Pre-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. EVALUATION OF THE PRE-AUDIT 5

4.2 GENERAL OBSERVATIONS ON THE QUALITY SYSTEM

DOCUMENTATION 5

4.3 EVALUATION OF THE INDIVIDUAL QUALITY SYSTEM

REQUIREMENTS 5

5 GENERAL NOTES 10

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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»
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 the laboratory has provided sufficient evidence to enter the
next phase of the TÜV Rheinland certification procedure or laboratory quality system.
Within the scope of the «Audit_Type», the laboratory has not provided sufficient evidence to
enter the next phase of the TÜV Rheinland certification procedure or laboratory quality
system.
The corrective action planned by the laboratory must be completed before the certification
audit.

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 and whether the company is ready to
proceed toward the certification audit.

The basis of the audit was as follows:

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

The auditors reviewed the quality manual and selected procedures before the pre-
audit.

3. Scope of application

The pre-audit refers to the laboratory quality system of the «Laboratory» including the
following sites / departments with regard to Field of «Field_of_Testing__Calibration»

Top Management
Laboratory Quality Management Representative

In the Pre-Audit, the sites/departments marked above were audited.

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4. Evaluation of the pre-audit

4.1 Procedure / Scope 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 processes.

4.2 General observations on the quality system documentation

Please refer to Pre-document Check Report date 2000.06.26

4.3 Evaluation of the individual quality system requirements

4 Management requirement

Note:
 Comments in italic text are deviations and shall be corrected until Certification
Audit
 Comments in regular texts are opportunities for improvement.

General
- There should be yearly tentative schedule specifying specific quality activities to be carry out
during the year to ensure that all activities required in laboratory management system will
be performed completely within one year.

Management Requirement
4.1 Organization
- The authority of key personnel (LMR, TM, etc.) is not defined.
- Job description of TM is not yet defined.
- The laboratory organization chart is not yet showed the relationships between laboratory
and parent organization and the quality access route.

4.2 Quality System

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- Qualtiy Objective is not defined.

4.3 Document Control

- All documents should clearly be marked and authorized as specified in Document
Control Procedure.
- It should be clearly defined how to handle document amended by hand.
- Control of external document (software, spec, manual) should be defined.
- Retention time for obsolete quality document should be clearly defined.
- The revision status of each document should be included in the Document Master List
to control the updating of documents in the file.

4.4 Review of requests, tenders and contracts

- Procedure for the contract review is not yet defined the required
- to clarify the client request
- to review of capability and resources to meet the requirement
- selected method to be used
- All records include change related to the client requirement should be maintained.

4.6 Purchasing services and supplies

- The criteria should be reviewed and revised to reflect the actual handling in both
selections of new vendor and on-going vendor evaluation for laboratory.
- Authorized personnel concerning the selection of subcontractors for both consumable
materials and services should be determined.
- An approved vendor (subcontractor / supplier) list should clearly define the scope of
activities for each subcontractor (e.g. test laboratory, calibration laboratory/
consumable materials suppliers, etc.).
- Procedure should also include party who has authority to review and approved
purchase order.

4.7 Service to the client

- Procedure to afford clients cooperation, client request, and to ensure client confidentiality is
not yet referred to.

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4.12 Control of records

- Since most of calibration data are save on hard disk, procedure to protect and back up
records stored electronically and to prevent unauthorized access should be established.
- Procedure STM00H039 which describes how to handle when there is customer visit at
laboratory, should also include how to protect other clients confidential data during the
visitation.

4.13 Internal audits

- Internal Laboratory Check List should mark which elements are not applied.
- The areas of activity audited, findings and corrective actions should be recorded.

4.14 Management reviews

- Agenda for topics to be discussed during management review should include review of
quality objectives.
- There should be yearly tentative schedule specifying specific agenda for each quarter for
management review meeting to ensure that all agendas required in management review
procedure will be performed completely within one year.

5. Technical requirements
5.2 Personnel
- In the case of on-the-job training, laboratory should define what information or training is to
be provided (train) to staff . (Training Matrix can be used)
- Monitroing procedure should be defined for laboratory staff who is undergoing training.
- Training need identification process should be established.

