ISO 9001 is the global quality management standard and the basis of Eurofins Genomics' QM/QA system.
ISO 9001 defines the general requirements of quality management systems (QMS). The standard promotes a process based QMS system or organisation. It is applicable to all organisations, companies, industries, products and services.
Focus on customers with the ISO 9001 standard
The main focus of ISO 9001 is the customer, customer satisfaction and continuous improvement of processes organisations and QMS.
Your benefits with ISO 9001 certified products and services
- Short production times due to highly optimized and structured processes
- Well trained, competent and highly qualified personnel
- Fully documented processes
- Effective complaint and CAPA management
Key requirements of ISO 9001
- Management responsibilities: QMS planning and defined responsibilities, internal communication, quality policy and quality objectives, quality management representative, customer feedback and customer satisfaction, process based QMS.
- Documentation requirements: Quality manual, document and record management and management review. Processes are described in SOPs, record keeping (storage and archiving).
- Management of resources: Provision of qualified staff, appropriate infrastructure and work environment, supplier qualification and assessment.
- Production requirements: Controlled purchase, production and service provision, development, validation of methods and equipment.
- Customer related processes: Clear communication lines, marketing and sales processes, complaint management, contract and order management.
- Monitoring requirements: Complaint and non-conformity management, internal and external audits, monitoring of services and products, data analysis, process controls and management reviews.
Compliance with ISO 9001 is achieved through certification by approved bodies and independent internal audits.
We are committed to delivering products and services that are at the highest quality.
ISO 9001 is the quality standard that is offered for all applications:
|Pharma & Diagnostics
- Pharmacogenetics & pharmacogenomics
- Assay development & validation
- Biological safety testing
|Agriculture & Food
- Plant breeding
- Farm animal breeding
- Pet breeding
- Food production & retail
- Residual host cell and pathogen DNA & RNA analysis
- GMO & genetic insert characterisation
- Basic genomic characterisation
- Metagenomic & genetic characterisation
- Research & development
The ISO 9001 standard is applied to the whole Eurofins Genomics products and services offering: