Guideline for conducting ATEX QAN audits

I-O-05 Rev 01

NOBEL CERT assesses the quality assurance system to determine whether it satisfies the requirements referred to in point 3.2 of module D (annex IV) or module E (annex VII) of EU ATEX directive, with special consideration to review the technical documentation referred to in point 3.1(e) to verify the manufacturer’s ability to identify the relevant requirements of ATEX Directive and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements.

NOBEL CERT presumes conformity with those requirements in respect of the elements of the quality assurance system that comply with the corresponding specifications of the relevant harmonized standard : UNI EN ISO/IEC 80079-34.

In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant product field and product technology concerned, and knowledge of the applicable requirements of ATEX directive, therefore one of NOBEL CERT's appointed product evaluators who his competency has been already approved for the product/s relevant to the certification scope accompanies quality assurance auditor.

In the cases of conducting remote audits for “surveillance” or “reissuing QAN”, the requirements of IAF MD4 shall be fulfilled.

For each audit, including document review prior to on-site audit operation as well as on-site assesment, after assigning an audit to the auditors, the following tasks must be done for each audited area (audited requirements of the standard, audited sector of the client organization and audited processes of the audited organization). The audited areas are specified in the audit plan.

to examine and verify the conformity of structure, policies and the relevant responsibilities which have been taken by top management,processes, procedures, records and related information, documents and evidences of the client relevant to EN ISO/IEC 80079-34 and applicable requirements of ATEX directive;
to determine that these meet all the requirements relevant to the intended scope of certification;
to determine that the processes and procedures are established, implemented and maintained effectively,i.e performance monitoring, measuring, reporting and reviewing against key performance objectives and targets consistent with the expectations in EN ISO/IEC 80079-34 and applicable requirements of ATEX directive, to provide a basis for confidence in the client's management system and its ability;
to check if the internal audit and management review of the client fulfill the requirements of EN ISO/IEC 80079-34 and applicable requirements of ATEX directive;
to communicate to the client, for its action, any inconsistencies between the client's policy, objectives and targets.

The auditing team shall review the technical documentation referred to in point 3.1(e) of annex IV and VII of ATEX directive to verify the manufacturer’s ability to identify the relevant requirements of ATEX directive and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements.

The audit shall include a preliminary document review (off-site) and an assessment visit to the manufacturer’s premises (on-site).

on the basis of effect of the off-site document review outcome on the on-site assessment, the below requirements are fulfiled by NOBEL CERT:

the interval between the two above assessments is determined according to the needs of the client to resolve areas of concern identified during the off-site document review;
revising arrangements for conducting on-site assessment;
in the case of occuring any significant change which would impact the client's quality assurance system, a part or whole off-site document review is repeated;
in the case of the result of off-site document review leads to postponement or cancellation of the on-site assessment, the client shall be informed.

If there is more than one auditor or if there is technical expert(s) in audit team, the lead auditor, in consultation with the other auditor(s) and the technical expert(s), assigns responsibility of each team member for "auditing" and "technical expertise" for the specific processes, functions, sites, areas, or activities with below considerations:

the assigned auditors and technical experts for auditing the desired areas, shall be competent for that areas;
effective and efficient use of the audit team;
the different roles and responsibilities of the auditors and technical experts.

One of the important responsibilities of lead auditor is prevention of involvement and influencing the outcome of audit operation by any present "observer(s)" and "guide(s)", including below parties.

members of the client organization;
consultants;
staff accompanying ACCREDIA;
authorities, or
other individuals whose presence is justified.

The responsibilities of an "auditor guide" may include:

Establishing contacts and scheduling for interviews between auditor and auditee (audited person);
Organizing and coordinating visits to specific parts of the manuafcturer's site or organization;
Ensuring that site safety rules and security procedures are known and followed by the audit team members and providing needed personal protective equipment for them;
witnessing with the audit on behalf of the client;
Providing clarifications or information regarding audited areas as requested by an auditor.

Note: in case of not existing any auditor guide, the auditee (audited person) will take the above mentioned responsibilities and serves as an auditor guide.

Conducting the opening meeting

The meeting shall be conducted formally and the top management of the client (or his representative) and relevant processes responsible shall be present;
Conducting the opening meeting shall be responsibility of lead auditor;
The duration of conducting the meeting shall be controlled and monitored by the lead auditor very carefully so that it does not exceed from it’s defined duration in the audit plan, therefore the descriptions shall be presented briefly.

