ISO 9001:2008 is the global quality management standard and the basis of Eurofins Genomics' QM/QA system.
ISO 9001:2008 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 9001:2008 standard
The main focus of ISO 9001:2008 is the customer, customer satisfaction and continuous improvement of processes organisations and QMS.
Your benefits with ISO 9001:2008 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 9001:2008
- 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 9001:2008 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 9001:2008 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 9001:2008 standard is applied to the whole Eurofins Genomics products and services offering: