ISO 9001:2015 STAGE 2 AUDIT REPORT

Certification Surveillance Pre-Audit Re-certification

AUDIT TYPE Scope Change Address Change Special Audit

REPORT NO

AUDIT TYPE STANDARD INTEGRATED COMBINED JOINT MULTIPLE SITES TEMP. SITE

COMPANY NAME WELDON BIOTECH INDIA PVT. LTD.

RELATION WITH OTHER

COMPANY

MAIN OFFICE ADDRESS
OTHER ADDRESSES
WHERE AUDIT IS REALISED
TEL / FAX NO / WEB /EMAIL
32-E ,First Floor , Patparganj , Opp. Una Enclave , Mayur Vihar , Phase-1, Delhi-110091
(India).
Tel:. 91-11-22790239 Fax:. 91-11-22794407 web:. www.weldonbiotech.com

TAX ADMINISTRATION TAX IDENTIFICATION NO 07AAACW5207G1ZJ

GENERAL MANAGER AUTHORIZED PERSON Mr.Anil Kumar

Mr. Gaurav Kumar
Choudhary

Engineer/Tech Worker Total Employee

EMPLYOEE NUMBER
Foreman Number .……….
Administrative Personnel

TECHNICAL Total Area (m²) 65 Engine Power (KW) : Production Cap.

……….

IMPORTING ,TRADING, SELLING AND DISTRIBUTION OF MEDICAL

AUDIT SCOPE DIAGNOSTIC PRODUCTS

PROCESS AND ACTIVITIES

NON-APPLICABLE
8.3
CLAUSES 

EA Code / NACE Code

Level of Risk Low Medium High The Highest
Audit Date Audit Man/Day

AUDIT TEAM Name Surname EA NACE SIGNATURE

LEAD AUDITOR
AUDITOR
AUDITOR
AUDITOR CANDIDATE
EXPERT
Auditing report has been verified with objectivity and confidentiality principles by justification of content and employee number based on ISO
9001:2015 standards. It is accepted that inspector will not be having any self-interest with customer which will affect neutrality within prior
and post 2 years of inspection date. Incongruity and investigations of this report are the result of illustrated auditing wherelese it  doesn’t
prove unchecked samples may have incongruity and investigations. Audit Objective is available within the plan that is sent to your attention.

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ALBERK QA TECHNIC, INTERNATIONAL TECHNICAL INSPECTION CERTIFICATION SURVEY GMBH
Theodor Heuss Strasse 6 D-70174 Stuttgart GERMANY www.qatechnic.de
 ISO 9001:2015 STAGE 2 AUDIT REPORT

Client

1 COMPANY INFORMATION
Date of Establishment: March 2002

Products: Medical Diagnostic Products

Services: Marketing

Core business processes: Purchase , Marketing, Store , QC

Outsourced processes:

Other important facts:

Relation to other N.A.

organizations:

 Please indicate any other address except the ones that are available at the first page of the report at the
table stated below.(branch,temprorary site,seasonal site,project, i.e) Do not forget to generate project audit
report for each audited site.
Sites to be included
Number of Audited
Site No. within certification scope Scope
employees (yes/ no)
Site name / Address
01

02

2 REVIEW PROCESS FOR AMENDMENTS DURING APPLICATION STAGE

Record and evaluate any amendment that have occurred within management system since the last realised audit.
Control how realised amendment has effected the relevant management system and its application to management
documentation within audit frame.
Criteria N/A Amendment is available (Explain)
Documentation
Number of employees
Organization
Structure
Commercial Structure
Scope
Address/(es)
Legal Regulations
Non-applicable Clause
Processes
Other

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 ISO 9001:2015 STAGE 2 AUDIT REPORT

Client

3 AUDIT FINDINGS
Audit findings are represented as annex to this report in accordance with audit standard.(review FR-211/FR-198/
FR-199)
Detected non-conformities are recorded by FR-31.Observations are stated below.

Observations
No Standard Explanations
Clause No

Note: You may add lines by clicking.

4 POSITIVE ASPECTS AND AREAS FOR IMPROVEMENT

Positive Points
Standard Explanations
Clause No

Note: You may add lines by clicking.

Areas for Improvement

No Standard Explanation
Clause
Number

Note: You may add lines by clicking.

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 ISO 9001:2015 STAGE 2 AUDIT REPORT

Client

AUDIT EVALUATION ( Table shown below is going to be completed by Lead Auditor after consultation with
members of audit team)

1 Has any deviation from audit

plan occured? If yes, please
specify the reasons
2 Has any significant issue
occured that could effect audit
programme?If yes, please
explain.
3 Has there been any significant
amendment effecting the
management system of
organization from their last
audit?
4 Please provide explanation for
personnel with whom an
interview has been made
during realisation of audited
processes.
5 Has there been any issue on
which mutual consensus was
not maintained with audited
organization at the end oft he
audit?Please explain.
DENETİM DEĞERLENDİRME ( Baş denetçi tarafından, ekip üyelerinin görüşü alınarak doldurulacaktır)
DENETİM DEĞERLENDİRME ( Baş denetçi tarafından, ekip üyelerinin görüşü alınarak doldurulacaktır)
DENETİM DEĞERLENDİRME ( Baş denetçi tarafından, ekip üyelerinin görüşü alınarak doldurulacaktır)

5 AFTER AUDIT EVALUATION Not Applicable

Not Applicable
Applicable

Applicable

Applicable

Applicable
Not Applicable

Not Applicable
Standart

Standart

Standart

Standart
Clause

Clause

Clause

Clause

4.1 7.1.3 8.2.3.2 8.5.6

4.2 7.1.4 8.2.4 8.6
4.3 7.1.5.1 8.3.1 8.7.1
4.4.1 7.1.5.2 8.3.2 8.7.2
4.4.2 7.1.6 8.3.3 9.1.1
5.1.1 7.2 8.3.4 9.1.2
5.1.2 7.3 8.3.5 9.1.3
5.2.1 7.4 8.3.6 9.2.1
5.2.2 7.5.1 8.4.1 9.2.2
5.3 7.5.2 8.4.2 9.3.1
6.1 7.5.3.1 8.4.3 9.3.2
6.2.1 7.5.3.2 8.5.1 9.3.3

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 ISO 9001:2015 STAGE 2 AUDIT REPORT

Client

6.2.2 8.1 8.5.2 10.1

6.3 8.2.1 8.5.3 10.2.1
7.1.1 8.2.2 8.5.4 10.2.2
7.1.2 8.2.3.1 8.5.5 10.3

According to data and audit findings included above mentioned report, audit team recommends that;

SYSTEM CERTIFICATE

Giving Certificate Making Scope Change Continue to use certificate Renewal

Cancel the certificate Suspend the certificate Continue to suspend position Making Address Change

6 APPROVAL

Next Audit Date

BAŞ TETKİKÇİ / TETKİKÇİ :

Lead Auditor/Auditor
TARİH/ Date
İMZA /Signature:

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