Understanding the Ex Certification Process
The Ex Certification Process is regulated by Governments, Accrediting Bodied and IECEx and requires significant input from both the customer and the certification body. Unlike other forms of testing such as EMC, Ex Certification requires products to comply with constructional requirements and to pass testing (where applicable). Often test samples will have to be modified to make the representative test samples that we require for our program.
If you are unsure as to what the terminology means, or what you may require, please contact us and one of our team will talk you through the process. The application form is a mandatory requirement for all ATEX Notified Bodied, but it is also vital that the project scope is defined and understood before we start, so typically for the Ex certification process you will need to understand or identify if you need:
- Standards/Protection Concepts that the product has been designed to comply with
- Ambient Temperature Ranges of use and equipment environmental conditions
- EPL or ATEX Category (or Zone the equipment is required to be used in)
- Gas/Dust groups and Temperature Class required
- Other certifications required (i.e. IECEx, Division 1, INMETRO etc.)
- Any CE Marking testing that should be conducted in parallel (EMC, LVD etc.)
Unless you are starting with a design review, the application form will ask you what Standards you are claiming compliance with. Ensure that you understand the requirements and testing procedures in these standards that your product may be assessed to (this should give you a good idea of whether the product is designed to meet these requirements). If you have not deigned to or referred to the Standard, the project should start with an initial certification review, as it may not be possible to successfully complete the certification project for non-compliant projects. Our quote for testing and assessment does not infer certification will be granted, the product must fully comply with the constructional and assessment requirements of the Standards applied for, and meet and pass all of the test requirements.
The timescale we quote starts when we have all of the necessary samples and drawings and assumes that the product is compliment (and will pass the required testing). Delays in providing information or test failures may delay the project by more than the elapsed time of the delay due to internal re-scheduling. The fastest way to gain certification is always to get it ‘right first time’ and if in doubts start with a design review to fast track the reviewing process and identify any potential problems. The final submitted document package must fully control all aspects required by the Standard, you will be forwarded a guidance documents that will guide you on this process at the beginning of the project.
Certification Information required for the Ex Certification Process
A typical list of things we need for an approvals project (once the quote is accepted) includes:
- General arrangement and certification drawings
- Material datasheets
- representative sample(s) of the product (our testing is often ‘destructive’ so please assume that the samples will be destroyed during testing)
- Test reports (if applicable)
- Compliance statement and/or evidence of compliance (for example, safety component calculations for intrinsic safety)
- Manufacturer’s ISO certificate If you are new to certification we strongly recommend a pre-compliance review so you fully understand the requirements of certification before you begin.
Ensure you have your quality management systems in place (again, ensuring no delays when it comes to manufacturing the product under certification requirements) and that you dedicate the internal resources and time to resolving any issues raised by the assessment. Our timescale estimates are based on prompt responses from clients; if we have to wait several weeks for a response we may have a delay before we can recommence the project.
When working with other schemes, such as MET or INMETRO, the issuing bodies may have additional fee’s (such as for use of their logo) or additional audit requirements for their Ex Certification Process (North America for example requires four ‘visits’ per year by the listing body). ExVeritas will advise on these costs as far as possible, but we only include the test and certification program in our quotes, as the follow up manufacturing audits are normally quoted and provided separately so that ‘local’ auditors can be used where possible.
Certification Schedule Drawings
When product certification relies on QAN/QARs (Quality Systems) for manufacture, it is the ‘Drawings’ listed on the certificate that are the basis of certification. For that reason there are some very specific information that must appear on the certification schedule drawings (which are normally different to the manufacturing drawings).
Delays on certification issue are often traced to incorrect drawings being submitted.
Understanding the ISO9001 Certification Process
ExVeritas follows International Organization for Standardization (ISO), ISO Technical Committee 176, or the International Accreditation Forum (IAF) guidance and procedures. These documents are available here.
