Technodent Quality Manual

Product: ACRYLIC TEETH & Dental Related plastic products
Subject: Quality Manual Rev. # 02

Date: Sept., 05, 2017 Document # TI/QM/01
62-Mozang Road, Lahore-Pakistan
QUALITY SYSTEM MANUAL
62-Mozang Road, Lahore (54000) Pakistan

Tel: +92 - 42 – 6362002, 6371946
Fax: +92 – 42 – 6316015
E-mail: tdent@brain.net.pk
www.technodent-ind.com
www.brain.net.pk/~tdent/Crisma.htm
www.brain.net.pk/~tdent/welbite.htm
IN COMPLIANCE WITH INTERNATIONAL STANDARDS

ISO9001 & COUNCIL DIRECTIVE 93/42/EEC
This Manual is the sole property of Technodent Industries, Lahore – Pakistan, and is subject to review by
authorised persons only. Any unauthorised reviewing, duplication or alteration of this Manual is strictly
prohibited.
Prepared by: Approved by:
Sign. Sign.
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I - TABLE OF CONTENTS
Section No Title Page
I Table of contents 2
II Change record 3
III Quality system Manual (General) 5
IV Company Profile 6
V Management Endorsement 6
1 Scope 7
2 Normative References 7
3 Terms and Definitions 7
4 Context Of The Organization 8
5 Leadership 10
6 Planning 14
7 Support 16
8 Operations 21
9 Performance Evaluation 25
10 Improvements 27
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II- CHANGE RECORD
This Quality Manual contains only the pages issued and reviewed by the Director Production and
approved by the Managing Director. The Director Production will process all authorized changes, inserting
amendment pages into the controlled distributed copies. He will see that all obsolete pages are withdrawn
from use and disposed of to prevent unintentional usage.
Reviewed Approved
Date Change
Page # By By
05-9-17 First Issue of the new manual in line with the

Dir. Prod M.D
requirements of ISO-13485 : 2003 and
ISO9001:2015
.
Page 3
Page 4
III. QUALITY SYSTEM MANUAL
GENERAL
This Quality Management System Manual specifies requirements for Technodent Industries’s
products to address customer satisfaction, to meet customer and applicable regulatory requirements
and to meet ISO 9001:2015 requirements, and is supported by additional procedures.
The system requirements of this manual are aimed at achieving customer satisfaction by consistently
providing conforming product and meeting or exceeding customer and applicable regulatory as well
as ISO 9001:2015 requirements. Through application of the system, continuous improvement and the
prevention of nonconformity is also ensured.
This document ensures that the company adequately identifies customer requirements, through all
quality management system processes, to achieve customer satisfaction with a closed-loop Process
Model methodology.
This document applies to all processes involved for manufacturing & export of ACRYLIC RESIN
TEETH and plastic moulded disposable equipment (used by Dentists as well as Dentistry related
laboratories)and satisfies the Quality Assurance requirements as required in ISO 13485:2003 &
Council Directive 93/42/EEC
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IV- COMPANY PROFILE

Established in 1991, Technodent Industries is a company manufacturing high quality Acrylic Resin Teeth,
using the latest technology and machinery from UK. Technodent Industries supply to demanding customers,
both in Domestic and International Markets.
Technodent Industries have the distinction of being the only quality teeth manufacturer in Pakistan.
Technodent Industries are currently exporting to Kenya, Indonesia, Sri Lanka, Bangladesh and U.K.
Technodent Industries is registered with FDA (Food and Drug Administration, USA)
Technodent Industries produce Cross-Linked Acrylic Resin Teeth in a vast range of beautiful moulds of
Anteriors and Posteriors. Our products comply to the given standards of ISO-3336 and BS-3990.
Technodent Industries; products have been tested on these standards and conform with their Scope and Field
of Application, Reference, Classification and their requirements which are as below:
 Material
 Size and Shape
 Colour and Blend
 Freedom from Irritants
 Freedom from Imperfections
 Surface Finish
 Retention of Finish
 Repolish
 Bonding
 Mechanical Properties
 Resistance to Blushing
 Resistance to Distortion
 Resistance to Crazing
 Dimentional Stability
Technodent Industries have two brands;
 Welbite®
 Crisma®
V. MANAGEMENT ENDORSEMENT
The Executive Management of Technodent Industries endorses this quality manual to demonstrate its
personal and organizational commitment to quality as well as to approve and support the policies described
and the documents referred in this manual.
Issued on September 15, 2017
________________________
Chief Executive
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1. SCOPE
This document specifies the Quality Management System of Technodent
Industries for the manufacture of ACRYLIC RESIN TEETH and plastic moulded disposable
Accessories (used by Dentists as well as Dentistry related laboratories) and their sale in the local and
International market.
Permissible exclusions:
Following clause & sub-clause of standard ISO-9001:2015 are excluded from the scope of
Technodent Industries.
Clause 8.3 Design and development (Whole with all sub clauses)
Sub-Clause 8.5.3 Property belonging to customers or External providers
Reason for not being applicable:

Technodent Industries; are producing Acrylic Resin Teeth as per design & material
specifications of Harmonized Standard(s)
 BS-3990:1980 (Specification for Acrylic Resin Teeth)
 ISO-3336:1997 (Dentistry – Synthetic Resin Teeth)
 Technodent Industries doesn’t hold any Property belonging to customers or External providers.
As such the above clauses and sub clauses are not applicable.
If any revision occurs in above mentioned standards Technodent Industries will incorporate these
changes in its quality management system.
2. NORMATIVE REFERENCES
A) ISO 9001:2015 Quality Management Systems – Requirements
B) Council Directive 93/42/EEC
3. TERMS AND DEFINITIONS

