5 0 obj Conformity assessment", http://www.iso.org/iso/products/standards/catalogue_ics_browse.htm?ICS1=03&ICS2=120&ICS3=20&, "23.040.01: Pipeline components and pipelines in general", http://www.iso.org/iso/products/standards/catalogue_ics_browse.htm?ICS1=23&ICS2=040&ICS3=01&, "ISO/TR 13881:2000 Petroleum and natural gas industries -- Classification and conformity assessment of products, processes and services", http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=23137, "ISO 18436-4:2008 Condition monitoring and diagnostics of machines -- Requirements for qualification and assessment of personnel -- Part 4: Field lubricant analysis", http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=37395, "ISO/IEC 18009:1999 Information technology -- Programming languages -- Ada: Conformity assessment of a language processor", http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=31051, Governance, Risk Management, and Compliance. << Tools and resources for CASCO members can be found here (a log in will be required). Alternatively, the procedure set out in annex X for the type-examination may be performed in combination with the product conformity verification according to annex XI. We know the details …, Product development of medical devices is subject to its own rules. /Type/ExtGState ���ǘ7�˨z�/r�4d��ҩ0�E�:�2`�pk@�!nQ���JΧ{�`Ţ�ژSi�G����"�1�K-,k��z��a� nO]N��+Q�����|��Ch�y5(�ֽj���oP��H�����)-C�zS݋�+����{��bU�J�B��\�. A conformity assessment procedure demonstrates that the device complies with the requirements of Directive 93/42/EEC. ○   Anagrams In order to assess the QM system, among others the following aspects must be documented: manufacturer’s quality objectives, organisation of the business, procedures and techniques for monitoring, verifying, validating and controlling the design of the devices, verification and quality assurance techniques at the manufacturing, tests before, during and after manufacturing. /ModDate(5J�y������r�V������G) /FontName/SQUIKY+Cambria-Bold The conformity assessment procedure with all its variants and forms may be overwhelming at first sight. Is each egg alike the other in the box? Any use, including reproduction requires our written permission. /BM/Normal 7 0 obj /XHeight 484 Resources for conformity assessment. International Software Benchmarking Standards Group. /LastChar 151 Yet, a number of products is excluded: Sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors. /SMask/None Choose the conformity assessment procedure from the modules called out by the directive for the product according to each category (level of risk) involved. A definition of the term “specified requirement” (3.1) is included. /OP true /Flags 34 The wordgames anagrams, crossword, Lettris and Boggle are provided by Memodata. /AIS false Each square carries a letter. You’ll need to contact an external certification body for that. /ca 1 It can take place in two ways: either the procedure for production quality assurance is applied or the one for product verification. /FontFile2 8 0 R The conformity assessment procedure is a proof that the general safety and performance requirements are fulfilled. The manufacturer shall draw up a declaration of conformity for the respecting product in order to demonstrate conformity with the underling type. Great things happen when the world agrees. See Article 14(6) for the global conformity assessment procedure. ○   Lettris CASCO has developed a number of standards that laboratories can follow to help ensure that their results can be trusted. << Among other things, the technical documentation must be reviewed for its product conformity and whether the type has been created in accordance with the documentation. However, once the risk class of the medical device has been determined, the possible options for conformity assessment procedures are relatively evident. /Count 11 The “third-party conformity assessment”4 definition 2.4 of ISO/IEC 17000 is applicable, specifying that the third-party organization is an accredited organization compliant with requirements of 4.3. Conformity assessment, also known as compliance assessment [1], [2], [3], is any activity to determine, directly or indirectly, that a process, product, or service meets relevant standards and fulfills relevant requirements.[4]. Undergoing the conformity assessment process has a number of benefits: ISO doesn’t provide certification or conformity assessment. In our data privacy statement you will find more information about cookies. For custom-made devices, the procedure in annex XIII (“procedure for custom-made devices”) is applied and a statement as specified in paragraph 1 must be drawn up before placing on the market. It shall be documented and implemented and this system must be effective throughout the entire product life cycle. endobj /Kids[30 0 R 41 0 R 53 0 R 55 0 R 57 0 R 67 0 R 69 0 R 71 0 R 73 0 R 75 0 R 77 0 R] Payment of 15% (fifteen percent) of the Contract price upon submission of the Conformity Assessment Report of the Investment Project or upon receipt of the completed Construction Permit. Give contextual explanation and translation from your sites ! In parts, the manufacturer themselves can declare conformity for their products, but often it requires defined and complex procedures. endobj The conformity assessment procedure is a proof that the general safety and performance requirements are fulfilled. seleon advises you on your individual questions without any obligation. 6��X��hg��d�=�C�3�ِy�mV�ط.��YAp�L��