Training Procedure | ISO 13485 | FDA QMSR

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Establish and document a structured employee training system with an editable Training Procedure plus the working forms and implementation guidance needed to identify training requirements, plan and document training, evaluate effectiveness and competency, and maintain training records.

What your download includes

Five editable Microsoft Word documents, supplied as a digital download:

Training and Job Descriptions Procedure — establishes responsibilities and methods for identifying, providing, documenting, evaluating, and maintaining employee training.

Training Plan / Matrix — helps define general, quality-system, safety, department-specific, job-specific, SOP, retraining, and developmental training requirements.

Group Training Record — documents common training delivered to multiple employees.

Training / Retraining Record — documents individual training methods and effectiveness or competency evaluation, including interviews, task demonstrations, examinations, audits, performance appraisal, and corrective-action monitoring.

Medical Device Training System Implementation Guide — practical companion guidance explaining how to use the procedure and forms together as an integrated training system.

The Training Procedure governs the methods used to ensure employees possess the necessary training and skills to adequately perform their particular job function. It applies to employees, temporary personnel, contractors, consultants and outside parties involved in applicable company activities.

The documentation supports new-hire and transfer training, individual training plans, retraining, training effectiveness checks, competency evaluation, training records, and ongoing review of training needs. The editable documents are intended to be reviewed and customized for your organization, personnel, processes, products, responsibilities, and quality management system before implementation.

How the training documents work together

Start with the Training and Job Descriptions Procedure to assign responsibilities and identify job-related training needs. Use the Training Plan / Matrix to organize required training. Record delivery with the Group Training Record or individual Training / Retraining Record, then document the appropriate effectiveness or competency evaluation. The implementation guide explains how to use these documents together.

Training matrix or complete documentation package?

Choose this package when you need the procedure, planning matrix, training records and implementation guidance together. A matrix organizes requirements; a completed training record documents the activity and evaluation. Customize the documents for your roles, processes and training methods before use.

For the broader allocation of QMS roles and authority, see the separately sold Organization, Responsibilities, and Authority Procedure.

Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.

Practical guide

Read Medical Device Training Matrix and Training Records for workflow guidance, a checklist and common mistakes.