ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, published by International Organization...

voluntary standards such as ISO 13485 and ISO 14971. The ISO Technical Committee responsible for the maintenance of this standard is ISO/ TC 210 working with...

text of ISO 9001:2015. ISO 13485:2016 is the medical industry's equivalent of ISO 9001. ISO 13485:2016 is a stand-alone standard. Because ISO 13485 is relevant...

health and safety are integrated into these Quality Management Systems. ISO 13485 specifies Quality Management System requirements for organizations involved...

International Standards Organization ISO 10006—Quality management—Guidelines to quality management in projects ISO 13485—Medical devices—Quality management...

regarding the topic for regulatory purposes is convened by ISO 13485 and ISO 14971. ISO 13485:2016 is applicable to all providers and manufacturers of medical...

respectively. AAEON was awarded the TL9000 certification in 2002 and the ISO-13485 Medical certification in 2007. In addition to numerous awards from Intel...

How to Establish a Document Control System for Compliance with ISO 9001:2015, ISO 13485:2016, and FDA Requirements. ASQ Quality Press. p. 156. ISBN 9780873899178...

specifications including: ISO 9001 (Quality), ISO 13485 (Quality management systems for medical devices) ISO 14001 (Environment), ISO 50001 (Energy management...

society.ISO 9001 is a set of standards for quality management systems.ISO 13485 is a set of standards, published in 2003, that represents the requirements...

ISO 4217 is a standard published by the International Organization for Standardization (ISO) that defines alpha codes and numeric codes for the representation...

address data integrity either directly or indirectly, including ISO 13485, ISO 14155, and ISO 5840. In early 2017, the Financial Industry Regulatory Authority...

both guidelines. ISO 13485 are harmonized with the European Union Regulation 2017/745 as well as the IVD and AIMD directives. The ISO standard is also...

FDA, CE, MHW, AERB and the facility has been accredited with ISO-9001; ISO-13485 and ISO-14001 certifications. GE-BEL also markets the conventional X-ray...

notation: ISO 2014, ISO 2015, ISO 2711, ISO 3307, and ISO 4031. It has been superseded by a second edition ISO 8601:2000 in 2000, by a third edition ISO 8601:2004...

Electrotechnical Commission (IEC) List of IEC standards IEC 60601 ISO 14971 ISO 13485 ISO 9001 International Standards for automating the software structural...

seek and advertise ISO 13485 certification. ISO 13485 (quality management for the design and manufacturing of medical devices) and ISO 10993 (biocompatibility...

Juran's Quality Handbook. McGraw-Hill. p. 22.65. ISBN 007034003X. "ISO 13485:2016". ISO. Retrieved 2020-12-26. "Electronic Code of Federal Regulations (eCFR)"...

[2][3] The company operates a quality management system certified under ISO 13485, and in the UK has passed UKCA marking assessment. Ada has been compared...

ISO 22000 is a food safety management system by the International Organization for Standardization (ISO) which is outcome focused, providing requirements...

History Record (DHR) Design History File (DHF) The sub-clause 4.2.3 of ISO 13485:2016 requires a manufacturer of medical device to establish a Technical...

IS/ISO 50001 Medical Devices Management System Certification Scheme IS/ISO 13485 Social Accountability Management System Certification Scheme IS 16001...

for medical devices, as outlined in ASME V&V 40. Also see guidance: and ISO 13485. Manufacturing process and cleaning validation are compulsory and regulated...

ISO 8583 is an international standard for financial transaction card originated interchange messaging. It is the International Organization for Standardization...

Another example of a sector working with a single international standard is ISO 13485 (medical devices), which is adopted by the International Medical Device...

revised and replaced by ISO/IEC 80000. The standard comes in 14 parts: ISO 31-0: General principles (replaced by ISO/IEC 80000-1:2009) ISO 31-1: Space and time...

described in the U.S. Quality Systems Regulation of the FDA and also in ISO 13485:2003. Software technology manufacturers that operate within the software...

ISO 45001 is an International Organization for Standardization (ISO) standard for management systems of occupational health and safety (OHS), published...

They export to over 190 countries. They are ISO 13485:2003, EN ISO 13485:2012, ISO 13485:2003-CMDCAS and ISO 9001:2008 certified[1] and is listed in Kuala...

2006) and SW-CMM Level 3 software certification (9 February 2006) and ISO 13485 for medical device design and development. On 8 September 2004 Foster-Miller...