Download QUESTIONNAIRE for preliminary evaluation of quality management

QUESTIONNAIRE
for preliminary evaluation of quality management system of applicant
1. General characteristics of applicant (name, address, details, legal status, corporate belonging,
information on human and technical resources)
__________________________________________________________________________________
__________________________________________________________________________________
2. Top management
2.1. Names and positions of responsible managers.
__________________________________________________________________________________
__________________________________________________________________________________
2.2. Name and position of responsible person for quality management system
______________________________________________________________________
__________________________________________________________________________________
3. Designation/name of standard, according to which certification will be performed:
__________________________________________________________________________________
__________________________________________________________________________________
4.
Detailed information on quality management system:
4.1 Sphere covered by quality management system according to Quality manual:
__________________________________________________________________________________
Exceptions to requirements of standard from sphere covered by quality management system (indicate
paragraphs of standard)
___________________________________________________________________________________
Indicate information on current quality management system certificates (if available):
__________________________________________________________________________________
__________________________________________________________________________________
1
2

Provide (attach) organization chart of head office and affiliates.

Indicate which companies provide their services to you.
Outsourcing processes*
Names and address of cooperating companies
Number of changes:
Total
Other
Service
Sterilization
Sales
Warehouse
Manufacture
Purchase
Name and address of head office and
affiliates
Research and
development
5. Indicate (approximately) number of
employees in departments
Quality assurance
Departments
-
-
* Research and development, Manufacture, Packaging, Sterilization, Storage, Service
6. Controlled environmental conditions / sterile products’ specifications
Manufacture performed under specific environmental conditions?
yes
no
yes
no
yes
no
If yes, which parameters or areas are managed and monitored?
temperature
ESD controlled zones
humidity
radiation protected zones
particle number
other
microbiological particles
Do you follow ‘clean room’ requirements?
If yes, define ISO classification according to EN ISO 14644:
Do you manufacture sterile products?
If yes, which sterilization procedures do you use?
ethylene oxide according to ДСТУ ISO 11135
moist heat according to ДСТУ ISO 11134
irradiation according to ДСТУ ISO 11137
other:
Is sterilization process validated using special products?
yes
no
List and classification of products on which certification of quality management system will be
performed
Products
Designation of corresponding
technical regulation
6. Additional information:
Yes/No
4.1
Is quality management system developed as to indicated products?
4.2 Are quality policy and objectives developed ?
4.3 Is Quality manual developed?
4.4 Is coordination of quality management processes described? Are systematic
measurements, monitoring, analyzing and continuous improvements provided?
4.5 Are authorities and responsibilities of quality assurance personnel identified?
4.6 Are appropriate procedures for training, preparation and checking of personnel
qualification adopted?
4.7
?
Are appropriate procedures for internal audits of quality management system adopted
4.8 Is periodic analysis of quality management system by management provided?
4.9
Are appropriate procedures for processing documents and records provided?
4.10 Is process of identification of requirements to quality of purchased products and
product control provided?
4.11 Is process of assurance of product identification and traceability provided?
4.12 Are appropriate control and testing procedures provided?
4.13 Is appropriate operating procedure for processing nonconforming products adopted?
4.14 Are appropriate procedures for development and implementation of corrective and
preventing actions adopted?
________________________________
_____________________
(name)
(position of enterprise’s head)
(signature)
______________
(date)
_____________________