ISO Standards for Pharmacy Quality Management
ISO Standards for Pharmacy Quality Management
Standards
ISO
NATALIA LAFARGA LASALA • Pharmacist.
P
to certify the quality of your
establishment, the pharmacy-
tico must adhere to and implement in
Practice quality standards
of the International Organization of
Normalization, known as ISO
in its English initials. Currently
There are three useful ISO standards for the
pharmaceutical (9001, 9002 and 9003)
but these are being grouped in the
ISO 9000 standard that will govern plenarily
you from the year 2003. Until that
On this date, both models will coexist.
One of the most important changes
this new ISO 9000 standard is
that the language has been simplified with
thepurposeofthesmallones
companies, such as pharmacies, can
apply it without the need for help.
THE QUALITY
Over time, the product loses qualities. PREPARATION These 8 principles are:
without that person performing it
realize. For this reason, it is necessary- The simple preparation of the PNT Customer-focused organization.
It is necessary to use some pro- at the pharmacy it already implies a willingness to improve, Leadership.
protocols that guarantee and legalize the what is a quality reflection. Following Staff participation.
quality and that they are reviewed periodically this reasoning, at this moment, - Focus on processes.
Certainly to achieve an improvement one could blame the pharmacists – System approach towards the management-
continue. with a lack of quality consequence tion.
Quality management in the office from the current lack of standard protocols Continuous improvement.
of pharmacy is the set of activities- job applications. Quality without pro- Objective approach to decision making
controlled and coordinated by three there may be protocols of action, decisions.
unidades: el producto, la organización but it is easier for it to exist if it is- Mutually beneficial relationship
internal of the pharmacy and the process these protocols are broken. with the supplier.
aimed at meeting certain needs When it comes to establishing some proto-
of the client and of society in general. working colors, as a general guideline Following these 8 principles, the ofi-
These three sets of activities three should be considered primarily Pharmacy China may start to
they synthesize work blocks in the office- aspects: the first, that they must be to create their own PNT, which afterwards
pharmacy chain that must, in turn, blecerse PNT in writing for all the can certify. If the management system-
sectioning into normalization protocols actions that take place in the farm- The quality management is satisfactory.
two of work (PNT). hi; the second, that each area of the implanted mind and reflects how it
pharmacy must have at its disposal works at the pharmacy, it may not be
immediate form copies that with- additional documentation necessary
PROTOCOLS have the PNTs that correspond to them and to have the ISO certificate. No
WORK NORMALIZED in which all the functions are described however, it should be emphasized that the
ones that take place in that physical space. PNTs are never considered finalized.
The protocols will help to define the co; and the third, that modifies all of them since its very reason for being implies
different processes, to link some with PNT actions must be dated. periodic reviews.
others, to involve all personnel in Once prepared, the pharmacy
the responsibility of continuous improvement will be governed by these protocols, which will be
bare, to delimit the tasks and protocol periodically updated and always FOCUSED ORGANIZATION
for the cleaning and hygiene of the premises they will be in favor of quality and of TO THE CUSTOMER
and utensils, among other functions. client.
Without these protocols, the office of As innovation, the new standards
pharmacy cannot either certify or ISO incorporates in the first princi-
evaluate the quality of your services and quality source of the organization of the
nor certify it. This work also- customer-focused company.
national, whose development can be Pharmacies depend on clients
be a difficult obstacle to overcome, it you, and therefore, must understand
you have to contemplate it as a system
that in the long term will serve to cut Pharmacies must their present and future needs and
satisfy them. In addition, they must strive-
efforts and, therefore, for profitability succeed in exceeding their expectations.
the pharmacy and the work of the pharmacist
pharmaceutical.
strive to surpass For this reason, it is necessary to pre-
to ask what needs they have
The protocols must be "the book" clients both in terms of
of text" from the pharmacy office.
Its chapters should cover everything.
the expectations products as services, what
expectations that the pharma can offer them
the processes that occur in the office pharmaceutical and who has these needs
pharmacy chain: order entry,
treatment of faults, cleaning of each
of the clients of what it means to identify the dife-
rents types of clients. With the
one of the local departments response to these three questions can-
worker hygiene, tasks of each we must develop memory or policy
employee, complaints, etc. The of the pharmacy quality.
