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Association QUALITY MANUAL

"Club 9000" Section 0


CONTENTS
Sofia

ASSOCIATION "CLUB 9000"

Address:
Sofia 1000
Post Box 431
G.S. Rakovski str. 108
phone./fax: 02 980 4910,
GSM 089 828 10 05
E-mail: club9000@sbline.net
www.club9000.org

QUALITY
MANUAL
According to БДС EN ISO 9001:2008

APPROVED:
Chairman
of Managing Board : ………………

(Doc. d-r Katerin Katerinov)

Enters into force: 15.05.2012

Sofia, 2012
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Association QUALITY MANUAL
"Club 9000" Section 0
CONTENTS
Sofia

SECTION NAME PAGE


0 CONTENTS 2
1 QUALITY POLICY AND OBJECTIVES STATEMENT 3
2 PRESENTATION OF THE ASSOCIATION "Club 9000" 5
3 TERMS AND DEFINITIONS 7
3.1 Terms and definitions 7
3.2 Terms and definitions, adopted by Association „Club 9000” 8
4 QUALITY MANAGEMENT SYSTEM 9
4.1 General requirements 9
4.1.3 Process based model of QMS 10
4.1.4 Sequence/ Interactions of Quality Management System Processes in 11
Association "Club 9000"
4.1.5 List of QMS processes in Association „Club 9000” 12
4.2 Documentation requirements 16
5 MANAGEMENT RESPONSIBILITY 18
5.1 Management commitment 18
5.2 Customer focus 18
5.3 Quality policy 19
5.4 Planning 20
5.5 Responsibility, authority and communication 21
5.6 Management review 23
6 RESOURCE MANAGEMENT 25
6.1 Provision of resources 25
6.2 Human resources 25
6.3 Infrastructure 26
6.4 Work environment 26
7 PRODUCT REALIZATION 28
7.1 Planning of product/service realization 28
7.2 Customer-related processes 28
7.3 Design and development 30
7.4 Purchasing 30
7.5 Production and service provision 31
7.6 Control of monitoring and measuring equipment 33
8 MEASUREMENT, ANALYSIS AND IMPROVEMENT 34
8.1 General 34
8.2 Monitoring and measurement 34
8.3 Control of nonconforming product/service 36
8.4 Analysis of data 36
8.5 Improvement 37
9 ANNEXES 39
9.1 List of QMS documents 39
9.2 List of forms to the Quality Manual 39
9.3 Organizational chart of Association "Club 9000" 40

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"Club 9000" Section 1
QUALITY POLICY AND OBJECTIVES STATEMENT
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QUALITY POLICY AND OBJECTIVES STATEMENT


of the Managing Board of Association „ Club 9000”
Dear customers and partners,
Dear members of the Association,
Dear employees,
Driven by our desire to strengthen the Association "Club 9000" as a leading organization in
the country to promote and support the implementation and maintenance of various management
systems in accordance with recognized international standards, the Managing Board developed,
documented, implemented, maintains and continually improves the Quality Management System
(QMS) for organizing and conducting of training, management of its information activities
and conducting events, related to dissemination of knowledge and practical experience in
management systems.
Managing Board developed and strengthened its policy on quality and popularizes it to be
understood, meaningful, applied and continuously improved by the employees of the Association
and all interested parties of its prosperity.
The Managing Board declares its readiness and determination to carry out activities for public
benefit and to provide its members and customers with products and high quality services that meet
their expectations and requirements and use them in their daily operation, maintenance and
continuous improvement of the management systems.
Quality policy of the Association is focused on:
● recognition of the Association as a national leader in promoting management systems by
increasing the satisfaction of our customers from the products and services provided to them;
● involvement in the managing bodies and teaching staff of most - erudite and distinguished
specialists in various management systems, and through realization of their leader skills to ensure
high professionalism and expertise in marketing our products and services;
● involvement of all members of the Association in implementing the quality policy and
objectives to expand its influence in society and in business circles as a national leader;
● achieving desired results through effective implementation of process approach in carrying
out the activities of the Association and the realization of the provided products and services, as
well as by applying a systematic approach;
● continual improvement of the maintained quality management system and evaluation of its
effectiveness by periodically conducting internal audits and management reviews;
● collecting, processing and analysis of other information (including customer satisfaction)
to enable the General Assembly and the Managing Board to make informed, competent and
effective decisions, that allow customers and members of the Association to form additional
benefits and to add value to the effective functioning of the managing systems implemented by
them;
● establishing of lasting and mutually beneficial relationships with its suppliers and partners
to provide high quality products and services;
● improving the quality of the provided products and services and increasing the customer's
and members' satisfaction by implementing training programs of the European Organization for
Quality - EOQ.

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QUALITY POLICY AND OBJECTIVES STATEMENT
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To realize the quality policy, the General Assembly sets Guidelines and based on them the
Managing Board approves the annual Program of activities and targets that are announced on the
website of the Association and are available to the public.
To implement the quality policy and objectives the Managing Board
DECLARES
its commitment to provide the necessary financial and human resources for maintenance, efficient
operation and continual improvement of the implemented Quality management system in
accordance with the requirements of BS EN ISO 9001:2008 and its responsibility for carrying out
the activities of the Association, including those for public benefit, in accordance with all
applicable laws and regulations of this country.

14.05.2012,
Sofia Chairman of Managing Board:
/К. Katerinov/

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„Club 9000“„ PRESENTATION OF ASSOCIATION Section 2
Sofia „CLUB 9000”

Association "Club 9000" is a national non-political professional creative non-profit


organization, whose goals and activities are designed to help business and society (hereinafter
"Club 9000").
As an NGO "Club 9000" defines its mission to work for the promotion of the modern
systems for management of quality (ISO 9001:2008), environment (ISO 14001:2004), occupational
health and safety (BS OHSAS 18001: 2001) and food safety (ISO 22000/HACCP), etc. in
accordance with the recognized international standards, of integrated management systems and to
assist businesses in implementing these systems in their daily practice by providing relevant
training and scientific and technical information at high professional level.
"Club 9000" informs and assists its members in respect of the activities of certification,
accreditation, standardization, metrological assurance, as well as other activities of the national
quality infrastructure.
Association "Club 9000" was founded on 05.02.1991 by 16 individuals and 10 legal
entities.
In 2011 the Association was registered to carry out activities for public benefit within the
meaning of the Law for Non-Profit Organizations.
Association "Club 9000" sees its mission to actively support the economic operators for
their successful operation in terms of membership in the European Union through the promotion of
quality management systems and other management systems.
The policy and the objectives of Association “Club 9000”, set out in the Statute, are aimed
at providing its members, customers and stakeholders with high quality products and services, that
meet their expectations and requirements. To achieve the objectives in Association “Club 9000”, a
quality management system is implemented and functions effectively in accordance with the
requirements of ISO 9001:2008, intended for organization and provision of training, management
of information activities, organization and conducting of events for dissemination of knowledge
and practical experience about various management systems.
To implement the policy and quality objectives Association “Club 9000”:
• provides timely and proactive business information on the latest international and national
standards, legislation, contemporary approaches and practices. "Club 9000" issues a periodic
newsletter with the latest information and a series of "Library" Club 9000 Consults" with the
current original and translated materials, annual "Quality Guide" and provides other useful business
thematic issues;
• organizes and conducts annual National Quality Conference, dedicated to the world day
of quality under the patronage of the Minister of Economy and Energy, in conjunction with
executive authorities and other organizations;
• organizes and provides training for acquisition of lasting knowledge, specific experience
and competence to successfully implement practical activities in the organizations. Association
"Club 9000" organizes and conducts targeted seminars, specific thematic courses for centralized
and corporate leadership training, management representatives, internal auditors, work teams and
professionals for development and implementation of management systems and implementation of
related practical tasks;
• provides opportunities for professional cooperation and assistance - delivers the necessary
information and facilitates contacts between professionals and businesses with consulting,
certification, governmental and other organizations of the national quality infrastructure.
Association "Club 9000" maintains and constantly improves the information in the website of the
association: www.club9000.org

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Sofia „CLUB 9000”
• implements forms for stimulating organizations, successfully implemented modern
management systems and disseminates their experience, by granting the annual award "Prize for
Quality of Association Club 9000";
• Association “Club 9000” assists the formation of national quality policy in order to elevate
the role and importance of quality and thus, to ensure the competitiveness of the Bulgarian
economy.
Association "Club 9000" achieved fruitful cooperation and interaction with authorities and
organizations in the country, concerned with quality, environment, health and safety, etc.
"Club 9000" is an associate member of the Federation of Scientific and Technical Unions,
member of the Bulgarian Chamber of Commerce and Industry and the Bulgarian Industrial
Association.
On international level the Association "Club 9000" as a non-profit organization is a
candidate to become official representative of the Republic of Bulgaria to the European
Organization for Quality - EOQ.
"Club 9000" realizes active cooperation with:
- Executive bodies - the Ministry of Economy, Energy and Tourism, Ministry of
Environment and Water, Ministry of Defense, Ministry of Health, Ministry of Regional
Development and Public Works, Ministry of Agriculture and Food, Ministry of Labor and Social
Policy,
- Bulgarian Institute of Metrology, Bulgarian Institute for Standardization, Executive
Agency "Bulgarian Accreditation Service", State Agency for Metrological and Technical
Surveillance,
- Union of metrologists in Bulgaria Union of Quality Specialists in Bulgaria, the
Bulgarian Union of standardizers and other NGOs,
- Certification bodies and consultancy organizations, companies and professionals -
members of the Association, as well as foreign organizations and experts.
During its 20-year hystory Association "Club 9000" has worked to the benefit of its
members and society, and implemented policy to meet their requirements and expectations. In this
way the Association has established itself as an authoritative non-governmental organization with
its own place, own identity, reputation and popularity.
The membership of "Club 9000" includes more than 80 organizations and over 400
professionals from various sectors of national economy.
The managing bodies of Association "Club 9000" are the General Assembly, the Managing
Board and Controlling Council with responsibilities specified in the Statute of the Association.
From 1991 to 1997, Chairman of the Board was Mr. Ivan Zapryanov and from 1997 to 2010
- Ms. Maria Zoeva.
The activity of Association "Club 9000" is controlled by Supervisory Council, elected by
the General Assembly, which operates under the Statute and prepares relevant information for the
Managing Board and the General Assembly.