5.3 Accommodation and environmental conditions

- There is no recording to AC electrical supply of 220VAC and the over or lower voltage might
be harmful to the electronic equipment

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5.4 Test and calibration methods and method validation

- There are some manufacturer’s manuals and employed national standard document such
as ULM600 manual and JIS standards are not controlled and authorized for use.
- The work instructions written by laboratory are not stated the specific models of equipment
used in specific works that might have no competence if other models used.
- Laboratory has no policy for authorization and justification if the deviation of approved
calibration method occurs
- The calibration methods used in the laboratory i.e. calibration instructions for pin/plug
gauge, ring gauge, height gauge, micrometer and etc. are written based on JIS standards
but not so much detailed. If another authorized staff in laboratory can perform those jobs
identically, correctly and consistently then they might be acceptable.
- The calibration procedure STM 98H004.07 for gauge block calibration is no detail stated
how to correct the measurement data if gauge blocks with different material are calibrated
together.
- Instructions are not controlled and they may be or may be not the latest editions
- The calibration range of depth vernier/gauge up to 1000 mm is larger than standard caliper
checker capability
- There is no evidence of: a) calibration method validation, b) inter-laboratory comparison,
c)quality control record.
 The original observation data are not recorded and laboratory has recorded the mean value
only.
 For repeatability (Type A uncertainty), the laboratory prefers selecting the largest standard
deviation of a group/type of measurement for single calculation of uncertainty that means
the client will get the unintended large uncertainty.
 The computer software for comparison of gauge block is not controlled and maintained such
as validated and documented

5.5 Equipment
- The ULM600 Linear Measuring Machine is defected. The measurement is not repeatable. It
looks like the cause from alignment error. It shall be repaired before the next assessment

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done The Laboratory has no procedure for handling, transport, storage of calibration items
for ourside client.
- The Laboratory has no policy or procedure to be followed if the outside permanent control
equipment has to used.
- There is no evidence of intermediate check record of standards used in the laboratory

5.6 Measurement traceability

- The calibration of gauge block comparator/Mahe/826E was performed by Mahr Singapore
but the laboratory is not able to demonstrate evidence of capability and competence of Mahr
Singapore.
- Laboratory does not have any records of interlaboratory comparison.
- Laboratory does not have procedure or plan for intermediate checks of standards.
- Laboratory does not have procedure for safe handling, transport, storage and use of
standards.

5.7 Sampling
- The laboratory has no sampling plan and procedure for sampling.

5.8 Handling of test and calibration items

- Laboratory does not have procedure for transportation, receipt, handling, protection,
storage, retension and disposal of calibration items from outside client.
- Laboratory does not have procedure for identifying of calibration items from outside client.

5.9 Assuring the quality of test and calibration results

- The laboratory does not have any activities of;
 quality control, participation in interlaboratory comparison, replicate testing and etc
and also those records.

5.10 Reporting the results

- The laboratory has no experience of issue certificate or calibration report for external client
and the laboratory has policy not to issue report for internal client

4.4 Conclusion

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The laboratory quality system documentation already complies with the requirements of
the standard. The laboratory quality system documentation does not yet comply with
the requirements of the standard, since important points are only described in part
and/or incorrectly.

The quality policy and the related concrete objectives have been defined and enforced /
not yet been defined. Measures which are necessary to implement the quality policy
and objectives have been introduced in the company / not yet been sufficiently
introduced. The measures are appropriate to achieve the quality policy / not yet
appropriate to achieve the quality policy.

The management and personnel act with awareness for quality and are striving for
continuous improvement / need to show more awareness for quality in the application
of the quality system.

The management representative with executive responsibility for the quality system has
the necessary independence and authority to enforce the requirements contained in the
quality manual and the pertinent procedures / does not have the necessary
independence and authority to enforce the requirements contained in the quality
manual and the pertinent procedures. It is necessary to definitely fulfill these
requirements before the certification audit.

The auditor established within the framework of the pre-audit that the quality system
introduced by the company is ready to proceed to the certification audit / can only be
certified after the important open items are clarified.
However, due to important nonconformities against the standard at this time, the
auditor does not consider it advisable to move to the next phase of the certification
procedure.

5 General notes
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 company from its responsibility to ensure compliance
with and constant observance of the requirements of the standards.

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