ISO standards must also be adopted. The key benefits that are obtained
in the role of health educators after this study of the clientele
what the pharmacists have. The pro- PRINCIPLES they are compiled in the ISO:
Protocols must remain written and
open so that they can be improved The new ISO standard manages quality- Increase in income and in the
two continuously. Dad based on 8 principles found- market share. Undoubtedly,
The PNT must always be easy mental. These principles are derived a pharmacy with ISO certificates
minds available as their indicates- of expert internal knowledge draw a greater share or possibility of
actions remember the way to proce- parties that participate in the committee open up market.
in every work block and ISO, which is responsible for developing It will improve the effectiveness of the far-
they may be necessary to make to the and keep the standards updated macia, understood as effectiveness
pharmacist reacting to which- ISO, which are made from the relationship between the results achieved
any eventuality. Thus, the processes global surveys. salaries and the resources used.
routines will be easier to Each of the 8 principles implies It will improve customer loyalty.
apply for being formalized. This a deep reflection on the way-
apparent rigidity of the protocols no to do and intend to study and The actions that must be taken to
it's real, as it has continuously been improve the current needs and cable to apply this first principle
to update and bring up to date. customers' futures. the following are:
Study and understand the needs these activities, one must not forget to happen with all the PNT, but
customer data. the review and self-inspection of everyone especially with the specific of
Ensure that the objectives and goals the PNT, including your own. each worker of the pharmacy.
from the pharmacy are oriented towards
the client. Human resources
–Communicatetheneedsand Participation The holder of the pharmacy office
customer expectations throughout the per- OF THE STAFF must decide and provide the resources
personal from the pharmacy. humans necessary to establish and
– Medir la satisfacción de los clien- The staff is the essential foundation of the protect the quality plan. Apart from
test and act according to the results. pharmacy office. You should feel a PNT for each employee, the office
– Manage systematically the valued for his work and must participate- The pharmacy must have a PNT.
customer relationships. by contributing to continuous improvement. of human resources that expresses and
Ensure balance between the satisfaction The "total involvement" of ensure the organization policy.
customer service and the entire environment of all staff, regardless Human resources aim to
the pharmacy (employees, supplied- of the level of qualifications held. Of objetivos:
res, local communities) and with the in this way, the set of the totality
society in general. dad of the capabilities of each individual Locate and meet the needs
duo can be used for the benefit of the of training.
company. Staff must be com- – Ensure the qualification of the
LEADERSHIP committed, engaged, and motivated. people.
For this, the opportunity must be offered to him/her. – Communicate the importance and the
The pharmacy owners unify to innovate, create, and promote impact of the work of each individual
the objectives of the pharmacy and direct actions in line with the objectives within the increase plan of the
your organization. The licensed pharmacist set by the holder or leader of the far- quality.
the one who acts as the leader of his farm- macia.
hi, within a management program The staff that works on the farm-
of quality, has the following quality plan and will obtain the
duties and responsibilities: following improvements:
personal what are the goals of the far- The quality plan supports the participation
macia and motivate him towards his consequence
ción.
already a will participation of all personnel and favors-
it is the continuous improvement of the company.
The idea of continuous improvement must
to be taught by example. to improve MANAGEMENT PROCESSES
The practical application of these
three points promote the following activities The work of the pharmacy must be sectioned
activities: to be born in processes and each process occupies
for a PNT. In each protocol there is
Establish a clear vision of Within the PNTs developed for some input elements that are
future of pharmacy. each person must be taken into account transformed into results. Frequent-
Set challenging goals and purposes. the following considerations: mind, these results become
– Consider the needs of The importance of their role and their in input elements of other pro-
clients, staff, local community and contribution to pharmacy. cesos. In this way all the proce-
society in general. Identify the limitations of your they relate to each other.
– Create ethical models of action work. Each pharmacy must plan and
at any level of the pharmacy and – Assume the acquisition of pro- listitsdifferentprocesses
that these be shared and internalized more and accept the necessary responsibility- depending on the characteristics of
saria would be enough to resolve them. each office. Some common processes
– Provide the staff with the resources Establish objectives and goals to all the pharmacies are, for example:
they are necessary for your training and personal and evaluate their performances
improvement. regarding these. PNT Order Management.
Give freedom to the staff to – Contemplate your knowledge and – PNT Placement of the genre.
act with responsibility and authority. actively seek a raise in your PNT Treatment of expirations.
Recognize the contributions of competencies and experiences. PNT Maintenance of devices.
personal. – Share the knowledge and – PNT Work of each employee.
freely experiences. – PNT Cleaning of the pharmacy, etc.
Like any other person who – Question the problems and the PNT Self-Inspection.
works at the pharmacy, the holder or leader solutions. PNT of each physical space of the
you must have your PNT immediately pharmacy (customer service area,
available at any time. The staff must identify themselves with consultations, laboratory, etc.).
this PNT will include the duties, the PNTs to the point that they continue
own responsibilities and activities without the need to think about them and without that Another type of protocols will be the
of the title or the titles. Inside of it is possible to separate from them. This has elaborated by the pharmacist as
Pharmaceutical care.
Correct preparation of magistral formulas.
Health promotion campaigns outside of pharmacy
CIA: conferences for groups, schools, the elderly, factories,
etc.
Implementation of the application criteria for acti-
preventive activities in this area, such as those described in
The White Paper for the Integration of Pre-Activities
ventilations in the Pharmacy Office, edited by the General
Council of Catalonia and the Council of Official Colleges of
Pharmacists from that autonomous community.
– Systematic health promotion campaigns since
the pharmacy: high blood pressure, obesity, physical activity
STDs, tobacco use, etc.
30PROFESSIONAL PHARMACY