Quality & Compliance
Sentwin builds dependable laboratory equipment around documented quality-management and compliance standards. Our ISO 9001, ISO 13485 and CE documents support the stated equipment scope behind the range.
Our commitment
Sentwin takes responsibility for the quality of the equipment we manufacture. These documents show the quality-management and compliance framework supporting our stated equipment range.
What it supports
Documents the quality-management framework behind Sentwin's manufacturing, assembly and commercial operations within the stated scope.
Gives distributors clear quality-management evidence to support conversations about the Sentwin range.
View source document for ISO 9001:2015 (opens in a new tab)What it supports
Documents the quality-management framework supporting the medical, hospital and veterinary equipment scope listed in the certificate.
Supports medical, hospital and veterinary procurement conversations with published quality-system evidence.
View source document for ISO 13485:2016 (opens in a new tab)What it supports
Connects the listed Sentwin equipment scope to the machinery directives named in the compliance document.
Supports model-level compliance conversations with a published equipment annexure and named directives.
View source document for CE compliance (opens in a new tab)Model-specific compliance
The equipment annexure identifies the product families referenced by the documents. For every enquiry, Sentwin can confirm which published document and listed scope applies to the quoted model.