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“Club 9000” Section 3
TERMS AND DEFINITIONS
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3.1. TERMS AND DEFINITIONS

The terms and definitions used in the documents of the Quality management system are
according to БДС EN ISO 9000:2007 and БДС EN ISO 9001:2008, the main ones being:
Quality management system – management system to direct and control Association "Club
9000" with regard to quality.
Quality policy – overall intentions and direction of Association "Club 9000" related to quality
as formally expressed by top management.
Quality objective - something sought, or aimed for, related to quality.
Management review – activity taken to determine the suitability, adequacy and effectiveness of
the subject matter to achieve established objectives.
Process - set of interrelated or interacting activities which transforms inputs into outputs
Outsourced process, - a process required for QMS of Association "Club 9000" which the
management selected to entrust its implementation to external party.
Product – result of a process.
Service – result of at least one activity necessarily performed at the interface between the
supplier and customer and is generally intangible.
Supplier – organization or person that provides a product.
Requirement – need or expectation that is stated, generally implied or obligatory.
Inspection – conformity evaluation by observation and judgment accompanied as appropriate
by measurement, testing or gauging.
Correction - action to eliminate a detected nonconformity.
Corrective action - action, taken to eliminate the cause of detected nonconformity) or other
undesirable situation.
Preventive action - action, taken to eliminate the cause of potential nonconformity or other
undesirable potential situation.
Audit – systematic, independent and documented process for obtaining audit evidence and
evaluating it objectively to determine the extent to which audit criteria are fulfilled.
Effectiveness – extent to which planned activities are realized and planned results achieved.
Efficiency - relationship between the result achieved and the resources used.
Customer satisfaction – customer's perception of the degree to which the customer's
requirements have been fulfilled.
Procedure – specified way to carry out an activity or a process.
Document – information and its supporting medium.
Quality manual – document specifying the quality management system of Association “Club
9000”..
Documented procedure means that the procedure is created, documented, applied and updated.
Record – document stating results achieved or providing evidence of activities performed.

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TERMS AND DEFINITIONS
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3.2. TERMS AND DEFINITIONS ADOPTED BY „CLUB 9000”


Top management – group of persons managing and controlling the Association "Club 9000" at
the highest level (the Managing Board, Executive Director, Organizer Marketing, Management
Representative for QMS).
Interested party - person or group having an interest in the performance or success of Association
“Club 9000” - society, partners, personnel, members of Association “Club 9000” (legal entities or
individuals, sharing the objectives and accepting the Statute of the Association) kept in up-to-date
list by the Technical Secretary and other legal entities and individuals.
Work documents (Statute, internal rules, instructions, plans, projects, programs) – documents,
describing activities or operations specific to Association “Club 9000”.
Form (blank) - document used to record data required by QMS.

Abbreviations:
Desig- Desig-
Name Name
nation nation
УС Managing board РО Regional organization
Chair- Chairman of the Managing board КРО Coordinator of regional organization
man of “Club 9000
ИД Executive director КС Controlling Council
ПР Management representative for Personnel Executive Director (ИД), employees in
QMS "Club 9000", Coordinator of regional
organizations (КРО) (Responsible
persons for implementation of QMS
processes)
ОМ Marketing Organizer ОБЗР Responsible for occupational health
ТС Technical Secretary and safety
ВО Leading auditor ЕО Audit team
СНИ Monitoring and measurement
equipment

СУК Quality management system НК Quality manual


КД Corrective actions П Procedure
ПД Preventive actions Ф Form
Club Association “Club 9000” НД Normative documents (standards,
9000 statutory and regulatory acts)

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4.1. GENERAL REQUIREMENTS


Association "Club 9000" has developed, documented, implemented, maintains and
continually improves the effectiveness of a Quality management system (QMS), in accordance with
the requirements of БДС EN ISO 9001:2008, as part of the overall management strategy of
Association “Club 9000”.

4.1.1. Scope of the Quality management system


1. Association "Club 9000" has developed and implemented Quality management system
for organization and conducting of training on management systems, promotion of management
systems by implementing information, publishing activities and conducting events, related to
quality and other management systems. QMS is applied in all units of the organizational structure
of Association "Club 9000".
2. For the implementation of the activities in Association "Club 9000", the necessary
structural units shown in the organizational structure of the Association "Club 9000" have been
established (Section 9 - Appendix 9.3).
3. The processes necessary for the operation of QMS include processes, related to the
activities for:
• management;
• provision of resources;
• product realization;
• measurement, analysis and improvement.
In each group of processes various processes, sub-processes and activities, specific and
characteristic for Association "Club 9000" as a nonprofit organization for public benefit are defined
and described. These processes are specified in 4.1.4. The requirements and responsibilities for
their implementation are described there and the criteria and methods to assess their effectiveness
are specified.
For each process the management has specified
• Person responsible for the process with the responsibility and authority to implement,
maintain, manage and improve;
• criteria and methods in the documents of QMS necessary to ensure the efficient operation
and management of these processes.
4. The sequence and interaction of processes, defined in the Flow chart of the sequence and
interaction of processes in the Association "Club 9000" (Section 4 - paragraph 4.1.3) procedures
and work documents.
5. The management provides information and resources necessary for operation and
monitoring of QMS processes.
6. The QMS processes are monitored, measured and analyzed at defined stages of their
implementation. When deviations from the requirements are found, timely adjustments, corrective
and preventive actions to achieve planned results and continual improvement of processes are
taken, in accordance with procedures П 5 "Corrective Actions" and П 6 "Preventive actions".
7. The procedures and documents required for the management of QMS processes are
developed and implemented and are shown in Annex 9.1.7.
8. Association "Club 9000" uses outsourced processes, related to:
• provision of translation services;
• implementation of publishing and distribution of information products;
• preparing the design of printed editions;
• maintenance of the website of Association “Club 9000”;
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• maintenance of office equipment;


• healthcare and risk assessment for occupational health and safety;
• courier services.
The management of these processes is carried out in order, regulated in the Quality Manual,
Section 7 paragraph 7.4 "Purchasing" and does not free Association "Club 9000" from
responsibility for the conformity of products and services with customer and regulatory
requirements.

4.1.2. Exceptions
The following requirements of БДС EN ISO 9001:2008 are excluded from the scope of
QMS:
• 7.3. Design and development - Association "Club 9000" does not carry out product design
and development activities.
• 7.5.2. Validation of processes for production and service provision - Association "Club
9000" does not implement processes for realization and provision of products and services
with output that cannot be verified by subsequent monitoring or measurement (special
processes).
• 7.5.1-f. In the part “the implementation of product … post-delivery activities” - products
and services provided by Association "Club 9000" do not require post-delivery activities.

4.1.3. Process based model of QMS

CONTINUAL IMPROVEMENT
OF THE QUALITY MANAGEMENT SYSTEM

Management S
a
responsibility t
C i C
U s
R f U
S e Measurement,
Resource a S
T q analysis, c
u management T
O improvement t
i i
O
M r M
o
E e n E
R m Input Product Output
e R
S n realization Product S
t
s

- value adding activities


- information flow

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4.1.4 Flow chart of the sequence and interaction of processes in the Association "Club 9000"
Processes of measurement,
analysis and improvement
Evaluation
Management processes Monitoring and mea-
Corrective and Control of of
surement of processes
Determining quality preventive nonconforming Customer
Internal satisfaction
policy and objectives actions product
audits
Resource Management
Analysis of data
management review

Main processes for realization and


provision of products and services Conducting of Certificates for
training completed
normative documentation

training
requirements, needs,

external processes
product, services,
Customer related
CUSTOMER

product, service

Purchasing of

CUSTOMER
Research and

realization of
Planning of
marketing

satisfaction
processes

Information activity, Monitoring and


publishing activity Printed matter measurement of
products and services

Organization of events Events in


related to quality and public benefit
management systems

Auxiliary processes
Control of Control of Control of monitoring and
documents records measuring equipment

