WG5/2004-01

IECEx QUALITY ASSESSMENT REPORT
Surveillance Audit
Report No.:
Initial QAR No.:
I

Manufacturer (auditee):

Address:

Include post code/zip code

(Include additional site is sec. 4)

Product (s) or range:

No. of Employees:

Include the total number of employees on site

and those involved in production of Ex equipment

Scope of Audit:surveillance

List all applicable Certificates (or attach copies) to which this audit applies and indicate product type.

Electrical equipment with type(s) of protection is d e m n other (specify) 

Surveillance Audit of Product Quality Plans and Quality System to the requirements of IECEx 0D/005

Audit Team Leader:

Print name

Auditing Organisation:

If not TestSafe

Report Date:

CONTENTS

1Summary Report

2.Critical Suppliers/Sub-suppliers

3Audit Data

4Document Review

5Observations
6Quality Management System

1.Summary Report

Assessment Summary and Conclusions:

State the most important results and conclusions of the assessment.

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2.Critical Suppliers / Sub-Suppliers

Assessment of Critical Suppliers / Sub-suppliers

List critical suppliers / sub-suppliers. List address, phone numbers, contacts etc.

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Nonconformities

1. Non-conformances from previous audit(s) cleared? Provide details

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2. Indicate the number (and serial No.) of nonconformities raised during this audit. Individual nonconformities are recorded on the nonconformity reports

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Audit Team Leader Recommendations:

No/minor non-conformances - corrective action to be verified at next surveillance visit

Major Non-conformances noted – Corrective Action Plan to be forwarded to CB within

specified time frame, and if acceptable, to be followed up at next surveillance visit

Major system deficiency noted - a complete re-assessment to be conducted 

and Scheme administrator to be immediately notified

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Audit Team LeaderQuality & Certification Manager

Signature Sign to accept audit team leader

Recommendations and Surv.Report

3.Audit Data

Scope of Audit:TypeC surveillance of manufacturer with a certified QMS*

TypeD surveillance of manufacturer without a certified QMS

Date(s) and Duration of Audit:

Departments / areas audited:

Composition of Audit Team:

Name / Position / Role in Audit (Team Leader, Auditor, Technical Specialist, etc)

Interviewed Representatives of Manufacturer (auditee):

Include name and position

Name / Position

Quality Plan reference no. : (If applicable)

(Include revision status)

4.Documentation review

List amendments that have been made to quality documentation since the last audit include revision status. Note: Minor amendments eg editorial, are not required.

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5.Observations

Additional assessor notes

Summary of audit trail (e.g. Who? What? Where? When? etc.)

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6. Quality Management System

ISO 9001 Certification status (attaches copy of certificate and summarise recent findings)

List amendments that have been made to the QMS since the last audit that have an effect on production of Ex equipment, incl. among others:

Quality objectives, records, document control, design and drawing control, resp. and authorities, Man Review, purchasing, supplier evaluation, calibration, inspection and testing esp routine testing, production control, internal audits, product markings, NC product, corrective and preventive action

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