Baseefa Quality Assurance Guide (P05) 
Quality Assurance Notiifcation and / or IECEx Quality Assurance Report Application Form (QAN1) 
Quality Assurance
Quality Assurance is the normal route to ensure that each manufactured product is identified to its specification. In addition to the baseline of ISO 9000 Series of standards and a regular auditing regime, it is often necessary to have a more detailed specification of the quality system requirements and such is the case in respect of the ATEX Directive.
Production Quality Assurance (ATEX Annex IV)
The requirements in the directive are derived from ISO 9002: 1994. For manufacturers whose system is based on ISO 9001: 2000, the requirements of EN 13980: 2002 may be used.
Conformity to Type (ATEX Annex VI)
This module requires that the manufacturer shall carry out tests and inspections "under the responsibility of a Notified Body".
There are no requirements given in EN 13980: 2002 since this module does not fit with the requirements of ISO 9001: 2000.Note that this module is not normally operated in the UK since it does not align with common practice.
Product Quality Assurance (ATEX Annex VII)
The requirements in the directive are derived from ISO 9003: 1994. For manufacturers whose system is based on ISO 9001: 2000, the requirements of EN 13980: 2002 may be used.Historically, ISO 9003: 1994 has not been used much in the UK.
For this reason, it has been normal practice to invoke the requirements based on ISO 9002: 1994, and to issue a QA Notification that covers both Annex IV and Annex VII.
QA Notifications and Quality Management System Certification
Although most of the requirements of the ATEX Directive can be related to the ISO 9000 series of standards, there are some additional requirements, and some that are in the standards that are omitted. For this reason, the existence of a Quality Management System Certificate (QMSC) from an accredited certification body cannot be accepted alone as confirming compliance with the ATEX requirements.
Neither can an ATEX Quality Assurance Notification be considered as evidence of compliance with all the system requirements of the ISO 9000 series standard.However, it is a requirement of the ATEX Directive that the Notified Body issuing the QA Notification should take account of any existing QMSC.
In practice, this means that the holder of an appropriate QMSC has a reduced assessment and surveillance regime, typically with a visit once every three years, compared with the annual visit where there is no QMSC.Note that for a QMSC to be recognised, it must have been issued by a certification body having accreditation from the United Kingdom Accreditation Service (UKAS), or from another accreditation body having a mutual recognition agreement with UKAS,
The Assessment Process
Pre-assessment Service
As a certification body, we cannot provide a consultancy service to create a suitable Quality System on your behalf. However, we have a great wealth of experience in the application of quality techniques to equipment for use in potentially explosive atmospheres, as well as other areas. If you are not sure about interpreting the requirements for a particular type of equipment, we will be only to pleased to provide you with assistance. As with most things, getting the right information at the start of a process is usually the best way forward.To take advantage of our pre-assessment service please contact us and we will arrange for you to visit us at Buxton, or for one of our staff to visit you.
Quotation and Order
To assist us with preparing a quotation for you, we ask you to compete our QA Customer Questionnaire.From the information in the questionnaire, we will prepare a free, no obligation, quotation.If you wish to accept the quotation, you only need to post or fax the acceptance slip and we will do the rest.
Document Review
We conduct an initial document review to establish that your documentation system covers the necessary requirements. This ensures that there is a sound basis for an assessment to take place. On completion of the document review we will advise you of any omissions or problems. If necessary, we will check that you have taken action to correct these nonconformities, either before or during the assessment, depending upon their criticality. It may be appropriate, under certain circumstances, for the document review to be carried out at your premises.
Assessment Visit
The purpose of the assessment visit is to examine and report upon the implementation of the requirements. Activities and records will be examined on a sample basis to check whether the system described in your documentation is in place, is being adhered to and is effective.
In addition, where practical, a product audit is conducted during all assessments and subsequent routine surveillance visits.
On completion we will give you the documented findings of the assessment. We will discuss with you the recommendations regarding the issue of a QA Notification. These will depend on the nature and degree of severity of any nonconformities that may have been found. If nonconformities are minor, and they do not constitute a failure to address a part of the requirements effectively, or an inability to identify and meet specified requirements for the product or service involved, a recommendation for the issue of a QA Notification may be made upon satisfactory completion of the agreed corrective actions.
If there are serious nonconformities, or a significant number of less serious ones relating to a particular area, the QA Notification may not be issued until these have been corrected and a reassessment has confirmed that the action taken is acceptable.
