Quality Management
All the companies preach quality and customer services. However, it is difficult to achieve these goals if a system of management of quality were not set up in the company. Since 2003, DenPlus is certified ISO 9001 and ISO 13485.
What is ISO?
What is Management Quality System?
Difference between ISO 9001 and ISO 13485
ISO13485 and Health Canada
Quality Policy of DenPlus
Certifications
Audits of our Management Quality System
Which is impact for you and your customers?
What is ISO?
ISO (International Organization for Standardization) is the world's largest developer of standards. Although ISO's principal activity is the development of technical standards, ISO standards also have important economic and social repercussions. ISO standards make a positive difference, not just to engineers and manufacturers for whom they solve basic problems in production and distribution, but to society as a whole.
ISO is a network of the national standards institutes of 157 countries, on the basis of one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. ISO is a non-governmental organization: its members are not, as is the case in the United Nations system, delegations of national governments.
Because "International Organization for Standardization" would have different abbreviations in different languages ("IOS" in English, "OIN" in French for Organisation internationale de normalisation), it was decided at the outset to use a word derived from the Greek isos, meaning "equal". Therefore, whatever the country, whatever the language, the short form of the organization's name is always ISO.
In canada, international standards are revised and modified by the Canadian Standard Association (CSA). Afterward, they are approved by the Standards Council of Canada (SCC) to become a national standard.
What is Management Quality System?
Management system refers to the organization's structure for managing its processes - or activities - that transform inputs of resources into a product or service which meet the organization's objectives, such as satisfying the customer's quality requirements, complying to regulations, or meeting environmental objectives.
Since 2000, ISO 9001 standard is oriented toward a process aproach instead of a product oriented approach. The obejctive is to increase the customer satisfaction by meeting customer requirement.
Several aspects are covered by the management quality system. Among most important, the following points must be covered:
Management and control of documentation and records
Quality policy and management responsibility
Customer satisfaction
Design and development
Risk Management
Purchasing and verification
Preparation of the product, labeling and traceability
Control of processes
Non-conformity
Recall procedure
Difference between ISO 9001 and ISO 13485
The ISO 13485 standard is a version directed towards the medical instruments and the safety of the users and it is much more demanding than the ISO 9001 standard. For example, ISO 9001 requires 6 documented procedures whereas ISO 13485 requires 34 documented procedures.
The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
Consequently, a ISO 9001 certification does not imply that an organization is certified ISO 13485 and vice versa. DenPlus chose to be in conformity with the two standards.
ISO13485 and Health Canada
In Canada, the manufacturers of medical instruments must obligatorily be registred according to criteria's of the international ISO 13485: 2003 standard. A distributor does not have this obligation.
Health Canada will only accept quality system certificates that have been issued by special third party auditing organizations called Canadian Medical Devices Conformity Assessment System (CMDCAS) recognized registrars. Registrars who audit medical device manufacturers within the scope of CMDCAS are responsible for assessing the conformity of a medical device manufacturer's QS to the standards ISO 13485.
DenPlus being a manufacturer and a distributor, it is the only entirely Canadian dental distributor certified ISO 13485 in Canada.
Quality Policy of DenPlus
The quality policy of DenPlus is founded on the following elements:
- To give our customers in dentistry products and services that satisfies their needs.
- To manufacture quality and innovative dental products
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To maintain the effectiveness of the management quality system in order to meet the requirements of our customers and of the regulation organizations
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To give resources to our employees to fulfill the requirements of the management quality system.
DenPlus is ensured to maintain the system effectiveness of quality for the medical instruments of class II but it can improve those, like those of class I, if the regulation requirements are respected.
This policy quality is communicated and understood within the company. It is re-viewed annually with each management review.
Certifications
DenPlus is certified ISO 9001 : 2002 and ISO 13485 : 2003.
DenPlus is audited twice a year!
Annually, an internal audit (verification) is carried out by an external consultant and a formal and obligatory audit is done by the registrar (Intertek) to certify that the procedures of quality management are strictly respected.
If major nonconformities in the quality system are found, DenPlus can lose its certification. These verifications ensure you an optimum level of satisfaction.
Which is impact for you and your customers?
The peace of mind! ISO 13485 ensures the continual control of all the stages of production, from design to manufacture and distribution. The system of quality set up is reflected on all the processes of the company and thus enable you to have very high level of comfort compared with the products you provide to patients
* All prices are in Canadian dollars by default and can change without notice.
