Certification (Recognition) Audit Report

for

«Laboratory»

«Company»

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Table of contents
Page

1. BRIEF EVALUATION 3

2. OBJECTIVES AND BASIS OF THE AUDIT 4

3. SCOPE OF APPLICATION 4

4. GENERAL PROCEDURE FOR THE EVALUATION OF THE AUDIT5

5. CONCLUSION 5

6. OPPORTUNITIES FOR IMPROVEMENT 5

7. GENERAL NOTE 6

8. ANNEX 7

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1. Brief evaluation
Laboratory Name / «Laboratory»
Address

Company Name / «Company»

Address :

Auditee´s : «ARName», «ARTitle»

Representative

Type of Laboratory «Type_of_laboratory»

Field of Testing «Field_of_Testing__Calibration» (also referred to scope attachment)
/Calibration
Standard Applied : ISO/IEC 17025 :1999
Order Number : «OrderNo»
Type of Audit : «Audit_Type» (Recognition) Audit
Date of Audit : «AuditDate»
Lead Auditor : «LeadAuditor»
Technical Auditor(s): «Technical_Auditor_s»
Auditor(s) : «Auditors»
Translator(s)/ : «Translator»
Interpreter(s)
Language of Audit : «Language»
Summary:

Within the scope of the «Audit_Type» (recognition) audit, the laboratory has furnished proof
that it maintains a laboratory quality system in accordance with the ISO/IEC 17025. 1999. In
addition, the laboratory has the competence to perform specific types of testing,
measurement and /or calibration for the scope as defined in the annex of this report. The
laboratory has furnished proof that the requirements of the standard are fulfilled.

The auditors recommend that the TÜV Rheinland Certificate of Recognition should be
issued.

The following pages contain more detailed information.

Date Lead Auditor Auditor(s)

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2. Objectives and basis of the audit

The laboratory instructed the certification body of TÜV Rheinland to establish, within
the audit whether the requirements for a laboratory quality management system
according to the standard below are fulfilled.

The objective was the attainment of the TÜV Rheinland Certificate of Recognition.

The basis of the audit was as follows:

 «Standard1»
 «Qmanual»
 Quality procedures, work and testing instructions corresponding to the overview and
revision list related to the quality manual.

The auditors reviewed the quality manual and selected procedures before the audit
(report on the review of quality system documentation dated…….). The outcome of the
review was positive. The open items pointed out in the document review report were
verified during the audit.

3. Scope of application

The audit refers to the laboratory quality system of the «Laboratory» including the
following departments / section with regard to Field of «Field_of_Testing__Calibration»
(for further details, Please see also the Annex of this report)

In the Certification Audit, the sites/departments/section marked above were audited.

The other sites covered by the certificate will be audited during the surveillance phase.

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4. General procedure for the evaluation of the audit

Within the scope of the audit, the auditors observed processes in the various
departments and functions of the laboratory in order to gain an understanding of the
overall operation. The auditors verified the processes in the laboratory for conformity
with the requirements of the standard and the descriptions in the quality manual or the
relevant procedures and work instructions. This verification was performed on a
sampling basis, by interviews, review of the corresponding documentation, and
observation of the individual measurement calibration processes.

5. Conclusion
Within the scope of application, the laboratory quality system is adequately described
for all applicable requirements of the standard.
The management has made known in the laboratory the binding quality policy and
targets. Suitable actions to achieve the targets are effectively implemented.
The management and personnel act with awareness for quality and are striving for
continuous improvement. It was observed that the quality system is effective.
The laboratory management representative with executive responsibility for the
laboratory quality system has the necessary independence and authority to enforce the
requirements contained in the quality manual and the pertinent procedures.
The laboratory has a system to evaluate the impact of complaints on the quality
system.
The laboratory personnel have the competence to perform specific types of testing,
measurement and /or calibration for the scope as defined in the annex of this report.
The laboratory has furnished proof that the requirements of the standard are fulfilled.
The audit team verified that corrective actions from the previous audit were effectively
implemented. (ONLY FOR FOLLOW-UP AND REPEAT AUDIT)
The audit team established nonconformities in ____ quality system requirements which
are documented in ____ deviation reports. These nonconformities do not deny the
confidence in the effectiveness of the system.
The corrections implemented by the laboratory were reviewed and accepted. The
corrective actions proposed by the laboratory were reviewed and are acceptable, their
implementation and effectiveness will be verified during the next audit.
However, due to major deviations of the standard the auditors consider a re-audit
necessary with respect to deviation reports No. ___ .

6. Opportunities for Improvement

The auditors wish to point out the following observations:
 The laboratory would benefit from simplifying the documentation.
 The recording of inspection and measuring equipment should be improved.

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 The evaluation of internal audits should be part of regular management meetings.
 Employee training should be planned / carried out / recorded more consistently

7. General Note
If the laboratory changes their quality system or their quality system procedures during
the time of validity of the certificate, it is requested that the certification body be
informed.
The audit was performed by means of sampling objective evidence. Therefore, further
deviations not established during the audit may exist. The findings and conclusions of
the auditors do not release the laboratory from its responsibility to ensure compliance
with and constant observance of the requirements of the standards.

End of Report

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Annex : Scope Defined for certificate of recognition

(Below table is to be chosen between Testing and Calibration Laboratory)

TESTING LABORATORY

FIELD OF ITEMS, SPECIFIC TEST SPECIFICATION DETECTION

TESTING MATERIALS OR OR PROPERTIES STANDARDS LIMITED
PRODUCTS MEASURED METHOD OR
TESTED TECHINIQUE
USED

CALIBRATION LABORATORY

CALIBRATION RANGE STANDARD/TEST BEST

FIELD METHOD TECHNIQUE / MEASUREMENT
EQUIPMENT CAPABILITY

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