The following main issues, shall be described during the meeting:

Introduction of the participants, including an outline of their roles (for both auditees and audit team members);
Confirmation of the scope of certification by stating by the lead auditor and confirming by the client’s manager or his representative;
Review the audit plan defined tasks by lead auditor and confirming by the representative of the client, as well as the type, scope, objectives and criteria of the audit;
if there are any changes, the issues and other relevant arrangements with the client, such as the date and time for the closing meeting, or intermediate meetings between the audit team and the client’s management, are negotiated and confirmed during the above task.
Confirmation of formal communication channels between the audit team and the client; such as face to face meetings with audited parts, reviewing the evidences that submitted to audit team, observing the prepared presentation media by audit team and other similar ways;
Confirmation that the resources and facilities needed by the audit team are available; such as suitable places for meetings between audit team and auditees, transportation facility for on-site visiting , suitable place for audit conclusion meeting by the audit team, the place and how to having lunch by audit team in the client’s premises or at restaurant, and other similar items;
Review of the confidentiality issues (such as product formulation, process technologies, information relevant to suppliers and so on) and relevant probable risks and confirmation of its acceptable situation;
Review of the safety and security conditions as well as emergency probable situations (including those have been identified during application review task) and to confirm that needed preventions for audit team have been considered by the client, such as providing personal protective equipment, existing first aids and so on;
To ensure that the needed auditor guide/s and observer/s have been identified and are available and their roles have been clarified;
Assignment the method for reporting audit findings, including the defined classification of the findings which is in the form of Possible audit verdicts as P = Pass, NA = Not applicable, F = Fail, and NC = Non-conformity (including major, minor or observation)
Explaining the circumstances that make the audit terminate ahead of time;
where the available audit evidence indicates that the audit objectives are unattainable, the audit team leader should report the reasons to the audited client and the auditee to determine appropriate actions. Such action may include reconfirmation or modification of the audit plan, changes to the audit objectives or audit scope, or termination of the audit (Clause 6.4.4 of ISO 19011:2011).

To state that the lead auditor and auditor/s are responsible for the audit and shall be in control of executing the audit plan including audit activities;
If applicable, the description about status of findings of the previous audit.
Methods and procedures to be used to conduct the audit based on sampling;
If one or more of audit team members are from other country or speak a language which is different from the client personnel language, the confirmation of the language to be used during the audit should be done;
Stating that during the audit, the client will be kept informed of the audit progress and of any concerns;
To state about having authority to ask questions during audit operation by the client.

Communication during the audit

ALL the audit team members shall assess periodically audit progress and exchange information, during the audit;
If there is any deviation between defined audit plan and the audit progress, the lead auditor shall reassign work as needed between the audit team members and periodically communicate the progress of the audit and any concerns to the client;
To report to the client and, if possible, to NOBEL CERT office, to determine appropriate action, where the available audit evidence indicates that the audit objectives are unattainable or suggests the presence of an immediate and significant risk (e.g. safety), until:
- The reconfirmation or modification of the audit plan is performed;
- Changes to the audit objectives or audit scope, is performed or;
- the audit becomes terminated.

Note: the lead auditor shall report the outcome of the action taken to NOBEL CERT office.

If any changes to the scope of the audit are revealed as on-site audit activities, the lead auditor shall review this situation with the client and shall report this issue to NOBEL CERT office.

Obtaining and verifying the information

The information relevant to the audit objectives, scope and criteria (including information relating to the interfaces between functions, activities and processes) shall be obtained by appropriate sampling and verified to become as audit evidences;
The audit team members, obtain information via the following methods:
- interviews;
- observation of processes and activities;
- review of documented information (documentation and records).

Note: a product evaluator accompanying QAN auditor (ATEX technical expert) must not be involved in "audit operating" and "audit result conclusion", i.e the technical expert is not authorized to act as the auditor and shall be accompanied by an auditor. this prohibition has already informed to the technical expert. He/she provides advice to the auditor(s) for the preparation, planning or audit.

Identifying and recording the audit findings

in the QAN audit checklist the Possible audit verdicts which shall be written are:

P = Pass including opportunity for improvement or OFI
NA = Not applicable
F = Fail or NC (non-conformity including major , minor or observation)

non-conformity report and corrective action form - download

in case of detecting any non-conformity during on-site assessment, the auditor must consider to below obligations:

discussing non-conformities with the client;
refraining auditor from consulting the client for the cause and solution of closing non-conformity.