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4.1.5. List of the Quality Management System processes in Association "Club 9000"
Evaluation of efficiency of operation
Process Regulating Responsible
and process management
document person
Name Input Output Criteria Methods
І. MANAGEMENT PROCESSES
Conducting internal
audits and management
review.
Implementation of the
Communicated and Monitoring of
Long term objectives of quality policy.
understood by the staff implementation of the
Association “Club 9000”, Implementation of planned
documented policy and Programs for the QM, Section 1;
Determination of customer requirements, quality objectives. Chairman of
measurable quality activities of Association Section 5 -
quality policy interested parties and Improving the economic Managing
objectives for relevant „Club 9000" and the paragraph 5.3
and objectives applicable normative efficiency of the activity of Board
functions and levels and plans of the regional and.5.4
documents, results from Association "Club 9000",
specific tasks to achieve organizations.
audit and QMS reviews. compared to previous
them. Analysis of planned and
periods.
achieved goals.
Annual report of income
and expenses.
Decisions for: improving Implementation of the Conducting internal
Documents and records the efficiency of the planned objectives and audits. Chairman of
Management QM, Section 5-
from the application of processes and QMS, quality policy. Reports and analyses of Managing
review of QMS paragraph 5.6
QMS products and services; Number of improvements effectiveness of QMS Board
needs of resources. to QMS and processes. processes.
Implementation of the
budget. Implementation of
Provided resources for
the requirements for Conducting internal
Human, financial and implementing, maintaining Executive
Resource qualification for the audits.
material (infrastructure) of QMS and improving its QM, Section 6 Director
management corresponding job. Analysis of the
resources. efficiency and customer (ИД)
Implementation of the effectiveness of training.
satisfaction.
planned training.

ІІ. MAIN PROCESSES FOR REALIZATION AND PROVISION OF PRODUCTS AND SERVICES

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% Increase in provided Conducting internal
QM, Section 7- Organizer
Research and Implemented products New customers, ne products and services, audits. Analysis of
marketing and services services and products compared to previous economic results.
paragraph 7.2, marketing
П7; П 8 (ОМ)
periods. .
Evaluation of efficiency of operation
Process Regulating Responsible
and process management
document person
Name Input Output Criteria Methods
Quality objectives, Conducting internal
Documents for processes,
Planning of product/service Implementation of the audits and management QM, Section 7- Executive
required for
product/service requirements, planned quality review. Analysis of paragraph 7.1, Director
product/service
realization documentation policy/objectives. economic results П7; П 8 (ИД)
realization.
requirements. .
Budget implementation. Analysis of economic
Identified requirements to
% increase of provided results and customer QM, Section 7- Organizer
Customer related Needs, requirements to product/service,
products/services. satisfaction. paragraph 7.2, marketing
processes product/service information on customer
Degree of customer Conducting internal П7; П 8 (ОМ)
satisfaction.
satisfaction. audits.
% orders executed in time,
Analysis of the results of
compared to the total
inspection of purchased
Required products, Products, services and number.
products, services and
services and external external processes, from Reducing the number of Executive
external processes. QM- Section 7-
Purchasing processes, identified approved suppliers, nonconforming purchased Director
Evaluation of suppliers. paragraph 7.4
requirements to them, conforming to identified products, services and (ИД)
Conducting internal
suppliers. requirements. external processes
audits.
compared to previous
.
periods.
Realization and Needs and requirements Completed and delivered Reducing the number of Monitoring and control in
provision of of Customers, interested products and services, nonconforming products providing product /
products and parties and normative complying with the and services, compared to service. QM, Section 7- Organizer
services - training, documents, infrastructure, identified requirements the total provided number. Analysis of customer’s paragraph 7.5, marketing
information applicable documents to and customer’s and Degree of customer applications П 7, П 8 (ОМ)
activities and product/service, interested parties’ satisfaction. implementation and
events related to competent staff. expectations. Implementation of the customer satisfaction.

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quality and annual budget. Conducting internal
management audits.
systems. .

Evaluation of efficiency of operation


Process Regulating Responsible
and process management
document person
Name Input Output Criteria Methods
Requirements to products
Monitoring and Products and services Number of claims and Analysis of monitoring
and services, QMS QM, Section 8- Responsible
measurement of conforming to identified signals, due to incorrect and measuring results.
documents for products paragraph 8.2.4, for the
products and requirements and inspection of the Conducting internal
and services, resources П 7, П 8 process
services normative documents. product/service. audits.
for inspection.
ІІІ. PROCESSES OF MEASUREMENT, ANALYSIS AND IMPROVEMENT
Information from customers
Decisions for
Evaluation of about meeting the Degree of customer Conducting internal Organizer
improvement of QM, Section 8-
consumer expectations, results from satisfaction. audits and management marketing
processes, products and paragraph 8.2.1
satisfaction the analysis of data, % increase of the provided review. (ОМ)
services.
claims. products and services.
Number of conducted
corrective and preventive Manage-
Objective evidence for Conducting internal QM, Section 8-
actions, implemented ment
Internal audits Audit criteria and functioning and audits and management paragraph.2.2,
functioning QMS maintenance of QMS.
improvements of QMS and
review. П3 representa-
processes according to tive (ПР)
results of internal audits.
Analysis of
Monitoring and QMS processes, Evidence for process Percentage of defective nonconforming products QM, Section 8- Responsible
measurement of requirements, planned capability to achieve the products / services due to and services. paragraph 8.2.3, for the
processes results. planned results processes. Conducting internal П 7, П 8 process
audits
Avoiding the use and Analysis of
Control of Established products / Number of claims from QM, Section 8- Responsible
delivery of nonconformities.
nonconforming services not conforming customers and interested paragraph 8.3, for the
nonconforming Conducting internal
product/service to the requirements. parties. П4 process
product/service. audits.

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Updated data and Manage-
Number of improvements,
Implemented QMS. analyses of QMS,
corrective and preventive Conducting internal QM, Section 8- ment
Analysis of data Records from QMS submitted to the
application. management for decision
actions as a result from audits. paragraph 8.4 representa-
analysis of data. tive (ПР)
making.
Evaluation of efficiency of operation
Process Regulating Responsible
and process management
document person
Name Input Output Criteria Methods
Implementation of the
Conducting internal Manage-
Effective corrective corrective actions in the
audits. QM, Section 8-
Corrective Found noncompliance actions, preventing determined deadlines. ment
Analysis of corrective paragraph.5.2,
actions with the requirements. nonconformity Percentage of effective representa-
actions at the management П5
recurrence. corrective actions against tive (ПР)
review.
the implemented ones.
Implementation of the
Conducting internal Manage-
Effective preventive preventive actions in the
audits. QM, Section 8-
Preventive Potential noncompliance actions, eliminating the determined deadlines. ment
Analysis of preventive paragraph.5.3,
actions with the requirements.. cause of potential Percentage of effective representa-
actions at the П6
nonconformity. preventive actions against tive (ПР)
management review.
the implemented ones.
ІV. AUXILIARY PROCESSES
Use of current and valid Manage-
Conducting internal
Developed, implemented Updated documents documents. QM, Section 4-
Control of audits. ment
and maintained available in the There shall be no paragraph 4.2;
documents Evaluation of process representa-
documents of QMS. workplaces nonconformities due to П1
effectiveness. tive (ПР)
documents.
Approved and Availability of sufficient Manage-
implemented documents Completed and well data for analysis and QM, Section 4
Control of Conducting internal ment
of QMS and available maintained record from implementation of paragraph.4.2;
records audits. representa-
applicable normative the application of QMS. corrective and preventive П2
documents. actions.. tive (ПР)
Control of Requirement for Determined monitoring, Monitoring and Conducting internal QM, Section 7- Manage-
monitoring and monitoring and methods and measurement appropriate to audits. paragraph 7.6 ment

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measuring measurement of the main measurements. specific processes and representa-
equipment processes of QMS. products - tests, tive (ПР)
questionnaires.

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"Club 9000" Section 9
ANNEXES
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4.2. DOCUMENTATION REQUIREMENTS

4.2.1. General
The documentation of QMS in Association “Club 9000” includes:
• documented and announced statements of quality policy and objectives (Statement -
Section 1);
• Quality Manual;
• documented procedures, according to the requirements of БДС EN ISO 9001:2008
(Annex 9.1);
• documents, necessary for effective process planning, implementation and control in
Association “Club 9000” – work documents (Statute, procedures, internal rules, instructions, plans,
projects, programs, etc.);
• external documents and records used in implementation of activities –
- normative documents (national and international standards, normative acts – laws,
regulations), created by legislative or other authority, applicable to the activities,
provided services and products of Association “Club 9000”;
- documents and data, provided by suppliers, subcontractors of outsourced processes,
customers and interested parties;
• records from QMS operation, including forms, according to the requirements of БДС
EN ISO 9001:2008 and the applicable normative documents.
Hierarchical documents structure of QMS is given in the procedure П 1 “Control of QMS
documents”.

