IECEx-OD-033-Ed1.1
IECEx-OD-033-Ed1.1
IECEx-OD-033-Ed1.1
IECEx
OPERATIONAL DOCUMENT
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IECEx
OPERATIONAL DOCUMENT
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
Document History
Date Summary
2010-11 Edition 1.0
2020 – 03 Edition 1.1
Address:
IECEx Secretariat
Level 33
264 George Street
Sydney NSW 2000
Australia
Contact Details:
Tel: +61 2 4628 4690
Fax: +61 2 4627 5285
e-mail: [email protected]
http://www.iecex.com
Introduction
A need exists within industry to issue IECEx Certificates that cover a defined number of
products/items that are produced under a single production run. This form of Certificate is
known as IECEx Unit Verification.
This Operational Document is supplementary to the Operational manuals and procedures of the
IECEx Certified Equipment Scheme, operated by IECEx Certification Bodies (ExCBs), to enable
ExCBs to issue IECEx Certificates of Conformity for individual equipment or apparatus
operating in explosive atmospheres where either explosive gases or combustible dusts may be
present.
The following principles, as agreed by ExMC, are applied in the course of issuing IECEx
Certificates of Conformity for Unit Verification:
• An IECEx Certificate covering Unit Verification can be issued for a Defined number of items
under a single production run. IECEx Unit Verification Certificates do not cover “future’
production runs.
• Certificates shall be the same as the existing CoC BUT listing the serial numbers or other
unique identification to be clear which specific items are covered by Certification. To be
listed on page 1 of the Certificate, or a reference from page 1.
• A Full and complete ExTR to be issued, according to IECEx 02.
• The ExTL and ExCB are responsible for verifying that all defined units are identical to the
items tested / evaluated prior to those shipped by the manufacturer.
• Full requirements of Standards apply. Additional samples/subassemblies may need to be
produced to undergo destructive tests.
• Use ISO/IEC Guide 67 as a reference.
• No Quality Assessment or ISO 9001 certification is required or verified at the time of issuing
an IECEx Unit Verification Certificate.
• Include “Unit Verification” Text for the QAR field of the Certificate.
• The certificate reference number shall the same as existing CoC system.
• No limit to the number of Units permitted to be covered, BUT all serial numbers or other
individual identifications SHALL be listed on the IECEx certificate- (IECEx ExMC will monitor
this policy).
• ExCBs/ExTLs currently operating in the IECEx 02 Scheme do not require scope extension
applications, however are required to have the requirements of this OD 033 embodied within
their internal operating procedures.
• New issues of Issued Unit Verification CoC are NOT permitted.
• Unit Verification may cover repaired items but does not address the repair process.
The purpose of the Operational Document is to ensure that each ExCB, accepted by ExMC for
the purposes of issuing IECEx Unit Verification Certificates, processes applications from Ex
manufacturers with the same approach and technical rigour, known as “certifying the IECEx
way”.
The preparation of this document has been done so with the aim of alignment with various
ISO/IEC International Standards and Guides, including but not limited to the following:
Guide 28 General rules for a model third-Party certification System for products.
Guide 27 Guidelines for corrective action to be taken by a certification body in the event of
misuse of its mark of conformity.
This Section is to be applied by ExCBs when processing applications for an IECEx Unit
Verification Certificate.
These steps are in line with the requirements of ISO/IEC 17065, in addition to the requirements
as laid down in the IECEx Scheme rules, IECEx 02 for certified product.
Annex A contains a checklist of documentation required to fulfil Application and IECEx OD 017
requirements.
The following is a broad outline of how applications for IECEx Unit Verification Certificates are
processed:
• The provisions of IECEx OD 024, IECEx Rules of Procedure covering off-site or witness
testing at a manufacturer’s, user’s or third party’s facility, concerning testing at other
locations may be used for Unit Verification
The marking for IECEx Unit Verification Certificates is the same as for conventional IECEx
Certificates of Conformity. See OD 011 Parts 1 and 2 for details.
Figure 1 – Applications for IECEx Unit Verification Certificate
Step Section 1- Procedures for the Issuing of an IECEx Unit Related By Whom Notes/Comments
Verification Certificate of Conformity – Documents
Description of Activity
1 Ex Manufacturer receives a contract to design and build a IEC Standards The Applicant (or
“one-off” or limited quantity/batch, usually for a special National codes for agent).
purpose or application. electrical and
Standards for design should be specified in the original mechanical safety
contract.
2 The design is approved by the Ex Manufacturer. The end All design The Applicant (and their
user may review and approve the design before applying for documents customer).
IECEx certification.
3 Product design documents are defined as a “package”. Design The Applicant.
4 Documentation covering the design is prepared. This Design The Applicant.
includes datasheets, drawings and Ex approval information
for any Ex- certified parts used in the product.
