Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
www.elsevier.com/locate/foodcont
Received 10 February 2006; received in revised form 28 June 2006; accepted 3 July 2006
Abstract
In this article we will review the planning and the implementation of a quality management system (QMS) according to ISO 9000 stan-
dards for a small-sized winery in Paros Island. Top Management of the organization seeks to gain all the internal and external beneWts
from the certiWcation of its QMS according to the requirements of the International Standard ISO 9001:2000 and also to increase the
share market and inWltrate into new markets. We will discuss the documentation of the QMS, the obstacles and the problems that the
organization faced during the implementation of the QMS, and the cost elements.
2006 Elsevier Ltd. All rights reserved.
0956-7135/$ - see front matter 2006 Elsevier Ltd. All rights reserved.
doi:10.1016/j.foodcont.2006.07.010
1078 D. Aggelogiannopoulos et al. / Food Control 18 (2007) 10771085
determinate whether they remain suitable for their applica- Quality, food safety and environmental management sys-
tion or if they need to be revised or withdrawn. At the tems in the food and drink industry, a combination of
annual meeting of ISOs Technical Committee 176 in 1990 it which, as well as with the support of the top management
was agreed that the series of ISO 9000:1987 should be of the organizations oVers an integrated system in the food
revised and that the revision should be done in two phases and drink industries that includes quality, productivity and
(Tsiakals, 2002). This approach was adopted because a safety of the products.
great numerous of organizations were familiar with the ISO 22000:2005 is a HACCP-type standard based on
1987 standards and would likely be resistant to major struc- and Wts very well with ISO 9001:2000 especially developed
tural changes. The results of these processes were a small to assure food safety. Total quality management (TQM)
revision of the ISO 9000 family in 1994 and a greater and and ISO 9000 focus more on management aspects and also
more important revision with major changes to structure aim to improve total quality. Furthermore, food manufac-
and content of the standards in the year 2000. After the tures are obliged by legislation to apply HACCP, while the
2000 revision ISO 9000 family consisted of the following other systems are applied voluntarily in the food industry.
three standards: ISO 9000:2000, ISO 9001:2000 and ISO The assurance of safe production and the supply of safe
9004:2000. ISO 9000:2000 is the general standard that food products appear to be the main aims of the food and
serves as an overall guide to the other standards. Its pur- drink industry. These aims can be attained by adopting a
pose is to provide deWnitions of terms and a basic explana- systematic and organizational structure, controlling activi-
tion of the ISO 9000 standards. ISO 9001:2000 consolidates ties, processes, procedures and resources according to the
the former ISO 9001/9002/9003 standards into a single doc- standards which constitute the basis for the quality and
ument and is the only standard to which certiWcation is cur- hygiene systems, including HACCP, ISO 9000 and 14000
rently assessed. ISO 9001:2000 is written for all types of series (Early, 1995). The implementation of a QMS, accord-
organization, including service organizations. DiVerent ing to ISO 9000 series in the Weld of food products, is
industries may have their own terminology, but the stan- related to ensuring quality procedures for the food compa-
dard is written using universal, generic terms. Whether an nies and reinforcing legislative requirements (Bolton, 1997).
organization is fabricating, assembling, manufacturing, Many food processing and packaging companies can
arranging, consulting, or providing services, it will beneWt start on the journey towards world class quality by building
from the implementation of the QMS requirements con- a solid structure using together GMP, HACCP and the ISO
tained in this standard. The 2000 version of ISO 9001 is 9000 family (Surak & Simpson, 1994). From this point of
written to be more user-friendly to small businesses and ser- view, the organization can add the principles of TQM
vice organizations and yet to remain useful to large manu- which include modern leadership and human resource prin-
facturing organizations. The standards generic controls ciples, customer focus, strategic planning, fact-based deci-
and terminology allow it to be used by all organizations; it sion making process, and modern process control
is not speciWc to any one particular organization. In all techniques. With this foundation the organization can
cases where ISO 9001:2000 was adopted by an organiza- incorporate a high quality strategy into their business that
tion, the QMS must be customized to Wt organization allows to enhance their competitiveness by continuing to
needs. ISO 9004:2000 provides further guidance for contin- improve the value towards their customers and by system-
uous improvement of internal quality management systems. atically improving all of the companys operational perfor-
The results of several studies showed that the most mances. These principles can eVectively transform the
important reasons for using the ISO 9000 family of quality company into a customer-driven organization which can
standards are: customer or marketing demands, needs for compete in the global marketplace.