The steps and processes fo4r issue are shown below. For ISO Take Over, New Application and Scope Change, all details are recorded on the application form in the CMS system. For voluntary (on request) or forced suspension or withdrawal of certification, please refer to our standard terms and out use of accreditation marks.
|Step||Description of Activity||Related Documents||By Whom||Notes/Comments|
|1||Review of manufacturer’s documents||ISO9001:2015
|Relevant manufacturer’s quality system documentation is to be reviewed to verify that documentation continues to comply with the requirements of ISO9001:2015
Where serious deficiencies in the manufacturer’s documented quality plans may give rise to non-complying product being produced, these shall be raised by the factory auditor as major non-conformances and the applicant and manufacturer required to take action to correct this situation (usually by the introduction or amendment of quality plans), prior to proceeding with the issue of an ISO9001:2015 Certificate
Where noncompliance is judged to be of a minor nature by the factory auditor, the process of on-site auditing may continue.
|2||The factory auditor conducts on-site audit.||ISO9001:2015
|ExVeritas Auditor||This on-site audit shall seek to verify that relevant quality system procedures and work instructions are in place and that there are records and evidence to demonstrate that the requirements of ISO9001:2015 are being met by the customer(s).
An Audit Report of the assessment/audit of the manufacture’s quality system, including site audit, shall be compiled by the factory auditor.
Accreditation Forum (IAF) are followed for audits and interpretations and are issued to all auditors
|3||Where non-compliance or deficiencies are found||ExVeritas Auditor
Certification Liaison Officer
|Where serious deficiencies in the manufacturer’s documented quality plans or system may give rise to non-complying product being produced, these shall be raised by the factory auditor as major non-conformances and the applicant and manufacturer required to take action to correct this. A re-audit may be required to check the implementation of the corrective actions.
Where noncompliance are judged to be of a minor nature by the factory auditor, then the clearance action scan be dealt with remotely and the auditor also has the option to confirm compliance at the next audit.
|Step||Description of Activity||Related Documents||By Whom||Notes/Comments|
|4||An independent review of the Factory Audit Report shall be conducted by the Certification Body.||ExVeritas company procedures||Certification Manager or Deputy(s)||This independent ExCB technical review is to ensure that a complete assessment and audit has taken place and that the recommendations are in line with the audit findings and any NCRs and related corrective actions.
Normally this review would be conducted by the Certification Manager or Deputy(s)
Where discrepancies are identified they shall be immediately raised within the Factory Auditor and a further review will be conducted by the certification body to confirm all details remain relevant.
The applicant may need to be informed where errors or discrepancies are of a major nature, eg incorrect audit personnel conducting the audit or insufficient audit depth revealed.
|5||Review corrective actions.||ExVeritas company procedures||Auditor & Certification Manager or Deputy(s)
|The Factory Auditor shall review proposed corrective actions relating to Non Conformance Reports (NCRs) in terms of
· The time to implement such action is appropriate
· Whether a follow up audit is necessary or can verification be handled at the next scheduled surveillance audit
It should be noted that where Major NCRs are raised consideration must be given to the likelihood of non complying product being released to the market.
The Certification Manager will need to determine whether the ISO9001 Certification needs to be suspended or cancelled. Given the seriousness of the situation, prompt action by ExVeritas is required.
|6||Prepare for next audit||ExVeritas company procedures||Certification Manager or Deputy(s)||Where ExVeritas is satisfied that a full and complete surveillance assessment/audit has been completed demonstrating compliance with the requirements of ISO9001|
|7||Certificate Issue||Certification Manager or Deputy(s)||Certificate decision will be taken (with clarifications from IAF guidance documents as applicable). Certificates will be drafted and only issued to customers when:
· No outstanding non-compliances
· Next audit date agreed.
· Issued on CMS (Current) after CB review
· When accompanied by terms and use of logo
· When accounts are in order.
A quality audit feedback will be sent with all certificates and will be collected by ExVeritas Administration and reviewed by the CB Reviewer for the project for changes/feedback and auditor evaluation.
When applying for certification through ExVeritas you will be required to complete an application form (refer to the certification process) and on submitting the application form you will be agreeing contractually to ExVeritas Standard Terms and Conditions should you accept our quotation for work.
All applications are reviewed and may be declined if we feel there is a conflict of interest or if the work request is outside of our accreditation scope (where accredited work is request). In such cases the client will be informed in writing of the reasons we have not quoted.
Where we do provide a quote for work, Our Quotations will also be issued subject to our terms, and this will be stated on the Quotation.
Certificates will be issued subject to our terms for certification and use of marks, this will be stated on the certificate.