Standards Database

ISAS-QMS Pharma-2010
Schweizerischer Apothekerverband - Société Suisse des Pharmaciens - Società Svizzera dei Farmacisti - Swiss Association of Pharmacists

The QMS-Pharmacy label (ISAS QMS-Pharma 2010) is aimed at all pharmacies desiring to continuously improve the quality of their services.The basic QMS-Pharmacy label is composed of 4 parts forming the framework of an original quality program designed for community pharmacists. This program is otherwise modular, and the base requirements described here will be able to be completed in the future by regional or national matrices (modules) describing the quality of benefits in a more specific and specialized manner. The normative requirements of the QMS-Pharmacy quality program presupposes that the legal requirements of the country concerned are being respected, in particular those concerning the official criteria of the sanitary police and any work laws (that is to say, those pharmacies already possessing an official practicing license).


Part 1: Requirements concerning structure and work procedures

These norms are of two types:

·Requirements concerning the internal structure and organisation of the pharmacy. These comprise the modern elements of management strategy, adequate resources in terms of equipment, the handling of stock and clients, and the management of personnel in terms of the availability of assistants and the means necessary to guarantee good working conditions.

·Requirements concerning all working procedures applied to the pharmacy. These include the elements of internal organisation of the job, the national and international recommendations concerning the pharmacy’s practices and the appropriate usage of medications, the documentation of pharmaceutical activities, the assurance that the pharmacy’s personnel possesses the necessary knowledge, the adequate utilisation of the information and the material intended to help patients/clients in the continuous improvement of pharmaceutical benefits.


Part 2: Basic pharmaceutical service requirements
These norms concern 3 types of requirements :
·The norms required in the validation of medical prescriptions. These define in particular the elements of security in delivery, the patient’s information and the utilization of medications prescribed by doctors.
·The norms required concerning the distribution of medication without a prescription (OTC) or an evaluation of symptoms in the pharmacy.They define in particular the elements of security in the evaluation of risks in the pharmacy, the patients’/customers’ information and the usage of medications on sale without a medical prescription.
·The norms required in the case of any communication between a patient/customer and a member of the pharmaceutical team.These are based on the following fundamental principal: the patient/customer is the centre of the pharmaceutical team member’s attention.

Part 3: Client satisfaction requirements·
The required norms in the case of an enquiry into customer satisfaction.These measure in particular the degree of satisfaction concerning the layout of the pharmacy, the attitude of the team, and its available benefits.


Part 4: Procedures concerning audits and labeling
The QMS-Pharmacy audit is performed uniquely by accredited certification units. The audit looks at the application and respect of the norms described in parts 1, 2, and 3 above. In the circumstance that a defined quality level is attained, a QMS Pharmacy label will be delivered, which will be considered valid for a period of 2 years. The QMS-Pharmacy program is founded on the national and international standards of good pharmaceutical practices. These are codified by the Swiss Association of Pharmacists under the form of a referential guide, which is kept and maintained by ISAS. It is compatible with the majority of reference guides existing in office organisations matter and most notably the series of norms ISO 9000-2000.


This Database contains only a summary.
If you want to access the complete information,
you need to become an ISAS Member.

« Go back