TETKİK PROGRAMI / AUDIT PROGRAMME

FİRMA ADI / COMPANY NAME WELDON BIOTECH INDIA PVT. LTD.

32-E,1ST FLOOR, PATPARGANJ, OPP. UNA ENCLAVE, MAYUR VIHAR,PHASE- I,
ADRES /ADDRESS
DELHI-110091 (INDIA).
TEL/ PHONE 91-11-22790239 FAX 91-11-22794407
IMPORTING ,TRADING, SELLING AND DISTRIBUTION OF MEDICAL DIAGNOSTIC
KAPSAM/ SCOPE
PRODUCTS
UYGULANABİLİR OLMAYAN
EA KODU/KATEGORİSİ MADDE/ NON-APPLICABLE 8.3
EA CODE/CATEGORY
CLAUSES 
BELG. STANDARDI AKREDİTASYON
ISO 9001:2015 DAKKS
CERT. STANDARD ACCREDITATION
DENETİM TÜRÜ STANDART ENTEGRE BİRLEŞİK ORTAK ÇOK ŞUBELİ GEÇİCİ SAHA
AUDIT TYPE STANDARD INTEGRATED COMBINED JOINT MULTI SITE TEMPRORARY SITE
REVİZYON NO REVISION NO REV.TARİHİ/ REV. DATE
REVİZYON SEBEBİ
REASON FOR REVISION

Sayın Yetkili / To whom it may concern ,

Ekte bulunan tetkik programı; üç yıllık belgelendirme döngünüz hakkında size bilgi vermek amacı ile firmanıza yollanmıştır. Yeniden belgelendirme
denetim sütunu; mevcut sözleşmenizin geçerlilik süresi dolduktan sonra yeniden sözleşme yapmanız durumunda geçerli olan sütundur.
Audit programme is sent to your company in order to keep you informed about certification cycle of three years. Recertification audit column is valid
after your relevant certification agreement would be expired and re-newed.
Firmanızın çalışan sayına, standardına ve risk faktörü gibi kriterlere göre belirlenen denetim süresi boyunca denetim yapabilmek amacı ile firmanızın
denetimde bir denetçi veya birden fazla denetçiden oluşan denetim ekibi görevlendirilecektir. Net denetim tarihi ve denetçi/denetçilerin bilgisi; denetim
öncesi size gönderilecek olan “Denetim Programı Onay Formu” ile tarafınıza bildirilecektir.
Audit team will be composed of one lead auditor or more than one auditor, it will be determined according to the criterias such as total number of
employee,standard or risk factor. Information of exact audit date and auditor / auditors will be sent to yourattention by means of an ‘’Audit
Programme Confirmation Form’’.
Denetimin ekip ile gerçekleştirilmesi durumunda tabloda belirtilmeyen kısa süreli ara değerlendirme toplantıları yapılacak ve bu toplantılarda denetim
ekibi kendi arasında denetimin gidişatı hakkında bilgi alışverişinde bulunacaktır.
In case, an audit team is required for realisation of the audit, mid-term evaluation meetings are to be organized and audit team will have a chance to
discuss the state of audit among themselves.
Açılış ve kapanış toplantıları; üst yönetim, yönetim temsilcisi ve tetkik heyeti arasında, son değerlendirme toplantısı ise; denetim ekibi ve yönetim
temsilcisi arasında gerçekleşecektir.
Opening and closing meetings will be conducted between upper management, management representative and audit team, whereas final
assessment meeting will be conducted between audit team and management representative.
Denetçilerin denetleyeceği departmanlar, denetim saatleri, saha denetimi süresi ve her departman için ayrılan net süre “Denetim Programı Onay
Formu” ile tarafınıza bildirilecektir. Tabloya dahil edilmemek ile beraber; 30-60 dk sürecek olan öğlen yemeği süresi;
You are going to be informed of Departments to be audited, auditing hours, on-site audit duration and exact time allocated for each and every
department, by `Audit Programme Confirmation Form`.Lunch time lasting for 30-60 minutes is not going to be included in total audit duration.
Bu formun .3. Sayfasında bulunan değişken durumlar takip tablosu ise ; üç yıllık belgelendirme döngünüzde firmanızın değişen durumları ile
ilgili bir özet tablodur. Bu tablo ALBERK QA TECHNIC yetkilileri tarafından takip edilecektir.
Variable Status Follow Up Table table existing at 3.rd page of this form is a summary constituting variable status of your company within 3 years
certification cycle.This table is going to be followed up by ALBERK QA TECHNIC representative.
Bu program web sitemizde yayınlanan Genel Belgelendirme Kurallarının kabul edildiği anlamındadır. Programın onaylanması bu kuralların kabul
edildiğini teyit eder.
*This programme means that General certification rules which is published at our website, is accepted. Confirmation of this programme verifies that
these rules are accepted.

