Quality Management Systems
We transform your quality with certifications that make a difference.
At Fartell we design and implement quality management systems and support companies in obtaining the corresponding certification.
Who this service is for
Is this service right for your company?
In the pharmaceutical and biotechnology sectors, the certification and implementation of quality management systems (QMS) is not a commercial merit; it is the indispensable requirement to operate and survive in the market. Companies need to certify quality systems (GMP, ISO 9001, ISO 13485, GLP) for the following critical reasons:
Legal licence to operate
Certification is the gateway to the regulated market. Without it, commercialisation and distribution in highly regulated sectors is not possible.
Trust in the B2B supply chain
Business clients require certified quality guarantees before subcontracting or establishing distribution agreements.
Operational efficiency and cost reduction
A well-implemented quality system reduces errors, rework and non-conformities, improving profitability in the medium term.
Certifications
ISO standards we work with
ISO 9001
The benchmark standard for quality management systems, internationally the most widely used, applicable to any organisation regardless of size or sector. Helps achieve customer and stakeholder satisfaction and can be integrated with other management systems.
ISO 22716
Cosmetics-specific standard providing guidelines for the production, control, storage and shipment of cosmetic products. Defines GMP activities to ensure products meet their defined characteristics.
ISO 13485
Specific standard for quality management systems in medical devices, complementary to compliance with MDR 2017/745 and IVDR 2017/746. Helps manage legal and safety risks while creating a more effective working environment.
ISO 22000
International standard for safety management across the entire supply chain, integrating HACCP principles with a structured management system.
BRC / IFS
Food safety standards required by European retail and distribution chains to ensure consistent product quality and safety.
Other sector standards
We adapt our work to any specific standard required by the client, their sector or their direct customers.
How we work
Our methodology in 6 phases
Diagnosis and design
- Definition of scope.
- Gap analysis: identifying missing elements and resources needed. Comparison of current vs. ideal state.
Plant adaptation
- Works and equipment.
- Equipment qualification and calibration.
QMS development
- Drafting of QMS documentation.
- Technical file creation and risk management.
- Staff training.
Run-in and audit
- Operating the real system to generate records.
- Conducting an internal audit of the system.
- Management review.
Application
- Submission of the online application.
- Sending documentation.
Inspection support and closure
- Inspection and resolution of deficiencies.
- Certificate issuance.
Why choose us
Why Fartell?
Multidisciplinary technical-legal team
We have direct experience and regular dealings with health authorities, allowing us to anticipate requirements and accelerate certification processes.
Regulatory peace of mind to grow
We provide the regulatory security your business needs to operate with confidence, avoiding penalties and compliance issues.
Quality as a competitive advantage
We design strategies that increase your market profitability. Quality and regulation open markets and prevent economic losses.
FAQ
Frequently asked questions about quality system implementation
Do you need to implement or renew your quality management system?
At Fartell we carry out the entire process from start to finish, from the initial diagnosis to support during the certification audit. Tell us your situation and we will indicate the most efficient path.