I read an excellent article on the DAN (Divers Alert Network) blog by Florine Quirion discussing the challenges faced by rebreather manufacturers, particularly in the US, to gain CE marks for their products. I thoroughly recommend you give it a read. It outlines the cost involved in getting the coveted CE marking on a rebreather and the background of ISO accreditation. The CE mark confirms conformity to European health, safety and environmental protection standards and is a de facto requirement for entry into the European market.
There are some good points raised: the process is onerous and expensive. US manufacturers also have no representation on setting the rules that contribute to the CE marking for rebreathers – it’s an EU funded body. It’s reported to cost up to $40,000 to get a single model marked. It’s argued this cost stifles innovation and the entry of new players into the market. This is mirrored in the cost of a business gaining ISO 9001 accreditation – an audited set of standards for the quality management of an organisation. Another hefty and reoccurring (it has to be maintained by regular audits) that smaller companies may struggle to afford. Overall, the article is a good read but there are parts I disagree with.
Cost of entry
By day I work in the maritime side of the defence industry – one that is governed by standards, accreditation and approvals. Assurance is crucial when you’re developing novel or bespoke products, especially when they are critical to safety. There are something like 25 manufacturers in the rebreather market which in my eyes is at a point of over-saturation. Rebreathers are a niche within the niche of diving. In this case I think having a price of entry to the marketplace, via the cost of a CE mark, has to be a good thing.
Diving has a long history of the enthusiast turned builder – developing kit and bringing it to market. I don’t think rebreathers should fall into this category. Purely from the cost perspective CE marking helps to raise the bar of entry, filter out pretenders and ensures the integrity of the products. I want to know that the company that produces complex life support equipment is willing to go the extra mile to demonstrate that their product is compliant, works and is fundamentally safe to use. AP Diving’s Inspiration was the first consumer rebreather to receive a CE mark and was a seminal moment in their widespread adoption.
Quality
The article sums up by suggesting all rebreather manufacturers should seek to gain ISO 9001 accreditation to help speed up CE marking. I couldn’t agree more but I would go further – I would not buy a rebreather from a manufacturer that doesn’t have this certification. The standard covers Quality Management – this is not limited to the quality control at the end of an assembly line. It certifies (then audits) the management systems of a business to continually provide goods or services to the required standard.
At its core it ensures a business has correctly managed and documented processes. It’s easy to think of examples in the design and manufacture of rebreathers where this would be incredibly valuable. What would happen if the lead engineer left a rebreather manufacturer, would the quality of the product be maintained without them? It’s the type of cottage industry where huge amounts of knowledge or experience can be focused into a couple of people. Do they have processes to manage the performance of their supply chain, the obsolescence of components or risk?
Rebreathers were originally defence products and the same level of rigour in their development and manufacture should still apply now they are widely used in the civilian market.
Final Thoughts
The importance of accreditation has been front page news in recent weeks with the Titan submersible disaster. After the wreckage of the submersible was found and an implosion all but confirmed the experimental design and lack of third party certification came to the fore. It’s an example of enthusiastic, but flawed, engineering going unsupervised – something that is certainly possible within the diving industry.
