Below is a sample portion of an ATEX Questionaire. The complete version of this document is included with our Internal Auditing resources.

This questionnaire is for ATEX audits only. Here is the ISO 9000 internal audit questionnaire.

ATEX certification requires 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 an audit check sheet / questionnaire about the additional requirements (above and beyond ISO 9001) 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 cannot 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

The complete questionaire is available with our internal auditing package.


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).

The complete questionaire is available with our internal auditing package.

 


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 suppliers 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 ISO9001standard?


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


6.0 Production procedures

The complete questionaire is available with our internal auditing package.

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.