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5s workplace organization methodology 7.5.4 - customer property 7.6 - control of monitoring & measurement devices 8d problem solving 21 cfr part 11 - electronic records and signatures 21 cfr part 801 - labeling 21 cfr part 803 - medical device reporting 21 cfr part 812 - investigational device exemptions 21 cfr part 820 - med. device mfger. qsr requirements 510(k) 510(k) exempt device 2016 2017 2018 2020 a2la (american association for laboratory accreditation) acceptance criteria accessories (product) accreditation bodies accuracy of a measurement device acronyms action plans active medical device adverse event reporting aea - aerospace experience auditor aerospace (general) aiag (automotive industry action group) aiag manual(s) alarp (as low as reasonably possible) aluminum (general topics) aluminum alloy ams 2750 - pyrometric requirements anab (ansi-asq national accreditation board) anda (abbreviated new drug applications) annex v/vii annex x anodized surface anova (analysis of variance) ansi y14.5 - dimensioning and tolerancing anvisa api (active pharmaceutical ingredients) api (american petroleum institute) api q1 - oil industry quality management system (qms) app (mobile device software) applicable clauses documents legal requirements etc. approvals apqp (advanced product quality planning) aql (acceptable quality level) article 12 as9100 - aerospace quality management systems as9100 revision d (2016) as9101 - aerospace qms audit requirements as9102 - aerospace first article inspection (fai) as9110 - aerospace maintenance quality systems asl (approved supplier list) aspects and impacts (environmental) asq (american society for quality) asq certifications assembly (a "unit" made up of various parts) assembly (general term) astm (american society for testing and materials) attribute data attribute data msa (measurement system analysis) audit checklist auditee audit man-days audit nonconformances and findings audit observation auditor qualification requirements and certifications auditor reporting auditors (general topics) auditor training audit plans and audit frequency audit questions audit reports audits and auditing audit scope australia authority and responsibility authorized representative autoclaves automated measurement gages automotive (general) automotive industry batch manufacturing (general) batch manufacturing records batch production battery (electric batteries) battery powered devices bcrp - business continuity & resiliency planning benefit(s) bias study (measurement) bill of materials (bom) bioburden biocompatibility biocompatibility requirements biocompatibility testing birthdays blood glucose meters and test strips boeing boeing d6-51991 books brazil bribes brochures bs 25999 - business continuity (bc) business continuity cables (general) calculation formulas calibration (general topics) calibration (metrology) laboratories calibration data calibration interval (aka frequency) calibration procedures and methods calibration reports and certificates calibration verification calipers canada canadian medical devices canned procedure(s) and documentation capa (corrective and preventive action) capability study (measurement device) capability study (part dimensions from a process or machine) careers cba (certified biomedical auditor) exam cdrh (center for devices and radiological health) ce mark and ce marking certificate of compliance (c of c) certificate of conformance (c of c) certificate of free sale certificates (general) certification audits certification bodies (cb) certification process certifications (professional) certifications (to a standard) certified calibration technician (cct) cfda (china food and drugs administration) cfr - code of federal regulations change(s) (general) change control change management change notice (process or product) aka pcn charts checklist or check sheet china chinese (language) classification(s) of parts or products class iii medical device class ii medical device class i medical device cleaning methods and processes cleaning validation cleanliness cleanrooms cleanroom validation clinical data management (cdm) clinical evaluations and reports clinical research clinical trials and studies and investigations cloud computing cmdcas (canadian med device conformity assmnt system) cmk cmm (coordinate measuring machine) cnc machine shop cnc machining coatings cofepris (mexico's medical device and ivd oversight) combination devices and related rules combination drug-device products communications community discussions company name change company organization company policies comparison matrix competence assessments competency complaint files and reports complaint handling process complaints (general) compliance (general) compliance to a standard components concessions connectors (electrical) construction company or industry consultants and consulting containment (related to nonconformances) contamination (also see fod - foreign object damage) context of the organization contingency plans continual improvement (also see continuous improvement) continuous improvement continuous process(es) contract audits and contract auditing contract manufacturing contract review and approval contracts