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A management system is only valuable if it is understood, owned and useful to the people who bring it to life every day.
Our approach
Too many management systems are built for the auditor. Not for the organisation. At QALIA, we help industrial companies design, deploy and sustain management systems that genuinely serve performance, compliance and customer satisfaction.
Consulting and support: diagnosis, implementation or optimisation of your QMS, preparation for initial certification or recertification, change management support.
Audit: internal audits, supplier audits, pre-certification audits. Conducted in accordance with ISO 19011, our audits are drivers of improvement, not paperwork exercises.
Training: participatory, hands-on courses delivered by experts with field experience. Qualiopi certified.
Outsourced Quality Manager: a flexible solution for SMEs and mid-sized companies that need senior expertise without recruiting a full-time position. Management of your QMS, interface with certification bodies, KPI monitoring, facilitation of management reviews.
Every engagement is built on our Q-SYNQ® methodology, which focuses on ownership by teams and on anchoring the system in the reality of your processes.
ISO 9001: the foundation of quality management
ISO 9001 is the universal standard for quality management. It applies to any organisation, whatever its sector or size, and is the foundation on which sector-specific standards are built (EN 9100, ISO 19443, ISO 13485, IATF 16949).
Its process approach, based on the PDCA cycle and risk-based thinking, structures the entire management system: from defining the quality policy to management review, through operational control, performance evaluation and continual improvement.
QALIA supports you with ISO 9001 at every stage:
Initial diagnosis and gap analysis, QMS design and structuring, deployment of the process approach, certification preparation (initial or renewal), and post-audit support to embed practices over the long term.
EN 9100: aviation, space and defence
EN 9100 supplements ISO 9001 with requirements specific to the aviation, space and defence industries: configuration management, key characteristics, control of critical items, enhanced traceability, prevention of counterfeit parts and control of work transfers.
QALIA supports organisations across the aerospace supply chain in deploying, maintaining and optimising their QMS in line with EN 9100. Our knowledge of the requirements of the sector’s major prime contractors complements our command of the standard.
ISO 19443: nuclear
ISO 19443 adapts ISO 9001 for the nuclear sector. It introduces the concept of items important to nuclear safety (ITNS), the graded approach, and enhanced requirements for traceability, nonconformity management and nuclear safety culture.
QALIA works with organisations across the nuclear supply chain, including equipment manufacturers, service providers and subcontractors, to deploy and optimise their QMS in line with ISO 19443.
ISO 13485: medical devices
ISO 13485 specifies QMS requirements for organisations involved in the life cycle of medical devices: design, production, storage, distribution, installation and servicing. It incorporates product risk management (in connection with ISO 14971) and regulatory compliance requirements (CE marking, FDA).
QALIA supports manufacturers and subcontractors in the medical sector in implementing or optimising their QMS in line with ISO 13485.
IATF 16949: automotive
IATF 16949 is the quality management standard for the automotive industry. It supplements ISO 9001 with specific requirements: control plans, statistical process control (SPC), measurement systems analysis (MSA), core tools (APQP, PPAP, FMEA), and a stronger approach to supplier risk management.
QALIA supports automotive suppliers and subcontractors in deploying their QMS in line with IATF 16949 and implementing the core tools.
ECSS: space
The ECSS standards (European Cooperation for Space Standardization) define the quality assurance and dependability framework for European space programmes. They cover product assurance (ECSS-Q), project management (ECSS-M) and engineering (ECSS-E), with specific requirements for contamination control, EEE component management, traceability and milestone reviews.
QALIA supports organisations in the space sector in integrating ECSS requirements into their management system, in conjunction with EN 9100 where both frameworks apply.
Why QALIA?
- Multiple standards, one point of contact: ISO 9001, EN 9100, ISO 19443, ISO 13485, IATF 16949, ECSS. We know the specific features of each standard and the links between them.
- Involved in standardisation: QALIA Performance led the ISO 10012 revision project, and our founder acts as liaison between the ISO 9001 and ISO 10012 committees. This close involvement in standards development directly informs our work with clients.
- Field expertise: our work is grounded in the reality of your processes, not in the theory of standards. We design systems that live on beyond the audit.
Related training courses
Participatory, hands-on training courses, Qualiopi certified:
Let's talk about your management system
Initial certification, transition, optimisation, audit or training: we tailor our approach to your standard and your sector.