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Custom DNA Oligos – Quality Control, Quality Assurance

Download Quality Brochure (PDF)

The foundation of Sigma's manufacturing process is a robust Quality Management System, which drives compliance to ISO 9001:2008 certification. This means the following to you:

  • Sequence integrity: Oligos and probes will be synthesized to exact specifications
  • Purity integrity: Full-length product will meet minimum guaranteed percentage
  • Yield integrity: Optical density will reflect the actual quantity to within ±10%

All of our oligos and probes undergo strict quality control measures, which are outlined in the following diagram.

Critical Raw Materials Synthesis & Processing

Quality Control Diagram

Quality assurance of Sigma's products is guaranteed by the following components of our Quality Management System:

  • Effective internal and external audits
  • Corrective and preventive actions
  • Change control and document control
  • Training programs

Effective Internal and External Audits
We maintain the integrity of our ISO certification through a rigorous series of audits including:

  • External surveillance registrar audits
  • Internal audits
  • Customer audits

Customers are welcome to audit any of our global manufacturing facilities for a first-hand view of our quality practices.

Corrective and Preventive Actions
Sigma strives to continually improve the effectiveness of our quality management system through the use of corrective and preventive actions. These procedures:

  • Eliminate and prevent the causes of nonconformance
  • Initiate process improvement
  • Validate actions taken and measures their differences

Sigma maintains a database-driven system that aids in managing inputs from both internal and external customers.

Change Control and Document Control
When changes and improvements to processes are needed, our change control process assists in identifying possible risks as an outcome of the proposed change. These procedures allow for:

  • Identification of documents within the changed process that need updating
  • Identification and evaluation of risks
  • Control and critical processes and procedures
  • Rigid revision and approval process for procedures

Controlled documents are linked to our training database which ensures staff has been trained when processes and documents are altered.

Training Programs
Properly trained professionals sustain our precision-engineered processes. Training programs ensure:

  • Critical skill sets are defined within each core process
  • Training modules are administered to continually advance skill sets
  • Programs are measured for effectiveness and skill sets are regularly assessed

Global Manufacturing
A key advantage of Sigma over the competition is that we have 11 manufacturing sites around the globe. When threatened by natural disasters or other events, production can be quickly shifted to other facilities, thereby ensuring an uninterrupted supply of product.

Click here to view Sigma's ISO 9001 certification and other worldwide quality registrations.



Materials