İşbirliğiniz için şimdiden teşekkür ederiz / Thanks for your cooperation in advance.

DENETİM PLANLAMA SORUMLUSU PROGRAMI ONAYLAYAN: AD/SOYAD / TARİH / KAŞE

AUDIT PLANNING RESPONSIBLE PROGRAMME APPROVER : NAME / SURNAME / DATE / STAMP

FR-174/TR/E, Rev.04, 17.11.2016 1/5

ALBERK QA TECHNIC, INTERNATIONAL TECHNICAL INSPECTION CERTIFICATION SURVEY GMBH
Theodor Heuss Strasse 6 D-70174 Stuttgart GERMANY www.qatechnic.de
 TETKİK PROGRAMI / AUDIT PROGRAMME

CERTIFICATION AUDIT 1. SURVEILLANCE 2. SURVEILLANCE RE-CERTIFICATION

1. STAGE AUDIT 2. STAGE AUDIT AUDIT AUDIT AUDIT
DURATION: DURATION: DURATION: DURATION: DURATION:
Opening Meeting Opening Meeting Opening Meeting Opening Meeting Opening Meeting
Site Audit Site Audit Site Audit Site Audit Site Audit

FR-174/TR/E, Rev.04, 17.11.2016 2/5

ALBERK QA TECHNIC, INTERNATIONAL TECHNICAL INSPECTION CERTIFICATION SURVEY GMBH
Theodor Heuss Strasse 6 D-70174 Stuttgart GERMANY www.qatechnic.de
 TETKİK PROGRAMI / AUDIT PROGRAMME

4 Context of the organization 4 Context of the organization 4 Context of the organization 4 Context of the organization 4 Context of the organization
4.1 Understanding the 4.1 Understanding the 4.1 Understanding the 4.1 Understanding the 4.1 Understanding the
organization and its context organization and its context organization and its context organization and its context organization and its context
4.2 Understanding the needs 4.2 Understanding the needs 4.2 Understanding the needs 4.2 Understanding the needs 4.2 Understanding the needs
and expectations of interested and expectations of interested and expectations of interested and expectations of interested and expectations of interested
parties parties parties parties parties
4.3 Determining the scope of 4.3 Determining the scope of the 4.3 Determining the scope of 4.3 Determining the scope of the 4.3 Determining the scope of the
the quality management system quality management system quality management system
the quality management system quality management system
4.4 Quality management 4.4 Quality management system 4.4 Quality management system
4.4 Quality management 4.4 Quality management system system 5 Leadership 5 Leadership
system 5 Leadership 5 Leadership 5.1 Leadership and commitment 5.1 Leadership and commitment
5 Leadership 5.1 Leadership and commitment 5.1 Leadership and 5.1.1 General 5.1.1 General
5.1 Leadership and 5.1.1 General commitment 5.1.2 Customer Focus 5.1.2 Customer Focus
commitment 5.1.2 Customer Focus 5.1.1 General 5.2 Policy 5.2 Policy
5.1.1 General 5.2 Policy 5.1.2 Customer Focus 5.2.1 Establishing the quality 5.2.1 Establishing the quality
5.1.2 Customer Focus 5.2.1 Establishing the quality 5.2 Policy policy policy
5.2 Policy policy 5.2.1 Establishing the quality 5.2.2 Communicating the quality 5.2.2 Communicating the quality
5.2.1 Establishing the quality 5.2.2 Communicating the quality policy policy policy
policy policy 5.2.2 Communicating the 5.3 Organizational 5.3 Organizational
5.2.2 Communicating the 5.3 Organizational quality policy roles,responsibilities and roles,responsibilities and
quality policy roles,responsibilities and 5.3 Organizational authorities authorities
5.3 Organizational authorities roles,responsibilities and 6 Planning 6 Planning
roles,responsibilities and 6 Planning authorities 6.1 Actions to address risks and 6.1 Actions to address risks and
6 Planning opportunities opportunities
authorities 6.1 Actions to address risks and
6.1 Actions to address risks 6.2 Quality objectives and 6.2 Quality objectives and
6 Planning opportunities
and opportunities planning to achieve them planning to achieve them
6.1 Actions to address risks and 6.2 Quality objectives and 6.2 Quality objectives and 6.3 Planning of changes 6.3 Planning of changes
opportunities planning to achieve them planning to achieve them 7 Support 7 Support
6.2 Quality objectives and 6.3 Planning of changes 6.3 Planning of changes 7.1 Resources 7.1 Resources
planning to achieve them 7 Support 7 Support 7.1.1 General 7.1.1 General
6.3 Planning of changes 7.1 Resources 7.1 Resources 7.1.2 People 7.1.2 People
7 Support 7.1.1 General 7.1.1 General 7.1.3 Infrastructure 7.1.3 Infrastructure
7.1 Resources 7.1.2 People 7.1.2 People 7.1.4 Environment for the 7.1.4 Environment for the
7.1.1 General 7.1.3 Infrastructure 7.1.3 Infrastructure operation of processes operation of processes
7.1.2 People 7.1.4 Environment for the 7.1.4 Environment for the 7.1.5 Monitoring and measuring 7.1.5 Monitoring and measuring
7.1.3 Infrastructure operation of processes operation of processes resources resources
7.1.4 Environment for the 7.1.5 Monitoring and measuring 7.1.5 Monitoring and 7.1.6 Organizational knowledge 7.1.6 Organizational knowledge
operation of processes resources measuring resources 7.2 Competence 7.2 Competence
7.1.5 Monitoring and measuring 7.1.6 Organizational knowledge 7.1.6 Organizational 7.3 Awareness 7.3 Awareness
