leave Coordination. Records are stored under R-005-003 Work Leave Coordination.

Associated Documents

• T-005-001 Job description
• T-005-002 Personnel card
• T-005-003 Training plan
• T-005-004 Training evaluation and record
• T-005-005 Certification that the onboarding training has been completed
• T-005-006 GDPR training
• T-005-007 Technical Responsible designation
• T-005-008 PRRC designation
• T-005-009 QMS procedures training
• T-005-012 Annual performance and competency evaluation
• Annex-4 Substitution table

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

• Author: JD-006 Human Resources Manager
• Reviewer: JD-003 Design & Development Manager, JD-004 Quality Manager & PRRC
• Approver: JD-001 General Manager

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