RFP QuestBeta
OpenStage · planning

The Common Services Agency (more commonly known as NHS National Services Scotland) ("NSS")

Quality Management System (MDR Compliance)

IT ServicesCPV 72000000
ValueValue not published
Deadline
Published11 May 2022
RegionNationwide

No value published

Who to contact
Ope Ore
ope.ore@nhs.scot
+44 7866157482

The procurement contact named on the official notice.

When this comes round again

The Common Services Agency (more commonly known as NHS National Services Scotland) ("NSS") publishes IT Services work continuously — 59 notices, roughly one every 9 days. This is a stream to watch, not a cycle to wait for.

91% of The Common Services Agency (more commonly known as NHS National Services Scotland) ("NSS")’s awards go to a supplier it has used before.

Which is the argument for getting on the list rather than winning this one. The incumbent is rarely the last winner — it is the roster. See the retention odds by category →


You'll hear when The Common Services Agency (more commonly known as NHS National Services Scotland) ("NSS") publishes IT Services work again. One email per notice, unsubscribe in one click. We don’t use your address for anything else.

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The brief

NSS occupies a unique place in the delivery of Health and Social Care across Scotland in that it manufactures (as defined by the MHRA), owns, manages, procures, maintains, uses, stores and disposes a large variety of Medical Devices (both hardware and software), which are subject to the UK Medical Device Regulations.

As part of the process to achieve and maintain compliance with the Regulations, a Quality Management System (consistent with ISO 13485) is required.

While the regulations do not define the nature of the Quality Management System (QMS), which may be paper based or electronic, NSS is interested in discovering available electronic QMS solutions that will complement the QMS processes.

Requirements

What the notice asks for

01

As part of the process to achieve

As part of the process to achieve and maintain compliance with the Regulations, a Quality Management System (consistent with ISO 13485) is required.

Sentences from the notice that state an obligation, surfaced automatically and shown in the order they appear. Not an exhaustive list — always confirm against the tender documents.

The gates

What this notice demands of you

1 named in obligation language, 1 mentioned. Each one is quoted from the notice.

ISO 13485 (medical devices)says mustStandards you certify to
As part of the process to achieve and maintain compliance with the Regulations, a Quality Management System (consistent with ISO 13485) is required.
MHRARegulator registrations
NSS occupies a unique place in the delivery of Health and Social Care across Scotland in that it manufactures (as defined by the MHRA), owns, manages, procures, maintains, uses, stores and disposes a large variety of Medical Devices (both hardware and software), which are subject to the UK Medical Device Regulations.

Matched against the notice text, so this is a floor — the tender pack will demand things the notice never mentions. “Says must” means the quoted sentence itself used obligation language; anything ambiguous is left as a mention.

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Source & provenance
OCID
ocds-h6vhtk-033665
Stage
planning · Planning
Source
Find a Tender
Buyer ref
012232-2022
View the original notice on Find a Tender

Contains public sector information licensed under the Open Government Licence v3.0. Source data © Crown copyright.

Market context

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