Does Epsilon have ‘lead times’ before a project can start?

The simple answer to this is frequently ‘yes’. Our loading varies just like any other Certification Body; however, Epsilon’s policy is to be honest about this, even if that means you can find a faster start at another Body. We would rather quote honest timescales and not win new customers than disappoint an existing customer; we concentrate on retaining our existing customers rather than spending our time finding new customers!

How do Epsilon’s costs compare with other European Certification Bodies?

Whilst there has certainly been a proliferation of ‘new’ ATEX Notified Bodies in Europe, there has been no sudden injection of ATEX certification experience in Europe. There is an inherent cost in maintaining experienced and qualified staff, requisite levels of insurance and appropriate accreditation; for that reason most Notified Bodies costs will in some way line up. Where something seems too good to be true, it generally is! Epsilon’s quoting process is transparent and you will be able to see where our quoted price is derived from. Be aware that some Notified Bodies may quote a cheaper price for certification than others but then charge additionally throughout the project!

Is Project Management important for Compliance Projects?

The key to a successful product certification is realistic and adaptable project management. For complex projects, Epsilon will form and provide a baseline project plan identifying the critical path based on the test schedule and R+D needs. Epsilon employs Masters Degree qualified and experienced Project Managers and Contractor Managers. We can manage an entire project (including installation where required) or integrate our work in to a larger project.

What is Total Compliance Management ?

Epsilon’s ‘Total Compliance Management’ scheme is designed to allow companies to concentrate on their core business with the assurance that all their product or site compliance issues are being monitored and maintained.  You inform Epsilon if you are thinking of making a change to you product, and we advice you on how that will effect compliance. In addition, through Epsilon’s unique compliance database system, if a Standard or Directive is going to change that will affect your product; we will notify you- monitoring and managing your compliance so you can concentrate on your core business. The cost of this service is frequently less than the cost of buying (let alone reading) all of the applicable documents that you would need to check your own compliance status.

How it works….

• We ‘either’ test and assess or review technical files to ensure a product is compliant with all mandatory Directives and Standards.

• At this point we issue a certificate and provide a correct Declaration of Conformity. At the same time, the product is entered in to our ‘Total Compliance Database’.

• If the manufacturer wishes to change the product at any time, they inform Epsilon (via an e-mail form or our fax form), we can then tell them the effect the change will have on CE marking (i.e., none, cost, time etc.) so they can make cost/benefit analysis. If they decide to make the change, we do whatever was necessary and ‘update’ the technical file (which we hold).

• In addition, any changes to Standards or Directives or any new legislation (which we monitor) is fed in to our database constantly, any time there is a change we run the database to see which customers it would effect and inform them automatically (giving them a commercial advantage in Europe).

Will I benefit from outsourcing compliance?

1. How many man-hours are spent on finding out what type of compliance is required, who can do the work, ordering standards and compiling information. Could you be doing work that is more beneficial to your company?

2. Do you have the in-house experience to ensure everything is done ‘right first time’ and at the lowest cost?

3. Are you 100% sure that you have the latest and correct approvals, would you be able to prove it if you were asked by a regulatory body, or even a customer?

4. Do you know when to test and when not to test, how to get flexible approvals that cover many product types and how to market your approvals?

5. Do you know what will become mandatory in the near future that may effect your equipment?

6. Do you know the cost of non-compliance?

7. How many sales are lost from not having the product to market on time due to slow or incorrect approvals?

Do I need a Design Review?

If you have designed the product to meet a recognised European Concept (such as Flameproof or Intrinsic Safety) and have read and applied the applicable Standards, then you do not need a Design Review and you should apply directly for Certification.

If you have not read and applied the Standards, then we highly recommend the design review route, as it will save both time and money in the certification process and will guarantee a fast start and early problem resolution.

Do I need an ATEX Quality Module?

If you do not already have an ATEX Quality Module and you are applying for Zone 0 or 1 electrical certification or Zone 0 non-electrical certification then you will need a Quality Module.

If you have a Quality Module, please ensure that the concept you are applying for and the equipment type is covered by your existing scope.