and agreements (general) control charts (general) controlled documents control limits control methods control of monitoring measurement & test equipment control plans controls convenience kits (medical device) copyrights corrective action (ca) corrective action request (car) corrective action systems correlation study cost estimation cots (commercial off-the-shelf) counterfeiting control counterfeit parts and products cpk (related to process capability) cqe (certified quality engineer) cqe exam cqi 9 - heat treat cqi 23 - molding system assessment creepage distance critical characteristics critical parts and components critical suppliers customer approval customer communication customer complaints and customer found nonconformance customer owned property customer property customer requirements customer satisfaction customer service customer specific requirements (csr) cycle time data (general) data (import from and export to applications) data analysis databases data collection and/or entry data control data integrity data security date of manufacture datum (gd&t) datum feature references dcma (defense contract management agency) deaths declaration of conformity defects and defectives definitions dental topics design and development design changes design control design exclusion design history file (dhf) design inputs and outputs design of experiments (doe) design validation design verification destructive tests and testing detection ranking (fmea) deviations from a print or requirement device history file (dhf) device history record (dhr) device master file device master record (dmr) dfars (defense federal acquisition regulation supplement) dfmea (design fmea) diameter measurement dielectric strength differences (general) dimensional inspection dimensions displays (video monitors) distribution of products distributors (distribution company) distributors (general) distributors (medical devices) dock audits document classification document content & structure document control document control (electronic) document control software documented procedures (requirements for) document identification and numbering document references document retention document review(s) and approval(s) document revisions and changes documents and documentation (general) documents of external origin dose audit draft documents drawing (also see prints) drug devices drug master file (dmf) drugs (medicinal) easa (european aviation safety agency) easa part - 145 maintenance organisation approval effectiveness efficiency electrical safety electronic components parts assemblies and products electronic documents forms and templates electronic records electronic signatures and approvals elsmar elsmar improvements (general) email (general) emc (electromagnetic compatibility) employee awareness employee development and motivation employees (general) employee training and qualifications ems (environmental management system) en 60601 - medical electrical equipment endoscopic equipment engineering change notice (ecn) engineering change order (eco) engineering changes engineering company engineering drawings environment (environmental related) epoxy (general) equipment qualification and validation equivalence studies equivalent medical devices erp software essential requirements checklist ethylene oxide (eo) etl (intertek's edison testing laboratories) eto (ethylene oxide) sterilization europe european medical device regulations european union european union regulations and standards evidence evop (evolutionary operation of processes) examinations (course or certification tests) exam preparation question exclusions of clauses in a standard exemptions expiration date exports and exporting external audits and auditors external communications external document control external documents - prints standards etc. external processes faa (federal aviation administration) faa part 145 (certified repair station) failure modes fda (food and drug administration) fda guidance fda requirements feedback final inspection and/or testing financial (finance) departments firmware first article inspection (fai) first article inspection report (fair) first piece approval fishbone diagram fixture(s) flowcharts fmea - failure modes and effects analysis fmea manual fmea rankings fod (foreign objects and debris) food (general) food packaging food safety football ford motor company foreign manufacturing formats and formatting forms and templates (general) formula (mathematics/statistics) for reference only for sale forum software (general) forum software instructions forum software problems fraud functional requirements functional safety furls (fda's electronic registration and listing system) furnaces gage blocks gage r&r (repeatability and reproducibility) gages (measurement and monitoring devices) gamma irradiation sterilization gap analysis gd&t (geometric dimensioning & tolerancing) gdpr (eu general data protection regulation) glass measurement devices (thermometers beakers etc) glp (good laboratory practices) gmp (good manufacturing practices) goals (quality environmental and other measureables) go no-go gage gp-12 early production containment gs1-128 barcodes gtin (global trade item number) gudid (fda global udi database) gui (graphic user interface) guidance documents handling hardness measurement hardness tester harmonization of standards hazard identification and risk assessment health (general) health canada health safety and environmental (hse) heat treatment height gages hibcc - health industry business communications council hipaa (health insurance portability and accountability act) hipaa rules obligations requirements history holidays and related occasions home healthcare hospitals human factors human tissues and organs humidity (general) humidity control humidity testing humor hurricanes hypothesis test analysis iaf (international accreditation forum) iaqg (international aerospace quality group) iatf (international automotive task force) iatf 16949:2016 identification (products and parts etc) identification and traceability (general) iec (international electrotechnical commission) iec 60335 - household electrical appliance safety iec 60601 - medical electrical equipment iec 60950 (information technology equipment - safety) iec 61010 - safety requirements for electrical equipment iec 61508 - functional safety of electronic controls iec 62133 - secondary cells and batteries safety requirements iec 62304 - medical device software life cycle processes iec 80002 - guidance on the application of iso 14971 imdrf (international medical devices regulators forum) imds (international material data system) implantable medical devices (imd) implementation of a standard in a company implementing a qms implementing iatf 16949 implementing iso 9001 imports and importation improvement improvement plans and projects incoming inspection (also see receiving inspection) india indian health ministry information security information technology (it) department infusion pumps and devices injection molding innovation inputs (general) inspection (general) inspection devices tools and fixtures inspection methods and plans inspection records installation qualification (iq) instructions for use (ifu) insurance (general) integrated management systems interaction of processes (see process interactions) interested parties internal auditors internal auditor training internal audits internal laboratory international standards internet (general topics and news) interpretations iran ishikawa diagram isms (information security management system) iso (int'l organization for standardization) iso 2859 - sampling for inspection by attributes iso 9001 - quality management systems iso 9001:2015 iso 10993 - biological evaluation of medical devices iso 11135 - medical device ethylene oxide sterilization iso 11607 - sterilized medical device packaging iso 13485 - medical device qms iso 13485:2016 iso 14001 - environmental management systems iso 14001:2015 iso 14155 - good clinical investigation practices iso 14644 - cleanrooms and controlled environments iso 14971 - medical device risk management iso 15197 - in vitro glucose monitoring systems iso 15223 - medical device label symbols iso 15378 - primary packaging materials for medicinal products iso 16269 - statistical interpretation of data iso 17025 - testing and calibration laboratories iso 19011 - quality (qms) and ems audits iso 22000 - food safety management systems iso 26000 - social responsibility iso 27000 series - information technology security iso 27001 - information security management system (isms) iso 31010 - risk assessment techniques iso 37001 - anti-bribery management systems iso 45001 - occupational health and safety management standard israel italy ivd (in vitro diagnostic) devices and reagens ivdr (in vitro diagnostic regulations) japan japan - ministry of health labour and welfare job openings jobs (general) key performance indicators (kpi) key product or process characteristics (kpc) knowledge management korea kpi data labeling - eu labeling directive labeling content labeling requirements labels and labeling (general) label symbols laboratories (general) laboratory scope language requirements layout inspection lead auditor course leadership leakage current leak test lean legacy products legal requirements level of concern (fda term) liability insurance life cycle of a device or product lithium ion batteries load cells log books and log sheets low voltage directive 2006/95/ec machine shop machining processes maintenance malaysia management management representative management review manufacturing processes marketing (general) mathematical equations matrix mdd (medical device directive) mdd 93/42/eec mdr (medical device regulations) mdr (medical device reporting) mds (material declaration sheet) mdsap (medical device single audit program) measureables (also see metrics) measurement (general) measurement and monitoring and test devices measurement equipment resolution and tolerances measurement systems measurement techniques and procedures measurement uncertainty (mu) meddev - ec guidelines on medical devices medical device accessories medical device company or industry medical device data systems medical device electronics and electrical equipment medical device file medical device licensing medical device listing codes and classifications medical device parts and components medical device registration medical device repair and servicing medical device reports including