We reserve the right to close any application where effective corrective action or progress towards an effective corrective action has not been taken within 6 months.
Post Assessment Service
Following an assessment or surveillance visit we can provide a post assessment service which is designed for the minority of our customers that are experiencing significant difficulties with respect to complying with the requirements. It is not appropriate for those customers who have only a few or minor problems, where we can provide assistance via correspondence or telephone. As with our Pre-Assessment Service, it is not a consultancy service. It can be arranged by simply contacting us, and arranging a visit to meet your needs.
Issue of QA Notifications
The final decision to grant a QA Notification is made at our Head Office, not during the assessment visit, and is dependant on the evidence in the assessment report and your response to any nonconformities that were raised.
When all the conditions have been satisfactorily met the QA Notification can be issued.
Maintenance of the QA Notification
Changes to your system
After your assessment visit and a QA Notification has been issued, you should consult us prior to making any significant changes to your system. Less significant changes to your system should be notified to our auditors during routine surveillance visits. It will normally be possible to evaluate the changes you wish to make during the normal course of routine surveillance visits but it is possible that extra time may have to be spent if the changes are significant.
If issue of the QA Notification was based partly on the existence of a Quality Management System Certificate from an acceptable certification body, you must inform us immediately should that certification become invalid for any reason.
Routine Surveillance
We will make routine surveillance visits to confirm that your system is being maintained. The dates for these visits will be arranged with you beforehand and the frequency will depend on whether or not you are undergoing routine audits from an acceptable QMS certification body. If such audits are to be taken into account, we will ask you to let us see copies of the audit reports.
Should any nonconformities be raised during the routine surveillance visit, we will ask you to confirm that you are taking appropriate corrective action within an acceptable time, normally not greater than three months.
If there are serious nonconformities, or a significant number of less serious ones relating to a particular area, or if you fail to take corrective action in the agreed time, we reserve the right to conduct a reassessment to confirm that the action taken is acceptable. In extreme cases, we reserve the right to suspend or withdraw the QA Notification pending an acceptable outcome.
Issue and Renewal
QA Notifications are issued for a period of 3 years and are renewed automatically, subject to continued compliance with the requirements. A QA Notification is issued to the actual manufacturer of a product, i.e. to the company that takes responsibility for production.
In most cases this will be the same company that has been responsible for the design of the product and who holds the type examination certificate. However, it is possible that the responsibilities for design and production are split, perhaps even with more than one company responsible for production. In this case, QA Notifications will be issued to each manufacturer (or manufacturing site) and the cross references between individual type examination certificates and the related QA Notifications will be maintained by us in a database.Terms and Conditions
1. All quality assurance work is subject to the General Terms and Conditions of Baseefa which are confirmed as applicable on registration. In addition, the following specific terms and conditions apply.
2. You will operate and maintain a quality system, or other appropriate system of work, as defined in EN 13980:2002.
3. We will carry out an initial assessment visit followed by routine surveillance visits at annual intervals if you do not have a Quality Management System Certificate from an acceptable certification body.
4. We will carry out an initial assessment visit followed by routine surveillance visits once every three years if you do have an appropriate Quality Management Systems Certificate from an acceptable certification body.
5. In respect of Quality Management Systems Certificates, an acceptable certification body is one which has been accredited for the purpose by the United Kingdom Accreditation Service (UKAS) or by an equivalent accreditation body recognised for the purpose by UKAS.
6. If you have a Quality Management Systems Certificate, you will make copies of the audit and surveillance reports available to us on an annual basis. These reports will form an input to our own audit process.
7. If the results of an assessment, audit or surveillance visit are satisfactory, we will issue a Quality Assurance Notification, or other similar document, valid for a period not exceeding three years.
8. If the results of an assessment, audit or surveillance visit are unsatisfactory we will require you to take remedial action. This remedial action may be subject to verification by documentary evidence alone, or additionally by a non-routine audit and surveillance visit.
9. In the event that an unsatisfactory result is not subject to acceptable remedial action within a reasonable period, we reserve the right to suspend or withdraw your QA Notification.
10. In exceptional cases, we reserve the right to suspend or withdraw your QA Notification immediately.
11. In accordance with the requirements of the ATEX Directive, we are required to publish information on QA Notifications that are issued and withdrawn.