QUALITY PLANNING
Part of quality management focused on setting quality objectives and specifying necessary
operational processes and related resources to fulfil the quality objectives
QUALITY CONTROL
Part of quality management, focused on fulfilling quality requirements
QUALITY ASSURANCE
Part of quality management, focused on providing confidence that quality is fulfilled.
QUALITY IMPROVEMENT
Part of quality management, focused on increasing effectiveness and efficiency
ORGANIZATIONAL TERMS
ORGANIZATIONAL STRUCTURE
Orderly arrangement of responsibilities, authorities and relationships between people
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WORK ENVIRONMENT
Set of conditions under which a person operates
CUSTOMER
Organization or person that receives a product
SUPPLIER
Organization or person that provides a product
CONFORMITY TERMS
CONFORMITY
Fulfillment of a requirement
NON CONFORMITY
Non-fulfillment of a requirement
PREVENTIVE ACTION
Action taken to eliminate the causes of a potential non-conformity or other potentially undesirable situation
CORRECTIVE ACTION
Action taken to eliminate the cause of a detected nonconformity or other undesirable situation
CORRECTION
Action taken to eliminate a detected nonconformity
DOCUMENTARY TERMS
DOCUMENT
Information and its support medium
QUALITY MANUAL
Document stating the quality management system of an organization
QUALITY PLAN
Document specifying the quality management system elements and the resources to be applied in a specific
case
PROCEDURE
Specified way to perform an activity or a process
RECORD
Document stating results achieved or providing evidence of activities performed
4. CONTEXT OF THE ORGANIZATION
4.1 Understanding the organization and its context
Technodent Industries clearly understands the external and internal issues that could affect the
implementation and following the Quality Management System It has planned and derived steps to
mitigate their impact 0n the system in case they happen as follows:
The external issues could be:
1. Although so far we have been able to compete in the international market on the basis of quality and
price. However any competitor in any of our enemy countries like India or Israel may come up with
lower prices just to let us down being from Pakistan. In the urge to mitigate this threat, we are
keeping our eyes open and searching for the latest development in teeth manufacturing throughout
the world. If anything is known which could help us bettering our quality with reduced cost, we will
definitely be following it.
2. One of the external issues could be devaluation of our currency. But this will not affect us adversely
as we sell n quote in US dollars.
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3. If there is a devaluation of the currency of the country where we are exporting it could affect our
business with them, however we try to cooperate with our regular customers as much as possible as
we want to maintain a long term business relation with them.
4. Political relationship of our and the countries where we export is also very important and can have
positive or negative impact on our business. So we remain conscious about it. If anything of the sort
happens, we would immediately take precautionary steps so as to not weaken our business relations.
5. The clients may have reservations for our late respond to their quarries etc. Our response to our
customers for their quarries or complaints if any is very important and we make sure we are very
quick on that so that relationship is not spoiled.
6. Any change in regulations by the government regarding our product or imposing any further export
duties on our products. For this we keep in touch with the concerned authorities so that we could
know such things in advance to enable us take precautionary measures.
7. We may have issues with SGS regarding the audit dates or the charges for external audit. We will
resolve these by negotiations and SGS has always responded positively.
8. Due to political reasons or otherwise the suppliers of Acrylic powder and Acrylic liquid may refuse
to continue their supplies. For this we have already tapped alternate suppliers in China and Iran just
in case such thing happens.
9. External issues from the suppliers, from the subcontractors of plastic accessories or any customer’s
adverse report (complaint) have been addressed in the Risk analysis report.
The internal issues could be:

1. Employees may leave without any prior information. This is not a big issue as we have a number of
candidates waiting for being employed due to large un employment. We will call out of them and
prepare them for the job through training.
2. There could be Electric break downs thus affecting our production and resulting in delay of order
completion. We have standby generator to mitigate this issue.
3. There could be a number of problems in the production process at different stages, These have been
discussed in the Risk analysis report.
4.2 Understanding the needs and expectations of interested parties

Technodent Industries is very well aware of the needs and expectations of the internal and external
parties and tries its best to come up to their expectations. The internal parties are the Management
and the Employees and the external parties are suppliers and the customers.
Internal:
1. The interest of the management is smooth running of the company affairs with increased
profits by increasing sales and production with reduced rejections. For this the top management is
always on the lookout of any opportunities for enhancing its sales. Not only that we send our
product brochures and other relevant literature to end users of our products around the world but
also participate in almost all International Exhibitions with the sole purpose of exploring more
business opportunities as well as collecting feedback of existing customers. Addition of new
plastic molded dentistry related products with the brand name of SHEHPAR is the result of this
effort. We are also keeping an eye on the new developments in regard of production processes in
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our field as per our quality policy. More than 150 new molds for teeth are under preparation on
CNC machines which will reduce our wastage and hence increase profits.
2. Interests of the employees are good salary, job security and safe & healthy working environment.
For this we train our employees to be more skilled & useful. We provide them with masks,
goggles and gloves where necessary. They are also provided conditional job security with
chances of promotion. They are well aware of the fact that if they work honestly according to
their job requirements, they will not be thrown out rather they have a chance of promotion to the
supervisory, foreman and even manager level. Awareness and motivating sessions are conducted
within the premises for the purpose.
External:
1. Customer”s interest is good quality delivered to them as per contractual agreement (in time) and
at compatible rates. Technodent Industries gives maximum importance and regard to its
customers. We make sure all queries are promptly responded and needs and demands of the
customers are clearly understood before making any commitments and then we honour our
commitments. Ref: Procedure for contract review (QSP/8.2.3/01) & Format TI/Mgmt/CR/01. We
keep in touch with our customers and try to get their feedback with the intention of evaluating
our performance and try to reach 100% satisfaction of our customers. Ref: Customer feedback
procedure (QSP/8.2.1/01) & format # TI/Mgmt/CR/01.
2. Supplier’s interest is to have maximum business from Technodent. We at Technodent also
believe in a long tern relationship with our suppliers but not at the cost of any harm to our
interests. In the beginning we judged them for quite some time before listing them on to the
approved supplier’s list but we have an evaluation and re- evaluation procedure enforced to
continuously monitoring their performance. Ref. (QSP/8.4.2/01)
4.3 Determining the scope of quality management system
The scope of the quality management system has been determined as mentioned at point 1
above. However it is subject to change any time depending upon threats and opportunities that may
come our way. We may include or exclude the product range to be covered by this Quality
Management System. (Ref: Quality Policy Statement)
4.4 Quality management system and its processes
The Quality Management System of Technodent Industries has been established, documented and
implemented covering the requirements of ISO 9001:2015. To implement the quality management
system, the organization has managed to identify the processes needed for the quality management
system. The processes and the way they are carried out and monitored under the Quality
Management system are:
Process Regulated By Procedure No.

