Change Control SOP PDF (Compass Health AI)

Compass Health AI SOP: Change Control Approvals Author Position Role Signature Date DD-MMM-YYYY Tenzin Head of Author +BO Yangzom QA/RA James Approver...

Compass Health AI SOP: Change Control Approvals Author Position Role Signature Date DD-MMM-YYYY Tenzin Head of Author +BO Yangzom QA/RA James Approver +BO Baskin COO Document #: QMS-SOP-0014 Kevin Approver +BO Kennedy Engineering Revision History Version Date Description 1.0 Ͳ͵Ǧ ƒǦʹͲʹͶ Initial Release Document #: QMS-SOP-0014 1 Introduction Š‹•†‘ —‡–‘—–Ž‹‡•–Š‡’”‘ ‡••ƒ†”‡•’‘•‹„‹Ž‹–‹‡•ˆ‘” ‘–”‘ŽŽ‹‰ƒ††‘ —‡–‹‰ ‡†‹ ƒŽ†‡˜‹ ‡’”‘†— –†‡•‹‰ Šƒ‰‡•ƒ†ƒ—ˆƒ –—”‹‰’”‘ ‡•• Šƒ‰‡•ƒ–‘’ƒ•• ‡ƒŽ–ŠǤ 1.1 Scope Š‹•’”‘ ‡†—”‡ƒ’’Ž‹‡•–‘ƒŽŽ†‡˜‹ ‡†‡•‹‰ Šƒ‰‡•ƒˆ–‡” ‘’Ž‡–‹‘‘ˆ‹–•†‡•‹‰Ǥ ’‡ ‹ˆ‹ ƒŽŽ›ǡ–Š‹•’”‘ ‡†—”‡ƒ’’Ž‹‡•ˆ”‘–Š‡–‹‡™Š‡ǣ  Š‡†‡•‹‰‹•”‡Ž‡ƒ•‡†–‘”‡‰—Žƒ–‘”•ˆ‘”’”‡Ǧƒ”‡–ƒ’’”‘˜ƒŽȋ‘”‘–Š‡””‡ƒ•‘•Ȍǡ‘”  Š‡†‡•‹‰‹•—†‡”‰‘‹‰ Ž‹‹ ƒŽ–”‹ƒŽ•ǡ‘”  Š‡†‡•‹‰‹•”‡Ž‡ƒ•‡†–‘’”‘†— –‹‘Ǥ —”‹‰–Š‡†‡•‹‰’”‘ ‡••ƒ†„‡ˆ‘”‡ƒ›‘ˆ–Š‡ƒ„‘˜‡Ž‹•–‡†‡˜‡–•–ƒ‡’Žƒ ‡†‡•‹‰ Šƒ‰‡•ƒ”‡ ‘–”‘ŽŽ‡†‹ƒ ‘”†ƒ ‡™‹–ŠSOP: Product Development ProcessǤŠ‹• ’”‘ ‡†—”‡ƒ’’Ž‹‡•ƒŽ•‘–‘ƒ—ˆƒ –—”‹‰’”‘ ‡•• Šƒ‰‡•Ǥ Document #: QMS-SOP-0014 2 Applicable and Reference Documents 2.1 Applicable Standards Š‡ˆ‘ŽŽ‘™‹‰•–ƒ†ƒ”†•ƒ†”‡‰—Žƒ–‹‘•ƒ”‡‹–‡†‡†–‘„‡‡–„›–Š‹•’”‘ ‡†—”‡ǣ  ȚͺʹͲǤ͵Ͳȋ‹Ȍ‡•‹‰Šƒ‰‡•  ͳ͵ͶͺͷǣʹͲͳ͸‡ –‹‘͹Ǥ͵Ǥͻ‘–”‘Ž‘ˆ‡•‹‰ƒ†‡˜‡Ž‘’‡–Šƒ‰‡•  ƒƒ†‹ƒ‡†‹ ƒŽ‡˜‹ ‡‡‰—Žƒ–‹‘•ǡȏͳͲȐ–‘ȏʹͲȐƒ†ȏ͵ͶȐȋƒȌ  —•–”ƒŽ‹ƒ ȋȌ Š͵ŽͳǤͷǦŠƒ‰‡ƒ••‡••‡–  Australian TG(MD)R Sch3 P1 Cl 1.6(4) - Change notification 