resources 7.2 Competence knowledge 7.4 Communication 7.4 Communication
7.2 Competence 7.5 Documented information 7.5 Documented information
7.1.6 Organizational knowledge 7.3 Awareness
7.3 Awareness 7.5.1 General 7.5.1 General
7.2 Competence 7.4 Communication 7.4 Communication 7.5.2 Creating and updating 7.5.2 Creating and updating
7.3 Awareness 7.5 Documented information 7.5 Documented information 7.5.3 Control of documented 7.5.3 Control of documented
7.4 Communication 7.5.1 General 7.5.1 General information information
7.5 Documented information 7.5.2 Creating and updating 7.5.2 Creating and updating 8 Operation 8 Operation
7.5.1 General 7.5.3 Control of documented 7.5.3 Control of documented 8.1 Operational planning and 8.1 Operational planning and
7.5.2 Creating and updating information information control control
7.5.3 Control of documented 8 Operation 8 Operation 8.2 Requirements for products 8.2 Requirements for products
information 8.1 Operational planning and 8.1 Operational planning and and services and services
8 Operation control control 8.2.1 Customer communication 8.2.1 Customer communication
8.1 Operational planning and 8.2 Requirements for products 8.2 Requirements for products 8.2.2 Determining the 8.2.2 Determining the
control and services and services requirements for products and requirements for products and
8.2 Requirements for products 8.2.1 Customer communication 8.2.1 Customer services services
and services 8.2.2 Determining the communication 8.2.3 Review of the 8.2.3 Review of the
8.2.1 Customer communication requirements for products and 8.2.2 Determining the requirements for products and requirements for products and
8.2.2 Determining the services requirements for products and services services
services 8.2.4 Changes to requirements 8.2.4 Changes to requirements
requirements for products and 8.2.3 Review of the
8.2.3 Review of the for products and services for products and services
services requirements for products and requirements for products and 8.3 Design and development of 8.3 Design and development of
8.2.3 Review of the services services products and services products and services
requirements for products and 8.2.4 Changes to requirements 8.2.4 Changes to 8.3.1 General 8.3.1 General
services for products and services requirements for products and 8.3.2 Design and development 8.3.2 Design and development
8.2.4 Changes to requirements 8.3 Design and development of services planning planning
for products and services products and services 8.3 Design and development 8.3.3 Design and development 8.3.3 Design and development
8.3 Design and development of 8.3.1 General of products and services inputs inputs
products and services 8.3.2 Design and development 8.3.1 General 8.3.4 Design and development 8.3.4 Design and development
8.3.1 General planning 8.3.2 Design and development controls controls
8.3.2 Design and development 8.3.3 Design and development planning 8.3.5 Design and development 8.3.5 Design and development
planning inputs 8.3.3 Design and development outputs outputs
8.3.3 Design and development 8.3.4 Design and development inputs 8.3.6 Design and development 8.3.6 Design and development
inputs controls 8.3.4 Design and development changes changes
8.3.4 Design and development 8.3.5 Design and development controls 8.4 Control of externally 8.4 Control of externally
8.3.5 Design and developmentprovided processes,products and provided processes,products and
controls outputs
outputs services services
8.3.5 Design and development 8.3.6 Design and development
8.3.6 Design and development 8.4.1 General 8.4.1 General
outputs changes changes
8.3.6 Design and development 8.4 Control of externally 8.4 Control of externally
changes provided processes,products and provided processes,products
8.4 Control of externally services and services
provided processes,products and 8.4.1 General 8.4.1 General
services
8.4.1 General