1. Human Resource Recruitment & Training QSP-7.2/01
2. Internal & External Communications QSP-7.4/01
3. Contract Review QSP-8.2.3/01 Format: TI/Mgmt/CR/01
4. Production Planning Production Chart & Batch Records
5. Purchase QSP-8.4/01& Format TI/Supp/Eval/01
6. Production (different steps) Concerned Work Instructions
7. Quality Control Concerned Work Instructions
8. Control of Non-Conformities QSP-8.7/01 & Format TI/Id & CA/01
9. Storage of finished goods Concerned Work Instruction
10. Dispatch & Follow up (Feedback) QSP- 8.2.1/01 & Format TI/Cust/fb/01
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11. Any adverse complaint handling QSP-8.2.1/02 & Format TI/Cust/Comp/01

12. Control of measuring & Monitoring Equip QSP-7.1.5.2/01
13. Control of documents QSP-7.5.3/01
Top Management is active and alert to avail any opportunity of growth either by changing
technology or adding new products and at the same time is conscious about any threats not only
for the business but also any threats that are foreseen internally in the processes or externally
posed by political, economical, social changes or by our competitors. The risks, their severity and
the steps that could be taken to mitigate them are listed in the Risk Analysis Report. (TI-01/04)
5. LEADERSHIP
5.1 Leadership and Commitment
5.1.1The leadership of Technodent Industries is fully determined and committed to implement this
Quality Management System in letter and spirit. For the purpose the management has provided and
is committed to provide any additional resources for successful running of the system as and when
required. The management has laid down and implemented the Quality System procedures and
work instructions so as to make sure that the system is followed and there is a vigilant monitoring to
ensure their true implementation with relevant records maintained. These Procedures and Work
Instructions are subject to change as and when required so for improvement in the system.
5.1.2 Customer Focus:
The top management ensures that the quality system of Technodent Industries follows a
customer-focused approach and all processes are designed to meet the customer needs
and expectations. To ensure a customer-focused approach, the top management
continuously monitors and reviews to ensures that:
i) All customer’s queries are promptly responded.
ii) Customer requirements are completely identified, understood and documented.
iii) The contract is adequately reviewed for available resources and time frame so that there no
hindrance in meeting the contractual agreement/ commitments.
iv) Any risk or opportunity that could affect the conformity of the product or timely delivery etc are
identified and taken care of. (Risk analysis report)
All the above steps are taken care of to ensure and enhance the customer satisfaction. In addition
to the above the management has a procedure to seek customer’s feedback (QSP- 8.2.1/01).
5.2 Quality Policy
Technodent Industries has established a Quality Policy as well as a Slogan which speaks of its
commitment to quality. It is as under:
WE WILL SEARCH AND RESEARCH FOR ANY DEVELOPMENTS IN THE TEETH
MANUFACTURING PROCESSES AND ADOPT ANY THAT COULD HELP US INCREASING
OUR PRODUCTION WITH DECREASED REJECTIONS AND RE-WORKS.
WE WILL ALWAYS LOOK FOR OPPORTUNITIES AND ADD NEW PRODUCTS TO OUR
PRODUCT RANGE IN THE SAME FIELD OF DENTISTRY OR OTHERWISE.
&
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WE WILL LEARN FROM OUR MISTAKES AND MAKE EFFORTS TO ALWAYS IMPROVE
OUR PRODUCT FOR ACHIEVING THE HIGHEST LEVEL OF CUSTOMER SATISFACTION.
Our Quality Slogan is,
“EXCELLENCE THROUGH RESEARCH”
5.2.1 Communicating the quality Policy

Quality policy is communicated to all levels of the employees not only
verbally but also displayed at different prominent locations in the company.
5.3 Organizational roles, responsibilities and authorities.

Technodent Industries has documented the duties and responsibilities of the
responsible people/ positions. The organogram and the duties and
responsibilities are as follows:
Technodent Industries Functional Organizational Chart
Managing Director
Director Production & Director Finance &

International Marketing Local Marketing
F.M. (Moulding) F.M. (Trim Insp) I/C Q. Control
F.M. (Finishing) F.M. (Assembly)
Managing Director:
The responsibility of system implementation lies with Managing Director of Technodent Industries.
Responsibilities of Managing Director/CEO includes but not limited to the following;
1. Provide appropriate resources for the management and maintenance of Quality Management
System
2. Create a working environment in which commitment and active participation of all personal can
be obtained and fostered
3. Ensuring that the company’s quality system and policy is understood, implemented and
maintained
4. Ensuring that sufficient periodic management review on the quality management system are
conducted in order to ensure its continuous suitability, effectiveness and improvement
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5. Overall look after management of the company business

Director Production & International Marketing:
1- He is responsible for arrangements of all necessary inputs to meet the production schedule as per
orders, like; raw material, packing material, manpower, machinery maintenance, etc.
2- He is responsible to make sure that all orders are completed as per agreed dates with the clients
3- He is responsible to ensure timely delivery of the goods to the clients
4- He is responsible for the for the quality of products and their proper packing.
5- He is responsible to find new buyers in the international market by correspondence, by sending
company brochures and samples etc.
6- He is responsible for reimbursement of LC’s from the bank after completion of the orders
For all activities he is answerable to the managing director as and when required.
Duties and responsibilities of the Dir. Local Marketing & Finance
1- He is responsible to find new local buyers for maximum sales

2- He is responsible to maintain the company finances and provide finances as and when required to
meet the day to day expenses
3- He is responsible to maintain the bank accounts for the exports in the name of the company,
however the finances for the day to day expenses, utility bills and salaries etc. are provided from
the cash liquidity against noting in the day book which at the end of every month are balanced
against the cash received from local sales and the balance is carried forward.
Duties & Responsibilities of Forman (Moulding)
1- He is responsible for the activities under his control after he has received the molding material in
the form of strips in his department from the mixing section
2- To ensure that the moulding machines are properly handled to avoid any damage to them
3- To ensure that all moulding machines, dyes, related equipment and the area (moulding stands)
are properly cleaned before the work starts in the morning and after each shift.
4- To ensure that the workers follow the production schedule as given to them and that each
moulder records his production in the note book meant for this purpose (separate note book for
each shift each machine)
5- To ensure the product quality and quantity before they are passed on to the next step. i.e.
finishing department (quantity as per note book) on the batch record form
6- To ensure that in the section the written work instructions are followed in true sense
Duties & Responsibilities of Forman (Finishing)
He is responsible for the following activities under his control after his section has received the
moulded teeth from the moulding department
1- To check the quantity as per the batch record form, separate them from the moulds, segregate
them according to mould no. and put them in the blasting (trimming) machine for removing the
flashes after which they are put into a bottle duly marked with batch number, mould number and
the shade on it
2- To get the trimmed teeth checked from the trimming inspection section to ensure the all teeth
have been properly trimmed. To polish the teeth after washing. Polishing is done in the polishing
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machine. After polishing the teeth are stored in the same bottle again and sent to assembly
department along with the batch record form
3- He is responsible to ensure all the above steps are performed with full care to avoide any damage
or loss to the product
Duties & Responsibilities of Forman (Trimming Inspection)
He is responsible for the following activities under his control after the teeth have been sent to him
from the finishing department for the purpose of inspection (along with the batch record form)
1- That the teeth are properly washed to get rid of any trimming dust etc. before the inspection
starts.
2- That each tooth is individually inspected to ensure that 100% teeth are properly trimmed and in
case of any traces of flashes left they are removed by grinding with the sand paper
3- That after the teeth have been inspected they are put back in the same bottle in which they are
delivered to his section and sent back to the finishing department with the batch record form.
4- For the all above activities he must ensure full care to avoided any damage
Duties & Responsibilities of Forman (Assembly)
He is responsible for the following activities under his control