2.2 Reference Documents Š‡ˆ‘ŽŽ‘™‹‰†‘ —‡–•ǡ–‡’Žƒ–‡•ƒ†ˆ‘”•ƒ”‡”‡ˆ‡”‡ ‡†™‹–Š‹–Š‹•’”‘ ‡†—”‡ƒ† ƒ”‡”‡Žƒ–‡†–‘–Š‡Šƒ‰‡‘–”‘Ž”‘ ‡••ǣ Document Title Document # SOP: Product Development Process QMS-SOP-0007 SOP: Document Control QMS-SOP-0002 SOP: Risk Management QMS-SOP-0013 Process Deviation Form QMS-FRM-0093 Engineering Change Order Form QMS-FRM-0002 Process Change Impact Assessment Form QMS-FRM-2435 Document #: QMS-SOP-0014 ͵‡ˆ‹‹–‹‘•ƒ† ”‘›• ƒ„Ž‡ͳǣ ”‘›• Acronym Meaning ECO Engineering Change Order SOUP Software of Unknown Provenance (“off-the-shelf software) ƒ„Ž‡ʹǣ‡ˆ‹‹–‹‘• Term Meaning Deviation A temporary change to a documented process, such as manufacturing processes or quality system procedures that would either not be appropriate for a permanent engineering change, or which subsequently will be made permanent. These deviations can include temporary use of alternate materials, or a temporary change to a documented procedure Device Master Device master record (DMR) is the term used in the Quality System (QS) Record regulation for all of the routine documentation required to manufacture devices that will consistently meet company requirements. 4 Process Roles Function Role Management Approves the ECO or not based on different functions assessments RA, Risk, R&D, Mnfg, Marketing, Finance QA Approves and closes the ECO Document #: QMS-SOP-0014  All functions can initiate an ECO/ECR RA Views for impact to current approvals, files for regulatory clearance of