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


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


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