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ATEX Internal Audit Questionnaire (EN13980:2002)

This questionnaire is for ATEX audits only. Here is the ISO 9000 internal audit questionnaire. ATEX certification required a quality system that is ISO compliant, a product that meet specific safety requirement, and a set of additional quality system requirement. The following is a audit check sheet / questionnaire about the additional requirements (above and beyond ISO9001:2000) that are required for ATEX approval. The ATEX approval will be based on a controlled set of drawing that describe the operational parameter for the product. The controlled documents can not be changed without prior approval from the certifying body. 1.0 General requirements Find evidence that the organization has a system for ensuring that each ATEX product is manufactured in accordance with the EC Type Examination certificate.

2.0 General documentation requirements Check the availability of documents and records to ensure that the company has:

Effective planning Operation control Process control

Check the availability of certification documents (e.g. EC Type Examination certificate. Quality Notification (license), ATEX technical documentation file, stamped drawings, supporting test reports).

2.1 Control of documents Check that engineering change order (ECO) system includes reference to external notified body. The Notified Body was be contacted before and changes are made to the product (as described in the controlled documentation).

Check that the drawings listed on the EC Type Examination certificate are readily accessible and are being used for production.

2.2 Control of quality records Obtain evidence for each of the example items listed in section 2.2. Confirm the document control or quality manual procedure that defines that records are retained for a minimum of 10 years after production has stopped.

3.0 Quality management system planning Check the written polices, procedures and work instructions relevant to production of ATEX products (ref 5.4.2)

3.1 Responsibility and authority Obtain the documents that identify the responsible persons and gives them authority (e.g. training or qualification records, job descriptions)

3.2 Management representative Obtain the documents that identify the (named) person/s responsible for liaising with the notified body for the EC Type Examination Certificate and the Quality Notification (ref 5.5.2) What document lists the Quality Representatives name, title and responsibility.

3.3 Competence, awareness and training Check that key personnel have appropriate education, training, skills and experience. In particular check for ATEX awareness and skills as required for assembly and test of the product (ref 6.2.1 and 6.2.2). Is ATEX (and ISO) awareness training done on an annual basis?

4.0 Review of requirements related to the product Obtain the information given to the user showing product category, marking

and reference to ATEX regulatory requirements within documents supplied with the product (ref 7.2.1).

4.1 Review of requirements related to the product Obtain the procedure governing how contract and ordering information provided by the customer is checked against the certification parameters of the EC Type Examination certificate (ref 7.2.2).

4.2 Customer communication In particular check procedures for the handling and documenting of customer complaints relating to ATEX product. Confirm recall procedure is there is a significant product failure.

5.0 Purchasing process Check purchasing procedures and in particular those relating to item. All supplier should have certified quality systems or have been audited by the company using a ISO level quality questionnaire. Critical vendors must be audited annually.

5.1 Purchasing information Obtain example of purchasing documents showing approval of vendors, and revision controlled purchasing. Are all suppliers certified to the ISO9001:2000 standard?

5.2 Verification of purchased product Check procedure for verification of critical parts and sub-assemblies. Review incoming inspection documentation.

6.0 Production procedures Obtain evidence of the procedures, work instructions and inspection records that show conformance with the relevant criteria set out in Annexes A and B

of EN13980:2002. Work through an example/s of the process with selected safety components.

6.1 Production tests Check that the production test requirements, including those set out in the EC Type Examination certificate, are documented and carried out. A formal test plan based upon the form RF358 should be in use (RF358 normally completed and agreed during the initial inspection.

6.3 Production documents Check that the production documentation is complaint to the ISO9001 standard.

6.4 Manufactured product Inspect an example of manufactured product to verify that it is in conformity with certification (controlled ) documents (certificate and drawings).

6.5 Intermediate testing Check procedures for production and intermediate testing

6.6 Identification and trace ability Check the complete product is uniquely identified (ref 7.5.3(b)).

6.7 Customer property Check that validation procedures include customer supplied equipment (ref 7.5.4 and 7.4.3).

6.8 Instructions Check that instructions are provided to the end user as per directive Annex II (ref 7.5.5).

6.9 Calibration of measuring devices

Obtain examples of calibration certificates and check availability of calibration procedures.

6.10 Monitoring and measurement - customer satisfaction Check contract review procedures for verifying compliance of product with the EC Type Examination certificate prior to shipping (ref 8.2.1).

7.0 Control of non-conforming product Obtain procedures for control of non-conforming product and check that these contain all items (a) to (f), including the implementation of the recommendations in the NOTES. In particular a product recall procedure should be in place with a means for keeping the notified bodies fully informed.

7.1 Correction action Check that suitable procedures are available.

7.2 Preventative action Check that suitable procedures are available.