A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction. It is expressed as the organizational goals and aspirations, policies, processes, documented information, and resources needed to implement and maintain it. Early quality management systems emphasized predictable outcomes of an industrial product production line, using simple statistics and random sampling. By the 20th century, labor inputs were typically the most costly inputs in most industrialized societies, so focus shifted to team cooperation and dynamics, especially the early signaling of problems via a continual improvement cycle. In the 21st century, QMS has tended to converge with sustainability and transparency initiatives, as both investor and customer satisfaction and perceived quality are increasingly tied to these factors. Of QMS regimes, the ISO 9000 family of standards is probably the most widely implemented worldwide – the ISO 19011 audit regime applies to both and deals with quality and sustainability and their integration.
Conformance testing — an element of conformity assessment, and also known as compliance testing, or type testing — is testing or other activities that determine whether a process, product, or service complies with the requirements of a specification, technical standard, contract, or regulation. Testing is often either logical testing or physical testing. The test procedures may involve other criteria from mathematical testing or chemical testing. Beyond simple conformance, other requirements for efficiency, interoperability, or compliance may apply. Conformance testing may be undertaken by the producer of the product or service being assessed, by a user, or by an accredited independent organization, which can sometimes be the author of the standard being used. When testing is accompanied by certification, the products or services may then be advertised as being certified in compliance with the referred technical standard. Manufacturers and suppliers of products and services rely on such certification including listing on the certification body's website, to assure quality to the end user and that competing suppliers are on the same level.
The ISO 9000 family is a set of five quality management systems (QMS) standards by the International Organization for Standardization (ISO) that help organizations ensure they meet customer and other stakeholder needs within statutory and regulatory requirements related to a product or service. ISO 9000 deals with the fundamentals of QMS, including the seven quality management principles that underlie the family of standards. ISO 9001 deals with the requirements that organizations wishing to meet the standard must fulfill. ISO 9002 is a model for quality assurance in production and installation. ISO 9003 for quality assurance in final inspection and test. ISO 9004 gives guidance on achieving sustained organizational success.
Medical software is any software item or system used within a medical context, such as:reducing the paperwork, tracking patient activity
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase.
Quality management ensures that an organization, product or service consistently functions well. It has four main components: quality planning, quality assurance, quality control and quality improvement. Quality management is focused not only on product and service quality, but also on the means to achieve it. Quality management, therefore, uses quality assurance and control of processes as well as products to achieve more consistent quality. Quality control is also part of quality management. What a customer wants and is willing to pay for it, determines quality. It is a written or unwritten commitment to a known or unknown consumer in the market. Quality can be defined as how well the product performs its intended function.
Product certification or product qualification is the process of certifying that a certain product has passed performance tests and quality assurance tests, and meets qualification criteria stipulated in contracts, regulations, or specifications.
ISO/IEC 17025General requirements for the competence of testing and calibration laboratories is the main standard used by testing and calibration laboratories. In most countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent. In many cases, suppliers and regulatory authorities will not accept test or calibration results from a lab that is not accredited. Originally known as ISO/IEC Guide 25, ISO/IEC 17025 was initially issued by ISO/IEC in 1999. There are many commonalities with the ISO 9000 standard, but ISO/IEC 17025 is more specific in requirements for competence and applies directly to those organizations that produce testing and calibration results and is based on more technical principles. Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results. Material in the standard also forms the basis for accreditation from an accreditation body.
A biomedical engineering/equipment technician/technologist or biomedical engineering/equipment specialist is typically an electro-mechanical technician or technologist who ensures that medical equipment is well-maintained, properly configured, and safely functional. In healthcare environments, BMETs often work with or officiate as a biomedical and/or clinical engineer, since the career field has no legal distinction between engineers and engineering technicians/technologists.
ISO 13485Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices. The latest version of this standard supersedes earlier documents such as EN 46001 and EN 46002 (1996), the previously published ISO 13485, and ISO 13488.
The British Standards Institution (BSI) is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
Verification and validation are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. These are critical components of a quality management system such as ISO 9000. The words "verification" and "validation" are sometimes preceded with "independent", indicating that the verification and validation is to be performed by a disinterested third party. "Integration verification and validation" can be abbreviated as "IV&V".
The Dental Laboratories Association (DLA) is the professional body for dental laboratory owners in the United Kingdom. It is estimated that members of the DLA are responsible for over 80 per cent of the dental laboratory services in the UK.
Design controls designates the application of a formal methodology to the conduct of product development activities. It is often mandatory to implement such practice when designing and developing products within regulated industries.
The Nordic Institute of Dental Materials AS (NIOM AS) is a Nordic Cooperative Body for dental biomaterials. The Institute’s activities in research, materials testing, standardisation and research-based consulting are directed towards dental health services and health authorities in the Nordic countries. The Institute is owned jointly by NORCE and the Norwegian Ministry of Health and Care Services. Activities are financed by the Nordic Council of Ministers and the Nordic ministries for health services. Materials testing and consulting services also generate income. As a joint Nordic resource center, NIOM collaborates with dental schools and research institutions and provides services to government health authorities, dental professionals, and the public in the Nordic countries in the field of dental biomaterials.
The Bureau of Indian Standards (BIS) is the National Standards Body of India under Department of Consumer affairs, Ministry of Consumer Affairs, Food & Public Distribution, Government of India. It is established by the Bureau of Indian Standards Act, 2016 which came into effect on 12 October 2017. The Minister in charge of the Ministry or Department having administrative control of the BIS is the ex-officio President of the BIS. BIS has 500 plus scientific officers working as Certification Officers, Member secretaries of technical committees and lab OIC's.
British Approvals Service for Cables is an independent accredited certification body headquartered in Milton Keynes, United Kingdom. Here, the organization's dedicated testing laboratory also operates which is believed to be the largest of its type in Europe. BASEC was established in 1971 and principally provides product certification services for all types of cable and wire, ancillary products and management systems within the cable industry. The organization maintains operations throughout the world including Africa, Middle East, America, Asia and Europe.
Eurogentec is an international biotechnology supplier, based in Belgium, that specializes in genomics and proteomics kits and reagents as well as cGMP biologics. The company was founded in 1985 as a spin-off from the University of Liège. Eurogentec's contract manufacturing organization facilities are licensed by the Belgian Ministry of Health to produce clinical trial and commercial biopharmaceutical material and also licensed by the US FDA to manufacture a commercial recombinant protein product for the US market. Eurogentec operates two manufacturing facilities in Belgium that provide custom biologics and oligonucleotide-based components for diagnostic and therapeutic/prophylactic applications.
Patient management software (PMS) is referred to as software that is regulated as a medical device. It is software that is used to acquire medical information from a medical device to be used in the treatment or diagnosis of a patient. It can also be software that is an adjunct to a medical device and directly contributes to the treatment of the patient by performing analysis, or providing treatment or diagnosis functionality that replaces the decision and judgment of a physician.
A custom-made medical device, commonly referred to as a custom-made device (CMD) or a custom device, is a medical device designed and manufactured for the sole use of a particular patient. Examples of custom-made medical devices include auricular splints, dentures, orthodontic appliances, orthotics and prostheses.
