Quality is defined as the degree with which a process, product or service is compliant with given requirements. In a business context there are many aspects to be considered as Quality related, depending on the specific product, whether it be a physical good or a service. How the good or the service is produced involves processes, procedures, tools, equipment, and personnel, which all fall under the Quality area of interest.
In business, engineering, and manufacturing, quality is also defined as how much a good or service is suitable (fitness for purpose) while satisfying customer expectations. Therefore, the Quality is measurable in the conformance, in the degree to which the product/service was produced correctly as well as in the degree that a product is reliable, maintainable, or sustainable.
Automotive SPiCE is a process maturity framework (Process Reference Model and Process Assessment Model) to assess the capability and maturity of organisational processes to develop software in embedded systems for the automotive industry. It is a variant of ISO/IEC 33020:2015 (previously ISO/IEC 15504-5:2006) tailored to the needs of the automotive industry.
The Medi SPICE standard describes the software process assessment; its model is voted to meet the specific safety-critical and regulatory requirements of the medical device domain. It also details the development of a subset of the Medi SPICE process reference model for inclusion in the next release of the IEC 62304 standard (Medical device software - Software life cycle processes).
IEC 62304 (Medical)
IEC 62304 is a key standard for medical device software development, approved by many national regulatory bodies in the United States and in the European Union. This standard also delineates 3 simplified methods for software process assessment, which have been developed together with the Medi SPICE committee.
ISO 13485 (Medical)
This standard, recently revised and confirmed (2020), specifies the requirements for a quality management system to provide medical devices and related services which can meet the regulatory requirements and the customer’s needs; it describes the lifecycle, including design and development, production, storage and distribution, installation or servicing and design and development or provision of the related activities (e.g. technical support).
ISO 900x (Quality standard family, for several areas)
In this series of standard, which covers a number of heterogeneous business sectors and products, ISO 9001 is the only one with which it is possible to be certified to: it defines the criteria for a quality management system applicable to any kind of organization (regardless of its dimension or its field of activity) to prove the products conformity to the customer requirements and to the statutory and regulatory rules or simply with the purpose to enhance the customer satisfaction improving its own production process.
IATF 16949 (Automotive)
ISO/TS 16949 was a standard based on ISO 9001, now superseded and replaced by the IATF 16949. It is issued to provide technical specification for the development of a quality management system for the defects prevention and to improve the efficiency in the automotive supply chain and production.