4.2.2. Quality Manual


The Quality Manual (QM) is basic QMS document, including:
• QMS scope, including details and evidence about exclusions;
• documented quality policy of Association “Club 9000” and references to documented
procedures and work documents;
• description of the interaction between the QMS processes and responsibility for their
realization.
QM serves as guidelines for the activities of the staff of Association “Club 9000”, related to
quality management and to demonstration of current QMS to customers, auditors and other
stakeholders, in order to create confidence that it complies with БДС ЕN ISO 9001:2008 and
Association “Club 9000” is able to provide quality products and services.
QM was developed by work group approved by the Managing Board and endorsed by the
Chairman of the Managing Board of Association “Club 9000”.
QM is done in nine sections and their scope is visible in the Contents.
QM distribution, archiving and amendment are done under the procedure П 1 “Control of
QMS documents”.
Every year the Management Representative conducts complete QM review and proposes
expedient amendments.
Quality Manual as a primary document of the Quality management system is mandatory
for all staff of Association "Club 9000".

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4.2.3. Control of documents
In the management of the QMS documents and to achieve confidence that at any time in
Association “Club 9000” only valid documents are used and applied, the order regulated in the
documented procedure П 1 “Control of QMS documents " is applied, including :
• approval of documents for adequacy by the Chairman of the Managing Board before
their distribution;
• review and updating, if necessary and re-approval of documents;
• ensuring identification of the changes and the valid versions of documents;
• ensuring, that at the points of use the relevant versions of applicable documents are
available;
• ensuring that documents remain legible and readily identifiable;
• ensuring that documents of external origin, identified by Association “Club 9000” to be
necessary for the planning and operation of the quality management system are
identified and their distribution is controlled;
• preventing the unintended use of obsolete documents, and applying suitable
identification to them, if they are retained for any purpose.
The form and the structure of the QMS documents are determined, and the accepted
designation allows unambiguous determination of the hierarchical level of the document and the
documents of higher-level with which it is related.
The order for archiving the documents and the access to them are determined, which
excludes intentional or unintentional interference in their control. The distribution of QMS
documents is realized in electronic environment.
Information about the actuality of the applicable regulations for the operation of "Club
9000" is maintained and the staff is informed timely about the requirements.

4.2.4. Control of records


In order to control the records, created to demonstrate compliance with requirements and
the effective operation of QMS, the documented procedure П 2 “Control of records” is applied.
The types of records of the Quality management system are given in the Quality manual,
procedures and working documents and are defined so as to be sufficient to monitor and
demonstrate the performance and the outcome of the processes.
The type, structure and content of the forms, intended for records, are developed, approved
and amended in accordance with the order, indicated in the procedure П 1 “Control of QMS
documents”.
The order and the requirements for control of records are applied for creation, identification,
storage within a specified time, protection from damage and loss, accessibility, preservation and
disposal of records.
The records can be in paper or electronic format and requirements are set for them to remain
legible, readily identifiable and accessible.

5.1. MANAGEMENT COMMITTMENT


The top management of Association "Club 9000" is committed to the development and the
implementation of the Quality management system (QMS) and to its continual improvement, as it:
• communicates to the personnel of Association “Club 9000” the significance of
satisfying the requirements and expectations of customers and other interested parties, as well as
the requirements of the normative acts, issued by legislative body or other authority;

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• ensures and guarantees management of activities and processes in Association “Club
9000” in full compliance with and strict observance of the above mentioned legislative and
regulatory framework;
• determines, documents and reviews for adequacy the quality policy of the Association
“Club 9000” in the order shown in Section 5 - paragraph 5.3 of HK;
• guarantees that quality objectives are defined in accordance with Section 5, paragraph
5.4 of HK and that they are in accordance with the mission of Association “Club 9000” ;
• plans and conducts management review at regular intervals and evaluates QMS status
and effectiveness in accordance with the requirements set out in Section 5, paragraph 5.6 of HK;
• provides the necessary resources for maintaining and continual improvement of QMS
and its processes, according to Section 6, paragraph 6.1 of HK;
• requires the application of QMS documents in the operations of Association “Club
9000” and encourages their maintenance and improvement by the personnel.
The Management Board plans and organizes the activities of Association “Club 9000” in
accordance with the approved statute and the Rules for activities in public benefit and for raising
and spending of property of Association "Club 9000". Records of the meetings of the Managing
Board shall be kept according to the procedure П 2 "Control of records".

5.2. CUSTOMER FOCUS


The overall activity of the Association is directed to satisfy the expectations and
requirements of customers and other interested parties.
The top management has provided:
• order for reception of inquiries and requests, identification of client requirements and
measures for their implementation - Section 7, paragraph 7.2 of HK;
• maintaining regular contacts and participation in joint events with Government, NGOs
and other organizations for the benefit of the members of Association “Club 9000” and the
society as a whole.
All QMS documents are designed to ensure the best identification and implementation of
the requirements of customers and interested parties in order to increase their satisfaction from the
performed activities, including provided services and delivered products.
Regular feedback is maintained with customers and interested parties in order to confirm the
implementation of their requirements and to evaluate their satisfaction, in accordance with the order
of Section 8, paragraph 8.2.1 of HK.

5.3. QUALITY POLICY


Top management guarantees that the quality policy, documented in the Statement of the
Managing Board (HK -Section 1) is appropriate and consistent with the mission and long term
objectives of Association “Club 9000”, with the main directions for development of the
Association, aimed at continuous improvement of its activities and quality of the delivered products
and provided services.
The quality policy includes commitment of the top management to meet the requirements
and expectations of customers and interested parties in compliance with applicable normative
documents, to continually improve the effectiveness of QMS.
The Quality policy of the Association provides a framework for establishing and reviewing
the long and short term quality objectives.
1. The overall activity of Association "Club 9000", of its Managing Board, Coordinators of
the regional organizations and partners is aimed at promoting various management systems and at
provision of high quality services - providing training, information and publishing activities,

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organization and conducting of events, in order to achieve maximum satisfaction of our members
and customers - the organizations developing, implementing and maintaining various management
systems in line with recognized international standards. We strive not only to meet the requirements
to our services, but also to respond to their expectations of professional and responsible delivery of
training, up-to-date information and various events on national level, related to the continuous
improvement of the management systems, implemented by our customers.
2. In our quality of leaders in promoting management systems, we adhere to the highest
standards of professional conduct. The members of "Club 9000" seek to elect in the Managing
Board of Association “Club 9000” the leading and recognized experts in various management
systems, to provide thus the required collective expertise and the leadership of the collective
managing body, guaranteeing the implementation of the policy and quality objectives of the
Association. The Managing Board elects the regional Coordinators among the acknowledged
experts in quality management and other management systems and active members of the
Association, to provide through their leadership skills serious representation and participation of
organizations from different regions in the conducted events. The aim of the Board is through the
selection of regional Coordinators to expand the representation of the regions, to increase the
influence and the appeal of the Association. The Managing Board approves in the composition of
the Committee on the annual award "Prize for Quality of Association Club 9000" renowned experts
in this field to ensure professionalism, impartiality and trust when ranking the candidates. The
managing Board includes in the teaching staff well known and knowledgeable experts on various
managing systems to guarantee and secure by realizing their leadership skills professionalism and
competence in the offering of our products and services.
3. The Managing Board upon implementation and realization of the quality policy and
objectives seeks to engage in the quality management not only employees under labor contract, but
also to use in its activities the collective mind of the members. The trust that we conquered among
our members and customers is the key to our success as an Association and as individuals.
4. In order the Managing Board of the Association to function efficiently it carries out and
controls a number of interrelated activities. To achieve the desired result the Managing Board
applies the process approach and has identified the processes, needed for the QMS operation, as
well as their sequence and interaction.
5. Beside the process approach the Managing Board strives to apply also the systematic
approach in its work.
6. The continual improvement of the developed, documented, implemented and maintained
QMS, in accordance with the requirements of ISO 9001:2008 is a major concern of the Managing
Board of the Association. Periodic conducting of internal audits of the system and management
reviews provides objective information on the effectiveness of its operations and identifies
opportunities for continual improvement in accordance with the constantly increasing requirements
and expectations of our customers to the delivered products and services.
7. The Managing Board of the Association collects processes and analyzes different
information in order to make correct, informed and effective decisions, ensuring the presence of the
Association in the corresponding market segment and providing the necessary revenues for its
operation. The management of the Association presents timely much of this information to the
General Assembly and to its members and customers, in order to realize more fully its mission to
promote the various management systems. Thus, the Association supports its members and
customers to form additional benefits and to add value by maintenance and continual improvement
of the implemented management systems, and creates preconditions for increasing their
satisfaction.
The managing Board seeks to build lasting and mutually beneficial relationships with its
suppliers to ensure high quality of products and services. Particular attention is given to the
requirements in the selection of teaching staff to ensure their competence and to guarantee the
customers' satisfaction from the delivered products and services.
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The quality policy is communicated, explained and understood by the staff of "Club 9000"
and is examined and evaluated for adequacy during QMS reviews by the management in
accordance with Section 5, paragraph 5.6.
The staff is trained and required to work actively for the practical implementation of the
announced policy and to comply with the requirements, stipulated in the documents of the QMS.
The revised Statement of the Managing Board on quality policy and objectives of
Association "Club 9000" is managed in accordance with П 1 “Control of QMS documents”.