improvement in process or systems, desire for global ISO 9001:2000 focuses on customers needs and expecta-
deployment and lack of focus inside the organization. The tions. One of the most important customer expectations is
adoption of a QMS according to the requirements of ISO to have safe food products. ISO 9001:2000 allows an orga-
9001:2000, should be a strategic decision of an organiza- nization to integrate its quality management system with
tion. The design and implementation of an organizations the implementation of a food safety system. The most com-
quality management system is inXuenced by varying needs, mon, in the food and drink industries, is the simultaneous
particular objectives, the products provided, the process operation of a QMS and a food safety system such as
employed and the size of the organization. HACCP. The application of HACCP within an ISO 9001
QMS can result in a food management system that is more
1.2. Management systems for the food and drink industry eVective than the application of either ISO 9001 or HACCP
alone, leading to enhanced customer satisfaction and
In the last decade, consumers have become very critical improving organizational eVectiveness (Sparling, Lee, &
about food quality and food safety due to several incidents Howard, 2001). In 2001, in order to facilitate the implemen-
of contaminated food (Spiegel, Luning, Ziggers, & Jongen, tation of HACCP and ISO 9001 in food and drink organi-
2003). In order to build and maintain the trust of consum- zations, ISO published ISO 15161:2001 which provided
ers in food quality and food safety, quality assurance and guidelines on the application of ISO 9001:2000 for the food
food hygiene is of major importance in the food sector. and drink industry. ISO 15161:2001 includes sourcing, pro-
D. Aggelogiannopoulos et al. / Food Control 18 (2007) 10771085 1079
cessing and packaging of food and drink products and it an external quality consultant who had the know-hows
explains the possibility to link the commonalities and the required for the design and application of the QMS.
communication between the two systems. It is important to
consider that ISO 15161:2001 is not a standard for the 3. Results
implementation of HACCP and cannot be a reference doc-
ument at certiWcation, but these guidelines are intended to The winery that is being examined, due to its small size,
provide a clear management system supporting HACCP has some particular characteristics which are presented in
controls for an eVective food safety system, under the rec- Table 1.
ognized framework of an ISO 9001 QMS. The eVective The development and the implementation of the QMS
integration of these two systems will improve the perfor- was the result of a well planned programme of procedures
mance of the organization and decrease the amount of with its Wnal goal the eVective operation of the quality system
paper work for the eVective operation of the systems. and its complete incorporation in the daily operation of the
Efstratiadis and Arvanitoyannis (2000) mentioned that organization. In Table 2 are presented the procedures that
HACCP as a part of a quality system not only manages to took place from the time that the top management decided
provide safety to the products, but also assure a better and to apply a QMS according to ISO 9000 family up to the cer-
more aVective implementation of the whole quality system. tiWcation audit that took place from an external registrar.
The new standard ISO 22000:2005 oVers an alternative to Top management plays the key role in ensuring that the
food enterprises that they do not implement ISO 9001 and QMS works as planned and applied. By its deWnition, it is
they want to have an eVective food safety management conWrmed that the QMS is a management responsibility. It
system. is conceived and driven by top management. The main top
The quality of the wine is usually related to the prod- managements responsibilities for an eYcient QMS are as
ucts appearance, acceptability, taste, Xavor, color and follows:
components (alcohol, acid), characteristics important for
consumer acceptance (Christaki & Tzia, 2002). Winemak- Top management shall be the recognized leader of the
ing is a very sensitive procedure and for that reason the QMS.
assurance of the quality during the whole processes is sig- Top management must create an environment in which
niWcant for the acceptance by the consumers. The imple- the QMS can be eVective.
mentation of a QMS according to ISO 9001:2000 and the Top management must assure compliance with a docu-
adoption of a food safety system such a HACCP in the mented QMS.
wine sector will provide a suitable frame to the organiza- Top management must supply the resources, training
tion to ensure the quality characteristics and the safety of and support for employees implementing the QMS.
the Wnal products. Top management must continually review the compli-
ance performance of the organization.
2. Materials and methods Top management must recognize the successful eVorts of
the workforce (Wilson, 2002).
