Validation of manufacturing processes — Building a solid file under ISO 13485 and MDR 2017/745
Process validation is not a documentary formality: it is the demonstration that your manufacturing produces, in a reproducible way, a medical device compliant with its specifications. A poorly built IQ/OQ/PQ file is a major non-conformity at the certification audit and, at worst, a real patient risk. This 2-day training equips QA, production and methods teams with the complete methodology, the basic statistical tools and deliverables directly reusable to validate, monitor and revalidate their manufacturing processes within the framework of ISO 13485 §7.5 and the requirements of Annex I of MDR 2017/745.
Audience QA managers and technicians, production managers, methods and industrialization engineers, regulatory affairs officers involved in the validation of manufacturing processes for medical devices.
Learning objectives
- ▸ Identify the requirements of ISO 13485 §7.5 and of MDR 2017/745 (Annex I GSPR) applicable to the validation of your organization's manufacturing processes.
- ▸ Distinguish verification, qualification and validation, and apply the IQ/OQ/PQ sequence to a concrete process.
- ▸ Build a structured Validation Master Plan (VMP), with scope, responsibilities, acceptance criteria and schedule.
- ▸ Write a qualification protocol (IQ, OQ, PQ) and the associated report compliant with notified bodies' expectations.
- ▸ Integrate process risk analysis (ISO 14971) into the validation approach: identify critical parameters, define control limits and justify sampling plans.
- ▸ Manage the maintenance of the validated state: routine monitoring, revalidation after change, link with the ISO 13485 §4.1.4 change control process.
- ▸ Prepare the validation documentation for an ISO 13485 certification or surveillance audit.
Expected outcomes
- ✓ Validation Master Plan (VMP) started on the participant's context.
- ✓ Templates of standard ISOFACADEMY IQ/OQ/PQ protocols, directly customizable.
- ✓ Annotated process FMEA table, capability cheat sheet (Cp/Cpk) and ISO 13485 validation audit checklist.
Accessibility & entry conditions
Access lead time
Registration up to 10 working days before the start of an open-enrolment session. In-house sessions can be scheduled within 3 to 4 weeks.
Prerequisites
Basic knowledge of the ISO 13485 standard and of how a medical device manufacturing environment operates. Familiarity with risk management concepts (ISO 14971) is a plus but is not mandatory — the necessary basics are recalled during the training. No advanced statistical prerequisite is required: the quantitative tools used are accessible without specific prior training.
Disability access
Any disability situation can be accommodated. Contact our officer before registration to explore possible adjustments (equipment, materials, pacing). Contact our officer →
Funding
- ·OPCO (all sectors)
- ·Skills development plan
- ·CPF (subject to the course being listed)
- ·Company self-funding
Detailed programme
A phone interview or positioning questionnaire is sent ahead of the session to calibrate the level, identify expectations and tailor the case studies to participants' real situations.
- 01
Day 1 · Regulatory and normative framework of process validation (1h30)
- ·ISO 13485 §7.5.6: requirements for the validation of production processes — operational reading and interpretation
- ·MDR 2017/745 Annex I (GSPR): requirements relating to manufacturing, links with process validation
- ·Fundamental definitions: special process vs standard process, verification vs validation, validated state vs maintenance of the validated state
- ·Responsibilities of the manufacturer, the subcontractor and the notified body regarding validation
- ·Validation gaps most frequently noted during ISO 13485 audits: review of typical observations
- ·Entry quiz on regulatory requirements and definitions
- 02
Day 1 · Validation Master Plan (VMP) — structuring and steering (1h30)
- ·Content and structure of a VMP: scope, list of processes to validate, classification by risk, schedule, responsibilities
- ·Prioritization criteria for processes to validate: product impact, patient risk, regulatory criticality
- ·Link between the VMP and the ISO 14971 risk management system: integration of the process FMEA
- ·Documentary organization: numbering, VMP-protocols-reports links, version management
- ·Workshop on the partial construction of a VMP on a case provided or brought by the participant
- 03
Day 1 · Equipment qualification — IQ, OQ (2h)
- ·IQ (Installation Qualification): definition, expected content, documentation, acceptance criteria
- ·OQ (Operational Qualification): parameters to test, limit conditions, test plans, records
- ·Management of deviations and non-conformities during qualification
- ·Special cases: refurbished equipment, second-hand equipment, multi-site equipment
- ·Critical review of a standard IQ/OQ protocol with identification of gaps
- 04
Day 1 · Performance Qualification (PQ) and process validation (2h)
- ·PQ: representativeness conditions, number of validation batches, statistical acceptance criteria
- ·Critical Process Parameters (CPP) and Critical Quality Attributes (CQA): identification and justification
- ·Basics of useful statistical tools: process capability (Cp, Cpk), control charts, sampling plans — an accessible approach, without advanced prerequisites
- ·Validation of special processes: sterilization (reference to ISO 11135/11137 standards), assembly, welding, marking
- ·Capability calculation exercise on fictitious data, interpretation and validation decision
- 05
Day 2 · Integration of risk analysis into validation (2h)
- ·Process FMEA (P-FMEA): method, standard table, severity/occurrence/detectability rating
- ·Process FMEA — control plan — PQ protocol link: a coherent chain
- ·Identification of validation parameters from the identified process risks: validation as a response to risks, not as a list of tests
- ·Articulation with the ISO 14971 product risk file and the MDR technical file
- ·Simplified process FMEA workshop on a fictitious medical device case
- 06
Day 2 · Maintenance of the validated state and change management (1h30)
- ·Routine monitoring: indicators, review frequency, revalidation triggers
- ·ISO 13485 §4.1.4 change control: which changes trigger a partial or total revalidation?
- ·Documentary management of post-validation changes: protocol revision, revalidation report, traceability
- ·Specific cases: equipment relocation, change of raw material supplier, change of qualified personnel
- ·Exercise assessing the impact of a change on the validated state
- 07
Day 2 · Writing qualification and validation reports (1h)
- ·Structure of an auditable qualification / validation report: executive summary, results, deviations and justifications, conclusion, validation decision
- ·Notified body expectations: objective evidence, signatures, dates, link to records
- ·Most frequent writing errors and how to avoid them
- ·Critical review of a standard validation report with an evaluation grid
- 08
Day 2 · Synthesis workshops and cross-cutting case studies (2h)
- ·Role-play: each participant (or group) produces a partial deliverable (VMP, OQ or PQ protocol, or validation report) based on a provided case or their own context
- ·Presentation and trainer feedback
- ·ISOFACADEMY feedback: real situations encountered during certification audits or consulting assignments
- ·Open questions and answers
Assessment of learning
Assessment methods
Collective corrections after each workshop · oral verification points at the end of Day 1 (synthesis of fundamental concepts) · final QCM of 20 questions (regulatory framework, IQ/OQ/PQ method, risk integration, change management — pass threshold: 60%) · Individual end-of-training deliverable: at least one partial deliverable (started VMP or standard protocol) on the participant's professional context, qualitatively assessed by the trainer. Training certificate issued subject to full participation in both days. This certificate does not constitute an RNCP/RS certification and does not amount to ISO 13485 certification of the organization.
Certificate
A certificate of completion is issued to each participant, detailing the objectives, duration, learning assessed and the result of the final assessment. The document can be kept in a skills record.
Satisfaction and results
Satisfaction rate: Being measured
First learner survey campaign under way — data published once the statistical threshold is reached.
Training team
Training delivered by the ISOFAC ACADEMY teaching team, made up of consultants specialised in medical devices, quality and regulatory affairs. Depending on the module, the session is led by a specialist with hands-on operational expertise in MDR compliance, ISO 13485 quality management systems, ISO 14971 risk management, clinical evaluation, technical documentation, regulatory audits and CE marking strategy.
Our trainers support manufacturers, distributors, importers, authorised representatives and other economic operators on a daily basis in bringing their medical devices into compliance. See the team's profiles →
Technical resources
In-person
Room equipped at the client site or in a partner centre (Montpellier, Lyon, Paris). Video projector, flipchart, printed materials.
Remote
Zoom (corporate) platform for the virtual classroom. Materials provided in PDF + access to additional resources for 12 months after the session.
Learner equipment
A connected computer with camera and microphone for remote sessions. No software to install.
Post-course follow-up
Advice line
Hotline included for 30 days after the session for operational questions arising back on the job. Reply within 48 working hours.
Follow-up review
3-month review sent to the sponsor for in-house courses: feedback on the skills put into practice and any residual points.
Open-enrolment price (excl. VAT)
1 490 €
EU VAT applicable depending on the buyer's status.
In-house price
On request, depending on headcount and location.
Funding
- ·OPCO (all sectors)
- ·Skills development plan
- ·CPF (subject to the course being listed)
- ·Company self-funding
Personalised quote and OPCO funding application prepared within 48 hours.
Would you like to attend this course?
Tell us your preferred format (open-enrolment, in-house or virtual classroom), the number of participants and your schedule. We will get back to you within 48 hours with the next available dates and a firm quote.