FR-174/TR/E, Rev.04, 17.11.2016 3/5

ALBERK QA TECHNIC, INTERNATIONAL TECHNICAL INSPECTION CERTIFICATION SURVEY GMBH
Theodor Heuss Strasse 6 D-70174 Stuttgart GERMANY www.qatechnic.de
 TETKİK PROGRAMI / AUDIT PROGRAMME

8.4.2 Type and extent of control 8.4.2 Type and extent of 8.4.2 Type and extent of 8.4.2 Type and extent of
8.4.3 Information for external control control control
providers 8.4.3 Information for external 8.4.3 Information for external 8.4.3 Information for external
8.4.2 Type and extent of control
8.5 Production and Service providers providers providers
8.4.3 Information for external
provision 8.5 Production and Service 8.5 Production and Service 8.5 Production and Service
providers
8.5.1 Control of production and provision provision provision
8.5 Production and Service
service provision 8.5.1 Control of production 8.5.1 Control of production 8.5.1 Control of production and
provision
8.5.2 Identification and and service provision and service provision service provision
8.5.1 Control of production and
traceability 8.5.2 Identification and 8.5.2 Identification and 8.5.2 Identification and
service provision
8.5.3 Property belonging to traceability traceability traceability
8.5.2 Identification and
customers or external providers 8.5.3 Property belonging to 8.5.3 Property belonging to 8.5.3 Property belonging to
traceability
8.5.4 Preservation customers or external customers or external providers customers or external providers
8.5.3 Property belonging to
8.5.5 Post-delivery activities providers 8.5.4 Preservation 8.5.4 Preservation
customers or external providers
8.5.6 Control of changes 8.5.4 Preservation 8.5.5 Post-delivery activities 8.5.5 Post-delivery activities
8.5.4 Preservation
8.6 Release of products and 8.5.5 Post-delivery activities 8.5.6 Control of changes 8.5.6 Control of changes
8.5.5 Post-delivery activities
services 8.5.6 Control of changes 8.6 Release of products and 8.6 Release of products and
8.5.6 Control of changes
8.7 Control of nonconforming 8.6 Release of products and services services
8.6 Release of products and
outputs services 8.7 Control of nonconforming 8.7 Control of nonconforming
services
9 Performance Evaluation 8.7 Control of outputs outputs
8.7 Control of nonconforming
9.1 Monitoring, measurement, nonconforming outputs 9 Performance Evaluation 9 Performance Evaluation
outputs
analysis and evaluation 9 Performance Evaluation 9.1 Monitoring, measurement, 9.1 Monitoring, measurement,
9 Performance Evaluation
9.1.1 General 9.1 Monitoring, analysis and evaluation analysis and evaluation
9.1 Monitoring, measurement,
9.1.2 Customer Satisfaction measurement, analysis and 9.1.1 General 9.1.1 General
analysis and evaluation
9.1.3 Analysis and evaluation evaluation 9.1.2 Customer Satisfaction 9.1.2 Customer Satisfaction
9.1.1 General
9.2 Internal Audit 9.1.1 General 9.1.3 Analysis and evaluation 9.1.3 Analysis and evaluation
9.1.2 Customer Satisfaction
9.3 Management Review 9.1.2 Customer Satisfaction 9.2 Internal Audit 9.2 Internal Audit
9.1.3 Analysis and evaluation
9.3.1 General 9.1.3 Analysis and 9.3 Management Review 9.3 Management Review
9.2 Internal Audit
9.3.2 Management Review evaluation 9.3.1 General 9.3.1 General
9.3 Management Review
Inputs 9.2 Internal Audit 9.3.2 Management Review 9.3.2 Management Review
9.3.1 General
9.3.3 Management review 9.3 Management Review Inputs Inputs
9.3.2 Management Review
outputs 9.3.1 General 9.3.3 Management review 9.3.3 Management review
Inputs
10 Improvements 9.3.2 Management Review outputs outputs
9.3.3 Management review
10.1 General Inputs 10 Improvements 10 Improvements
outputs
10.2 Nonconformity and 9.3.3 Management review 10.1 General 10.1 General
10 Improvements
corrective action outputs 10.2 Nonconformity and 10.2 Nonconformity and
10.1 General
10.3 Continual improvement 10 Improvements corrective action corrective action
10.2 Nonconformity and
Logo usage 10.1 General 10.3 Continual improvement 10.3 Continual improvement
corrective action
10.2 Nonconformity and Logo usage Logo usage
10.3 Continual improvement
corrective action
Logo usage
10.3 Continual improvement
Logo usage

Last Assessment
Last Assessment Meeting Last Assessment Meeting Last Assessment Meeting Last Assessment Meeting
Meeting
Closing Meeting Closing Meeting Closing Meeting Closing Meeting Closing Meeting

FR-174/TR/E, Rev.04, 17.11.2016 4/5

ALBERK QA TECHNIC, INTERNATIONAL TECHNICAL INSPECTION CERTIFICATION SURVEY GMBH
Theodor Heuss Strasse 6 D-70174 Stuttgart GERMANY www.qatechnic.de
 TETKİK PROGRAMI / AUDIT PROGRAMME

VARIABLE STATUS FOLLOW UP TABLE

Audit Type
2.nd
Stage 1 Stage 2 1.st Surveillance Re-certification
Surveillance
Variable Status

Scope

Non-Applıcable
Clauses 

EA/Nace/Category

Employee Number

Address

Total: Total: Total: Total: Total:

Number of Non
…..… Major …..… Major …..… Major …..… Major …..… Major
Conformities and
…….. Minor …….. Minor …….. Minor …….. Minor …….. Minor
Explanation
…. Observation …. Observation …. Observation …. Observation …. Observation

Audit Team

Company Manager

Authorized Person

Customer Oriented
Complaints
communicated to
QA Technic

Legal Legislations

Certification
Condition

FR-174/TR/E, Rev.04, 17.11.2016 5/5

ALBERK QA TECHNIC, INTERNATIONAL TECHNICAL INSPECTION CERTIFICATION SURVEY GMBH
Theodor Heuss Strasse 6 D-70174 Stuttgart GERMANY www.qatechnic.de