Quality and compliance

Our mastery of standards requirements, regulatory compliance and traceability, ensures the success of your projects and deliverables from design to operation.

Requirements and standards
Control and inspection
Regulatory compliance
Quality audits and files
Context and issues

Elevating quality to safeguard industrial performance

Guaranteeing the quality of a product or an industrial facility means much more than applying a process. It means mastering the requirements, making every decision reliable and documenting them with impeccable accuracy.

Industrial organisations are evolving in a demanding landscape, shaped by:

Ever stricter standards and regulations

A requirement for total traceability throughout the entire life cycle

Non-compliances with potentially high operational, financial or reputational impact

Increasingly rigorous audits of customers and authorities

Multiple stakeholders, making interface management critical

Digital transformation which calls for new quality tools and practices

Our approach

Our Quality approach is based on a simple conviction: compliance is built upstream and proven over time.

1. Rigorous control of requirements and standards

We analyse the applicable standards, identify the key requirements and build clear, robust and indisputable traceability to ensure project compliance and credibility.

2. Quality management based on facts, never intuition

We analyse deviations, quality risks and non-conformities in an objective, verified and documented way, so that decisions are based on evidence rather than personal judgement.

3. Greater consistency between processes, documentation and practices

We harmonise methods, align teams and ensure successful operational execution, including in a multi-site or multi-stakeholder environment.

4. Demanding, structured preparation for audits and inspections

We compile the supporting documentation, structure the quality files, anticipate critical points and support the teams right up to the day of the audit, so that they can tackle them with confidence and control.

5. Complete, secure control of the supplier chain

We qualify, inspect and verify suppliers’ technical and documentary contributions in order to guarantee the reliability of external deliverables and overall compliance.

Building quality at the root of projects means mastering requirements, making decisions based on facts and producing evidence. At agap2, this is how we create industrial confidence.

Marjorie S.
Head of QH2SRE (Quality, Health, Safety, Security, Radiation Protection and the Environment) at agap2

Our offer

Our quality and compliance offer covers all the levers needed to prepare, demonstrate and maintain the compliance of projects and organisations in a regulated environment.

01

Project and product quality

We put quality at the heart of our projects to safeguard deliverables, requirements and commitments.

• Deployment of project and product quality approaches

• Quality plans, monitoring plans and document management

• Monitoring of requirements and inspection of deliverables

• Stabilisation and reliability of technical data

02

Regulatory and normative compliance

We analyse, structure and demonstrate regulatory and normative compliance for projects and systems.

• Analysis of applicable standards and associated documentation

• Creation of complete, auditable compliance files

• Assistance with regulatory compliance

• Qualification of equipment and suppliers

03

Control and inspection

We ensure successful execution through control, inspection and rigorous processing of deviations.

• Monitoring and processing of non-conformity

• Technical inspections and field checks

• Analysis of deviations and corrective action plans

• Documentary and equipment checks

04

Preparing for audits

We prepare and support audits so that you can approach them with control, evidence and peace of mind.

• Internal, supplier customer or authority audits

• Compilation of evidence, evaluation grids and checklists

• Team coaching and audit simulations

• Enhanced support in regulated environments

Methods and solutions

Our services are based on structured methods, recognised benchmarks and tried and tested tools, guaranteeing the reliability and auditability of quality processes.

Quality and risk management methods

We structure and manage quality using tried-and-tested methods focused on prevention, proof and continuous improvement.

  • FMEA and quality risk analysis
  • Project and product quality assurance
  • Internal and supplier audits
  • Processing of deviations and continuous improvement
Standards, benchmarks and regulatory requirements

We are fully conversant with the norms and sector-specific standards applicable to the most demanding industrial environments.

  • ISO 9001 – Quality management system
  • ISO 19443 - Nuclear quality
  • EN 9100 – Aeronautics, Space and Defence
  • Sector-specific standards: energy, transport, health, industrial processes
  • Customer, contractual and official requirements
Supplements available depending on the context

Depending on the project and the regulatory environment, we mobilise complementary expertise.

  • Supplier qualification and monitoring
  • Management of multi-standard regulatory requirements
  • Harmonisation of multi-site quality practices
  • Support for certifications and renewals
  • Change management and team skills development

Benefits for your projects

Demonstrate compliance with the regulations and standards in the long term, in a controlled and indisputable way.
Significantly reduce non-compliance and the associated operational, regulatory and reputational risks.
Obtain clear, traceable and immediately audit-ready documentation throughout the entire life cycle.
Harmonise quality processes, including in a multi-site, multi-supplier environment.
Help quality and operational teams to develop their skills in response to regulatory requirements in the long term.
Boost the confidence of customers, authorities and partners through solid, shared evidence.

Quality and compliance assignments on projects that count

Sanofi
x
Life Sciences
Risk management and Quality Assurance compliance at an API manufacturing site
See the case study
Safran Landing Systems
x
Aeronautics, Space and Defence
Program Quality Management and Structuring
See the case study
See all the projects
of the Quality and Compliance business line