1- That all teeth delivered to him for assembly purpose are assembled in the boxes in their
respective places i.e. shade, die and packing style wise
2- That all teeth being assembled are of the required quality and if any found not of desired standard
are separated and noted on the batch record from for record
3- The separated product must be kept in a separate envelope and submitted to the Director
Production for analysis as to reason of rejection and finding the solution to avoide recurrence.
4- That he wax used for mounting these teeth has the required adhesiveness and if not it must be
reported to Director Production immediately for its disposition.
Duties & Responsibilities of In-Charge Quality Control
He is responsible for the following activities under his control

1- Each box coming from the assembly section is inspected thoroughly to see that the packing is
proper from all points of view i.e. quality of teeth, shade and die, assembly in proper position and
quality of wax used.
2- After through inspection he must mark the shade and mould number outside the box at
designated places to show that the box has been through inspected.
3- Inspected boxes are delivered to the director for final packing and delivery. However the director
also inspects the boxes at random to ensure that only good quality products are being delivered to
the client.
6. PLANNING
6.1 Actions to address risks and opportunities
Technodent Industries has established a document no TI – 01/04 with the
name of Risk Analysis report in line with the ISO9001:2015 requirements to
address this clause.
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6.2 Quality Objectives and Planning to achieve them
Technodent Industries chalks out its Quality Objectives on yearly basis and
. And also make a planning to achieve them. Its objectives for the year 2017
– 2018 are:
6.2.1 QUALITY OBJECTIVES
LONG TERM (ANNUAL)
1. Make sure that the new standard requirements are not only understood but followed in true
letter and spirit throughout the organization. (Responsibility: Dir. Production)
2. Try and control the rejection rate up to a maximum of 6.5% (Responsibility: Dir. Production)
3. Try and increase the sales of Acrylic teeth by 5% this year. (Responsibility: Dir. Production)
4. Develop more plastic products by consulting/ discussing with the dentists and the dental labs.
(Responsibility: Dir. Production)
5. Prepare new manual for ISO13485 in line with its requirements for revised standard 2016
(Responsibility: Tech. Consultant)
6. Make sure that the new molds being prepared for teeth are received and put into operation as they
will help reducing the wastages. (Responsibility: Dir. Production)
SHORT TERM (To be completed by Mid December, 2017)
1. Develop all companywide procedures in line with the new requirements of ISO9000:2015
specially Hiring & Training, Supplier’s evaluation, Customer’s feedback and satisfaction.
(Responsibility: Tech. Consultant)
2. Review the whole ISO9001:2015 manual and bring it in line with the standard requirements and get
the major CAR resolved by mid December,2017. (Responsibility: Tech. Consultant)
3. To take corrective action on the minor CARs issued in the external audit.
4. Bring the new suppliers of plastic parts also into the system
6.2.2 PLANNING FOR ACHIEVING QUALITY OBJECTIVES:
The objectives have been categorized into Long Term and Short Term. Achievement target is also set with
them. Dir. Production has been given a free hand for executing these. He can seek the help of the technical
consultant for executing the tasks assigned to him as and when he requires so. The technical consultant has
been requested to complete the tasks assigned to him as per schedule and also extend his guidance for the
Dir. Production for the execution of his part of assignments whenever he requires so.
A) Technical consultant has been requested not only to revise the documentation in line with the
requirements of the latest version of the ISO standards i.e; ISO9001:2015 but also create awareness
about it and make the changes that are required for it. He will also be requested to hold meetings
with all staff as well as the management for the purpose.
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B) A culture of being vigilant and always striving for continuous improvement will be created in the
overall company through lecturing and training.
C) All operational activities will be monitored closely and vigilantly to ensure that non conformities if
any are promptly noted and taken care off. Any suggestions for improvement in products or services
by clients/ customers and even our own employees will be valued and taken care of with the idea to
continuously improving our products and services and achieve customer satisfaction.
D) Efforts will be made through mails and visits abroad as well as contacting clients locally to enhance
sales.
E) All short term objectives will be verified for completion by the Dir. Finance who is also the internal
auditor, by the last week of December, 2017.
F) All long term Objectives will be reported by Dir. Production and verified by the Management
committee for compliance.
6.3 PLANNING FOR CHANGES:
Any changes either in the Quality Objectives or any other document or procedure will be discussed
in the Management Review meeting and be made after approval of the committee. A proper change
notice along with the changed document will be sent to the concerned authority and later be verified
by the issuing authority to ensure that the change has been incorporated and the obsolete documents
or pages have been removed from the controlled documents. All such changes whether due to
change in technology, customer requirements or any ambiguity traced during internal or external
audit are not only listed in the change record of this manual but change notices are also kept in file,
“Change Record file”.
7. SUPPORT
7.1 Resources
7.1.1 General
A) Technodent Industries has determined and managed to provide all necessary resources like
Human resources, Technology, Machinery, energy resources like Electricity & Gas , communication
resources like telephone & internet etc. needed for the establishment, implementation, maintenance,
smooth running and continual improvement of the quality management system. The management is
vigilant about any constraints that may come its way and have sorted out how to mitigate them. Any
resources that have to be arranged from outside which could be helpful in smooth running of the
Quality Management system is arranged on top priority basis.
7.1.2 PEOPLE
Our product nature is such that we do not find skilled people from the market. We have to
recruit raw hand but people who are little educated to understand the process through
instrustions. Technodent Industries ensures their training under the supervision of skilled
workers and they are not made to work independently till they are capable of it.
Ref: QSP-7.2/01 and Format:TI/HR/Trg.Ass/01
7.1.3 INFRASTRUCTURE
Technodent Industries has its own triple story building (at 15 marlas) with identification of
different sections/ departments. The building is airy with a provision of a wash room on
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every floor. All machinery and equipment including the measuring equipment have been
provided for smooth running of the company.
7.1.4 ENVIRONMENT FOR THE OPERATION OF PROCESSES

A comfortable environment both physical and psychological exists at Technodent Industries.
There is an atmosphere of mutual respect and mutual trust. The employees are given all
equipment necessary for their safety; such as gloves, masks n goggles etc. where necessary.
They are also assisted for medical expenditures where needed. They are provided clean
drinking water. A proper lunch & prayers break with allocation of separate place is provided to
the employees.
7.1.5 MONITORING AND MEASURING RESOURCES

7.1.5.1 GENERAL
Technodent Industries maintains a monitoring system for the calibration of its critical
measuring equipment which can have an adverse effect on the quality of its products if
not taken care of. Measurement traceability is maintained throughout the production
process as well as for all the equipment’s covered under calibration program.
7.1.5.2 MEASUREMENT TRACIBILILITY
Calibration records of all equipment whether done in house or from external resources
are maintained and where necessary are displayed on the equipment.
7.1.6 ORGANIZATIONAL KNOWLEDGE

