Definition of quality
There are three methods of ensuring that one obtains a treatment, a service or a product of high quality:
- certification of an organisation,
- certification of the product,
- certification of a person.
Certification of an organisation
Quality management in an organisation can be assured by ISO 9001 certification, or by a service certification derived from 9001 certification. Elements can be added which are specific to the industry. This is how orthodontists implement a quality certification process linked to the management of their clinics.
In professions where there is a risk to health, the ISO 9001 standard is insufficient or even irrelevant to quality assurance. Specific standards have been set up:
- In the food industry, ISO 22000 was developed from ISO 9001 by adding various criteria specific to food safety. Certification is increasingly required in order to participate in this industry,
- In the medical devices industry, ISO 13485 was developed from ISO 9001 by adding criteria relating to sterility, traceability, etc. ISO 13485 has become a stage in the procedure for European Union CE marking of products.
ISO 22000 and ISO 13485 have replaced ISO 9001 which is inadequate for these industries
The quality of a product is assured by compliance with standards for that product. In the case of orthodontics, there are no ISO norms relating to braces and so no way for the practitioner to be sure of the quality of the product.
European Union Directive 93/42, which sets out the procedure for EU (CE) conformity marking, refers to product standards. In orthodontics, where there are no product standards, it has no impact on quality. To claim that a CE mark is any form of guarantee of the proper function of a dental brace is simply misleading.
Where there are no applicable product standards, CE marking is only a safety standard. It is therefore possible, quite legally, to put brackets on the market of which the slot, for a nominal .018, is anything from .016 to .022; or to claim an angle of torque of 7° when the measured angle is 9° with a tolerance of 5°. The treatment will be ineffective, brackets will be dislodged, and the funder will have to pay for a longer period of treatment. It is legal and will continue to be so unless the manufacturers work together on a product standard
CE marking can only prevent the appearance on the market of a bracket which has lead in the welds or is made of toxic heavy metals. It is not relevant to American or German products. CE marking has no benefits for manufacturers of braces; it simply increases their manufacturing overheads. Braces which do not comply with the Directive are placed on the market without CE marking, or with counterfeit marking, with no repercussions.
The new Directive provides for legislation to be tightened up. Personal certification will be requested (with a requirement that the manufacturer have a degree in pharmacy, medicine or engineering; spot checks; and product analysis). The Orthonorm Association has sought these measures for 15 years. Only the creation of standards for product quality and safety will permit the rejection of products which are mediocre or even poor. Quality controllers do not have the necessary training to validate a product in the absence of a quality standard.
Certification of a person
Personal certification relates to both theoretical and practical competence. It takes 10 years of study to be an orthodontist, but no qualifications are required before one can be a manufacturer of medical appliances or put potentially hazardous implants on the market, such as breast implants or cardiac stents. That was what gave us the PIP breast implant scandal. Personal certification of the head of the business should be the first requirement in certification of an organisation, as is the case in banking, for example. Directive 93/42/CE is rather late in being amended to fill this huge gap.