Organisation Name and Address
Company Name:
CliniSys
Company Address:
Two Bridges Guildford Street Chertsey KT16 9AU
Contact Name:
Mark Smith
Email:
[email protected]
Telephone:
01932 581200
Fax:
Product or service details
Product/Service
Details:
Model/ Item Number:
LIMS
WinPath version 7 & 5
PathManager
Interfaces to automation/EPR/CyberLab/traceability
systems
SUPPLIER AUDIT QUESTIONNAIRE
QUESTION
Do you currently hold any Quality Accreditation?
YES
Yes
NO

Yes

Yes

Yes

Are staff appropriately qualified and trained to carry out
procedures correctly?
4. Internal Quality Audits
Yes

Are there procedures in place for planned quality audits?
Yes

Is there a review of the effectiveness of your governance
systems to ensure data integrity and traceability?
Yes

QF-GEN-SUPPAUDQ1 v2.1
Page 2 of 5
Please detail:
Inspection Body: ISOQAR
Accreditation Number/Reference: 3733
Date of last inspection: Oct 2014
Outcome: Successful
1. Quality Policy
Is there a quality policy in place?
2. Organisation
Are all responsibilities clearly defined?
3. Training
Are there systems in place for training?
QUESTION
YES
NO
Yes

Yes

Are there documented procedures for the processes?
Yes

Are there any process / quality controls?
Yes

Is there a formal release process?
Yes

Is there a unique batch documented for each batch?
Yes
Are certificates of analysis available?
Yes
5. Purchasing
Is there a procedure in place for the control/assessment of
suppliers, including verification of supplier’s/manufacturers
bona-fides?
Does this procedure define actions to be taken when dealing
with suppliers that do not meet the requirements?
6. Process Control
Have critical steps of the processes/premises and production
and any significant changes been validated?
Are records of manufacture including distribution retained in a
comprehensible and accessible form?
QF-GEN-SUPPAUDQ1 v2.1
Yes




Page 3 of 5
QUESTION
YES
Yes
NO
7. Process Change Control
Yes
Is there a documented procedure in place for change control to
processing and materials used?


Are there procedures for the investigation of non-conformances
and documentation of corrective actions?
8. Recall
Yes
Yes

Yes

Yes


No

No
Is there a procedure for the recall of a product?
Is the effectiveness of the recall system regularly tested?
Are complaints about products examined, the causes of quality
defects investigated and appropriate measures taken in respect
of the defective product and to prevent reoccurrence?
9. Handling, Storage and Delivery of the product
Are these stages controlled to maintain product quality?
Is the temperature monitored during transport?
If Yes, how/when is this reviewed and how are OTC events
actioned?
(detail below)
QF-GEN-SUPPAUDQ1 v2.1
Page 4 of 5
QUESTION
YES
NO
Yes

10. Do we have your permission to share this questionnaire
with the Joint TAG on the London & SE Coast RTC website?
http://www.transfusionguidelines.org.uk/
Additional Comments
Please provide an explanation or brief description to any answers that were
marked “NO”:
Questionnaire completed by: Mark Smith
Position:
Client Services Manager
QF-GEN-SUPPAUDQ1 v2.1
Date:
07/11/2014
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