The Top Management is the same since 1991 and therefore are fully aware of the
Organization as they established it and have been working in it since long.
As for the other employees, mostly employees are working with us for years and they
understand almost what is necessary for them about the organization.
The management keeps an eye on any development in the field of teeth manufacturing
through internet as well as by attending exibitions all over the world. In case of any
technical development, the management would be very keen to adapt to changes.
7.2 COMPETENCE
7.2.1 Since Technodent Industries has a unique product and the process, we don’t find
experienced workers from the market. WE have to recruit people and train them ourselves to be
competent for work.
7.2.2 There is no special education level required, the employee should have the basic education may
be just Matric or even below, but should be able to understand and apprehend the instructions
and follow them.
7.2.3 Technodent Industries has ON THE JOB training system. Whenever a new person/s are
recruited, they are made to work under the supervision of some senior worker. A report of work
is submitted to the Director Production (on the production note book maintained in the
particular section/s). When the Foreman /Supervisor of that section are satisfied with his/their
performance , he informs the Director and looking at his daily progress, if it is satisfactory, he
is allowed to work independently.
7.2.4 Technoent Industries do not recruit supervisors or foremen directly but the senior workers are
promoted as supervisor when he has an experience of at least five years and satisfactory
performance. Supervisor may be promoted as Foreman after another 5 years of experience and
satisfactory performance, however this time period for promotion may be relaxed if the
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candidate is educated for a Matriculate the total time to reach Forman may be seven years and
for F.A or higher it may be even less than that subject to satisfactory performance and vacancy.
7.3 AWARENESS
The Quality Policy is communicated to all employees of Technodent Industries through display
posters at appropriate locations in the factory. Dir. Production/ Manager Production conducts
regular sessions with existing employees and new employees at least every three months to ensure
that quality policy is understood to all. The employees are also made aware of the benefits of
following the QMS (to them personally and to the company as a whole) and of course losses in case
of not adhering to it. Records of such lectures is maintained in a register with control no.
TI/Trg-Awareness/01
7.4 COMMUNICATION
The management of Technodent Industries clearly understands as to what?, when?, How?, and
who? is to communicate with whom?
i) All external communications with the clients/ buyers is through E-mail. Order information
or placement of order by the clients is through mail, a copy of the order after the order is
final is printed and made a part of the record in that customer’s file.
ii) For new clients, Technodent brochure is sent either through mail as a hard copy a soft copy
of the same sent through e mail depending upon customer’s will.
iii) Finally agreed order is then divided into parts according to mold / shade nos for execution
along with other orders for the same category.
iv) A production chart is made by the Director Production and given to the Foreman molding
from where the process starts and travels down the process line along with the products.
v) Any change in any order or process is immediately informed to the concerned by Director
Production.
7.5 DOCUMENTED INFORMATION
7.5.1 GENARAL
The company has prepared its quality management system documentation, which includes:
a) documented statements of a quality policy and quality objectives,

b) a quality manual,
c) documented procedures required by this International Standard,
d) documents needed by the organization to ensure the effective planning, operation and
control of its processes,
e) records required by ISO- 9001:2015 Standard
f) any other documentation specified by national or regional regulations.
Where this ISO9001:2015 Standard specify that a requirement,
procedure, activity or special arrangement be “documented”, it is implemented and
maintained. Ref: clause 4.4
For each type or model of medical device, the organization has establish and maintains a
technical file containing/identifying documents defining product specifications and quality
management system requirements. These documents define the complete manufacturing
process.
Page 18
7.5.2 CREATING AND UPDATING
7.5.2.1 All system related documents as per following are created and maintained up to date to
reflect changes if any. They are duly approved by the concerned authority.
LEVEL – i Quality Manual

(Policy, Job Descriptions, Quality System Procedures)
LEVEL – ii Technical File / Quality Plans / SOP/ Work Instructions
Technodent Industries has established and maintains files containing documents
Standard Operating Procedures, Work Instructions defining for each type / model of
medical devices, product specifications and quality system requirements (process &
quality assurance) for complete manufacturing & usage.
LEVEL – iii Quality Records
(forms, registers etc.)
QUALITY MANUAL
The Quality Manual is current and up-to-date to reflect changes to the system. It is simply stated,
easy to use, and fully approved by all affected functional groups. This quality manual includes;
a) the scope of the quality system, including details of and justification for any exclusion or non-
application;
b) reference to the Quality System Procedures, Departmental Procedures, or related documentation;
c) a description of the sequence and interaction of the processes included in the quality management
system
d) outlines the structure of the documentation used in the quality management system;
Technodent Industries has documented quality system procedures that further describe how the
specific policy objectives and goals are met. The Quality Manual includes references to documented
Job Descriptions, quality system procedures. Where applicable, Standing Operating Procedures
(SOP), Quality Plans, Work Instructions are also referred in the quality manual.
Procedures, Quality Plans and Work Instructions are implemented as written. The quality system
procedure explains how Technodent Industries implements the requirements of ISO9001:2015 &
ISO-13485:2003in accordance with its Quality Policy. These are revised, as necessary, to reflect the
actual objectives, flow of tasks, and staff responsibilities.
Quality records
Documents include the specifications and the quality record such as filled formats. These
documents serve as objective evidence and demonstrate that the quality system is implemented and
functional.
Document Structure
Type of Document Description

System Documents Quality System Manual including Quality
System Procedures
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Process Documents Quality Plans

Work Instructions
Drawings
Technical Files
Control of Documents: Ref: Procedure QSP-7.5.3/01
Approval and Issue Changes

Documentation affecting quality are reviewed, approved and authorized for adequacy by Director
Production / International Marketing prior to issue. Changes to documents are reviewed and
approved by the same functions that performed that original review and approval. Documents are
issued and maintained, identifying the nature of the changes wherever practicable.
Copy Control
All documents, which affect quality, are issued on a “Controlled” basis. Holder of controlled copies
are automatically issued with updated versions. Holder of controlled copies shall destroy or return the
obsolete versions to the sender on receipt of an update.
A proper record of distribution of controlled documents like the manual and work instructions is
maintained in file # B-09, A master list of the current revision and issue of documents is maintained
in order to preclude use of non-applicable documents and to identify obsolete documents which
require retention for commercial, legal or historical reasons.
A unique numbering system for the control of documents has been developed in the organization.
Since Technodent is producing with two brand names WELBITE & CRISMA, we have two
numbering systems for both in order to distinguish, the system is as follows;
For control of Batch record of WELBITE, the numbering system is:

