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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.
A safety data sheet (SDS), material safety data sheet (MSDS), or product safety data sheet (PSDS) is a document that lists information relating to occupational safety and health for the use of various substances and products. SDSs are a widely used type of fact sheet used to catalogue information on chemical species including chemical compounds and chemical mixtures. SDS information may include instructions for the safe use and potential hazards associated with a particular material or product, along with spill-handling procedures. The older MSDS formats could vary from source to source within a country depending on national requirements; however, the newer SDS format is internationally standardized.
Medical software is any software item or system used within a medical context, such as reducing the paperwork, tracking patient activity
Hazard symbols are recognizable symbols designed to warn about hazardous or dangerous materials, locations, or objects, including electromagnetic fields, electric currents; harsh, toxic or unstable chemicals ; and radioactivity. The use of hazard symbols is often regulated by law and directed by standards organizations. Hazard symbols may appear with different colors, backgrounds, borders, and supplemental information in order to specify the type of hazard and the level of threat. Warning symbols are used in many places in place of or in addition to written warnings as they are quickly recognized and more universally understood, as the same symbol can be recognized as having the same meaning to speakers of different languages.
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.
European Standards, sometimes called Euronorm, are technical standards which have been ratified by one of the three European Standards Organizations (ESO): European Committee for Standardization (CEN), European Committee for Electrotechnical Standardization (CENELEC), or European Telecommunications Standards Institute (ETSI). All ENs are designed and created by all standards organizations and interested parties through a transparent, open, and consensual process.
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.
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. "Independent verification and validation" can be abbreviated as "IV&V".
Information technology risk, IT risk, IT-related risk, or cyber risk is any risk relating to information technology. While information has long been appreciated as a valuable and important asset, the rise of the knowledge economy and the Digital Revolution has led to organizations becoming increasingly dependent on information, information processing and especially IT. Various events or incidents that compromise IT in some way can therefore cause adverse impacts on the organization's business processes or mission, ranging from inconsequential to catastrophic in scale.
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.
IEC 62304 – medical device software – software life cycle processes is an international standard published by the International Electrotechnical Commission (IEC). The standard specifies life cycle requirements for the development of medical software and software within medical devices. It has been adopted as national standards and therefore can be used as a benchmark to comply with regulatory requirements.
ISO 13849 is a safety standard which applies to parts of machinery control systems that are assigned to providing safety functions. The standard is one of a group of sector-specific functional safety standards that were created to tailor the generic system reliability approaches, e.g., IEC 61508, MIL-HDBK-217, MIL-HDBK-338, to the needs of a particular sector. ISO 13849 is simplified for use in the machinery sector.
The Annex SL is a section of the ISO/IEC Directives part 1 that prescribes how ISO Management System Standard (MSS) standards should be written. The aim of Annex SL is to enhance the consistency and alignment of MSS by providing a unifying and agreed-upon high level structure, identical core text and common terms and core definitions. The aim being that all ISO Type A MSS are aligned and the compatibility of these standards is enhanced.
A secure signature creation device (SSCD) is a specific type of computer hardware or software that is used in creating an electronic signature. To be put into service as a secure signature creation device, the device must meet the rigorous requirements laid out under Annex II of Regulation (EU) No 910/2014 (eIDAS), where it is referred to as a qualified (electronic) signature creation device (QSCD). Using secure signature creation devices helps in facilitating online business processes that save time and money with transactions made within the public and private sectors.
A nursing care bed is a bed that has been adapted to the particular needs of people who are ill or disabled. Nursing care beds are used in private home care as well as in inpatient care.
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.
Electromagnetic compatibility (EMC) with regulations and standards is a global requirement for electrical and electronic devices prior to their commercialization. EMC is essential for ensuring the safety, performance, and quality of electronic devices. However, achieving and maintaining EMC presents a significant challenge due to the rapid development of new products with evolving technologies and features.
References
- ↑ "FOREWORD - SUPPLEMENTARY INFORMATION". www.iso.org/foreword-supplementary-information.html.
- ↑ ISO Catalogue: Medical devices -- Application of risk management to medical devices
- ↑ "ISO/IEC Guide 51:2014 - Safety aspects -- Guidelines for their inclusion in standards". www.iso.org.
- ↑ "ISO/IEC Guide 63:2012 - Guide to the development and inclusion of safety aspects in International Standards for medical devices". www.iso.org.
- ↑ "ISO 14971:2019 Medical devices — Application of risk management to medical devices, the European Forward". www.iso.org. 14 July 2020.
- ↑ "Medical devices -- Application of risk management to medical devices". ISO. 2 May 2013. Retrieved 13 September 2015.
- ↑ Manookian, Brian. "Technical Information About ISO 14971". Cummings Manookian. Retrieved 13 September 2015.
- ↑ Council Directive 93/42/EEC of 14 June 1993
- ↑ Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
- ↑ Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
- ↑ REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017
- ↑ REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017
- ↑ "ISO/TR 24971:2013 - Medical devices -- Guidance on the application of ISO 14971". www.iso.org.
- ↑ "ISO/TR 24971:2020 - Medical devices -- Guidance on the application of ISO 14971". www.iso.org. 18 December 2019., the Forward
- 1 2 3 "Applying Human Factors and Usability Engineering to Medical Devices" (PDF). U.S. Department of Health and Human Services Food and Drug Administration. February 3, 2016.
This article incorporates text from this source, which is in the public domain . - ↑ One or more of the preceding sentences incorporates text from this source, which is in the public domain : Applying Human Factors and Usability Engineering to Medical Devices, U.S. Department of Health and Human Services Food and Drug Administration
