Fill in please the following Questionnaire with Appendixes according to the present-day situation and working conditions.
In "answer" section put on the Name of corresponding manual (documents) with corresponding clause number.
QUESTIONNAIRE
1.
The ground of filling in of the
questionnaire
is :
Application
No _______ for the certification of the following product:
name
of the product
manufactured
by
name
of the manufacturer, address
2.
This questionnaire and the enclosed documents form the base for the analysis of
the manufacturing conditions of the products to be certified and it is supposed
to provide the preliminary information to the certification body about the
applicant (manufacturer, supplier) and about his potential in the field of the
quality management and assurance of production stability in accordance with the
established requirements during the term of the certificate validity.
2.1.
According to the results of the manufacturing conditions analysis ‘POZHTEST’
certification body specifies the term of the certificate validity and the
regularity of the inspection control over the certified products.
2.2.
The questionnaire should be filled in by the applicant and sent to the
certification body.
2.3.
The applicant should present for each of the suggested questions, if required,
extra documentation to the certification body including the procedures, drawings,
test results, descriptions of official duties etc. that could prove the
potential of the manufacturer. Copies of these documents are kept in the records
of the certification body.
2.4.
Information presented in the questionnaire would be periodically checked and
updated by the certification body personnel during their subsequent visits to
the factory for the detection and registration of any possible changes.
2.5.
Contents of the questionnaire and the enclosed documents are treated as
confidential information by the certification body.
3.
Instruction for Filling In the Questionnaire
3.1.
All presented information should depict the typical conditions at the factory at
the moment of filling in of this questionnaire.
3.2.
In items with “Yes” or “No” answers ”, the
wrong version shall be crossed out.
3.3.
In the section “Answer”, the numbers and/or names of the relevant documents
shall be indicated.
3.4.
Appendices (their numbers are indicated in the table) shall be attached if it is
required by the Table.
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¹ |
Question |
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Answer |
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1.
|
Is there any document to determine the policy of the
company in the field of quality of the products? Enclose the copy of the certificate for the quality
management system according to ISO 9000 requirements if available |
Yes |
Appendix No 1.1.1 (Quality policy) Appendix No 1.1.2 (Copy of quality management system
certificate) |
|
2.
|
Is there a department or a person in the company
responsible for the quality of the product to be certified? (If affirmative indicate a division or a person (post, name) |
Yes |
|
|
.
|
Give an organizational
structure of the enterprise showing the position and functions of the
quality representative with relation to administration |
|
Appendix No 1.2 |
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4.
|
Indicate the document specifying the authority of the
head of the department or the person responsible for quality of the
products. |
|
Appendix No 1.3 |
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5.
|
Indicate the documented procedure specifying introduction of changes in
quality management documents and technical documentation |
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6.
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Indicate the document specifying the persons who
authorize the introduction of changes |
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7.
|
Are
any materials and component parts produced at other plants used for the
manufacturing of the products under certification? |
Yes |
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8.
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Indicate the procedure which describes the
requirements to the input control, determines the volume of the input control and the order of putting the component
parts and raw materials into production |
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9.