5 Ex Manufacturer reviews documents to requirements of OD 017 The Applicant.
IECEx OD 017.
6 Documentation package has been reviewed by the Applicant The Applicant. The Manufacturer should
as being complete and now prepared for submission with the contact the ExCB once
application to an ExCB. documentation is complete.
7 Application is submitted to an ExCB: IECEx 02 The Applicant. Applications for an IECEx
The application must be made to an ExCB that has been OD 019 (finance) Unit Verification Certificate
accepted by the IECEx Management Committee to operate of Conformity will verify
under the IECEx Certified Equipment Scheme, according to compliance with the
IECEx 02. requirements of the IECEx
Applicant Ex Manufacturers are encouraged to check the Scheme and relevant
completeness of the application using the checklist in Annex Operational Documents, e.g.
A of this OD 033. The ExCB shall review the application OD 009 for the purposes of
package as part of their contract review. generating an ExTR.
Where the Ex Manufacturer is located in a non-IECEx
participating country, the ExCB shall in conjunction with the
ExMC Secretary, arrange for payment to the IECEx account
of the surcharge, in accordance with OD 019.
Step Section 1- Procedures for the Issuing of an IECEx Unit Related By Whom Notes/Comments
Verification Certificate of Conformity – Documents
Description of Activity
8 Contract review is conducted by the ExCB receiving the ExCBs own ExCB The results of the contract
application, in accordance with the ExCB's own Quality Certification review shall be documented
System and as required by ISO/IEC 17065. Contract review procedures as and recorded.
shall include: included in their Annex A can be used as a
• A review to ensure that the application is within the scope Quality System summary of the documents
of acceptance of the ExCB, eg protection techniques. and ISO/IEC supplied.
• The application package is complete. 17065.
• Whether a surcharge applies for applicants or
Manufacturers from non IECEx member countries.
• Estimation of time and costs to complete project.
• Determination of any special requirements, eg travel for
any assessments or tests to be conducted on site.
• Agreement on method and system of payment by
applicant, in accordance with ExCB’s own policy and
quality system.
ExCB shall only proceed where the contract review has
been successfully completed.
Where unsuccessful, ExCB shall communicate in writing to
the applicant with the applicant free to amend their
application or select another ExCB.
Change of ExCB’s may be required if the equipment to be
certified is not covered by the ExCB scope of operation.
Step Section 1- Procedures for the Issuing of an IECEx Unit Related By Whom Notes/Comments
Verification Certificate of Conformity – Documents
Description of Activity
9 The product (unit) is prepared for testing. Test Plan ExCB A Test Plan may not always
The ExCB and their associated ExTL will prepare a Test ExTL conducts the be required. Testing may
Plan as required. Use of a Test Plan ensures that all tests testing. follow the headings given in
performed are logged, and they have the test acceptance the ExTR (test report form).
criteria. Often, testing will involve a number of ExTR (test Where destructive testing is
reports) due to the need to cover components, and the required additional samples
overall system. or materials, representative
NOTE: The Test Plan is a controlled document. of the completed item(s),
Any Plastic components are thermally conditioned before may be required to prevent
testing, as required by the Standard. destruction to the completed
Test samples of critical items are submitted for destructive item(s).
test.
Some components which are not certified may need testing.
10 The product is tested according to the Test Plan. Test Plan ExTL
Testing is be carried out by the ExTL associated with the Test Log
ExCB. ExTR
The Test Plan ensures that all tests are agreed and cover all
certification issues. A record of all tests performed is kept in
the Test Log.
The tests performed are listed with pass/fail criteria and
have provision for comments on the report.
11 The ExTR shall be prepared by the ExTL, using the standard Test Plan ExCB monitors all Standard ExTR blank
IECEx ExTR blank templates. ExTR testing. templates are available from
The ExTR is then reviewed by the ExCB for endorsement. the IECEx website.
Where the product fails tests listed in the Test Plan, the Ex
Applicant/Manufacturer will be notified so that the product
may be modified to pass the test which failed.
For re-tested items, please refer to step 9 in this document.
Failed tests which require correction or further action must
be re-tested in full, to obtain a “pass” result in the ExTR.
12 A draft of the ExTR maybe issued to the Draft ExTR
Applicant/Manufacturer for their review prior to being
formally issued. This may assist to check for any errors.
Step Section 1- Procedures for the Issuing of an IECEx Unit Related By Whom Notes/Comments
Verification Certificate of Conformity – Documents
Description of Activity
13 Upon review and endorsement by the ExCB the ExTR is ExTR ExTL issues report Guidance given in OD 011
issued. ExCB registers the test Part 2.