the change and documents the change in the QMS and regulatory files (update of the Technical file) R&D and Engineering Reviews impact to risk and prepares technical documentation 5 General Change Control Process ‡“—‡•–•ˆ‘”’”‘†— –†‡•‹‰ƒ†ƒ—ˆƒ –—”‹‰’”‘ ‡•• Šƒ‰‡•ƒ›„‡‹‹–‹ƒ–‡†„› ƒ›‘‡‹–Š‡ ‘’ƒ›ǡƒ†„›‡š–‡”ƒŽ ‘•—Ž–ƒ–•ƒ† ‘–”ƒ –‘”•Ǥ‘ˆ–™ƒ”‡ Šƒ‰‡•ƒ”‡ –”ƒ ‡†–Š”‘—‰Š”‡‰—Žƒ”•‘ˆ–™ƒ”‡”‡Ž‡ƒ•‡’”‘ ‡••ƒ†ƒ••‹‰‡†–‘ƒˆ—–—”‡”‡Ž‡ƒ•‡˜‡”•‹‘ ‘ˆ–Š‡’”‘†— –Ǥ ƒ”†™ƒ”‡ Šƒ‰‡•ƒ”‡–”ƒ ‡†‹–Š‡Šƒ‰‡”†‡”‘‰Ǥ Š‡•‡ Šƒ‰‡•ƒ”‡’”‘ ‡••‡†ƒ††‡˜‡Ž‘’‡†–Š”‘—‰Š‘‡‘ˆ–Š‡ˆ‘ŽŽ‘™‹‰ǣ  †‡•‹‰’”‘Œ‡ – ‘–”‘ŽŽ‡†„›–Š‡SOP: Product Development Process. Š‹•‹•†‘‡ ™Š‡ ‘’”‡Š‡•‹˜‡ Šƒ‰‡•ƒ”‡‡‡†‡†”‡“—‹”‹‰”‡˜‹•‹‘‘ˆ–Š‡‘”‹‰‹ƒŽ†‡•‹‰ ‹’—–”‡“—‹”‡‡–•ǡ•— Šƒ•ƒ††‹‰‘”‘†‹ˆ›‹‰ˆ— –‹‘ƒŽ Šƒ”ƒ –‡”‹•–‹ •‘ˆ–Š‡ †‡˜‹ ‡ǡ‘”•‹‰‹ˆ‹ ƒ–’‡”ˆ‘”ƒ ‡—’‰”ƒ†‡•ǤŽŽ Šƒ‰‡•ˆ‘ŽŽ‘™–Š‹•’”‘ ‡••Ǥ  ‰‹‡‡”‹‰Šƒ‰‡”†‡”ȋȌǤŠ‡•›•–‡‹•‹–‡†‡†ˆ‘”‹’Ž‡‡–‹‰ •’‡ ‹ˆ‹ ƒ†Ž‹‹–‡† Šƒ‰‡•–‘ ‘””‡ –†‡•‹‰’”‘„Ž‡•‘”‹’”‘˜‡”‡Ž‹ƒ„‹Ž‹–›ǡ •‡”˜‹ ‡ƒ„‹Ž‹–›‘”ƒ—ˆƒ –—”ƒ„‹Ž‹–›‘ˆŠƒ”†™ƒ”‡†‡˜‹ ‡•ǤŠ‡•›•–‡ƒ›„‡ —•‡†ˆ‘”‘ˆ–™ƒ”‡Šƒ‰‡ ‘–”‘Ž‹ˆ†‡‡‡†ƒ’’Ž‹ ƒ„Ž‡ƒ†ƒ’’”‘’”‹ƒ–‡Ǥ  –‡’‘”ƒ”›†‡˜‹ƒ–‹‘ˆ”‘’”‘†— –‹‘’”‘ ‡••‡•‘”“—ƒŽ‹–›•›•–‡’”‘ ‡••‡•ƒ› „‡‹’Ž‡‡–‡†ƒ† ‘–”‘ŽŽ‡†–Š”‘—‰Šƒ”‘ ‡••‡˜‹ƒ–‹‘Ǥ  Šƒ‰‡•–‘’”‘ ‡••‡•‘”ƒ –‹˜‹–‹‡••ŠƒŽŽ„‡’”‘’‡”Ž›ƒ••‡••‡†ƒ† ‘–”‘ŽŽ‡† –Š”‘—‰Š–Š‡”‘ ‡••Šƒ‰‡ ’ƒ –••‡••‡– ‘”ȋǦ ǦʹͶ͵ͷȌƒ†–Š‡  ’ƒ –••‡••‡–‘‰ȋǦǦͲͻͶʹȌˆ‘” Šƒ‰‡•ƒ†‡–‘• 6 Engineering Change Order ‰‹‡‡”‹‰Šƒ‰‡”†‡” ‘”ȏǦ ǦͲͲͲʹȐ‹•‹‹–‹ƒ–‡†„›ƒŽŽ‘’ƒ••’Ž‘›‡‡ ˆ‘”ƒ Šƒ‰‡‘”ƒ ‘ŽŽ‡ –‹‘‘ˆ Šƒ‰‡•–‘„‡‹’Ž‡‡–‡†ǤŠ‹•ˆ‘”‹•‹–‡†‡†ˆ‘” Šƒ‰‡ Document #: QMS-SOP-0014  ‘–”‘Ž‰‘˜‡”‹‰Šƒ”†™ƒ”‡’”‘†— –•ƒ–‘’ƒ•• ‡ƒŽ–ŠǤ ‘™‡˜‡”ǡ–Š‡ƒ›„‡—•‡† ˆ‘”‘ˆ–™ƒ”‡Šƒ‰‡ ‘–”‘Ž‹ˆ†‡‡‡†ƒ’’Ž‹ ƒ„Ž‡ƒ†ƒ’’”‘’”‹ƒ–‡ǤŠ‡ˆ‘”‹• ‘’Ž‡–‡† ƒ•ˆ‘ŽŽ‘™•ǣ  ‡• ”‹’–‹‘‘ˆŠƒ‰‡ǣŠ‡‹‹–‹ƒ–‘”ˆ‹ŽŽ•‘—––Š‹••‡ –‹‘‘ˆ–Š‡ˆ‘”ǡƒŽ‘‰™‹–Š –Š‡ˆ‹”•–•‡ –‹‘‹†‡–‹ˆ›‹‰–Š‡’”‘†— –Ȁ’”‘ ‡••–‘„‡ Šƒ‰‡†ƒ†–Š‡’ƒ”–‹ —Žƒ” ‡‰‹‡‡”‹‰†‘ —‡–•–Šƒ–•’‡ ‹ˆ›–Š‡’ƒ”–ǡ’”‘†— –ǡˆ‡ƒ–—”‡ǡ‘” Šƒ”ƒ –‡”‹•–‹ •–Šƒ– ‹•–‘„‡ Šƒ‰‡†ǤŠ‡Dz‡• ”‹’–‹‘‘ˆŠƒ‰‡dz•‡ –‹‘†‡• ”‹„‡•–Š‡”‡“—‡•–‡† Šƒ‰‡ƒ†”‡ˆ‡”‡ ‡•ƒ›†‘ —‡–•–Šƒ–ƒ”‡”‡“—‹”‡†–‘„‡—’†ƒ–‡††—‡–‘–Š‹• Šƒ‰‡ȋ†‡•‹‰ǡ”‹•ǡŽƒ„‡Ž‹‰ǡƒ—ˆƒ –—”‹‰†‘ —‡–•ȌǤ  ’ƒ –‘ˆŠƒ‰‡ǣŠ‡‡‰‹‡‡”‹‰ƒƒ‰‡”Ȁ’”‘†— –ƒƒ‰‡”‡˜ƒŽ—ƒ–‡•–Š‡‡ˆˆ‡ –• ‘ˆ–Š‡’”‘’‘•‡† Šƒ‰‡ƒ†”‡ ‘”†•–Š‡”‡•—Ž–•‘ˆ–Š‡‡˜ƒŽ—ƒ–‹‘‹–Š‡Dzˆˆ‡ –‘ˆ Šƒ‰‡Ƭ‹•’‘•‹–‹‘dz•‡ –‹‘‘ˆˆ–Š‡ˆ‘”ǤŠ‡‡ˆˆ‡ –‘ˆ Šƒ‰‡‹ Ž—†‡•ƒ ƒ••‡••‡–‘ˆ‹’ƒ –‘”‹•ƒ••‡••‡–ǡ‘–Š‡”†‡•‹‰†‘ —‡–•ǡ’”‘†— –‹‘ ’”‘ ‡••‡•ǡ–”ƒ‹‹‰ǡƒ†ˆƒ ‹Ž‹–‹‡•ȋ•‡‡ ‘”ǣ‰‹‡‡”‹‰Šƒ‰‡”†‡”ˆ‘”–Š‡ ‘’Ž‡–‡Ž‹•–‘ˆ‡ˆˆ‡ –•™Š‹ Šƒ”‡‡˜ƒŽ—ƒ–‡†ȌǤ Š‡‹’ƒ –ƒ••‡••‡–‹ Ž—†‡•ƒƒ••‡••‡–‘ˆ–Š‡’”‘†— –•–Šƒ–ƒ”‡ƒŽ”‡ƒ†› ƒ—ˆƒ –—”‡†ǡ‹Ǧ•–‘ ǡ‹Ǧ’”‘ ‡••ƒ†–Š‘•‡‹–‡•‹–Š‡ˆ‹‡Ž†Ǥ Š‡”‡“—‹”‡†˜‡”‹ˆ‹ ƒ–‹‘ƒ†˜ƒŽ‹†ƒ–‹‘–ƒ••ƒ••‘ ‹ƒ–‡†™‹–Š–Š‡ Šƒ‰‡ƒ”‡ƒ••‡••‡†ƒ† †‘ —‡–‡†ƒ†–Š‡ƒ’’Ž‹ ƒ„Ž‡ƒ ‡’–ƒ ‡ ”‹–‡”‹ƒ‹•†‘ —‡–‡†Ǥ  ‡‰—Žƒ–‘”›‘•‹†‡”ƒ–‹‘•ǣˆ‹ŽŽ•‘—––Š‹••‡ –‹‘‘ˆ–Š‡ˆ‘”Ǥ ‡‡”ƒŽ ‘•‹†‡”ƒ–‹‘—•–„‡‰‹˜‡–‘–Š‡‡ˆˆ‡ –‘ˆ–Š‡ Šƒ‰‡ǡ‹–••‹‰‹ˆ‹ ƒ ‡ƒ†Ȁ‘”‹–• ‡ˆˆ‡ –‘•ƒˆ‡–›ƒ†‡ˆˆ‡ –‹˜‡‡••‘ˆ–Š‡’”‘†— –Ǥ ‘˜‡”‹‰”‡‰—Žƒ–‘”› „‘†‹‡•Ȁƒ—–Š‘”‹–‹‡••ŠƒŽŽ„‡‘–‹ˆ‹‡†ƒ•ƒ’’”‘’”‹ƒ–‡ȋ‹ƒ ‘”†ƒ ‡™‹–Š–Š‡†‹”‡ –‹˜‡ ’‡” ‘—–”›ȌǤ‡‡SOP: Device Licensing ˆ‘”†‡–ƒ‹Ž•‘”‡’‘”–‹‰‘ˆ”‡‰—Žƒ–‘”› Šƒ‰‡•Ǥ  ‡Ž‡ƒ•‡ ’Ž‡‡–ƒ–‹‘—–Š‘”‹œƒ–‹‘ǣ –Š‹••‡ –‹‘ǡ–Š‡”‡˜‹•‡††‘ —‡–• ƒ”‡Ž‹•–‡†‘–Š‡ˆ‘”ǡƒ†ǡ™Š‡”‡ƒ’’Ž‹ ƒ„Ž‡ǡƒ›˜‡”‹ˆ‹ ƒ–‹‘Ȁ˜ƒŽ‹†ƒ–‹‘ ’”‘–‘ ‘Ž•ƒ†”‡’‘”–•ƒ”‡”‡ˆ‡”‡ ‡†Ǥ —”–Š‡”ǡ‹†‡–‹ˆ›–Š‡•—’’Ž‹‡”•ǡ ‘–”ƒ – ƒ—ˆƒ –—”‡”ǡ —•–‘‡”ƒ†”‡‰—Žƒ–‘”›ƒ‰‡ ‹‡•‘–‹ˆ‹‡†™Š‡”‡ƒ’’Ž‹ ƒ„Ž‡Ǥ ˆƒ ȋ‘””‡ –‹˜‡ –‹‘‡“—‡•–Ȍ‹•‹‹–‹ƒ–‡†–‘†‡ƒŽ™‹–Š™‹†‡”ǡ•›•–‡‹ ’”‘„Ž‡• ”‡Žƒ–‡†–‘–Š‡ Šƒ‰‡ǡ–Š‡„‘š‹• Š‡ ‡†ƒ†–Š‡—„‡”‹•”‡ ‘”†‡†ƒ– –Š‡„‘––‘‘ˆ–Š‡Žƒ•–„Ž‘ Ǥ Š‡ˆ‘”ƒ†ƒ—–Š‘”‹œ‡•–Š‡‹’Ž‡‡–ƒ–‹‘‘ˆ–Š‡ Šƒ‰‡‹’”‘†— –‹‘‘””‡Ž‡ƒ•‡‘ˆ ’”‘†— –ƒ•ƒ’’”‘’”‹ƒ–‡‘ ‡ ‘’Ž‡–‹‰–Š‡ ƒ”†™ƒ”‡‡•‹‰Šƒ‰‡Š‡ Ž‹•–ȋǦ Ǧͳͷ͸͸ȌǤŠ‡ƒ—–Š‘”‹œƒ–‹‘ƒ›‘Ž›„‡‰‹˜‡ƒˆ–‡”–Š‡†‡•‹‰ Šƒ‰‡Šƒ•„‡‡˜‡”‹ˆ‹‡† ƒ†Ȁ‘”˜ƒŽ‹†ƒ–‡†ǡ–Š‡ƒ ‡’–ƒ ‡ ”‹–‡”‹ƒ‹•‡–ǡƒ†ƒŽŽƒˆˆ‡ –‡††‘ —‡–•Šƒ˜‡„‡‡ Document #: QMS-SOP-0014 —’†ƒ–‡†ǤŠƒ‰‡‘”†‡”ƒ’’”‘˜ƒŽ•ƒ††ƒ–‡‘ˆƒ’’”‘˜ƒŽƒ”‡ ƒ’–—”‡†ƒ•’ƒ”–‘ˆ–Š‡Ǥ ‘” •‘’‡‡†ˆ‘”•‘ˆ–™ƒ”‡ Šƒ‰‡•ǡ–Š‡•‘ˆ–™ƒ”‡”‡Ž‡ƒ•‡’”‘ ‡•••ŠƒŽŽ„‡ˆ‘ŽŽ‘™‡†–‘‡•—”‡ –Š‡†‡•‹‰ Šƒ‰‡Šƒ•„‡‡˜‡”‹ˆ‹‡†ƒ†Ȁ‘”˜ƒŽ‹†ƒ–‡†ǡ–Š‡ƒ ‡’–ƒ ‡ ”‹–‡”‹ƒ‹•‡–ǡƒ†ƒŽŽ ƒˆˆ‡ –‡††‘ —‡–•Šƒ˜‡„‡‡—’†ƒ–‡†Ǥ 7 Software Change Control 7.1 Software or system change requests must be documented in writing and should include:  ‡• ”‹’–‹‘‘ˆ–Š‡’”‘’‘•‡† Šƒ‰‡ ƒ–‹‘ƒŽ‡ˆ‘”–Š‡ Šƒ‰‡Ǥ ‘”‡šƒ’Ž‡ǣ Šƒ‰‡™‹ŽŽ’”‡˜‡–•›•–‡ˆƒ‹Ž—”‡ Šƒ‰‡™‹ŽŽˆ‹šƒ„—‰ Šƒ‰‡‹’”‘˜‡•ˆ— –‹‘ƒŽ‹–›‘”’‡”ˆ‘”ƒ ‡ Šƒ‰‡•‘Ž˜‡•ƒ‹†‡–‹ˆ‹‡†’”‘„Ž‡ 7.2 Change Control Process Šƒ‰‡•–‘‘’ƒ•• ‡ƒŽ–Š•‘ˆ–™ƒ”‡•ŠƒŽŽ„‡‹‹–‹ƒ–‡†‘ ‡ƒ‡‡†ˆ‘” Šƒ‰‡Šƒ•„‡‡ †‡–‡”‹‡†ǤŠƒ‰‡•ƒ”‡–›’‹ ƒŽŽ›‹‹–‹ƒ–‡†ƒ•ƒ”‡•—Ž–‘ˆ‹••—‡•”‡’‘”–‡†‘”™Š‡‡™ ’”‘†— –‡Šƒ ‡‡–ƒ†Ȁ‘”ˆ‡ƒ–—”‡•ƒ”‡–‘„‡‹–”‘†— ‡†‹–‘–Š‡•‘ˆ–™ƒ”‡Ǥ‘–”‘ŽŽ‡† Šƒ‰‡•‹ Ž—†‡ǡ„—–ƒ”‡‘–Ž‹‹–‡†–‘ǡƒ††‹‰‘”‘†‹ˆ›‹‰ˆ— –‹‘ƒŽ Šƒ”ƒ –‡”‹•–‹ •‘ˆ –Š‡†‡˜‹ ‡ǡ‘”•‹‰‹ˆ‹ ƒ–’‡”ˆ‘”ƒ ‡—’‰”ƒ†‡•ƒ†‹’”‘˜‡‡–•Ǥ ••—‡•”‡’‘”–‡†„›’ƒ”–‡”•ǡ‡˜ƒŽ—ƒ–‘”•ǡ‘”‡†Ǧ—•‡”•ƒ”‡”‡ ‡‹˜‡†‹ƒ ‘”†ƒ ‡™‹–ŠSOP: Complaint HandlingȋǦǦͲͲʹ͸ȌǡSOP: Feedback and Customer SatisfactionȋǦ ǦͲͲʹʹȌǡ‘”SOP: Usability Engineering ȋǦǦͲͲͳͳȌǤ ••—‡•ƒ”‡–”‹ƒ‰‡†ƒ†‡˜ƒŽ—ƒ–‡†„›ƒ’’”‘’”‹ƒ–‡’‡”•‘‡Žȋ‰‹‡‡”‹‰ǡ”‘†— –ǡ‡– ǤȌƒ† ‹–‡•ˆŽƒ‰‰‡†ƒ•’‘–‡–‹ƒŽ‘””‡“—‡•–‡† Šƒ‰‡•ƒ”‡”‡˜‹‡™‡†„›‘’ƒ••–‡ƒǤ ‡™ˆ‡ƒ–—”‡ƒ†’”‘†— –‡Šƒ ‡‡–•ƒ”‡ ‘•‹†‡”‡†„ƒ•‡†‘ —•–‘‡”ˆ‡‡†„ƒ •ǡƒ• ™‡ŽŽƒ•ˆ‡ƒ–—”‡•‹–‡”ƒŽŽ›†‡˜‡Ž‘’‡†ˆ”‘—•‡”‡š’‡”‹‡ ‡”‡•‡ƒ” Š–‘‹–”‘†— ‡‘˜‡Ž •‘Ž—–‹‘•ˆ‘” —•–‘‡”•Ǥ‡™ˆ‡ƒ–—”‡•ƒ†‡Šƒ ‡‡–•”‡“—‡•–•ŠƒŽŽ„‡‡˜ƒŽ—ƒ–‡†ƒ† Document #: QMS-SOP-0014 ƒ’’”‘˜‡†„›ƒ’’”‘’”‹ƒ–‡’‡”•‘‡Žȋ”‘†— –ǡ‰‹‡‡”‹‰ǡ—•–‘‡”— ‡••ǡ‡– ǤǤȌǤ Šƒ‰‡••ŠƒŽŽ„‡‹’Ž‡‡–‡†‘Ž›ƒˆ–‡”ˆ‘”ƒŽƒ’’”‘˜ƒŽŠƒ•„‡‡”‡ ‡‹˜‡†ˆ‘”–Š‡ †‡–ƒ‹Ž‡†’”‘’‘•ƒŽ•ǡƒ†ƒ•ƒ’’”‘’”‹ƒ–‡ǡƒˆ–‡”‡•—”‹‰ƒ—–Š‘”‹œ‡†—•‡”•ƒ ‡’– Šƒ‰‡• ’”‹‘”–‘‹’Ž‡‡–ƒ–‹‘Ǥ ’’”‘˜‡†ƒŒ‘” Šƒ‰‡•–‘‘’ƒ•• ‡ƒŽ–Šƒ’’Ž‹ ƒ–‹‘•ǡ•‘ˆ–™ƒ”‡ƒ†‡–™‘”•ƒ”‡ ‘–”‘ŽŽ‡†–Š”‘—‰Š–Š‡ˆ‘”ƒŽ•‘ˆ–™ƒ”‡†‡˜‡Ž‘’‡–’”‘ ‡••‡•‹ƒ ‘”†ƒ ‡™‹–ŠSOP: Product Development Process ȋǦǦͲͲͲ͹Ȍ ƒ† SOP: Software Development Process ȋǦǦͲͲͲͺȌǤ ’’”‘˜‡†‹‘” Šƒ‰‡•–‘‘’ƒ•• ‡ƒŽ–Šƒ’’Ž‹ ƒ–‹‘•ǡ•‘ˆ–™ƒ”‡ƒ†‡–™‘”•ƒ”‡ ‘–”‘ŽŽ‡†–Š”‘—‰Š–Š‡’ƒ– Š”‡Ž‡ƒ•‡’”‘ ‡••‹ƒ ‘”†ƒ ‡™‹–Š–Š‡Product Development Plan‘ˆ–Š‡’”‘†— –Ǥ‹‘” Šƒ‰‡•ƒ”‡”‡•‡”˜‡†ˆ‘”’ƒ– Š”‡Ž‡ƒ•‡•Ǥ‹‘” Šƒ‰‡•ˆ‘” •‘ˆ–™ƒ”‡•ŠƒŽŽ‘Ž›‹ Ž—†‡„—‰ˆ‹š‡•–Šƒ–—”‰‡–Ž›‡‡†•–‘„‡†‡’Ž‘›‡†–‘”‡•–‘”‡–Š‡ ‘”ƒŽˆ— –‹‘ƒŽ‹–›‘ˆ–Š‡†‡˜‹ ‡ƒ†Ȁ‘”’”‘˜‹†‡•ƒ”‡•‘Ž—–‹‘–‘‘‡‘ˆ–Š‡ˆ‘ŽŽ‘™‹‰ǣ  ƒŽ–•—•‡”•‹’”‘†— –‹‘  ƒ–ƒ‹•Ž‘•–‘” ‘””—’–‡†  ’”‹ƒ”›‘” ”‹–‹ ƒŽˆ— –‹‘ ƒ‘–„‡—•‡†Ǥ  Ž‹‹ ƒŽ”‹•Ǧ–Š‡‹ ‘””‡ –‹ˆ‘”ƒ–‹‘™‹ŽŽ„‡”‡ ‘”†‡†ƒ„‘—–ƒ’ƒ–‹‡–‘” –”‡ƒ–‡–™‹ŽŽ„‡†‡Žƒ›‡†Ǥ   ˜‹‘Žƒ–‹‘  „”‡ƒ Š  ‘–‡ǣƒ– Š”‡Ž‡ƒ•‡••ŠƒŽŽ‘– ‘–ƒ‹‡™ˆ‡ƒ–—”‡•–Šƒ–ƒ”‡„‡‹‰‹–”‘†— ‡†‹–Š‡†‡˜‹ ‡ ˆ‘”–Š‡ˆ‹”•––‹‡Ǥ •’ƒ”–‘ˆ–Š‡ Šƒ‰‡ ‘–”‘Ž’”‘ ‡••ǡƒŽŽ Šƒ‰‡••ŠƒŽŽ„‡”‡˜‹‡™‡†ǡ˜‡”‹ˆ‹‡†ƒ†˜ƒŽ‹†ƒ–‡† ȋƒ•ƒ’’”‘’”‹ƒ–‡Ȍƒ†ƒ’’”‘˜‡†„›ƒ••‹‰‡†ƒ’’”‘˜‡”•ȋƒ•†‡–‡”‹‡†‹–Š‡”‘†— – ‡˜‡Ž‘’‡–ŽƒȌ’”‹‘”–‘‹’Ž‡‡–ƒ–‹‘‘ˆ–Š‡ Šƒ‰‡Ǥ Document #: QMS-SOP-0014  ‹‰—”‡ͳǣ‘ˆ–™ƒ”‡Šƒ‰‡‘–”‘Ž”‘ ‡•• Š‡”‡˜‹‡™‘ˆ†‡•‹‰ƒ††‡˜‡Ž‘’‡– Šƒ‰‡••ŠƒŽŽ‹ Ž—†‡‡˜ƒŽ—ƒ–‹‘‘ˆ–Š‡‡ˆˆ‡ –‘ˆ–Š‡ Šƒ‰‡•‘ ‘•–‹–—‡–’ƒ”–•ƒ†’”‘†— –‹’”‘ ‡••‘”ƒŽ”‡ƒ†›†‡Ž‹˜‡”‡†Ǥ ’ƒ –‘ˆŠƒ‰‡ •ŠƒŽŽ„‡ ‘•‹†‡”‡†ƒ†‡˜ƒŽ—ƒ–‡†„›–Š‡‰‹‡‡”‹‰ƒƒ‰‡”ƒ†–Š‡‡‰—Žƒ–‘”›ˆˆƒ‹”• ‡ƒ†‘–Š‡‡ˆˆ‡ –•‘ˆ–Š‡’”‘’‘•‡† Šƒ‰‡ƒ†–Š‡”‡•—Ž–•‘ˆ–Š‡‡˜ƒŽ—ƒ–‹‘•ŠƒŽŽ„‡ ”‡ ‘”†‡†‹–Š‡”ƒ•‹–‹‘–‘‡˜‡Ž‘’‡–Š‡ Ž‹•–ˆ‘”ȋǦ ǦͲͲͷ͸ȌǤŠ‡‡ˆˆ‡ –‘ˆ Šƒ‰‡‹ Ž—†‡•ƒƒ••‡••‡–‘ˆ‹’ƒ –‘”‹•ƒ••‡••‡–ǡ‘–Š‡”†‡•‹‰†‘ —‡–•ǡ —•ƒ„‹Ž‹–›ƒ••‡••‡–•ǡ’”‘†— –‹‘’”‘ ‡••‡•ǡ„—•‹‡••ƒ••‡••‡–•ȋ•‡‡ ‘”ǣ”ƒ•‹–‹‘ –‘‡˜‡Ž‘’‡– Š‡ Ž‹•–ˆ‘”–Š‡ ‘’Ž‡–‡Ž‹•–‘ˆ‡ˆˆ‡ –•™Š‹ Šƒ”‡‡˜ƒŽ—ƒ–‡†ȌǤŠƒ‰‡•ƒ”‡ ƒŽ•‘•—„Œ‡ ––‘ˆ‘”ƒŽ”‹•ƒƒ‰‡‡–ƒ –‹˜‹–‹‡•‹ƒ ‘”†ƒ ‡™‹–Š–Š‡”—Ž‡•ƒ† ‹•–”— –‹‘•‡•–ƒ„Ž‹•Š‡†‹–Š‡QMS-SOP-0013: Risk ManagementǤ ”‘’‘•‡† Šƒ‰‡•–‘ƒ•‘ˆ–™ƒ”‡’”‘†— –•ŠƒŽŽ„‡ƒƒŽ›œ‡†–‘†‡–‡”‹‡™Š‡–Š‡”ǣ  ƒ††‹–‹‘ƒŽ’‘–‡–‹ƒŽ ƒ—•‡•ƒ”‡‹–”‘†— ‡† ‘–”‹„—–‹‰–‘ƒŠƒœƒ”†‘—••‹–—ƒ–‹‘Ǣ  ƒ††‹–‹‘ƒŽ•‘ˆ–™ƒ”‡”‹• ‘–”‘Ž‡ƒ•—”‡•ƒ”‡”‡“—‹”‡†Ǣand  –Š‡•‘ˆ–™ƒ”‡‘†‹ˆ‹ ƒ–‹‘ ‘—Ž†‹–‡”ˆ‡”‡™‹–Š‡š‹•–‹‰”‹• ‘–”‘Ž‡ƒ•—”‡• ȋ‘’–‹‘ƒŽˆ‘”Žƒ•••‘ˆ–™ƒ”‡•›•–‡•’‡” ͸ʹ͵ͲͶȌǤ —”–Š‡”ǡ‰‡‡”ƒŽ ‘•‹†‡”ƒ–‹‘—•–„‡‰‹˜‡–‘–Š‡•‹‰‹ˆ‹ ƒ ‡‘ˆ–Š‡ Šƒ‰‡–‘ˆ— –‹‘ǡ ’‡”ˆ‘”ƒ ‡ǡ—•ƒ„‹Ž‹–›ƒ†‹–•‡ˆˆ‡ –‘•ƒˆ‡–›ƒ†‡ˆˆ‡ –‹˜‡‡••‘ˆ–Š‡’”‘†— –ƒ†‹–• ‹–‡†‡†—•‡ǤŠ‡”‡•—Ž–‘ˆ–Š‹• ‘•‹†‡”ƒ–‹‘•ŠƒŽŽ„‡”‡ ‘”†‡†—†‡”–Š‡Dz‡‰—Žƒ–‘”› ‘•‹†‡”ƒ–‹‘•dz‘–Š‡”ƒ•‹–‹‘–‘‡˜‡Ž‘’‡–Š‡ Ž‹•–Ǥ ‘˜‡”‹‰”‡‰—Žƒ–‘”› „‘†‹‡•Ȁƒ—–Š‘”‹–‹‡••ŠƒŽŽ„‡‘–‹ˆ‹‡†ƒ•ƒ’’”‘’”‹ƒ–‡ȋ‹ƒ ‘”†ƒ ‡™‹–Š–Š‡†‹”‡ –‹˜‡’‡” Document #: QMS-SOP-0014  ‘—–”›ȌǤ‡‡QMS-SOP-0027: Device Licensingˆ‘”†‡–ƒ‹Ž•‘”‡’‘”–‹‰‘ˆ”‡‰—Žƒ–‘”› Šƒ‰‡•Ǥ  7.3 Changes not subject to the Change Control process  ‹–‹ƒ–‹‘‘ˆ ‘–‹‰‡ ›ƒ††‹•ƒ•–‡””‡ ‘˜‡”›’Žƒ•  Šƒ‰‡•–‘‘Ǧ’”‘†— –‹‘‡Ž‡‡–•‘””‡•‘—” ‡•  ƒ••™‘”†”‡•‡–•  •‡”ƒ††•Ȁ†‡Ž‡–‡•  •‡”‘†‹ˆ‹ ƒ–‹‘•  ††‹‰ǡ†‡Ž‡–‹‰‘””‡˜‹•‹‰•‡ —”‹–›‰”‘—’•  ‡„‘‘–‹‰ƒ Š‹‡•™Š‡–Š‡”‡‹•‘ Šƒ‰‡–‘ ‘ˆ‹‰—”ƒ–‹‘‘ˆ–Š‡•›•–‡  ‹Ž‡’‡”‹••‹‘ Šƒ‰‡•  8 Process Deviation –‡’‘”ƒ”› Šƒ‰‡–‘ƒ†‘ —‡–‡†’”‘ ‡••ǡ•— Šƒ•ƒ’”‘†— –‹‘’”‘ ‡••‘”“—ƒŽ‹–› •›•–‡’”‘ ‡†—”‡ƒ›„‡‹’Ž‡‡–‡†—•‹‰ƒ’”‘ ‡••†‡˜‹ƒ–‹‘Ǥ — –‹‘ƒŽ‡ƒ†Ȁ’‡”•‘‡Ž•ŠƒŽŽ ‘’Ž‡–‡ƒ”‘ ‡••‡˜‹ƒ–‹‘ ‘”ȋǦ ǦͲͲͻ͵Ȍ ™Š‡‡‡†‡†ǤŽŽƒˆˆ‡ –‡†’ƒ”–•ƒ††‘ —‡–•ƒ”‡Ž‹•–‡†ǡƒ†–Š‡”‡‰—Žƒ–‘”›‹’ƒ –ǡ”‹• ƒ••‡••‡–‹’ƒ –ǡƒ†‹’ƒ –‘†‡•‹‰ǡ˜‡”‹ˆ‹ ƒ–‹‘ƒ†˜ƒŽ‹†ƒ–‹‘ƒ”‡‡˜ƒŽ—ƒ–‡†ǤǦ •ŠƒŽŽ”‡˜‹‡™–Š‡”‡‰—Žƒ–‘”›‹’ƒ –‘ˆ–Š‡’”‘ ‡••†‡˜‹ƒ–‹‘ƒ†ƒ’’”‘˜‡–Š‡ˆ‘”Ǥ Ǧƒ† — –‹‘ƒŽ‡ƒ†•ƒ”‡”‡•’‘•‹„Ž‡ˆ‘” ‘ˆ‹”‹‰–Šƒ–ƒ†‡˜‹ƒ–‹‘‘”†‡”‹• ‹’Ž‡‡–‡†’”‘’‡”Ž›ǤŠ‡†‡˜‹ƒ–‹‘‹•‹ ‘”’‘”ƒ–‡†‹–‘–Š‡’”‘ ‡••‘”’”‘ ‡†—”‡•ƒ•‹ˆ‹– ™‡”‡ƒ‘”ƒŽ’”‘ ‡•• Šƒ‰‡Ǥ›”‡“—‹”‡†–”ƒ‹‹‰‹• ‘’Ž‡–‡†ǡƒ†–Š‡–”ƒ‹‹‰•‡ –‹‘ ‘ˆ–Š‡‡˜‹ƒ–‹‘ ‘”‹• ‘’Ž‡–‡†ǤŠ‡‡˜‹ ‡ ‹•–‘”›‡ ‘”†ˆ‘”ƒ›ƒ••‡„Ž‹‡•‘” †‡˜‹ ‡•ƒˆˆ‡ –‡†„›–Š‡†‡˜‹ƒ–‹‘ƒ”‡—’†ƒ–‡†–‘”‡ˆ‡”–‘–Š‡†‡˜‹ƒ–‹‘ˆ‘”Ǥ Š‡ ”‹–‡”‹ƒˆ‘” Ž‘•‹‰–Š‡†‡˜‹ƒ–‹‘ƒ†ƒ”‡ˆ‡”‡ ‡–‘–Š‡’”‘†— –•ƒˆˆ‡ –‡†„›–Š‡ †‡˜‹ƒ–‹‘•ŠƒŽŽ„‡”‡ ‘”†‡†ǤǦƒ† — –‹‘ƒŽ‡ƒ†•ŠƒŽŽ•‹‰‘ˆˆ‘–Š‡ Ž‘•‹‰‘ˆ–Š‡ †‡˜‹ƒ–‹‘Ǥ ˆƒ› ‘””‡ –‹˜‡ƒ –‹‘•™‡”‡–ƒ‡ǡ‹–•ŠƒŽŽ„‡†‘ —‡–‡†ƒ•’‡”QMSǦSOP- 0031: Corrective and Preventive ActionǤ Document #: QMS-SOP-0014