5.4. PLANNING

5.4.1. Quality objectives


Top management defines quality objectives consistent with policies, including those needed
to meet requirements to the activities carried out and the products and services provided, at two
levels:
• long run objectives of Association "Club 9000" formulated in the Statute of Association
“Club 9000”;
• annual general objectives of Association “Club 9000”, set forth in "Guidelines for the
activities of Association" Club 9000 "and approved by the General Assembly.
Based on this the Executive Director and the Management Representative develop specific,
short-term and measurable objectives in the annual Program of activities and targets of Association
“Club 9000”, taking into account:
• the status of implementation of the requirements of members, customers and interested
parties;
• the requirements of applicable normative documents for products, services and activities
of Association “Club 9000”;
• opportunities for improvement;
• results of internal and external audits and management reviews of QMS, according to П
3 "Internal Audit" and Section 5, paragraph 5.6 of HK;
• the results of the analysis of data from the implementation of QMS (Section 8 paragraph
8.4);
• implemented corrective and preventive actions, according to П 5 "Corrective Actions"
and П 6 "Preventive actions";
• suggestions of the staff and the regional Coordinators for improvement of QMS
processes and products in accordance with customer requirements.
Short-term quality objectives are planned, along with evaluation criteria and specific
objectives for their achievement, the required financial resources, time and responsible persons for
their implementation and are approved by the Managing Board.
To achieve the objectives, the Coordinators of the regional organizations plan specific tasks
in the annual plan of the regional organizations, which is adopted by the General Assembly of the
corresponding regional organization.
The achievement of the objectives is accounted for in the management review of QMS
(Section 5 paragraph 5.6) and at the General Assembly of Association “Club 9000”. The Executive
Director and the Management Representative continuously monitor and report the implementation
of the quality objectives to identify areas for improvement.

5.4.2. Planning of QMS


Top management ensures that:
• the planning of QMS is carried out in order to meet the requirements for the defined
processes of QMS and to continually improve its effectiveness in accordance with the
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requirements of БДС EN ISO 9001:2008, and thus to achieve the quality objectives of the
Association;
• system integrity is maintained when planning and implementing changes to QMS in the
process of its continual improvement.
The planning of the QMS is carried out during:
• the annual determination of guidelines for the activities of Association “Club 9000”;
• the identification of the processes needed for QMS, including external processes and their
application to all structural units of the "Club 9000";
• ensuring the availability of resources and information necessary for the operation and
monitoring of QMS processes;
• the identification of quality objectives and the annual management review;
• the implementation of the actions necessary to achieve planned results and continual
improvement of QMS, its processes and documentation.

5.5. RESPONSIBILITY, AUTHORITY AND COMMUNICATION

5.5.1. Responsibility and authority


The organizational structure of Association "Club 9000" shows the management structure
and functional relationships to implement the processes, identified as necessary for the operation of
QMS. Top management has defined responsibilities and authority in the structural units of
Association “Club 9000” and ensured their communication.
The Management Board decides on the opening and closing of regional offices of
Association “Club 9000” on the territory of Republic of Bulgaria. Regional organizations are
established by the General Assembly of the members of the corresponding region.
The management bodies of Association "Club 9000" are the General Assembly, the
Management Board and the Control Council. Their responsibilities are specified in the
Statute of the Association "Club 9000".
The main responsibilities and powers of the Managing Board of Association “Club 9000”
related to the operation of QMS are:
• adopts a program for the activities of Association “Club 9000” and directs its
implementation;
• determines the order and organizes the activities of Association “Club 9000” for public
benefit;
• determines the order, organizes activities and makes decisions on all operational issues
in implementing the policies and goals of Association “Club 9000”;
• implements and controls the economic activities of the Association;
• prepares and adopts regulations and other internal documents, regulating the activities of
Association “Club 9000;
• reviews the operation of QMS and evaluates its effectiveness;
• prepares and submits to the General Assembly report on the overall activity of
Association “Club 9000”.

The CHAIRMAN of the Managing Board:


• organizes the work of the Managing Board and the implementation of its decisions and
the resolutions of the General Assembly;
• is responsible for the maintenance, efficient operation and continual improvement of
QMS;
• approves regulations and other internal documents regulating the activities and processes of
Association “Club 9000”;
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• concludes contracts with the Executive Director and other employees of Association “Club
9000” after corresponding decision of the Managing Board.

The EXECUTIVE DIRECTOR is responsible for implementing the overall activity of


Association “Club 9000” for implementation of the policy and achievement of the quality
objectives, as follows:
• develops and organizes the implementation of the Program of activities of Association
“Club 9000” for the calendar year;
• ensures the achievement and implementation of the approved indicators of
Association’s budget;
• creates conditions for social development of the staff in Association “Club 9000” and
for improvement of the working conditions;
• manages the activities related to the maintenance, efficient operation and continual
improvement of QMS;
• provides the necessary material, financial and human resources for the effective
operation of the quality management system, to achieve the objectives of the Association and to
ensure customer’s stakeholders.
The Chairman of the Managing Board acts as Executive Director when no Executive Director
is appointed.
The COORDINATORS of the regional organizations implement policies and objectives of the
Association in the corresponding regions, such as:
• operate under the Rules for activities and financing of regional organizations and the
signed contracts;
• coordinate the activities of the regional organizations to achieve quality objectives and
implement annual work program of Association “Club 9000”;
• apply the documents of QMS and offer improvements.
Responsibilities and powers of the officials of the structural units of the Association and
the persons responsible for the processes are defined in the documents of QMS, the Rules of
internal order, Orders of the Executive Director, Job descriptions and in the labor contracts.

5.5.2. MANAGEMENT REPRESENTATIVE, appointed by order of the Executive Director has


the authority and responsibility to:
• ensure that processes needed for QMS operation are determined, established,
implemented and maintained
• supervise the implementation, maintenance and continual improvement of the
effectiveness of QMS, in accordance with the requirements of БДС EN ISO 9001:2008;
• ensure that the awareness of the importance of customer requirements from the entire
staff of Association “Club 9000” is encouraged;
• report to the top management on the performance of QMS and about.

5.5.3. Internal communication


Internal relationships are defined in the organizational structure of the Statute of
Association “Club 9000”, Rules of internal order and in job descriptions.
The Executive Director and the Management Representative promptly inform the staff of
Association “Club 9000” for:
• The quality policy and objectives;
• visions for the future development of Association “Club 9000”, organizational and
structural changes, tasks and programs to improve work, role and tasks of the staff for their
implementation;
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• the requirements of the position held and the responsibilities arising from the QMS;
• ongoing work with customers and interested parties to study their requirements and
expectations;
• changes in applicable normative documents and documents of QMS;
• operation of QMS, the results of internal audits, management review and decisions.
Internal communication is done through meetings, conferences, workgroups, training,
distribution of documents, fixed and mobile telephone network, subject to the internal order in
Association “Club 9000”.
The staff of Association "Club 9000" participates in the process of improvement of QMS,
making suggestions for improvement, corrective and preventive actions..

5.6. MANAGEMENT REVIEW

5.6.1. General
The top management of Association "Club 9000" plans and conducts a comprehensive
review of the QMS at least once a year, in order to ensure its continuing suitability, adequacy and
effectiveness. At the management review of QMS the opportunities to improve QMS, its processes
and documentation, including quality policy and objectives are evaluated.
The review is conducted in accordance with Order of the Executive Director, which defines
the deadlines and those responsible for preparing the information on the inputs.
The records from management reviews are completed in a protocol and stored in accordance
with documented procedure П 2 "Control of Records."

5.6.2. Input for the review


Inputs for the management review of QMS include information on:
• implementation of short-term quality objectives and verification of the quality policy for
adequacy;
• results of QMS audits and evaluation of the work of the internal auditors;
• feedback from customers and interested parties on their satisfaction (surveys, etc.), and
signals, claims, etc.;
• performance and efficiency of QMS processes, including outsourced ones;
• compliance of purchased and provided products and services and evaluation of
suppliers;
• evaluation of the conducted staff trainings;
• status of preventive and corrective actions taken;
• verifying the actions from previous management reviews;
• changes that could affect the QMS;
• recommendations for improvement.
The Management Representative and the persons responsible of processes, with the
assistance of the Coordinators of the regional organizations analyze and report on the inputs for the
management review of QMS and present it to the top management.

5.6.3. Output from the review


Top management reviews and analyzes the information, makes decisions and determines
appropriate actions, related to:
• improving the effectiveness of the QMS and its processes;
• improving services and products in accordance with the requirements and expectations
of customers and interested parties;
• competence of the staff, including the internal auditors;
• resources needed for the functioning of processes and QMS.
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All findings, recommendations and decisions as a result of the review are documented in a
protocol.
Decisions of the management review of the QMS manual are included in the "Guidelines
for the activities of Association" Club 9000 ", which are approved by the General Assembly.
The Management Representative distributes the documented decisions from the review to
the responsible persons and monitors their implementation.
6.1. PROVISION OF RESOURCES
The top management "Club 9000" determines plans and provides material, human and
financial resources required for:
• implementing and maintaining the QMS and continually improving its effectiveness;
• increasing the satisfaction of customers and interested parties, fulfilling their requirements.
Financial resources are determined with the adoption by the General Assembly of the
Association's annual budget prepared by the Executive Director based on the submitted
information, membership fees and necessary expenses for carrying out activities for public benefit
and provision of products and services. Necessary funds for the activities of regional organizations
are provided in accordance with the Rules for activities and financing of regional organizations.
Implementation of the budget for revenues and expenses is reported annually to the
Managing Board and the General Assembly of Association “Club 9000”.

