Employee Qualification Records

HR & training template

Employee Qualification Records for medical device personnel competence

Use this editable Employee Qualification Records to define roles, track competence, record training and demonstrate that personnel are qualified for their QMS responsibilities.

Define roles clearlyMap responsibilities and required competence per position.

Track training recordsDocument attendance, qualification and effectiveness of training.

Demonstrate complianceProvide evidence for ISO 13485 personnel requirements.

Best for: training management, competence matrices, job descriptions and qualification records.
Includes: editable sections for roles, training plans, attendance, competence assessment and records.
Format: editable template available through the standard WooCommerce download flow.

Need the editable file?
Add the free template to cart

Lexqara supports medical device manufacturers in building competent teams that meet QMS and regulatory expectations. Explore the Resource Center or review our Medical Device Regulatory Training.

Description:
This Employee Qualification Record documents employee details, competence evidence, QMS document qualification, and follow-up actions to maintain controlled staffing decisions.

Capture Employee detail including Hiring date, Contract number, and signed agreements.
Link the approved Job description with Document, Revision, and approval status.
Confirm essential Resources (equipment, software, access) as Applicable and Available.
Record Competence and education requirements from the Competence Matrix with Evidence of conformity.
Assess qualification for QMS documents using the Master Document List and record Qualifications.
Define Training need and planning with timelines and Evidence of implementation.
Document Annual performance review with Acceptance Criteria, results, and conclusions.
Track Follow-up actions and finalize Approval with names, dates, and Signature.

Your needs:

Employee qualification record
Employee qualification record for ISO 13485 and MDR compliance
Reduce rework, strengthen onboarding consistency, and improve audit readiness.

Use this form when onboarding, changing responsibilities, or reviewing annual competence to ensure every role has documented evidence and controlled approvals.

It covers qualification requirements end-to-end. A Competence Matrix defines the minimum skills and evidence expected; it matters because it makes qualification decisions consistent. The Master Document List identifies controlled QMS documents; it matters because people must be qualified to the right revisions.

Record employee identity and employment status data.
Reference an approved job description tied to current responsibilities.
Provide required resources and access needed to perform duties.
Collect objective evidence for education/experience requirements.
Confirm qualification to required QMS documents and current revisions.
Define training actions when gaps are identified, with evidence.
Record objectives, acceptance criteria, and results for reviews.
Close actions and approvals with signatures and dates.

At Lexqara, we help implement controlled qualification workflows, align competence evidence to roles, and prepare you for internal audits and inspection readiness. Resource Center [https://lexqara.com/resource-center] and QMS Implementation [https://lexqara.com/services/qms-implementation]. See ISO 13485 [https://www.iso.org/standard/59752.html]. Request a short gap assessment.

Template preview

Template preview: Employee Qualification Records

Review the key sections included in the Employee Qualification Records template before downloading it. This preview shows the structure and content you will receive in the editable file.

Download the editable template

View the full template preview

Employee Qualification Record

For

[Employee Name]

Document Number: EQR-XXXX

Revision: Y

Employee detail

Employee first and last name	[Employee Name]
Address:
Phone number:
Email address:
Hiring date:		Hiring Status:
Contract number:		Contract Signed:	Yes
Additional agreement:	Yes N/A

Job description

Document	Revision	Title	Approved
			Yes Ongoing

Document

Revision

Title

Approved

Yes

Ongoing

Resources

The following table lists the essential resources allocated to the employee to support their role, including those required for daily tasks. Each item is marked to indicate its applicability and availability, ensuring that all required tools are provided for optimal performance.

To be customized to cover all possible employee needs

Resources	Applicable	Description	Available
Equipment
Laptop	Yes No		Yes
Setting up	Yes No		Yes
Email address	Yes No		Yes
Dock station	Yes No		Yes
Second monitor	Yes No		Yes
Keyboard & mouse	Yes No		Yes
Headset	Yes No		Yes
Company phone	Yes No		Yes
Phone subscription	Yes No		Yes
Business card	Yes No		Yes
Printer	Yes No		Yes
Security badge	Yes No		Yes
Building access	Yes No	Badge or code	Yes
VPN access	Yes No		Yes
Company credit card	Yes No		Yes
XXXX	Yes No		Yes
XXXX	Yes No		Yes
Software
Adobe Acrobat PRO	Yes No	PDF editing and signing	Yes
Microsoft Office	Yes No	Word, Excel, Powerpoint	Yes
Anti-virus	Yes No		Yes
Communication tools	Yes No	Teams, Zoom	Yes
Access to internal software	Yes No		Yes
ERP	Yes No		Yes
Company intranet	Yes No		Yes
Server/database access	Yes No		Yes
XXXX	Yes No		Yes
XXXX	Yes No		Yes
XXXX	Yes No		Yes
Advantages
Supplemental health insurance	Yes No		Yes
Life and disability insurance	Yes No		Yes
XXXX	Yes No		Yes
XXXX	Yes No		Yes
Other
Register of signatures is updated	Yes No		Yes
XXXX	Yes No		Yes

Employee education & competence

The following table provides a review of the employee’s competence and experience in relation to their assigned responsibilities.

Competence and education requirements (e.g., experience, diploma, qualification for equipment, manufacturing process, etc.) must be obtained from the Competence Matrix

Competence and education	Evidence of conformity	Qualifications
XXX	e.g., CV, diploma, external training	Yes No, plan a training*
		Yes No, plan a training*
		Yes No, plan a training*

*to be reported in see section 6

Employee qualifications for QMS documents

The following table outlines the assessment of the employee’s qualifications for the QMS documents they are required to be proficient in.

For the activities assigned to the employee (e.g., AUD), the associated QMS documents must be obtained from the Master Document List.

Document	Revision	Qualifications
		Yes
		Yes
		Yes
		Yes
		Yes
		Yes
Is the employee qualified for all current documents of the Quality Management System (QMS)? Note: the EQR cannot be approved and signed until the employee is not qualified to current QMS documents as defined in the Master Document List		Yes

Training need and planning

Taking into account the training needs identified in Section 4, along with those recognized by the direct manager and/or process owner(s), the following training plan has been developed for the employee.

Training description	Expected timeline	Evidence of implementation
Trainings from the previous review


New trainings

Annual performance review

The following table presents an evaluation of the employee’s performance over the specified periods. It outlines the objectives set, the corresponding acceptance criteria, and the achieved results. This assessment aims to ensure alignment with company goals, recognize accomplishments, and identify areas for improvement. The conclusions drawn from each period will support future development plans and career progression.

Employees objectives	Acceptance Criteria	Result
Period: from MM-YYYY to MM-YYYY
XXXX
XXXX
Conclusion
Period: from MM-YYYY to MM-YYYY
XXXX
XXXX
Conclusion

Follow-up actions

The table below tracks necessary follow-up actions, including their completion status, whether an action is a prerequisite for document approval, the need for follow-up in the next year, and the target or completion date.

Actions	Status			Target / Completion Date
Actions	Completed	Required for approval	Follow-up next year	Target / Completion Date

Approval

	Employee	Direct Manager
Name
Position
Date
Signature

The complete template content is displayed above. The editable file is available after adding the product to cart.

Free

Category Quality documents

Employee Qualification Records