The ExCB endorsing the ExTR shall “Register” the ExTR on report “on-line”.
the IECEx “On-Line” Certificate of Conformity System.
14 The draft IECEx Unit Verification Certificate is prepared and IECEx Unit ExCB certification panel ExCB shall be assigned a
may be issued as a draft to the applicant for a review for any Verification reviews the draft unique password to allow
errors. Certificate. certificate. entry of the ExTR and
All test documents, design data and design drawings are certificate details. The data
filed. is entered “On-Line”.
Once satisfied that the test data and the supporting Contact the IECEx
documentation are adequate the Certificate shall be issued, Secretariat for any questions
by the ExCB with the original sent to the Applicant and a or concerns.
copy retained on the ExCB file. The ExCB MUST maintain
The registration process provides a database of information security over the passwords
such as: provided and notify the
• Unique Certificate reference number or identifier. Secretariat of any possible
• Name and address of Manufacturer of equipment covered breaches of this security, for
by Certificate. which new passwords
• Details of IECEx Unit Verification Certificate such as type maybe assigned.
of protection. OD 011 Part 2 provides
• Any comments that the ExCB feels should be noted. guidance to ExCBs on the
registering of issued ExTR
and also the compiling and
issuing of On-Line
Certificates of Conformity
under the IECEx Unit
Verification Program.
Step Section 1- Procedures for the Issuing of an IECEx Unit Related By Whom Notes/Comments
Verification Certificate of Conformity – Documents
Description of Activity
15 The ExCB to whom the application for an IECEx Unit IECEx 02 The person authorised Contact the IECEx
Verification Certificate was made shall conduct a ExCB’s own to conduct such review Secretariat for any questions
certification review, in accordance with their quality quality within the ExCB to or concerns.
management system, ensuring among others that: management whom the original
• All stages of the certification process have been system. application was made.
documented and followed, including those contained in
this manual.
• The ExCB have a signed commitment by the Applicant to
abide by the rules of the IECEx Scheme and ExCB’s
certification conditions.
• The Applicant is aware of his/her obligations under the
IECEx scheme.
15a Where the review undertaken in step 15 is not successful, Management of the Contact the IECEx
the ExCB management shall refer the matter to ExCB staff ExCB to whom the Secretariat for any questions
or Applicant personnel as appropriate. original application was or concerns.
made.
16 IECEx Unit Verification Certificate shall be now be Refer IECEx The person authorised Contact the IECEx
completed, taking account of any adjustments arising from website to issue IECEx Secretariat for any questions
the review in step 15 using the IECEx “On-Line” system via OD 011 Part 2 Certificates of or concerns.
the password protected system. Conformity within the
ExCB to whom the
original application was
made.
17 Prior to issue a final draft of the IECEx Unit Verification Original The person authorised The Electronic version
Certificate is to be reviewed for errors. It may be beneficial application form to issue IECEx residing on the IECEx “On-
to pass a draft copy to the Applicant for them to assist in the submitted by the Certificates of Line” System remains the
final review prior to issuing the certificate. Applicant. Conformity within the master version.
While the Draft Certificate is created “On-Line” the ExCB OD 011 Part 2 ExCB to whom the Any printing or copying is
may create a protected PDF copy and send this to the original application was considered an “un-
Applicant, made. controlled” copy.
refer to OD 011 Part 2 for guidance. The Applicant. Contact the IECEx
Every attempt shall be made to correct errors prior to Secretariat for any questions
issuing the certificate. or concerns.
Step Section 1- Procedures for the Issuing of an IECEx Unit Related By Whom Notes/Comments
Verification Certificate of Conformity – Documents
Description of Activity
18 Certificate is issued via the IECEx “on-Line” registration The person authorised Contact the IECEx
system with the Applicant being informed in writing by the to issue IECEx Unit Secretariat for any questions
ExCB, via letter, fax or E-mail. Verification Certificate or concerns.
within the ExCB to
whom the original
application was made.
SECTION 2
Requirements concerning changes to products covered by IECEx Unit
Verification Certificates
As Unit verification certificates covers specific items, any changes to products covered by an
IECEx Unit Verification Certificate, that are not already provided for by the certificate, eg
additional cable / conduit entries, shall require the issuing of new Unit Verification Certificate.
In such situations, it is recommended that the owner of the equipment, seeking product changes
consults the equipment manufacturer, prior to undertaking any such modification.
Annex A
The following is a list of specific documentation that an Applicant needs to make available to
the ExCB, when seeking IECEx Unit Verification Certification of individual equipment.
1. Applicant Name…
Date…
7. The Applicant confirms that it is in full possession of all necessary rights on the
product to be tested (including its components), insofar as testing and/or
certification is applied for.
Signed: Dated: