ISO 13485 and IATF 16949 consultancy meets sector certification requirements; we establish supply-chain qualification and product-safety controls.
The critical topics this service addresses and the outcome we deliver in each.
We help you build a quality management system aligned with ISO 13485 and IATF 16949 requirements; the certification decision is left to the accredited body.
We organise FMEA, APQP and PPAP files as evidence ready for OEM customer audits and the certification auditor's review.
We make product-safety and traceability indicators trackable through measurement targets and acceptance criteria.
We own the ISO 13485 quality-system readiness; the final decision on CE marking and MDR conformity assessment rests with the notified body and the regulatory authority.
How we phase the service across delivery, governance, and connected service pillars.
We begin with a sector requirement analysis, preserving the shared ISO 9001 framework and adding sector-specific requirements as a layer.
We proactively manage product and process risks through FMEA (DFMEA/PFMEA) workshops and APQP/PPAP process setup.
We build supply-chain qualification with a supplier evaluation and development programme and prepare for audit with a mock audit.
Illustrative surfaces where this service is commonly activated.
Preparing for sector quality-certification requirements to access the medical or automotive market.
Meeting OEM and Tier-1 customers' supplier qualification and audit expectations.
Systematically reducing recall risk through product-safety and traceability controls.
This service's depth on sector-specific technical and compliance topics.
We assess design and process risks with the AIAG-VDA 7-step FMEA methodology and design controls accordingly.
We prepare the new-product approval process with five-phase APQP and PPAP packages matched to the customer level.
We support traceability with UDI and IQ/OQ/PQ in medical and lot/serial tracking and MSA/SPC in automotive.
Medical device manufacturers and automotive suppliers face stringent quality management requirements that are non-negotiable prerequisites for market access — ISO 13485 for medical devices and IATF 16949 for automotive production. These standards require documented quality management systems, rigorous process controls, supplier qualification programs, and ongoing surveillance auditing that exceed general ISO 9001 requirements in both technical depth and regulatory consequence. Our consulting practice delivers certified QMS implementations for both sectors, supported by technical specialists with direct industry experience in regulated manufacturing environments.
Support audit and compliance readiness with evidence records instead of unsupported public outcome promises
Meet IATF 16949 customer-specific requirements (CSRs) for OEM supply chain qualification
Turn the outcome into a measurable target with baseline, owner, and review cadence
Medical and automotive QMS implementations cover the full quality system lifecycle from initial gap assessment through certification audit. For medical device organizations, this includes device classification, regulatory pathway analysis, technical file structuring, and integration of quality requirements with regulatory affairs. For automotive suppliers, implementation covers all applicable IATF 16949 requirements plus customer-specific requirements (CSRs) from the relevant OEM customers, and the full APQP/PPAP product quality planning lifecycle.
Complete OEM customer PPAP submissions on first-time pass with structured APQP program management
Establish CAPA system reducing average corrective action closure time from 45 to 15 days
Pass IATF certification audit on first attempt with our structured pre-audit readiness assessment
QMS implementation engagements deliver a fully documented, audit-ready quality management system with trained personnel, a functional CAPA system, and certification achieved. For medical devices, deliverables include regulatory pathway documentation and technical file structure aligned to MDR requirements. For automotive suppliers, deliverables include complete core tools documentation (APQP, FMEA, Control Plans, MSA studies) and PPAP package readiness for first customer submission. Post-certification, we provide surveillance audit support and quality improvement programs.
Make risk, control, and compliance indicators visible through measured targets and evidence records
Enable OEM customer approvals and contract awards contingent on IATF 16949 certification
Make cost and resource impact measurable against the agreed baseline and review cadence
Turkey's Medical Device Regulation (Tıbbi Cihaz Yönetmeliği), aligned to EU MDR 2017/745, requires CE marking for most medical devices. CE marking under MDR requires a technical file demonstrating compliance with essential requirements, which in turn requires an ISO 13485-compliant QMS for the manufacturing processes. While ISO 13485 certification is not itself the legal requirement, it provides the most practical and recognized pathway to demonstrating QMS compliance for CE marking.
AIAG/VDA FMEA is the harmonized Design FMEA (DFMEA) and Process FMEA (PFMEA) methodology jointly developed by AIAG (North America) and VDA (Germany) and adopted by IATF 16949. It replaced the earlier separate AIAG FMEA methodology and is now required by most major automotive OEMs (GM, Ford, Stellantis, BMW, Volkswagen). Incorrect FMEA methodology is a common major nonconformity in IATF audits — our consultants are trained in the current AIAG/VDA FMEA 1st Edition methodology.
PPAP (Production Part Approval Process) is the formal submission of evidence to an automotive customer proving that the supplier's manufacturing process consistently produces parts meeting all design and specification requirements. A full Level 3 PPAP requires 18 elements including DFMEA, PFMEA, control plan, MSA study results, initial process studies (Cpk), and a sample warrant (PSW). Preparation is planned through a scoped timeline agreed during discovery depending on part complexity and the readiness of design and manufacturing processes.
Yes. ISO 13485 is built on ISO 9001's structure but adds sector-specific requirements for medical devices. Organizations holding ISO 9001 can transition to ISO 13485 by implementing the additional requirements — particularly design control, risk management integration, and regulatory compliance records. Integrated audits covering both standards are available from most accredited certification bodies, reducing audit burden and cost.
Multi-site implementations require a common QMS framework with site-specific procedures reflecting local manufacturing processes, equipment, and applicable CSRs. We design the QMS architecture at the corporate level and deploy site-specific documentation in parallel tracks, using a master procedure library supplemented by controlled site annexes. IATF allows multi-site certification under a single certificate subject to sampling of sites during audits.
EU MDR 2017/745 (Medical Device Regulation) replaced EU MDD and fully applied from May 2021. MDR significantly increased technical documentation requirements, introduced mandatory clinical evaluation reporting, and tightened notified body oversight. ISO 13485 certification under MDR requires the QMS scope to explicitly address MDR Annex IX/X requirements. We ensure ISO 13485 implementations are scoped and documented to satisfy MDR notified body expectations from the outset.
This short form routes your request to the right support team. We clarify context first, then define the safe sharing method.
Privacy-aware first contact; safe sharing flow when needed; no sales pressure.