Note: for ALL audit findings, the lead auditor shall attempt to resolve any diverging opinions between the audit team and the client concerning audit evidence or findings, and unresolved points shall be recorded.

Preparing audit conclusions

It shall be done, prior to the closing meeting and under responsibility of the lead auditor;

The following tasks are done for an audit conclusion:

Review the audit findings, and any other appropriate information obtained during the audit, compared to the audit objectives and criteria, and to classify the Non-Conformities;
Agreement upon the audit conclusions, taking into account the inherent uncertainty in the audit process;
Agreement on any necessary follow-up actions;
Confirmation of the appropriateness of the audit programm or identify any modification required for future audits (e.g. scope of certification, audit time or dates, surveillance frequency, audit team competence).

Conducting the closing meetings

The purpose of the closing meeting is to present the audit conclusions, including the recommendation regarding certification. Any Non-Conformity shall be presented in such a manner that they are understood (it does not necessarily mean that the Non-Conformities have been accepted by the client), and the timeframe for responding by client shall be agreed.

The meeting shall be conducted formally by the lead auditor;
The top management of the client (or his representative) and relevant processes responsible shall be present;
Attendance list shall be recorded;
The degree of details which are presented in the closing meeting, shall be consistent with the familiarity of the client with the audit process;
To Advise the client that the audit evidence obtained was based on a sampling of the information, thereby representing an element of uncertainty;
To Define the method and timeframe of reporting by client, including any grading of audit findings;
To Define the NOBEL CERT process for handling the Non-Conformities including any consequences relating to the status of the client’s certification;
To Define the timeframe for the client to present a plan for corrective actions for any Non-Conformities identified during the audit, according to the NOBEL CERT rules and regulations for certification;
To Define the NOBEL CERT post audit activities;
To Present the information about the complaint and appeal handling processes and informing the client that the appeal and complaint handling procedures and forms are available, if needed by the client, to be filled.
To the client shall be given the opportunity for questions. Any diverging opinions regarding the audit findings or conclusions between the audit team and the client shall be discussed and resolved, where possible.

Guideline for conducting ATEX QAN audits

Guideline for conducting ATEX QAN audits

I-O-05 Rev 01

NOBEL CERT presumes conformity with those requirements in respect of the elements of the quality assurance system that comply with the corresponding specifications of the relevant harmonized standard : UNI EN ISO/IEC 80079-34.

In the cases of conducting remote audits for “surveillance” or “reissuing QAN”, the requirements of IAF MD4 shall be fulfilled.

to determine that these meet all the requirements relevant to the intended scope of certification;

to check if the internal audit and management review of the client fulfill the requirements of EN ISO/IEC 80079-34 and applicable requirements of ATEX directive;

to communicate to the client, for its action, any inconsistencies between the client's policy, objectives and targets.

The audit shall include a preliminary document review (off-site) and an assessment visit to the manufacturer’s premises (on-site).

on the basis of effect of the off-site document review outcome on the on-site assessment, the below requirements are fulfiled by NOBEL CERT:

the interval between the two above assessments is determined according to the needs of the client to resolve areas of concern identified during the off-site document review;

revising arrangements for conducting on-site assessment;

in the case of occuring any significant change which would impact the client's quality assurance system, a part or whole off-site document review is repeated;

in the case of the result of off-site document review leads to postponement or cancellation of the on-site assessment, the client shall be informed.

the assigned auditors and technical experts for auditing the desired areas, shall be competent for that areas;

effective and efficient use of the audit team;

the different roles and responsibilities of the auditors and technical experts.

One of the important responsibilities of lead auditor is prevention of involvement and influencing the outcome of audit operation by any present "observer(s)" and "guide(s)", including below parties.

members of the client organization;

consultants;

staff accompanying ACCREDIA;

authorities, or

other individuals whose presence is justified.

The responsibilities of an "auditor guide" may include:

Establishing contacts and scheduling for interviews between auditor and auditee (audited person);

Organizing and coordinating visits to specific parts of the manuafcturer's site or organization;

Ensuring that site safety rules and security procedures are known and followed by the audit team members and providing needed personal protective equipment for them;

witnessing with the audit on behalf of the client;

Providing clarifications or information regarding audited areas as requested by an auditor.

