Biomet Corporate Quality Policy Statement
It is important that each Team Member understand their responsibility to provide the highest quality products to our customers and ultimately to the patient. Biomet is committed to meeting the needs of our customers and their patients in order to remain the most responsive company in our industry. As a Team Member, you will work daily on products that will be used to provide medical treatment to other human beings. You should never forget the importance of what you do or the responsibility that you have been given. Approach your job as though the product for which you are responsible will be used by you, a family member or a close friend. After all, you never know when this might actually be the case.
The management of Biomet is also committed to meeting statutory and regulatory requirements related to safety and performance for the medical devices produced or sourced from external suppliers by the Biomet family of companies. Biomet and each of its manufacturing facilities have designed Quality Systems to ensure compliance with these requirements. Your company's policy can be found on bulletin boards and in the Quality Manual. These Quality Systems are tailored to meet the special needs and requirements of the medical community, and define the requirements of technologically oriented medical device manufacturing. Accordingly, the Biomet companies have developed operating practices which address the requirements of the US Food and Drug Administration's (FDA) Quality System Regulations (QSR) 21 CFR 820, (CGTP) 21 CFR 1270, Tissue regulations, 21 CFR Parts 210 & 211, Combination Products, (AATB) American Association of Tissue Banks, and the Quality System Requirements of ISO 13485, EC Directives 93/42/EEC (amendment 2007/47/EC) and 90/385/EC, Japan Quality Management System Compliance – MHLW/PMDA Ordinance #169, Medical Devices Regulations – Canada and U.S. State requirements, China SFDA – Regulation on Medical Device Good Manufacturing Practice for Implantable Devices and Brazilian Resolution No. 59 / 2000 GMP requirements, as applicable. Each Biomet company's Quality System establishes quality objectives to ensure that these and other national and international requirements are met.
Biomet's Quality Systems establish objectives to provide products to the medical community and ultimately the patient, which have been designed and developed to be safe and effective where the benefits outweigh the risk to the patient, and manufactured and distributed to meet the design specifications through the use of established processes. Additionally, products meet applicable requirements of known product and material standards, and are processed and inspected using published standards as appropriate. These objectives apply equally to Biomet and its suppliers.
It is the intent of this policy to ensure Team Member awareness of Biomet's commitment to quality standards and quality objectives. It is the responsibility of all Biomet Team Members to perform work activities in accordance with the procedures and requirements of their Quality System, and strive to achieve the Quality objectives applicable to their work.