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Is the volume of the input control of the component
parts and raw materials determined? |
Yes |
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10. |
List the main types of the raw materials and
component parts subject to the input control with indication of controlled
parameters and the volume of input control. |
|
Appendix No 2.1
(Form is attached) |
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11. |
Present a structural scheme or a list of the
technological processes which demonstrates the process of the
certified items production and indicates the main operations, including
the control ones, and technological equipment. |
|
Appendix No 3.1 |
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12. |
Indicate the documented procedure specifying the
control operations and/or the tests during the production of the certified
products (operation control). Appendices (a list
of the main control operations in the production process and a copy of a document accompanying the product through its production and
bearing notes of the control operations conducted). |
|
Appendix No 3.4.1 (the form for the list is attached) Appendix No 3.4.2
(copies of the documents) |
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13. |
Supply the questionnaire with a list of operations during which the
most quantity of non-appropriate products is produced |
|
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14. |
Indicate the documented procedure specifying the
requirements to the maintenance and the repair of the technological
equipment. Attach an extract from the maintenance schedule of the production
equipment for the current year (not more than 15 items) |
|
Appendix No 3.6 |
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15. |
List the main production equipment Indicate name of the equipment, its type, model, identification number,
regularity of maintenance, date of the last maintenance (Present copies of the documents confirming the maintenance) |
|
Appendix No 3.7 (the form for the list is attached) Appendix No 3.8
(copies of the documents) |
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16. |
Indicate the documented procedure specifying the
final products acceptance control and/or testing and the way the results
are registered (the list of parameters under
control during testing of the final product , a copy
of a document bearing notes of the control operations or testing conducted). |
|
Appendix No 3.9 (the form for the list of parameters under
control during testing of the final product is attached) Appendix No 3.10
(copies of the documents) |
|
17. |
Is there a department or a person in the company
responsible for the metrological control of the test equipment and
measuring devices (procedures of calibration and approval), (If
affirmative, give the name of such department or the post and name of such
person) |
Yes |
|
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18. |
Indicate the documented procedure specifying the
metrological control (calibration and approval of the test equipment and
measuring devices) |
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19. |
Indicate external companies engaged to perform the
metrological control (calibration) |
Yes |
|
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20.
|
Attach the list of the main measuring and test
equipment used to test final products.
Indicate the name of measuring devices and testing equipment, model,
serial number, date of the last metrological control (calibration),
regularity of calibration. Attach copies of any three calibration
protocols as examples |
|
Appendix No 4.5
(the form for the list is attached) Appendix No 4.6
(copies of the documents) |
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21. |
Indicate the documented procedure specifying the
isolation, access, storage of the non-appropriate (defective) products in
the special stock-place |
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22. |
Indicate the documented procedure specifying the
storage, identification, packing of the products. Indicate a division or a
person responsible for the operation of the warehouses (Name, position) |
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23. |
Indicate the documented procedure specifying the
requirements to registration and analysis of the defects which have been
revealed during exploitation by the customers (claims) Attach information on the confirmed claims available
relating to the quality of the certified products for the last and current
years Enclose copies of the documents relating to registration, consideration
and making a resolution on a claim as an example |
|
Appendix No 6.3.1
(data about claims) Appendix No 6.3.2
(copies of the documents relating to registration, consideration and
making a resolution on each claim) |
|
Administration representative
of the manufacturing company |
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|
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signature, seal |
|
Name, position |
Appendix No 2.1
A list of main types of raw materials and component parts subject to incoming control
|
Name of raw materials and component
parts |
Main
suppliers |
Controlled
parameters |
Type
of input control (visual control, tests, quality documents supplied by the
manufacturer) |
Regularity Volume of the input control |
Who
controls |
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Head
of quality management |
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signature |
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name |
Appendix No 3.4.1
List of the main control operations in the production process
|
Parameter under control |
Technological process |
Type of the control (visual, tests, automatic control) |
Regularity |
Who
controls |
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Head
of quality management |
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signature |
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name |
Appendix No 3.7
A list of main production equipment
|
Name of equipment |
Type, |
Manufacturer (company,
country) |
Identification
number |
Regularity of maintenance |
Date of the last preventive |
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Head
of quality management |
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signature |
|
name |
Appendix No 3.9
List of the main controlled parameters when testing the final products
|
Parameter
under control |
Regulated
value |
Permissible
deviation |
Type
of the control (visual, tests) |
Sample
size |
Regularity |
Who
controls |
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Head
of quality management |
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signature |
|
name |
Appendix No 4.5
A
list of measuring and testing equipment used in the control of final products
|
Name of measuring devices and testing equipment |
Type, model |
Manufacturer (company, country) |
Manufacturer’s serial number or identification number |
Regularity of metrological control |
Date of the last metrological |
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Head
of quality management |
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signature |
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name |