What is meant by "Ready for Use", as used in the ATEX Guide? The ATEX (Blue) Guide states that certain products that can be put into service after the end of the transitional period if ready for use at the time they are placed on the market. However most spare parts will require some work to install them.

Each spare part must be considered in its own circumstances and it is difficult to generalise out of context. However, for spare parts which are not equipment, a protective system, a component or a device according to Article 1 of the ATEX Directive the answer is provided for at Chapter 7 of the Commission's Guidance notes to the Directive, the ATEX Guidelines, 2001 Edition. Spare parts that are not equipment, protective systems, components or devices, as defined in the ATEX Directive, are not subject to the ATEX Directive. Therefore, there is nothing in the ATEX Directive to prevent them from being placed on the market any time after the end of the transitional period.

Spare parts which are equipment, a protective system, a component or a device according to Article 1 of the ATEX Directive will have to comply with the ATEX Directive when placed on the market after the end of the transitional period.

Generally, repaired products, which are within the scope of the ATEX Directive, need not be assessed against the requirements of the ATEX Directive after repair, as a repair does not substantially modify the product.

The Standing Committee considered that, although each case must be assessed on it own merits, in general terms "Ready for use" means the ability to be incorporated or installed without a change to the performance or safety characteristics as originally anticipated by the manufacturer.

Can there be some relaxation on the use of safe but non-compliant spares that may be held by end-users for use during the foreseeable life of the equipment/ assembly?

In general, equipment, protective systems, components and safety devices, as defined in Article 1of the ATEX Directive which are spare parts and which are held by the end-user are likely to have been have been placed on the market already.

If the above spare parts were placed on the market prior to the end of the transition period and they were ready for use at that time then, according to the Blue Guide, they can be first used after the end of the transition period. Whether a product is ready for use must be assessed on a case by case basis and any subsequent alteration of the product would have to be taken into account in considering whether it was ready for use when placed on the market.

However, there may be spare parts falling within the scope of the ATEX Directive, which may be held by an end-user that may not have already been placed on the market. This is the case for equipment, protective systems or devices that are manufactured by the user for own use. In these circumstances the spare part will need to comply with the requirements of the ATEX Directive when it is first put into service.

Can the installing of a spare part allow the freedom to ensure the overall continuing integrity of the system by using non-compliant parts subject only to the requirement to provide a satisfactory risk assessment under the relevant "Use" Directive?

The consequences of installing each spare part must be assessed individually. However, in general, equipment, protective systems, components or devices, as defined in the ATEX Directive, which are intended to be integrated into an installation will inevitably be placed on the market and/or put into service and consequently will have to comply with the requirements of the ATEX Directive at that time.

After the end of the transitional period, will manufacturers be able to sell non- compliant stock to the owners of relevant installations, which are not in scope of the ATEX Directive? This would mean that these installations would only be subject to the relevant "Use" Directive (92/91/EEC, 92/104/EC or 1999/92/EC), requiring only an overall risk assessment?

If this stock represents equipment, protective systems, components or devices as defined in the ATEX Directive it must comply with the requirements of the ATEX Directive when placed on the market.

In respect of the second question installations are not covered by the ATEX Directive but are covered by the relevant "Use" Directive.

on a case-by-case basis, equipment sold down the distribution chain may be considered to be placed on the market. However, there are cases when the distribution chain is part of the commercial chain of the manufacturer rather than a separate organisation. Footnote 31 of the Commission's "Guide to the New and Global Approach" recognises this situation and makes it clear that equipment moving down this type of distribution chain could also be considered as having been placed on the market. However, market surveillance authorities would need to ensure that a "transaction" had taken place even if the equipment was not as such "sold".

This evidently needs to be considered by the market surveillance authorities of the Member States on a case-by-case basis. In effect, there is a general burden of proof on the manufacturer to show that the equipment has been given to the authorised representative distributor with the real intention of distribution and use rather than a mechanism of treatment of stocks.

Products manufactured for "Own Use" are subject to the ATEX Directive, but will they be required to CE mark them and hold a signed DOC, in addition to the technical construction file?

Generally, though each case must be examined individually, persons manufacturing for own use will be putting the equipment, protective systems or devices into service and will be subject to those requirements of the ATEX Directive, which are placed on any other manufacturer.