6.2. HUMAN RESOURCES

6.2.1. General
The management of Association “Club 9000” provides competent staff on the basis of
appropriate education, professional training, skills and experience. With its work the staff affects
the compliance of the products and services with the customer requirements.

6.2.2. Competence, training, awareness


The Executive Director with the assistance of the Management Representative:
• Determines the in the job descriptions the required competence of the personnel, performing
work having an impact on the compliance with the product / service requirements. Job
descriptions are updated periodically, at least in three years, depending on the changes of
the objectives and processes in Association “Club 9000”;
• Provides appropriate training or takes other actions to achieve the necessary competence of
the personnel;
• Helps staff to realize the significance and importance of the activities performed and how
they contribute to the achievement of quality objectives;
• Prepares information for the management review about the effectiveness of training or
about other actions taken to achieve the necessary competence of the staff.
The Executive Director, in consultation with the Managing Board, selects staff based on the
requirements of the approved job descriptions and the details of the individual candidates. If the
requirements are fulfilled, a contract is signed.
The Technical Secretary (TS) maintains employment records of personnel, in which
documents and records of appointment, qualifications, training and development of the
corresponding official are stored.
In order to ensure and maintain the required competence and qualifications of staff in view
of the present and future needs and the awareness of staff about the importance and significance of
the activities performed and its role in policy implementation and achievement of quality objectives

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initially and periodic training is conducted. Information and documents for self-training are
provided and actions are undertaken, as for example, exchange of experience, etc.
The Management Representative plans annually the necessary training in the Program of
activities of Association "Club 9000", including:
• the newly appointed / reappointed staff;
• to ensure the necessary competence for the corresponding workplace;
• on the quality management system and the documents, regulating it.
The results of the conducted trainings are documented in Ф НК 1 "Protocol for conducted
training" or documents from participation in external training.
The person responsible for occupational health and safety (OHS) conducts and documents
initial and periodic briefing on occupational health and safety, as required by the regulations
(OHS).
The Technical Secretary maintains appropriate records of education, training, skills and
experience of staff under П 2 "Control of records".
The Managing Board assesses the effectiveness of the training in the management review
(Section 5 paragraph 5.6).

6.3. INFRASTRUCTURE
The infrastructure, needed to achieve conformity to requirements of products, services and
normative documents, is identified, provided and maintained. If the services are to be expanded, the
Executive Director takes decision on the project development, the disposal of premises, equipment
and other infrastructure elements, necessary to meet the requirements for effective operation of the
processes. The Executive Director supervises the maintenance of the premises in accordance with
the contract with the lessor, provides annually the required resources and outsources organizations
under Section 7 paragraph 7.4 repairs, modernization and renovation of office equipment.
The technical means for the processes (equipment and software) needed to achieve
conformity of the products and services with the specified requirements, are maintained by
performing routine maintenance and prevention.
The Technical Secretary plans prophylactic examinations of the equipment and stores the
information about the maintenance and repair activities in "Inventory of equipment” and Ф НК 2 "
Registration card".
The Technical Secretary maintains in good working order the communication and
information systems, maintains information on the applied software and its validation.
The external communication with suppliers and customers is carried out in accordance with
the agreements.

6.4. WORK ENVIRONMENT


The management of "Club 9000" has defined and provided in all workplaces the necessary
work environment, ensuring compliance of the products and services required. Work environment
and its parameters are defined in the relevant normative documents.
In the work premises and workplaces the prescribed conditions, good micro-climate, good
order and purity are maintained, which is responsibility of all staff of the Association “Club 9000”.
Work environment, necessary for safe execution of activities is provided in accordance with
the normative documents. The Association assigns to specialized organizations the measuring of
the parameters of the work environment in the work premises (lighting and micro-climate) the
results being recorded and stored.
In case of deviations from the requirements, the management takes measures for their
elimination or in consultation with the relevant authorities takes decisions for reducing their
harmful effects.
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In Association “Club 9000” a periodic assessment of the work environment and risk
assessment of the workplaces is carried-out with the purpose of achieving objectives, for
motivation, satisfaction and development of the staff.
The documents about the status and control of the work environment are kept by the person,
responsible for OHS, according to П 2 „Control of records”.
7.1. PLANNING OF PRODUCT/SERVICE REALIZATION
The activity of "Club 9000" is defined in the Statute of Association "Club 9000", Rules for
activities in public benefit and for raising and spending of property, Rules for raising and spending
funds and accounting of financial activity and in the Rules for activities and financing of regional
organizations.
The Executive Director plans and develops the processes needed to carry out activities in
public benefit, the creation of products and services in accordance with the requirements to the
other processes of QMS.
The process of planning is continuous process and determines as appropriate:
• quality objectives; requirements to the product/service, including those from customers,
interested parties and applicable normative documents;
• processes and documents necessary for product realization, service provision and
delivery to the customer, including outsourced processes;
• resources necessary for product realization and service provision;
• activities of verification, validation, monitoring, inspection of the product / service;
• acceptance criteria for the product / service;
• records necessary to provide evidence, that the realization processes and the final
product will meet the requirements.
Procedures П 7 "Organization and conducting of training” and П 8 “Control of information
activities" are designed for the main processes and determine the planning of processes sequence,
methods of implementation and control. They show also the records, necessary to validate the
compliance with the requirements of the processes for realization of products and services.
The rules and requirements specified in them play the role of quality plans. Only in some
cases, at the discretion of the management, specific plans for quality are develop.
The required external resources are planned, by choosing of suitable suppliers / contractors
guaranteeing compliance with requirements specified for them.

7.2. CUSTOMER RELATED PROCESSES

7.2.1. Determination of requirements, related to product/service


The Executive Director and the Management Representative define and document
requirements for products and services offered by the "Club 9000", including:
• requirements specified by the customer, including the requirements for delivery;
• requirements not stated by the customer but necessary for specified or intended use
• statutory and regulatory requirements applicable to the product;
• any additional requirements considered necessary by Association “Club 9000” for each
specific product, project or contract.
The Marketing Organizer of publishes information about products and services in the web
site of Association “Club 9000”.

7.2.2. Review of requirements, related to product/service


The Marketing Organizer applies П 7 "Organization and conducting of training and П 8
“Control of information activities" and reviews the requirements to products/services before taking
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commitment for provision to the customer (before publishing information in the web site of
Association “Club 9000”, preparing proposal or executing an order) to ensure that:
• customer requirements are properly understood, clearly defined and documented;
• differences between the requirements in the request and those announced beforehand
have been solved;
• Association “Club 9000” is able to meet the specified requirements for the product /
service, including customer requirements and requirements of normative documents.
Inquiries and requests of customers are accompanied by written, confirmed specific customer
requirements for products and services. When customer requirements are not presented in
documented form, they are confirmed before being accepted.
When changing the requirements for product/service, the relevant documents are amended
and the customers and contractors are notified in writing.
The records of the results of the review and actions, arising from the review, are kept in
accordance with П 2 "Control of records".

7.2.3. Communication with customers


Effective measures for communication with customers and interested parties are defined and
implemented in Association “Club 9000”, related to:
• activities carried on in public interest, and the delivered products and services;
• processing of inquiries and requests, including their amendments;
• analysis of feedback from customers and stakeholders, including their claims and
signals.
The Marketing Organizer, the Coordinators of regional organizations and the Technical
Secretary provide updated information on the products and services, presented in the web site of
Association “Club 9000”, at the meetings with interested parties, through printed publications, etc.
Inquiries and requests received are processed in accordance with П 7 "Organization and
conducting of training” and П 8 “Control of information activities".
The Marketing Organizer, the Coordinators of regional organizations and the Technical
Secretary receive and process feedback from customers and interested parties by the means of
organizing meetings and surveys on satisfaction from trainings and activities of Association “Club
9000” (Ф П 7-6 "Inquiry", Ф НК 3 “Questionnaire card"), analysis of assessments, reports and
complaints.
The Marketing Organizer registers, examines and analyzes each complaint/signal received
in accordance with П 4 "Control of nonconforming product" in order to establish the kind of
nonconformity, the reasons for its appearance and to take corrective actions to eliminate the causes.
Information regarding the compliance of the products and services provided is analyzed and
if necessary corrective or preventive actions are taken or improvements are planned according to П
5 “Corrective actions” and П 6 "Preventive actions".
Association “Club 9000” watches closely the evaluation of the organizations of the
operation and efficiency of the management systems implemented by them. Periodically, at the
discretion of the Managing Board, the Management Representative and the Coordinators of the
regional organizations:
• prepare and conduct a survey in the organizations with implemented management
systems;
• conduct analysis of the satisfaction with the management systems. The Management
Representative provides information about conferences on quality.

7.3. DESIGN AND DEVELOPMENT

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In its work the Association does not perform the process "Design and development" of the
product, therefore in Section 4 of the Quality Manual the exclusion of the requirements of
paragraph 7.3 of the standard is justified.