TI / X / BB / CC / DD (For Welbite brand)
Where “TI” represents Technodent Industries, “X” represents the color shade starting from 1 and
goes up to 8, “BB” represents the date, “CC” represents the month and “DD” represents the year.
This form will travel though all the functions where relevant people will just tick the function after
completion or fill in the figure required if required.
At the end of this batch record form will be kept in record for a period of two years after the delivery
of the batch to the client after which it is discarded as in case of any complaint by the client it will
reach within 2 years. The same number is then shifted onto boxes in which the teeth made from the
batch are packed.
For the control of batch record of CRISMA

The numbering system and the whole procedure will remain the same except “X” this will change to
“X-Y” where “X” stands for alphabets; A / B / C or D and “Y” stands for digital representation 1/2/3
etc. and a combination of both these alphabets and digits represents the color shade of the interiors
and posteriors such as A-1, A-2, B-1, B-2, C-1, C-2, D-1, D-2, etc. (This coloring system is
recognized and understood internationally. However the numbers used with “A” are 1.2, 3, 3.5 & 4.
With “B” are 1, 2, 3 & 4. With “C” are 1, 2, 3 & 4 and with “D” are 1, 2, & 3. so there are a total
number of sixteen color shades.
Page 20
The control system for the work instructions is as follows;

TI / WI / XX / YY where “TI” stands for Technodent Industries, “WI” for work instruction and
“XX” stands for the function for which the work instruction has been written, i.e “SM” for shade
making, “CM” for color mixing, “MD” for molding, “FI” for finishing, “TR” for trimming, “AS” for
assembly, “QC” for quality control, “CLB” for internal calibration, of thermal gauges, “YY” stands
for the serial number of the instruction (for the particular function mentioned at “XX” starting from
01.
Control of External Documents;

All external documents like Material Safety Data Sheets, standards, literature, legal requirements,
etc. are controlled and properly filed in file no. B-18, A list of all such documents is available in the
same file.
Technical Files and Data (CE Marking)

All the technical files and data for CE marking are retained with Director Production and he is
responsible for the issuance and control of such documents related to CE marking. Documentation
referred to in the Master Device Record; stored for the period of at least two years after the last
product has been manufactured.
Obsolete Documents
The departmental Heads/ Director Production dispose of obsolete documents. An “Obsolete” stamp
identifies such documents. However the obsolete documents are retained for a period of six months.
Since it is difficult to specify the product life as well as its traceability after use by the doctors, the
records of production as against the batches are not necessary to be maintained for more than six
months, however these are maintained for a period of two years.
8. OPERATIONS
8.1 OPERATIONAL PLANNING AND CONTROL

8.1.1 Technodent Industries clearly understands and maintains all resources required for the smooth
running of operations in line with the requirements to ensure that the products and services meet
or exceed customer expectations.
8.1.2 Starting from the preparation color mixing batch till its final packing, products are inspected at
every stage to ensure that not even a single unit (teeth) is passed on to the next stage.
8.1.3 All parameters ensuring that the products at any stage are not contaminated are ensured . The
respective Foremen are responsible to take care of all parameters.
8.2 REQUIREMENTS FOR PRODUCTS AND SERVICES
8.2.1/2 Director Production and International Marketing is responsible for all sorts of
communication with the customers which includes but limited to.
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1. requirements specified by the customer, including the requirements for delivery

and post-delivery activities
2. requirements not stated by the customer but necessary for specific use or known and
intended use
3. statutory and regulatory requirements related to the product, and any additional
requirements determined by the company
4. Seek feed back from the customers for improvement in our own product and
services. Ref: Procedure (QSP-8.2.1/2 – 01)
8.2.3 Director Production in consultation with MD reviews the requirements related to the
product. This review is conducted prior to the company’s commitment to supply a
product to the customer and ensures that:
1.Product requirements are clearly defined & documented;
2.where the customer provides no written statement of requirement, the order
requirements are confirmed before acceptance;
3. contract or order requirements differing from those previously expressed are
resolved;
4.The company has the ability to meet the customer requirements for the product.
The results of reviews and subsequent actions are recorded.
Ref: QSP- 8.2.3/01
Note: Since Technodent is a manufacturer of Acrylic teeth of standard designs and colours as per
its well established and recognized mould charts and shade guides, there is hardly anything
to be reviewed in the contract in this respect, however the contractual requirements needed
to be reviewed are: delivery dates, payment schedules and/or any change in the packing
instructions/ design of the packing other than the standard used by the Technodent
industries.
8.2.4 Changes to requirements for products and services
In case the customer desires to change any requirement after the order has been confirmed,
Director Production in consultation with MD, reviews the nature and impact of change
desired. Again the specification, price, mode of payment and terms of shipment are reviewed
as discussed above. The amendment is communicated to all relevant departments
Ref: Procedure (QSP-8.2.3/01)
8.4 Control of externally provided processes, products services
8.4.1 General
Technodent Industries has the following products, Raw materials being provided to
it by external sources.
1.Poly Methyle Acrylic Resin (imported from UK)
2.Mono Methyle liquid (imported) from local market.
3.Packing boxes for Wellbite & Charisma brand teeths
4.Wax sheets for teeth mounting in strips for packing
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5.We have newly taken up Plastic molded dental related products (with the brand name of
SHEHPER) used by the Dentists as well as Dental Labs.
8.4.2 Item at serial # 1 is being imported from M.R. Dental (UK),a very well known firm since the
beginning of our company and we have never had any problems with quality or delivery. On
our request (for ISO 9000) certification purpose, they also us with the safety data sheet as
well as Quality/ chemical certificate of this product.
Item # 2 is being purchased from the local market where we don’t get any quality certificate
but we test it ourselves at our end practically. The test is that Acrylic Poly methyl liquid will
form a smooth paste for forming a cake only with Acrylic Mono methyl liquid otherwise it
will not.
For items at serial # 3&4, the suppliers are on our approved suppliers list and we have a
contractual agreement with them. We have approved samples signed by both parties, buyers
as well as the supplier. We just check the quantity on receipt, however the quality is verified
practically during actual use. Any articals not qualifying for use are returned back to the
supplier and not paid for these rejections.
Item #5 Since these externally made/ provided products are not to be incorporated
into our own products rather they are absolutely of different nature and use, we
have not put any sort of controls over the providers or their processes. We have got
prepared the dies for these parts and get as many pieces in whatever colour we require from
any known quality Injection molding factory. The provided products are inspected at our own
premises and any rejections are returned back to the provider and not paid for. The only
inspection criteria is the finish of these products because no other parameter such as colour
size etc are important. For this we have a signed contract with these two or three producers.
Since it’s a beginning, at a later stage when we have sufficient orders and sales volume, we
may go for our own Injection Molding section.
** There are no further controls required over these externally provided products as
they are disposable and by no means risky for their use.
8.4.3 Information for External providers