The following case study covers a small-sized traditional
winery in a Greek island named Paros. The winery founded
Table 1
in 1917, occupies twelve permanent personnel while the Singularly characteristics of the organization
annual production of the organization does not exceed
Direct management from the chief executive (owner of the winery)
600,000 bottles of wine. Top management of the winery Instant contact between the personnel and the top management
seeking to improve the interior operation of the organiza- Simple and eVective system for internal communication
tion, to inWltrate in new markets and increase the market Short number of permanent personnel
share, decided that the implementation of a quality man- Great number of seasonal personnel
Great number of suppliers in grapes
agement system according to the requirements of ISO
Direct contact with the organizations customers
9001:2000 will yield the desirable results. None of the mem- Short-range planning
bers of the organizations top management had previous
experience in plan and design of a quality system and had
limited knowledge about the ISO 9000 family. The Wrst Table 2
action of top management was to purchase the three main QMS certiWcation process
documents which consists the ISO 9000 series (ISO 9000/ Decision making and commitment of the top management
9001/9004), to purchase ISO 15161:2001 which provides the Allocation of the available resources
necessary guidelines on the application of ISO 9001:2000 to Initial assessment of the organizations structure
IdentiWcation and analysis of the organizations processes
food and drink industry and to obtain as much more infor- Documentation of QMS
mation about ISO 9000 family. After a short period of time Training of personnel
top management realized that it was very diYcult to design Trial of the system for a small period
an appropriate quality system with the resources that were Internal audit
allocated to the organization, and for that reason they hired CertiWcation audit
1080 D. Aggelogiannopoulos et al. / Food Control 18 (2007) 10771085
determining whether a procedure needs to be documented dures according to the special needs of the organization.
is whether it must be in written form or not, for the proper Documented procedures of winerys QMS which are
operation of the QMS. Almost all organizations have deter- included into the quality procedures manual are presented
mined that some level of discretionary written procedures is in Table 4. All documented procedures of the winerys
necessary to consistently maintain the intended operation QMS are written in the same form. They include the scope
of the QMS. Procedures that aid in the deployment of the of the procedure, the Weld of application, the responsible
policies and objectives of the organization or the satisfac- individuals for the establishment, implementation, and
tion of the customers requirements and other interested maintenance of the procedure, the relevance to the proce-
parties, as well as regulatory requirements (i.e.: identiWca- dure documents and the analytic description of the proce-
tion and traceability), are obvious candidates for being pre- dure.
sented in written form. Documented procedures should In addition to the quality manual and the documented
always be written with the reader and user in mind and procedures that describe the overall processes of the
should use simple language. Most procedures should be rel- QMS, organization is speciWcally required to prepare
atively short documents and should include only informa- other documentation needed for control of processes.
tion that is relevant to the process being described. Every The type and extent of these documents is determined by
organization has the Xexibility to select the format and the organizations needs and special features. These doc-
structure of the documented procedures that best suit their uments are called work instructions. Work instructions
needs. Each procedure normally has administrative ele- are to be used by the workforce to aid in performing
ments to provide for document control. These normally detailed tasks. Since these tasks must be performed in the
include a title of the procedure, code number to identify the same manner each time, often with intervals between
document, revision status, editors name or signature and applications, written work instructions for proper perfor-
approval. For each of the documented procedure the writer mance are necessary. The extent of details in this type of
should answer the following questions: document is usually based on the training and experience
level of the personnel of the organization. Work instruc-
What is required to be done? tions should exist when the process is complex, when the
How will it to be done? skill level of the workers is low and when the absence of
Any special facility or equipment needed? such instructions would compromise the organizations
Who has the authority? ability to meet requirements. Similar considerations
Which records are essential? apply to the detail needed. If the process is simple and the
workers are highly trained, work instructions probably
Winerys top management besides the six mandatory need less detail. Top management of the winery decided
documented procedures has documented ten more proce- that due to the low skill level of its workers the work
1082 D. Aggelogiannopoulos et al. / Food Control 18 (2007) 10771085
Table 3
Processes map
Inputs Outputs Acceptance criteria Monitoring process control Performance indicators
Management responsibility
Process performance and Decisions on changes Solving customers Review of the QMS Maintenance of ISO
product conformity. of the QMS. Changes complaints. Achievement a time per year. 9001:2000 certiWcate
Results of audits. Results of the quality policy of quality objectives. Control of review for three years
from previous management and the quality objectives. Ascertainment of realization via