7.4. PURCHASING

7.4.1. Purchasing process


Association “Club 9000” ensures that the purchased product/service/outsourced process is
in compliance with the requirements, and the type and scope of the management applied by the
supplier and of the purchased product/service depends on the impact of the purchased product on
the subsequent realization of Association’s product/service.
Purchasing of products and services essential to the quality of the provided products and
services is carried out from approved suppliers/contractors.
The Executive Director, the Management Representative and the Technical Secretary make
evaluation and selection of suppliers, based on their ability to supply product/service in accordance
with the requirements of Association “Club 9000” in accordance with particular methodology in Ф
НК 4 and to the following criteria – the required quality to be lasting and confirmed for all
quantities and supplies, price, terms of delivery and payment, warranty conditions. The results are
recorded in Ф НК 4 „Supplier evaluation protocol ". The Marketing Organizer maintains "List of
approved suppliers Ф НК 5", which is approved by the Chairman of the Managing Board/Executive
Director.
Executive Director, The Marketing Organizer and the Technical Secretary perform
periodically, at least annually, review and re-evaluation of suppliers.
Mutually beneficial business relationship and feedback system on the quality of procured
products and provided services/performed processes are established with the approved suppliers.
Legal relationships with the suppliers are built based on contracts or orders.
The evaluation criteria are reviewed by Executive Director every two years, as necessary.
Records from the evaluation results and any necessary actions, arising from the evaluation,
are retained as required by the П 2 "Control of records".

7.4.2. Purchasing information


The purchasing needs of materials, equipment, services or outsourced processes are
determined on the base of planned activities for public benefit of Association “Club 9000” and
necessary for the provision of the products and services of the Association.
Purchasing is done only if there is clear and accurate data available, describing the
requirements to the purchased product/service / process assigned to be performed, reflected in an
Order made by the Marketing Organizer / Technical Secretary / Coordinators of regional
organizations / the responsible person for OHS in a free form and approved by the Executive
Director.
The Marketing Organizer/Technical Secretary sends a purchase order to the approved
supplier in writing (letter, order or contract), which includes a description of the
product/service/process (quantity, delivery/performance, reception conditions, etc.), including
requirements, where appropriate, for:
• approval of products, procedures, processes and equipment;
• qualification of contractors;
• Quality management system.
The Marketing Organizer/Technical Secretary review for adequacy the specified purchase
requirements prior to communicate them to the supplier/contractor. The purchasing request is
registered in Ф НК 6 "Purchasing log".

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When buying from suppliers that are not included in the "List of approved suppliers" at least
three offers for delivery are required. The received offers are examined and evaluated in accordance
with the applicable law and specific supplier is selected.

7.4.3. Verification of purchased product


Association "Club 9000" exercises control to ensure that the products purchased and
activities outsourced meet the specified requirements.
The Marketing Organizer / Technical Secretary / Coordinator of regional organization check
the conformity of:
• purchased products with respect to quantity, marking, accompanying documents for quality
and warranty obligations of the supplier;
• supplied services and implemented processes with the terms of the contract.
The results of the inspection it reflects in Ф НК 6.
Purchased products are identified according to the results of the inspection, if possible and
are entered in balance sheet only if positive results are obtained from the verification.
In cases where the verification of purchased products will be done by representative of
Association “Club 9000” at the site of the supplier, the procedure for this is specified in the
purchase documents.

7.5. PRODUCTION AND PROVISION OF PRODUCT AND SERVICES

7.5.1. Control of production and service provision


The main processes in "Club 9000" for the promotion of management systems, based on
recognized international standards, product realization and service provisions are, as follows:
• organizing and conducting of training for acquisition of competence and increase of
qualification, related to the management systems in accordance with applicable standards for
quality, environmental, health and safety management and conformity assessment (documented
procedure П 7 "Organization and conducting of training ");
• provision of up-to-date information about: global and national developments, standards
and regulations related to the management systems, organizations with certified management
systems in the country, certification bodies, consultants and other organizations;
• creation and distribution of information products (publishing) about quality,
environmental, information security, working conditions, social responsibility management and
other under П 8 "Control of information activities" - Directory “Quality”, "Club 9000 consults”
Library, Newsletter for the latest information in the field of quality management systems and other
publications;
• organization and conducting of events (workshops, conferences, discussions,
exhibitions) and other scientific and technical and information events (П 8 “Control of information
activities ");
• organization and conducting of the event, related to the annual award "Prize for Quality
of Association Club 9000" in accordance with the established rules;
• advertising.
The Managing Board plans on annual basis the provision of products and services in the
Program of activities of "Club 9000", based on analysis of data from the previous year, results of
market research, queries of customers and interested parties.
The Executive Director on the base of the planned activities provides materials, services,
processes and any external resources required for the provision of goods and delivery of services.
Association "Club 9000" plans and carries out activities to create information products and
services under controlled conditions by providing:
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• availability of information, describing specific requirements for provided products and
services;
• availability of established documented procedures, working papers and other applicable
regulations;
• qualified and trained personnel;
• use of appropriate office equipment, software, methods and tools for monitoring and
control;
• implementation of activities for monitoring and measurement.
During the provision of goods and performance of services continuous monitoring is carried
out to meet the requirements of the documented procedures, work documents and requests from
customers. The results are documented and provide the necessary information for timely
implementation of corrective actions.

7.5.2. Validation of processes for production and service provision


In the activities of Association "Club 9000" there are no processes where the resulting
output cannot be verified by observation or measurement and as a consequence, deficiencies
become appear after the product is in use or the service has been provided.
Therefore, in Section 4 of Quality Manual the exception to the requirements of paragraph
7.5.2 of the standard is justified.

7.5.3. Identification and traceability


The persons, responsible for processes use appropriate forms of identification of the
product/service through the entire process of realization - name, date of inquiry/request, designation
of a product for a particular customer, records in the relevant forms, designations, reflecting the
status of the product compared to the results of inspection. Depending on the need and the specific
conditions one or more forms of identification are used.
Products that are not accepted, not inspected or nonconforming, are identified and kept in
isolated and identified locations. Purchased defective products are marked with red color, excluding
unintentional use.
Mandatory traceability is performed in case of: established nonconformities in the
requirements to the products, customer complaints, audits of QMS and in assessing the
effectiveness of the implemented corrective and preventive actions.

7.5.4. Customer property


The Marketing Organizer, the Technical Secretary and the Coordinators of regional
organizations ensure the customer property provided for use or incorporation into the product /
service to be identified, tested, adopted with protocol, protected and preserved so as to maintain its
quality.
In case of damage, loss or inability to use for other reasons, the Marketing Organizer
informs the client in writing and in accordance with the contract takes appropriate actions, which
are documented.
To protect customers' personal data the Association “Club 9000” is registered as
“Administrator of personal data” under the Law for Protection of the Personal Data.

7.5.5. Preservation of product/service


Preserving the conformity of the product with the requirements of the customer
documentation and is ensured during all stages of execution of the delivery to the intended

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destination through: identification, packaging, storage and protection. The requirements for
preservation apply in relation to purchased products/results of outsourced processes.

7.6. CONTROL OF MONITORING AND MEASURING EQUIPMENT


The Management Representative with the help of Marketing Organizer defines in the
Quality Manual the procedures, methods and equipment for monitoring and measuring required
demonstrating compliance of the product/service with the specified requirements and for the proper
process flow.
During the delivery of training information about the training process is collected through
surveys and tests, gathering of comments and recommendations from the users of the product,
evaluation of the effectiveness of training by the Managing Board, and opinions/references from
the Association members, customers or other interested parties.
Given the specificity of the processes and products of Association "Club 9000", classic
technical equipment to monitor and measure, according to the Law on measurements is not used.
The means of monitoring and measuring in the association "Club 9000" are as follows:
• tests for the specific training;
• questionnaires for measuring and evaluating the satisfaction from the activities of
Association “Club 9000”, etc.
The persons, responsible for the processes, review the resources, allocated prior to the initial
use and validate them, if necessary.

8.1. GENERAL
The management of Association "Club 9000" plans and implements processes for
monitoring, measurement, analysis and improvement, needed to:
• demonstrate compliance with the requirements for the product / service;
• ensuring the conformity of the Quality management system;
• improve continually the effectiveness of QMS.
This includes determination of applicable methods, including statistical methods (if
necessary), and the extent of their use.

8.2. MONITORING AND MEASUREMENT

1.2.1. Customer satisfaction


Management of "Club 9000" monitors the information, related to the perception of
customers and interested parties – to what extent their expectations are met, as one of the
performance indicators of the Quality management system.
The Management Representative and the Coordinators of regional organizations receive and
process the information from measuring the satisfaction of customers and interested parties. The
Management Representative conducts analysis of:
• provided products and services related to the trends of their development - an increase
of delivered products and provided services, the reduction or preservation of their number
compared to previous periods, new and retained customers;
• conformity of the products and services - identified nonconformities in their execution;
• received signals and claims;
• perception of the product / service by the client based on information from direct contact
with customers;
• feedback from customers and interested parties , as reflected in the questionnaires (Ф
НК 3; Ф П 7-6), references and others.
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Feedback is maintained with customers and stakeholders to clarify their opinion about the
quality of products and services, to take the necessary actions in case of problems and to ensure
continuous improvement of the Association’s activities.
Information on the satisfaction of customers and interested parties is prepared and
considered in the management review and the Managing Board meetings.