The external providers for raw materials are given information clearly describing the
materials ordered and quality certificates are also asked for specially for imported items.
The management reviews and approves purchasing documents for adequacy of the
specification of requirements prior to release. Records of purchasing activities are
maintained. Records of all purchased material are maintained in different registers. For
local materials, the suppliers are ordered either on phone or via email. However the
records are also maintained in the form of hard copy in the supplier’s files for monitoring
purpose.
8.5 Production and service provision

For sub contracted items, the suppliers are ordered either on phone or via email.
However the records are also maintained in the form of hard copy in the supplier’s files
for monitoring purpose.
8.5.1 Control of Production Provision

8.5.1.1 General Requirements
Page 23
The company plans and carries out the production and service provision activities under
controlled conditions. Controlled conditions include:
a) availability of specifications that define the characteristics of the product;
b) availability of documented SOPs, work specifications & reference standards;
c) use and maintenance of suitable equipment;
d) availability and use of suitable measuring and monitoring equipment;
e) implementation of suitable monitoring and measurement activities;
f) Implementation of defined processes for release, delivery and post delivery activities.
g) Implementation of defined labeling and packaging operations to prevent errors
8.5.2 Identification and Traceability

8.5.2.1 General
Technodent Industries record is established and maintained for each batch of product that
provides traceability. The organization has established a documented system identifying
the product requirements. The products are identified and distinguished at all stages of
production and this record also identifies the quantity manufactured and quantity
approved for distribution. All batch records are maintained.
8.5.3 Property belonging to customers or external providers

Not applicabe
8.5.4 Preservation
Technodent Industries has established documented procedure for preserving the
conformity of product during internal processing and final delivery of product or services
to the intended destination, the conformity of product with requirements is maintained.
This includes product identification, packaging, storage, preservation and handling. At
Technodent Industries no product is identified with a limited shelf life or requiring special
storage, so no special storage conditions need to be controlled. Products are packed as per
Procedure (QSP-8.5.4/01)
8.5.5 Control of changes
Technodent Industries do not provide any services but products only. There are no post
delivery activities involved as such as the products have an unlimited bench life.
Customer’s requirements are taken care of while taking and executing the order. However
in case of any complaints from the customer (which so for in 27 years has been only one)
and that too was not our fault. We will take appropriate measures to ensure they do not
happen again.
8.6 Release of Products and Services
This clause is taken care of as mentioned in 8.5.1.1
8.7 Control of nonconforming outputs
8.7.1 The company ensures product, that does not conform to requirements is controlled
Page 24
to prevent unintended use or delivery. The controls and related responsibilities

and authorities for dealing with non-conforming products are defined and
documented.
The nonconforming products are dealt with in any of the following ways:
 There is no way that a nonconformity could be removed or accepted on concession
except the small fins that may have been over looked during manual trimming. These fins
are removed even at the packing stage.
 All other defects render the product to straight away rejection. Rejected pieces are
noted in quantity and defect category wise and thrown into the RED COLOUR
waste bin, from where they are disposed off to waste.
Records of nature of nonconformity and any subsequent actions taken are maintained.
In case the nonconformity is detected after delivery, the company takes action
appropriate to the effects, or potential effects, of the nonconformity.
8.7.2 The company takes action to eliminate the causes of non-conformities in order to prevent
recurrence. The extent of corrective actions taken depend on the impact of the problems
encountered. The procedure for the corrective action process includes:
 Identification and review of non-conformities (including customer complaints);
 Determination of root causes of non-conformities;
 Evaluation of the need for actions to ensure that non-conformities do not recur;
 Determination and Implementation of any actions necessary to ensure that Non-
conformities do not recur; Recording results of actions taken; Follow-up to ensure
corrective action taken is effective and recorded. Ref: QSP-8.7/01
9. PERFORMANCE EVALUATION
9.1 General
Technodent Industries has determined the following activities need to be monitored
for ensuring the performance of its products and customer’s satisfaction.
9.1.1 Customer Feedback / Satisfaction

Technodent Industries has determined and established processes for monitoring
information on customer satisfaction and/or dissatisfaction to assess whether the company
has met the customer requirements. The methods and measures for obtaining this
information and its use is defined in documented procedures.
Also the company has established a documented feedback system to provide early
warning of quality problems and for input to the corrective & preventive action process,
and also experience from the post-production phase is gained and the review of this
experience became a part of the feedback system.
Director Production is responsible for post production monitoring, proposal of corrective
actions and their implementation. Ref: QSP-8.2.1 /01
9.1.2 Measurement and Monitoring of Processes

The company applies suitable methods for measurement and monitoring of processes
necessary to meet customer requirements and to demonstrate the processes continuing
ability to satisfy its intended purpose. In case of non-conformance with the planned result,
correction and corrective action are taken to ensure conformity of product. Refer to
Page 25
preventive maintenance record of the molding machines and that of trimming and
polishing machines.
9.1.3 Measurement and Monitoring of Product

The company applies suitable methods for measurement and monitoring of the
characteristics of the product to verify that requirements for the product are met. This is
carried out at appropriate stages of the product realization process in accordance with the
planned arrangements and documented procedure.
Evidence of implementation of required measurement and monitoring and conformance
with the acceptance criteria used is recorded. Product does not proceed to next stage or is
not dispatched until all specified activities have been satisfactorily completed and the
related documentation is available and authorized. Product release never proceeds until
the planned arrangements have been satisfactorily completed as per following flow chart;
Shade Preparation  Color Mixing in Ball Mill  Cake Formation &

Refrigeration  Slice Cutting  Molding  Trimming  Washing 
Polishing  Assembly
9.2 Internal Audit
The internal audit process acts as a management tool for independent assessment of any
designated process or activity. The internal audit process provides an independent tool
for use in obtaining objective evidence that the existing requirements have been met. The
company has established a process for performing internal audit at least once per year in
order to determine if the quality management system:
a) Conforms to the requirements of this international standard;
a) Has been effectively implemented and maintained
The company plans audit program, which is based on the status and importance of the
activities, areas or items to be audited, and the results of previous audits.
The company has documented and implemented for internal audit that covers the audit
scope, frequency and methodologies, as well as the responsibilities, requirements for
conducting audits, recording and reporting results to management. Personnel other than
those who performed the work being audited perform audits. The management of the
company takes timely corrective actions on deficiencies found during audit. Follow up
actions include the verification of the implementation of corrective action and the
reporting of verification results.
The internal auditor (normall Mr. Liaqat Ali Humayun Dir. Finance and Local Marketing)
will prepare a checklist/areas and activities to be audited before each audit depending
upon their criticality and importance. Please refer to serial # 28 (TI/Int.Audit/01) of the
list of controlled documents and for internal audit schedule no. 29 (TI/Int.Audit/02) of list
of controlled documents. The audit report is generated in the form of non-conformities on
prescribed format no. TI/Int.Audit/03 and closed out on the same.
9.3 Management Review