Note: in case of not existing any auditor guide, the auditee (audited person) will take the above mentioned responsibilities and serves as an auditor guide.

Conducting the opening meeting

The meeting shall be conducted formally and the top management of the client (or his representative) and relevant processes responsible shall be present;

Conducting the opening meeting shall be responsibility of lead auditor;

The duration of conducting the meeting shall be controlled and monitored by the lead auditor very carefully so that it does not exceed from it’s defined duration in the audit plan, therefore the descriptions shall be presented briefly.

The following main issues, shall be described during the meeting:

Introduction of the participants, including an outline of their roles (for both auditees and audit team members);

Confirmation of the scope of certification by stating by the lead auditor and confirming by the client’s manager or his representative;

Review the audit plan defined tasks by lead auditor and confirming by the representative of the client, as well as the type, scope, objectives and criteria of the audit;

if there are any changes, the issues and other relevant arrangements with the client, such as the date and time for the closing meeting, or intermediate meetings between the audit team and the client’s management, are negotiated and confirmed during the above task.

Confirmation of formal communication channels between the audit team and the client; such as face to face meetings with audited parts, reviewing the evidences that submitted to audit team, observing the prepared presentation media by audit team and other similar ways;

Review of the confidentiality issues (such as product formulation, process technologies, information relevant to suppliers and so on) and relevant probable risks and confirmation of its acceptable situation;

To ensure that the needed auditor guide/s and observer/s have been identified and are available and their roles have been clarified;

Assignment the method for reporting audit findings, including the defined classification of the findings which is in the form of Possible audit verdicts as P = Pass, NA = Not applicable, F = Fail, and NC = Non-conformity (including major, minor or observation)

Explaining the circumstances that make the audit terminate ahead of time;

To state that the lead auditor and auditor/s are responsible for the audit and shall be in control of executing the audit plan including audit activities;

If applicable, the description about status of findings of the previous audit.

Methods and procedures to be used to conduct the audit based on sampling;

If one or more of audit team members are from other country or speak a language which is different from the client personnel language, the confirmation of the language to be used during the audit should be done;

Stating that during the audit, the client will be kept informed of the audit progress and of any concerns;

To state about having authority to ask questions during audit operation by the client.

Communication during the audit

ALL the audit team members shall assess periodically audit progress and exchange information, during the audit;

If there is any deviation between defined audit plan and the audit progress, the lead auditor shall reassign work as needed between the audit team members and periodically communicate the progress of the audit and any concerns to the client;

To report to the client and, if possible, to NOBEL CERT office, to determine appropriate action, where the available audit evidence indicates that the audit objectives are unattainable or suggests the presence of an immediate and significant risk (e.g. safety), until:

The reconfirmation or modification of the audit plan is performed;

Changes to the audit objectives or audit scope, is performed or;

the audit becomes terminated.

Note: the lead auditor shall report the outcome of the action taken to NOBEL CERT office.

If any changes to the scope of the audit are revealed as on-site audit activities, the lead auditor shall review this situation with the client and shall report this issue to NOBEL CERT office.

Obtaining and verifying the information

The information relevant to the audit objectives, scope and criteria (including information relating to the interfaces between functions, activities and processes) shall be obtained by appropriate sampling and verified to become as audit evidences;

The audit team members, obtain information via the following methods:

interviews;

observation of processes and activities;

review of documented information (documentation and records).

Identifying and recording the audit findings

in the QAN audit checklist the Possible audit verdicts which shall be written are:

P = Pass including opportunity for improvement or OFI

NA = Not applicable

F = Fail or NC (non-conformity including major , minor or observation)

non-conformity report and corrective action form - download

in case of detecting any non-conformity during on-site assessment, the auditor must consider to below obligations:

discussing non-conformities with the client;

refraining auditor from consulting the client for the cause and solution of closing non-conformity.

Note: for ALL audit findings, the lead auditor shall attempt to resolve any diverging opinions between the audit team and the client concerning audit evidence or findings, and unresolved points shall be recorded.

Preparing audit conclusions

It shall be done, prior to the closing meeting and under responsibility of the lead auditor;

The following tasks are done for an audit conclusion:

Review the audit findings, and any other appropriate information obtained during the audit, compared to the audit objectives and criteria, and to classify the Non-Conformities;

Agreement upon the audit conclusions, taking into account the inherent uncertainty in the audit process;