1.2.2. Internal audit


Internal audits are conducted in Association "Club 9000" at planned intervals to obtain
objective evidence of conformity of QMS with the planned arrangements, with the standard БДС
EN ISO 9001:2008, applicable normative documents and with the requirements of the QMS. The
applicable guidance of БДС EN ISO 19011:2011 is also taken into account during the internal
audits.
In the documented procedure П 3 "Internal audits" the activities, responsibilities and
requirements for planning and conducting internal audits, establishing records and reporting results
are specified.
The internal audits are planned in the annual Audit Program, taking into consideration the
status and importance of the processes and areas to be audited, and the results of previous audits. In
the audit program the criteria, scope, frequency and methods of audit are defined.
The selection of auditors and conduct of audits ensure the application of the principles of
auditing – adherence to principles, impartial presentation, professionalism, confidentiality,
independence and an approach based on evidence gathered during the audit.
The nonconformities found are documented and those responsible for the area being audited
ensure that any necessary corrections and corrective actions are promptly implemented to eliminate
nonconformities found and the reasons for their recurrence.
Follow-up activities are carried out after the audit (if necessary) to review the
implementation and effectiveness of actions taken on the results of the audit and reporting the
results to the Executive Director.
Records of the audits and their results are stored in accordance with П 2 "Control of
records".
The Management Representative informs the Executive Director and the Managing Board
on the results of each audit and prepares information on the results of the internal audits for the
purposes of the management review.

8.2.3. Monitoring and measurement of processes


QMS processes are given in НК 4.1. Association “Club 9000” uses suitable methods for
monitoring and, where applicable, for measuring the processes of the Quality management system
in order to demonstrate the suitability of the processes to achieve planned results.
Implementation of QMS processes is regulated in the Quality Manual and the approved
procedures and documents. Each year the management plans the process results and establishes
measurable targets for the structural units or the persons responsible for their implementation. The
Management Representative performs control to achieve planned results and objectives and reports
on their execution in the management reviews of QMS.
Planning and controlling the processes to create products and services is done, taking into
account the requirements of the procedures and working documents. Monitoring of processes for
provision of products and services is done by trained and qualified personnel using current and
valid documents, available at the work places.
When the planned results are not achieved, corrections and corrective actions are taken in
accordance with П 4 "Control of nonconforming product" and P 5 "Corrective Actions".

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8.2.4. Monitoring and measurement of product/service
Monitoring and measuring of products and services is performed in Association “Club
9000”, in order to verify that requirements are met.
Planning and implementation of control and monitoring of products and services is carried
out at appropriate stages of the process of realization of the product/service provision, in
accordance with the planned arrangements.
The inspection is performed provided the following is in place: up-to-date documentation
(documented procedures, work documents and regulations), customer requirements, trained and
qualified personnel. The Inspection is carried out:
• during acceptance of purchased products, services and results from outsourced
processes;
• during the service provision;
• on finished products;
• to verify the compliance with the specified requirements.
The frequency and volume of the inspections are specified in documented procedures and
working documents. Inspection results and conclusion of conformity of products/services are
documented in the records provided in the documents of the QMS as accurately and clearly record
the outcome of the inspection date, surname and signature of the person making control.
Inspection results and conclusion on conformity of products / services are documented in
the records provided in the documents of QMS and the outcome of the inspection, date, surname
and signature of the person making inspection are accurately and clearly recorded.
Only products and services are delivered to the customer, that meet the conditions laid down
in the documents, the foreseen observations and measurements have been finished with an
affirmative result, compliance with the requirements is confirmed and documents/records reflecting
the results of the inspection are completed.
Records of the inspection results and proof of compliance with the acceptance criteria are be
stored in accordance with П 2 "Control of records."
The results of the monitoring are analyzed and made available to the management of
Association “Club 9000” to take corrective and/or preventive actions to improve QMS.

8.3. CONTROL OF NONCONFORMING PRODUCT/SERVICE


The application of П 4 "Control of nonconforming product" ensures that a product/service
that does not meet the requirements is identified and controlled to prevent its unintended use or
delivery.
Measures, responsibilities and powers, associated with the disposal of nonconforming
product / service are defined by:
• identifying and separating in areas isolated and marked as appropriate;
• taking actions to eliminate the detected nonconformity;
• permission to use, release or acceptance under concession by a relevant authorized
person or, where applicable, by the customer;
• taking actions to prevent its original intended use or application;
• taking actions, appropriate to the consequences, actual or potential, of the
nonconformity, when nonconforming product is detected after delivery or when its
use has started.
When nonconforming product is corrected it is rechecked to prove its conformity with the
requirements.

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Received claims and signals from customers/stakeholders are recorded and analyzed to
identify the type of non-conformity and the reasons for its occurrence. The customer is informed
about the decision on the settlement of the claims.
The process for control of nonconforming product/service is documented. Records of the
nature of nonconformities and any subsequent actions taken, including concessions and obtained
permits for deviations are stored according to П 2 "Control of records."

8.4. ANALYSIS OF DATA


The Management Representative determines, collects and analyzes data to determine how
suitable and effective QMS is and to evaluate the potential for continual improvement of its
effectiveness.
The analysis of data provides information on:
• customer satisfaction according to НК, Section 8, paragraph 8.2.;
• suppliers - compliance to the delivered products, executed services and outsourced
processes;
• conformity of the delivered products and services with the specified requirements;
• characteristics and trends for development of processes, products and services;
• opportunities for undertaking of preventive actions (where applicable).
Data sources for the analysis are records, reflecting the results of the monitoring and
measurement of processes, products and services and records relating to complaints from
customers, evaluation of suppliers, etc.
The conformity of purchased products / services delivered / performed outsourced processes
is assessed by established criteria for the specific supply/contract.
The Management Representative presents to the management the results of the data analysis
in the form of text information, tables and/or graphs for taking corrective and / or preventive
actions and measures for improvement.
Analyses (based on questionnaires) that require specialized statistical analysis are carried
out by order of the Executive Director.

8.5. IMPROVEMENT

8.5.1. Continual improvement


Top management of the Association "Club 9000" makes efforts, and takes appropriate
actions to continually improve the effectiveness of the quality management system by
implementing and using quality policy, quality objectives, audit results, analysis of data, corrective
and preventive actions, management review and proposals from the staff.
Planning of improvement is made after analysis and evaluation of the achievement of the
individual processes objectives, of policies and objectives of QMS. As a result of the received
proposals for improvement, the Program for activities of Association “Club 9000” and the annual
plans of the regional organizations are updated.
The Management Representative controls tasks and at least twice a year reports the results
to the Executive Director.

8.5.2. Corrective actions


In Association "Club 9000" action are taken to eliminate the causes of nonconformities in
order to prevent recurrence.
Documented procedure П 5 "Corrective actions" is applied to determine the requirements
for:

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• reviewing nonconformities (including customer complaints);
• determining the causes of nonconformities;
• evaluating the need for action to prevent repeating of inconsistencies;
• determining and implementing action needed,
• evaluating the effectiveness of the corrective actions taken.
Appropriate corrective actions are taken to guarantee the permanent removal of
nonconformities found.
The whole process of identifying and removing the causes of established nonconformities,
and evaluating the effectiveness of the actions taken is documented. Records with the results of
implemented corrective actions are stored under the requirements of П 2 "Control of records".

8.5.3. Preventive actions


To eliminate the causes of potential nonconformities in order to prevent them, the
documented procedure П 6 "Preventive actions" is applied.
The procedure determines the requirements for:
• identification of potential nonconformities and possible reasons for their occurrence;
• evaluating the need for taking action to prevent occurrence of nonconformities,
• determining and implementing of the actions needed;
• evaluating the effectiveness of the preventive action taken.
Taking preventive actions is preceded by an assessment of the significance of the potential
problem.
Records of the results of the preventive actions are stored under the requirements of П 2
"Control of Records."

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Annex 9.1

LIST OF QMS DOCUMENTS


Designation Name
НК Quality Manual
PROCEDURES
П1 Control of QMS documents
П2 Control of records
П3 Internal audits
П4 Control of nonconforming product
П5 Corrective actions
П6 Preventive actions
П7 Organization and conducting of proposed training
П8 Management of information activities

WORK DOCUMENTS
- Statute of Association „Club 9000”
- Rules, regulating specific activities of Association „Club
9000”, maintained in the Register Ф П 1-2

Annex 9.2

LIST OF FORMS TO THE QUALITY MANUAL


Designation Name
Ф НК 1 Protocol of conducted training
Ф НК 2 Registration card
Ф НК 3 Questionnaire card
Ф НК 4 Protocol of supplier evaluation
Ф НК 5 List of approved suppliers
Ф НК 6 Log „Purchasing”

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Annex 9.3.

ORGANIZATIONAL CHART OF ASSOCIATION “CLUB 9000”

Approved, Chairman
of the Managing Board: ......................
(....................., .............. date)

GENERAL ASSEMBLY

MANAGING BOARD CONTROL BOARD


CHAIRMAN Chairman
Members Members

EXECUTIVE
DIRECTOR
Management
Representative for QMS

Regional
organizations Organizer Marketing
General Assembly
Coordinator Technical Secretary

Responsible for OHS

Note:
1. „-------„ - Composition of the top management of Association “Club 9000”.
2. The Technical Secretary maintains up-to-date List of established regional organizations (name,
coordinator, contact data).

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