reviews. Nonconformities. Provision of resources. continual improvement proceedings. Control
Results from corrective and Corrective and of the QMS of supervisors
preventive actions. Customer preventive actions meetings via
feedback proceedings
Resource management
Needs of personnel training. Decisions for the realization Trained personnel. Monitoring and Number of trained
Maintenance needs of of training programmes. Calibrated monitoring control of realization personnel on the
plant facilities and Maintenance of mechanical and measuring devices of training programmes. total. Number of
equipment. Calibration equipment. Calibration of according to accredited Monitoring and control calibrated monitoring
and maintenance needs monitoring and measuring procedures. Maintained of calibration and measuring devices
of monitoring and devices and well functioning programmes. Monitoring on the total
measuring devices equipment and control of
maintenance
programmes
Ordering procedure
Customers requirements Customers orders. Schedule ConWrmation of telephone Monitoring and control Number of achieved
(by personal contact, of orders. Planning of orders. ConWrmation of orders from sales orders on the total
telephone or fax). Products product realization of orders via fax manager. Maintenance
lists and price lists for and control of the
services and products appropriate records
Purchasing
SpeciWcations and Receiving of raw materials, Purchased products Quality and quantitative Number of disqualiWed
characteristics of raw secondary materials and according to inspection of purchased products per purchased
materials, secondary packaging materials speciWcations products. Evaluation supply. Percentage of
materials and packaging and scoring of suppliers suppliers that has
materials. List of evaluated been marked as
suppliers excellent, on the
total of suppliers
Product realization
Customers requirements. Final products SatisWed quality inspection Monitoring of control Number of nonconforming
SpeciWcations and of Wnal products measures during products
characteristics of Wnal productive procedure
products. Work instructions and inspection of
production records
Sales distribution to customer
Final products. Distributions Orders. Distribution of On time distribution Quality and quantitative Number of customers
schedule. Accompanying Wnal products to to customers inspection of the order complaints as for the
documents customers before it is forwarded quality of products and
to the customer. the delivery time
ConWrmation by the
customer that received
the products in even
condition, and in the
determined time
Customer satisfaction
Contact between the customers Corrective and preventive Written down and Control of questionnaires Percentage of very satisWed
and the organization. actions. Resolved complaints. worked out customers sending. Evaluation of customers on the total of
Customers satisfaction SatisWed customers complaints answered questionnaires answered questionnaires
questionnaire. Customers by top management
complaints
instructions should in written form. Work instructions as description of the instruction. The written work instruc-
documented procedures; include the scope, the Weld of tions that consist the work instructions manual, are pre-
application, the responsible individuals and an analytical sented in Table 5.
D. Aggelogiannopoulos et al. / Food Control 18 (2007) 10771085 1083
management system according to ISO 9001:2000 require- The cost of the above actions was estimated at D10,000.
ments. Finally there was a cost of about D500, which included
Another obstacle was that of gaining workforce commit- the purchase of the ISO 9000 standards, and the interna-
ment to QMS implementation as the eVective systems tional standard ISO 15161:2001 Guidelines on the appli-
implementation requires the commitment and cooperation cation of ISO 9001:2000 for the food and drink industry.
of the workforce. To help gain this commitment, top man-
agement ensured that all employees were informed of how 4.3. BeneWts of the QMS
the QMS would beneWt them. Top management, informed
the personnel of how the QMS would help the organization QMS would help the organization in critical areas such
in critical areas such as the reduction of defective products, as the reduction of defective products, the improvement of
the improvement of internal communication, the increase internal communication, the increase of customers satis-
of customers satisfaction, the increase of share market and faction, the increase of share market, the opportunities for
the opportunities for inWltration in new markets. inWltration in new markets and global deployment. More-
over, implementation of the QMS gives additional beneWts
4.2. Cost of the QMS planning, establishment and to winery such as decrease of the cost of quality and mis-
certiWcation process takes; higher quality of the wine, waste reduced, late deliv-
ery reduced, productivity improved, returns down and
There were four factors that appeared to be the primary advertising potential. The understanding of these beneWts
concerns regarding the cost of the winerys QMS planning, will be the motivation force for the winery to continue its
establishment and certiWcation. The main elements which journey towards quality improvement.
constituted the total cost are the expenses of the quality
consultant, the training costs, the registration fees and the Acknowledgments
costs in employee time. Secondary elements that endorsed
the total budget were, among others, the investments in The authors would like to express their gratitude to the
equipment, the collaboration with exterior laboratories for owner of the winery for providing the appropriate informa-
conducting essential chemical analyses and some functional tion for the conduct of this case study.
modiWcations. As mentioned a quality consultant was hired
to assist the organization in the design and the establish-
References
ment of the QMS and also to conduct a ten hour seminar.
