European inspection of quality of the services ISO 9001:2008 (audit of 2013)
21 August 2013
Audit report
about application of auxiliary reproductive technologies
for the organization of work of clinic according to standards
ISO 9001:2008
and embryological office according to standards
ISO 15189:2007
1. Scope and objective of the audit
The main objective for this audit was to provide the organisation with an informal assessment of the establishment. During a full day visit procedures and routines, both clinical and
laboratory was audited.
Providing good clinical service is a huge task and sometimes after many years of practice it
is difficult to see the small things that can contribute to overall improvement. The audit aims
to assist in the finding of areas of improvement and each finding is followed by a
recommendation of improvement.
The elements of practice was described to the auditor by the clinic representative and the
work instructions and Standard Operating Procedures (SOPs) were spot-checked on site by
interviewing the employees, watching the work processes and review of documents.
Date/place of audit: 12th July 2013
Auditor: Dr. Cecilia Sjoblom, Scientific Director, Westmead fertility
Centre, A/Professor University of Sydney, Lead Auditor
Audit language: English
Conflict of Interest
The auditor has no ownership or other beneficial (financial or otherwise) connection to any
company or product recommended in this audit report.
2. Involved staff of the Organisation
During the audit the clinic representative, medical director Victoria Zaletova and embryologist Helen Zacharova
accompanied the auditor and were available for questions and discussions that took place on
site.
3 Statements about the ART Centre
General statements about the Centre and the carried out audit
MAMA IVF Centre is a large centre.
The visit is a follow up from the initial visit in April 2012, with the aim to see how and if clinics
have implemented any changes.
During the audit the aspects of quality assurance were reviewed.
4 Main Audit Report
Facilities
There have been no major changes to the facilities since my last visit apart from an
amazing cleaning effort, making the lab look as a new place!
Embryology practices
During the visit I had the opportunity to witness most procedures in the lab.
The majority of procedures in the lab has not changed since the last visit.
QA / QC and Risk Management
Every day system generates a type of daily work list where all patients with embryos in incubators are listed. Also all clinical histories are registed and aviliable for monitoring.
The laboratory has extended the quality work and the process map is now much more
extensive. Each process has a document controlled SOP written at a set format with
contents including scope, method, quality control etc. Very impressive SOP work!
The clinic has introduced a very good system for the monitoring of KPI’s.
The outcome of the KPI monitoring is discussed at monthly meetings.
5 Overall summary
It was a true pleasure to come and inspect MAMA IVF Centre. I was very well looked after
during the day and enjoyed our discussions and exchange of experiences. The team working
in the clinic, doctors, nurses, embryologists and other staff all join in to create a friendly and professional environment for the patients.
Sydney, July 2013