Quality Management Workshop: Feedback on ISO Certification in a Pharmaceutical Technology Unit

A workshop on certification was organised during the Gerpac European conference, held in Giens (France) in October 2016. The aim of this workshop was to discuss and share experiences about the ISO certification of pharmaceutical technology units in the framework of the hospital global certification process.

In April 1996 the certification process was introduced to our health system and has progressively found its place in French hospitals [1]. This external and independent procedure concerning the quality of services of a hospital and its trustees is performed by health professionals mandated by the French health authority (HAS) [2]. Those health experts based their inspection on the manual edited by this health authority [3]. This referential allows evaluating the global functioning of the health institution. Other independent certifications being part of a voluntary process are also applicable to our public and private hospitals, like the ISO 9001 norm [4, 5] for example, which defines the organizational requirements needed for a proper management system. This process has a 3 year validity and is organized as shown in Figure 1.

Figure 1:

Certification steps in France concerning ISO certification in hospitals.

Thanks to their expertise in terms of certifications inside their pharmaceutical technology unit certified ISO 9001: version 2008 for about 10 years, the experts invited to chair the workshop have been able to analyze the specificities of each of these certifications and to highlight the benefits of agreeing to an ISO 9001 process.

A survey launched inside the workshop attendees allowed us to highlight the fact the participants were involved in a HAS certification process inside their health institute, complying with requirements launched in 2014 (V2014), but only 1/3 of the workshop attendees had simultaneously started an ISO certification process, and only one institute was certified in compliance with the new ISO version.

A concrete enlightening on the norm on the new requirements launched in 2015 (V2015) allowed us to showcase to the participants the possible benefits in terms of quality management concerning preparation units:

Multiple examples are based on the appropriation of the requirements concerning knowledge and technique management:

1. using an initial and continuous training plan for the medical and paramedical staff,

2. Implementing annual interviews of the medical staff,

3. assessing annual records on knowledge and skillset with a defined progression plan and training, created and dispensed by the teams themselves,

4. management commitment with the definition of risks and opportunities related to the current system,

5. definition of processes including the customer,

6. subcontractor and concurrent interfaces,

7. optimization and continuous improvement.

Most questions reported by the pharmacists were about the numbers of people and the time spent to do this quality activity and how to involve the directors in this quality approach. The relative part of health institutes having already started the two certification processes shows the difficulties and challenges represented by motivation of directions and operational teams. However, seventy-five percent of the participants revealed that the examples proposed by the experts where instantly applicable inside their pharmaceutical technology units.

In conclusion, the sake of the ISO process in terms of valorisation of quality for preparation activities appeared as a key element, especially concerning the development of subcontracted preparation activities [6]. Experts also identified different common points related to the convergence of the exigencies relatives to HAS and ISO certifications, thus emphasizing the interests of such processes in pharmaceutical technology units. A future workshop fully devoted to the new ISO certification standards in its 2015 version has been proposed.