Case Studies

FERTILITY ASSOCIATES

The Company

Fertility Associates is New Zealand’s largest provider of fertility services, operating three clinics in Auckland, Wellington, and Hamilton, along with regular clinics in all major cities in the North Island. Its treatments of male and female infertility include IVF (in vitro fertilisation), ICSI (intracytoplasmic sperm injection), donor sperm, donor egg, ovulation induction, insemination using the partner’s sperm and microsurgery.

The company has also pioneered a number of other advances in the IVF area, including successful embryo freezing, egg and embryo donation, sperm microinjection and identifiable sperm donors.

Good quality management systems are critical for companies dealing in reproductive technology, which is why Fertility Associates opted in 2006 to certify all of its operating processes and procedures to ISO 9001 standards. The company’s group operations manager, Dr John Peek, traces his company’s journey to ISO 9001 and the benefits it has produced.

ISO 9001

“In 1990, Fertility Associates voluntarily sought accreditation to the Australia’s Reproductive Technology Accreditation Committee (RTAC), but by the early 2000s a number of leading IVF clinics worldwide were looking beyond technical accreditation to ISO certification and we opted to join them. IVF laboratories have often chosen to be certified to the medical laboratory standard ISO 15189 only, but we went a step further to ISO 9001 because it covers all aspects of the organisation. However, we sought this extra certification because of the discipline we expected it to provide rather than to correct specific problems.”

Why Telarc?

“We employed Telarc because of its prominent position in the New Zealand accreditation market and were encouraged by Peter Rose’s support as its CEO.”

The Benefits of Partnership

Implementation benefits

“Our Telarc auditor worked with us to improve the organisation in areas where it had put less focus (e.g. purchasing, internal customer satisfaction). He challenged our approach by providing examples of how other companies did it. He asked questions about our management reviews and if and how those reviews resulted in improvements. This is very important to us because we have three clinics with parallel medical, embryology, nursing, counselling and administrative teams, with lots of within-clinic and cross-clinic meetings.

“Of particular value was the auditor’s suggestion that we decentralise our management reviews and make them the responsibility of local management teams as a way of improving operational efficiency. Now that we are moving in that direction, our auditor prods us to keep thinking about what management reviews mean to us and how to perform them more effectively.

“With our auditor’s encouragement, we have formally trained 20 staff in Root Cause Analysis (RCA) and will soon be training our internal auditors in facilitative auditing. As a result of the latter, we expect our internal auditors to spend more time on discovering why gaps in our systems occur, not only where they occur.”

Certification benefits

“Most of the elements of an effective quality management system were already in place at Fertility Associates before we sought ISO certification—for example, good team coordination, good mechanisms for reviewing and improving clinical practice. What ISO certification has given us, however, is:

• A better appreciation by staff and managers of the value of our quality system and acceptance of the work needed to maintain it;
• A pride in knowing that we have a good quality system;
• Appreciation of the value of internal auditing and the reassurance it gives staff in their day-to-day work.

“It is very easy for an organisation full of health professionals to focus on the technical side of the operation and to postpone non-clinical activities when the workload increases. Certification provides our company with a discipline that goes beyond the technical aspects of IVF work to encompass management reviews and comprehensive internal auditing. In essence, Fertility Associates has embraced ISO 9001 as a tool for self-improvement.”

Why ISO 9001?

ISO 9001 is the most commonly used international certification standard. It provides a framework that enables businesses to develop and implement their own effective quality management systems for the manufacture and supply of virtually all products and services.

September 2008

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