incident reporting medical devices medical devices (disposable) medical device safety medical device software medical device standards and regulations medical equipment (general) metal forming and stamping method validation metrics (measurables such as for objectives) mhlw (japan's ministry of health labor and welfare) mhra (medical & healthcare regulatory agency) micrometers microsoft excel .xls .xlsx spreadsheet microsoft sharepoint software minimum requirements minitab (statistical analysis software) mmc (maximum material condition - gd&t) mobile medical devices and applications (apps) monitoring monitoring and measurement moop (means of operator protection) mop (means of protection) mopp (means of patient protection) movies mra (mutual recognition agreement- tga australia and eu) msa (measurement system analysis) msa manual msa study multiple business units multiple national or international locations multiple sites multiple standards in a company nadcap (nat'l aerospace & defense contractors accred. pgm) nadcap ac7114 nested gage r&r new products and new product requirements news nist (nat'l institute of standards & technology) non-normal data distribution non-sterile medical devices nonconformance recurrence nonconformance report (ncr) nonconformances nonconformance system nonconforming material product or service notified bodies medical devices (nb-med) notified body oasis (online aerospace supplier information system) oasis database objectives (quality environmental and other measureables) obl (own brand labeling) occupational health and safety (oh&s) occurrence ranking (fmea) oem (original equipment manufacturer) off the shelf (ots) equipment or parts or software ohsas 18000 & 18001 & 18002 online internet training courses and universities operational planning operational qualification (oq) opportunities (general) opportunities for improvement (ofi) optical comparators order processing organization organizational knowledge orthopedic implants osha (occupational safety and health admin) outputs (general) outsourced calibration outsourced products and processes outsourcing ovens packaging (general) packaging labeling and related requirements packaging standards and specifications paper documents and records particulates pcb (printed circuit board) pear (process effectiveness assessment report) pems (programmable electrical medical system) peppol (pan-european public procurement online) performance measureables performance qualification (pq) personal health information pfd (probability of failure on demand) pfmea (process fmea) pharmaceuticals and pharmaceutical industry philippines pin gages planning plastic injection molding plastic parts plastics plating & coatings pmda (japan) poka yoke policies and policy statements policy documents post delivery activities post market clinical follow up post market surveillance powder coat paint ppap (production part approval process) ppk (related to process performance) ppm (parts per million) precision machining predicate devices and parts premarket approval premarket review process premarket submissions presentations pressure gages preventive action (pa) preventive maintenance print (drawing) callouts prints (drawings or blueprints) print tolerances problem solving procedure content procedure examples procedure format procedure pack (medical devices) procedures (general) process approach process audits process capability process changes and change notifications process controls and control plans process design and development processes (general) process flowcharts (process diagrams) process fmea process interactions process mapping process measurement and monitoring process performance process validation process variation process verification and validation product audits production production control product limits product requirements product safety products and services professional certifications and degrees profile of a surface project management prototypes and prototype testing psw (part submission warrant) purchase orders purchasing purchasing controls purchasing requirements qms (quality management system) qualification of equipment and processes quality quality assurance (qa) quality control (qc) quality department quality management systems quality manuals (general) quality manuals - structure contents and examples quality objectives quality plans and quality planning quality policy quality records quality system manuals quality systems quotes (quotations for a service or product) radius measurement raps (regulatory affairs professionals society) raw materials raw material suppliers reach (ec 1907/2006) reach rohs recalls (general) receiving inspection recertification (to a standard) record retention requirements records (evidence) and records control reference documents reference standards refurbishing registrar audits registrars (registration bodies) registration audits registration certificate registration requirements registration to a standard regulations and regulatory requirements regulatory affairs (ra) regulatory compliance regulatory requirements relabeling (of products) reliability (general) reliability analysis and testing remanufacturing remote locations and sites repackaging repair and or overhaul reports (general) required documents required procedures required processes requirements and specifications research and development (r&d) research use only (ruo) device or software reselling resistance (electrical) resources response time responsibilities returned products and/or parts revalidation of a process or product revision control revisions to a document or standard rework rework and repair procedures rfid (radio frequency identification) ring gage risk and opportunities risk based compliance risk based thinking (rbt) risk management and analysis risk management file (rmf) risk register robotics rohs (restriction of hazardous substances) root cause failure analysis routers (process) rpn (fmea risk priority number) safety (general) safety requirements and regulations sample frequency samples and sampling plans sample size sampling plans for attribute data sampling plans for variables data sanctioned interpretations sap erp (enterprise resource planning) saudi arabia scales and balances scar (supplier corrective action request) scope (general term) scope of accreditation scope of certification (aka registration) scope of registration/certification changes scope of the qms scrap second party audit self declaration service calls service company or industry service providers service provisions severity ranking (fmea) shelf life shipping (general) and shipping requirements signatures single fault condition single use devices (sud) six sigma (general) small companies (small businesses) smed (single minute exchange of dies) software (general topics) software (off the shelf) software bugs software development life cycle (sdlc) software medical devices software tools (for qa statistics doc control etc.) software validation soldering sole source supplier sop (standard operating procedure) sorting out nonconforming material or goods south africa spain spanish spc (statistical process control) special characteristics special processes specifications (general term) spectrophotometer sri lanka stability testing stainless steel stakeholders in a company standard deviation (stdev in statistics) standards (e.g. iso mdd ansi etc.) standards (measurement) statistical analysis and studies statistical analysis tools statutory requirements stc (supplemental type certificate) steel plating sterile medical devices sterility and sterilization techniques sterilization (general) sterilization validation storage (general) strategic planning and objectives student questions subcontracted goods processes and services subcontracting and subcontractors substantial equivalence supplier audits supplier control and monitoring supplier corrective & preventive action supplier development supplier evaluation/rating/approval supplier nonconformances supplier performance supplier quality supplier requirements suppliers (general topics) supplier selection qualification and approval support processes surgical products sustainability swot (strengths weaknesses opportunities and threats) symbolization for devices systems taguchi designs and analysis tape measure taper gages targets (aka objectives) technical documentation technical files for medical devices temperature (general) temperature control and tolerances tensile strength and tensile strength testing terminology test equipment testing (general testing topics) testing laboratories test methods and procedures and plans test reports thermocouples third party audits and auditing thread inspection gages thread plug gages and set plugs thread ring gages and setting plugs threads (of fasteners such as nuts and bolts) tl 9000 tolerances (dimensional or other units) tools and tooling (general) top management torque torque wrench or tool toyota tpm - total productive maintenance traceability (misc) traceability of calibration (measurement) standards traceability of parts materials and products trade shows training (general) training effectiveness training materials training plan and training matrix training records training requirements training sources and resources transfer (general) transformer (electrical) transition (between standards or revisions to a standard) transition audits transition period translations (languages) true position ts 16949 - automotive quality system standard turtle diagrams tus (temperature uniformity survey) uae (united arab emirates) ultrasonic testing uncertainty (aka mu - related to calibration) uncertainty budget (measurement) unilateral dimensional tolerances unique device identification (udi) united kingdom (uk) upper management upper management commitment upper management support usability of a product user manuals validation (general) validation of machines equipment processes design etc. validation plan validation requirements validation testing variables data vda 6.3 - process audit vda standards verification (general) verification of calibration version changes and change control veterinary medical devices virtual manufacturing vision measurement systems (electronic) visual inspection volkswagen want to buy warranties (general) webinar weee (waste electrical and electronic equipment) weekend random topics welding white papers wire wire harnesses work instructions (wi) zero defects

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