9.3.1 General
Technodent Industries has Management Committee which consists of Chief Executive,
Director Production & International Marketing, Director Finance & Local Marketing who
Page 26
periodically but not less than twice per year review the effectiveness & continuing
suitability, adequacy and effectiveness of the whole Quality System. The review includes
evaluation of the need for changes to quality management system, including quality
policy and quality objectives. Records of review meeting are documented and maintained
in file # B-24.
9.3.2 Management Review input
At Technodent Industries, It is ensured that the following points are essential part
of the Management Review meeting agenda.
1. The status actions from previous management reviews.
2. Changes in external and internal issues that are relevant to the quality of management
system.
3. Information on the performance and effectiveness of the quality management system
including:
 Customer satisfaction and feedback from relevant interested parties.

 The extent to which the Quality Objectives have been met.
 Process performance and conformity of products and services.
 Audit results
 Non conformities and corrective action as against Internal Audit
 Monitoring and measurement results
 The performance of external providers
4. The adequacy of resources.
5. The effectiveness of actions taken to address risks and opportunities
6. Opportunities for improvements
9.3.3 Management Review Output

The outputs of the management review includes decisions and actions related to.
1. Opportunities for improvement.
2. Any need for changes to the quality management system.
3. Resource needs.
10. IMPROVEMENTS
10.1 General
Technodent Industries maintains a Procedure to evaluate the suitability and
effectiveness of the Quality Management System.
Procedure (QSP-10.1 -01)

The QMR collects and analyzes appropriate data to evaluate the suitability and effectiveness of
the quality management system and to identify areas for continual improvement. This includes
data generated by measuring and monitoring activities and other relevant sources. Decisions
based on facts are based on effective and efficient use of appropriate statistical techniques.
The analysis of data provides information on:
 Customer satisfaction and/or dissatisfaction;
 Conformance to customer requirements;
 Characteristics of processes and products and their trends;
 Suppliers
Form TI/Id & CA is used for the purpose
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10.2 Continual improvement

The company continually strives to continually improve the effectiveness of quality
management system through the use of quality policy, quality objectives, audit results,
analysis of data, corrective and preventive action and management review. The quality
objectives are up-graded gradually on routine basis for improving performance of different
departments. There is a proper planning for improvements in different areas/functions of
the company like who, when, what, where the action to be initiated, the results of such
actions are recorded. Further actions are initiated only if there is a success in those planned
actions.
10.3 Corrective Action

The company takes action to eliminate the causes of non-conformities in order to prevent
recurrence. The extent of corrective actions taken depend on the impact of the problems
encountered. The procedure for the corrective action process includes:
 Identification and review of non-conformities (including customer complaints);
 Determination of causes of non-conformities;
 Evaluation of the need for actions to ensure that non-conformities do not recur;
 Determination and Implementation of any actions necessary to ensure that Non-
conformities do not recur; Recording results of actions taken; Follow-up to ensure
corrective action taken is effective and recorded.
10.4 Preventive Action

The company determines actions to eliminate the causes of potential non-conformities in
order to prevent their occurrence. Extent of preventive actions depends on the impact of the
potential problems. The procedure addresses:
 Identification of potential non-conformities and their causes;
 Determination and ensuring the Implementation of preventive Action
 Recording of results of action taken;
 Review of preventive action taken is effective and recorded.
Ref: QSP-8.7/01 and Format: TI/Id&CA/01
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Product: ACRYLIC TEETH & Dental Related plastic products

Subject: Quality Manual Rev. # 02

QUALITY SYSTEM MANUAL

62-Mozang Road, Lahore (54000) Pakistan

IN COMPLIANCE WITH INTERNATIONAL STANDARDS

Prepared by: Approved by:

Section No Title Page

III Quality system Manual (General) 5

3 Terms and Definitions 7

4 Context Of The Organization 8

II- CHANGE RECORD

05-9-17 First Issue of the new manual in line with the

III. QUALITY SYSTEM MANUAL

IV- COMPANY PROFILE

Issued on September 15, 2017

Reason for not being applicable:

3. TERMS AND DEFINITIONS

4.1 Understanding the organization and its context

The internal issues could be:

4.2 Understanding the needs and expectations of interested parties

Process Regulated By Procedure No.

11. Any adverse complaint handling QSP-8.2.1/02 & Format TI/Cust/Comp/01

5.2 Quality Policy

Our Quality Slogan is,

“EXCELLENCE THROUGH RESEARCH”

5.2.1 Communicating the quality Policy

5.3 Organizational roles, responsibilities and authorities.

Technodent Industries Functional Organizational Chart

Director Production & Director Finance &

F.M. (Moulding) F.M. (Trim Insp) I/C Q. Control

F.M. (Finishing) F.M. (Assembly)

5. Overall look after management of the company business

Duties and responsibilities of the Dir. Local Marketing & Finance

1- He is responsible to find new local buyers for maximum sales

Duties & Responsibilities of Forman (Moulding)

Duties & Responsibilities of Forman (Trimming Inspection)

Duties & Responsibilities of Forman (Assembly)

He is responsible for the following activities under his control

He is responsible for the following activities under his control

6.2 Quality Objectives and Planning to achieve them

6.2.1 QUALITY OBJECTIVES

LONG TERM (ANNUAL)

6.2.2 PLANNING FOR ACHIEVING QUALITY OBJECTIVES:

7.1.4 ENVIRONMENT FOR THE OPERATION OF PROCESSES

7.1.5 MONITORING AND MEASURING RESOURCES

7.1.6 ORGANIZATIONAL KNOWLEDGE

a) documented statements of a quality policy and quality objectives,

7.5.2 CREATING AND UPDATING

LEVEL – i Quality Manual

Type of Document Description

Process Documents Quality Plans

Control of Documents: Ref: Procedure QSP-7.5.3/01

Approval and Issue Changes

For control of Batch record of WELBITE, the numbering system is:

For the control of batch record of CRISMA

The control system for the work instructions is as follows;

Control of External Documents;

Technical Files and Data (CE Marking)

8.1 OPERATIONAL PLANNING AND CONTROL

8.2 REQUIREMENTS FOR PRODUCTS AND SERVICES

1. requirements specified by the customer, including the requirements for delivery

8.4.3 Information for External providers

8.5 Production and service provision

8.5.1 Control of Production Provision