Quality assurance forum

Quality System Certificates

Spencer, operates in the field of emergency medicine where products need to meet the high technological standards while at the same time remaining easy to use. Maximum results like this can be obtained rapidly only if the company has the correct structure and is fully orientated towards quality and efficiency. This is why Spencer has based her company assets on two key factors:

  • Since 1998  Spencer has been operating as specified in our Quality approved System compliant with both the norm  ISO 9001 (certificate n° 50 100 6189 issued by  TÜV ITALIA ), and with the advanced standards stipulated for businesses operating in the Medical Device field  EN ISO 13485 (certificate n° Q1 N 17 11 33230 026 issued by  TÜV Product Service GmbH, Germany)
  • Research and development for the creation and production of highly advanced technical devices.

Here is a summary of some of the norms we use most frequently as reference points:

  • UNI EN ISO 9001 Quality Management systems: requirements
  • EN ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes
  • UNI ISO 2859-1 Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
  • UNI ISO 2859-2 Sampling procedures for inspection by attributes — Part 2: Sampling plans indexed by limiting quality (LQ) for isolated lot inspection
  • UNI EN ISO 19011 Guidelines for auditing management systems
  • UNI CEI 70015 Relationship customer-supplier (Supplier assessment form)
  • UNI ISO 10015 Quality management — Guidelines for training
  • UNI 11097 Monitoring and measurement of the quality managment system processes