The cost of the consulting service was estimated at D10,000. Aldowaisan, T. A., & Youssef, A. S. (2006). An ISO 9001:2000 based
Registration fees were estimated at D6000. This amount framework for realizing quality in small businesses. Omega, 34, 231235.
included the registration cost of the CertiWcation Body Bergman, A. J. (1994). What the marketing professional needs to know
(D2000), and the cost of the initial audit (D4000). A great about ISO 9000 series registration. Industrial Marketing Management,
part of both registrations and consultants fees were cov- 23, 367370.
Bolton, A. (1997). Quality management systems for the food industry: A
ered, as reported, by the Greek Ministry of Development. guide to ISO 9001/2. London: Blackie.
Training cost was an important part for the total expenses Christaki, T., & Tzia, C. (2002). Quality and safety assurance in winemak-
of the QMS implementation. Training courses were con- ing. Food Control, 13, 503517.
ducted by the quality manager and external trainers. Early, R. (1995). Guide to quality management systems for the food industry.
The total training cost including trainers fees were esti- London: Blackie.
Efstratiadis, M. M., & Arvanitoyannis, I. S. (2000). Implementation of
mated at D4000. During the twelve months period that was HACCP to large scale production line of Greek ouzo and brandy: a
required for the QMS planning and establishment, winerys case study. Food Control, 11, 1930.
quality manager occupied exclusively to that purpose. For Ferguson, W. (1996). Impact of the ISO 9000 series standards on industrial
that reason qualitys manager annual salaries (D18,000), marketing. Industrial Marketing Magazine, 25, 305310.
were included to QMS design and application cost. The Geraedts, H. P. A., Montenarie, R., & van Rijk, P. P. (2001). The beneWts of
total quality management. Computerized Medical Imaging and Graph-
compliance to ISO 9001:2000 requirements obliged the ics, 25, 217220.
organization to invest in new equipment and to make some Hooper, J. (2002). The process approach to quality management systems.
functional modiWcations. The organization realized the fol- In C. A. Cianfrani, J. J. Tsiakals, & J. E. West (Eds.), The ASQ ISO
lowing actions: 9000:2000 handbook (pp. 1116). Milwaukee: ASQ Quality Press.
ISO (2000). International Standard ISO 9000:2000. Quality management
systems Fundamentals and vocabulary. Geneva: ISO.
Upgrading of the Wre Wghting system. ISO (2000). International Standard ISO 9001:2000. Quality management
Improvement of the lighting system. systems Requirements. Geneva: ISO.
Upgrading of the winerys laboratory. ISO (2000). International Standard ISO 9004:2000. Quality management
Establishment of programs for the elimination of rats systems Guidelines for performance improvements. Geneva: ISO.
and insects. ISO (2001). International Standard ISO 15161:2001. Guidelines on the
application of ISO 9001:2000 for the food and drink industry. Geneva:
Purchasing of working clothes and equipment for the ISO.
safety of the personnel. Pallet, A. J. M. (1994). ISO 9000 the companys viewpoint. Food Technol-
Collaboration with an external laboratory. ogy, 48(9), 6062.
D. Aggelogiannopoulos et al. / Food Control 18 (2007) 10771085 1085
Sparling, D., Lee, J., & Howard, W. (2001). Murgo Farms Inc.: HACCP, Surak, J. G., & Simpson, K. E. (1994). Using ISO 9000 standards as a qual-
ISO 9000, and ISO 14000. International Food and Agribusiness Manage- ity framework. Food Technology, 48(9), 6365.
ment Review, 4, 6779. Tsiakals, J. J. (2002). The need for change and the two-phase revision
Spiegel, M., Luning, P. A., Ziggers, G. W., & Jongen, W. M. F. (2003). process. In C. A. Cianfrani, J. J. Tsiakals, & J. E. West (Eds.), The
Towards a conceptual model to measure eVectiveness of food quality ASQ ISO 9000:2000 handbook (pp. 6372). Milwaukee: ASQ Quality
systems. Trends in Food Science and Technology, 4, 424432. Press.
Stevenson, T. H., & Barnes, F. B. (2002). What industrial marketers need to Wilson, L. A. (2002). The quality management system. In C. A. Cianfrani,
know about ISO 9000 certiWcation: a review, update, and integration J. J. Tsiakals, & J. E. West (Eds.), The ASQ ISO 9000:2000 handbook
with marketing. Industrial Marketing Management, 31, 695703. (pp. 107128). Milwaukee: ASQ Quality Press.