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5 whys (problem solving method) 5s workplace organization methodology 7.5.4 - customer property 7.6 - control of monitoring & measurement devices 8.2.2 - internal audits 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 820 - med. device mfger. qsr requirements 510(k) 510(k) exempt device 2016 2017 2018 aami (assn for the advancement of medical instrumentation) accelerated life and stability testing acceptance criteria accessories (product) accreditation bodies accuracy of a measurement device acquisitions and mergers acronyms active medical device adhesives adverse event reporting aea - aerospace experience auditor aerospace (general) aerospace manufacturer aiag (automotive industry action group) aiag manual(s) alarp (as low as reasonably possible) aluminum (general topics) ams 2750 - pyrometric requirements anab (ansi-asq national accreditation board) anda (abbreviated new drug applications) andons 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) api q2 - oil and gas industry service suppliers apple (the company) 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) as9104 - aerospace qms registration requirements as9110 - aerospace maintenance quality systems asl (approved supplier list) asq (american society for quality) asq certifications assembly (general term) astm (american society for testing and materials) attribute data attribute data msa (measurement system analysis) audit checklist audit man-days audit nonconformances and findings audit observation auditor qualification requirements and certifications auditor reporting auditors (general topics) audit plans and audit frequency audit questions audit reports audits and auditing audit scope australia australia tga authority and responsibility authorized representative autoclaves automotive (general) automotive industry batch manufacturing (general) batch manufacturing records batch production battery (electric batteries) battery powered devices bcrp - business continuity & resiliency planning benchmarking benefit(s) bias study (measurement) bill of materials (bom) bioburden biocompatibility biocompatibility requirements biocompatibility testing biological evaluations birthdays blood glucose meters and test strips boeing bonus tolerance books brazil bribes brochures bs 25999 - business continuity (bc) business continuity business development business processes 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 (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 conformance (c of c) 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) change(s) (general) change control change management charts checklist or check sheet china chrysler classification(s) of parts or products class iii medical device class ii medical device class i medical device cleaning methods and processes cleanliness cleanrooms cleanroom validation 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 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 contractors (goods and services providers) contract review and approval contracts and agreements (general) contract services control charts (general) controlled documents control limits control methods control plans controls copyrights corrective action (ca) corrective action request (car) corrective action systems 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 feedback customer owned property customer property customer requirements customer satisfaction customer service customer specific requirements (csr) customer survey dashboard software for measureables data (general) data (import from and export to applications) data analysis databases data collection and/or entry data control data security date of manufacture dates (general) datum (gd&t) 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 controls detection ranking (fmea) deviations from a print or requirement device history file (dhf) device history record (dhr) device master record (dmr) dfars (defense federal acquisition regulation supplement) dfmea (design fmea) diameter measurement dielectric strength dies differences (general) dimensional inspection dimensions disaster preparedness and recovery displays (video monitors) distribution of products distributors (distribution company) distributors (general) distributors (medical devices) dock audits 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 dosimeter dppm (defective parts per million) 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 ec certificate/certification effectiveness efficiency electrical components parts and products electrical safety electrocardiographs (general topics) electronic components parts assemblies and products electronic data (general) 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 980 (ifu graphical symbols) en 60601 - medical electrical equipment endoscopic equipment energy sources engineering changes engineering drawings environment (environmental related) equipment qualification and validation equivalence studies equivalent medical devices erp software essential requirements checklist etl (intertek's edison testing laboratories) eto (ethylene oxide) sterilization europe european medical device regulations european union european union medical device directives (mdd) european union regulations and standards evop (evolutionary operation of processes) examinations (course or certification tests) exam preparation question exclusions of clauses in a standard 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 regulations and requirements failure modes fda (food and drug administration) fda guidance fda requirements feedback final inspection and/or testing firmware first article inspection (fai) first article inspection report (fair) fishbone diagram florida flowcharts fmea - failure modes and effects analysis fmea manual fmea rankings fod (foreign objects and debris) food (general) food packaging food safety ford motor company ford q1 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 forum suggestions (general) 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) gdsn (global data synchronisation network) general motors (gm) 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 gum - measurement uncertainty document haccp (hazard analysis & critical control points) handling harmonization of standards 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) history holidays and related occasions home healthcare hospitals human error human factors human tissues and organs humidity (general) humidity control humor hypothesis test analysis iaf (international accreditation forum) iaqg (international aerospace quality group) iaqg 9100:2016 - aerospace quality management systems 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) immunity tests implantable medical devices (imd) implementation (general) implementation of a standard in a company implementing iso 9001 imports and importation improvement improvement plans and projects in-house laboratory incidents and incident reports 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 intended use (medical devices) 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 irca (int'l register of certificated auditors) ishikawa diagram isms (information security management system) iso (int'l organization for standardization) iso 9001 - quality management systems iso 9001:2015 iso 10993 - biological evaluation of medical devices iso 11135 - medical device ethylene oxide sterilization iso 11137 - medical device radiation sterilization iso 13485 - medical device qms iso 13485:2016 iso 14001 - environmental management systems iso 14001:2015 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 isolation israel italy itsm - it service management ivd (in vitro diagnostic) devices and reagens ivdr (in vitro diagnostic regulations) japan japan - ministry of health labour and welfare japanese pharmaceutical and medical device act job openings jobs (general) kaizen 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 issues language requirements layout inspection lead auditor course leadership leakage current lean legacy products legal requirements level of concern (fda term) liability insurance lithium ion batteries load cells lot numbering low voltage directive 2006/95/ec machine shop maintenance malaysia management management representative management review manufacturing processes marketing (general) mathematical equations matrix maude database of fda medical device reports mdd (medical device directive) mdd 93/42/eec mdel (medical device establishment license) 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 capability analysis 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 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) medwatch (fda safety info & adverse event reporting system) metal forming and stamping metrics (measurables such as for objectives) mexico mhlw (japan's ministry of health labor and welfare) mhra (medical & healthcare regulatory agency) micrometers microsoft excel .xls .xlsx spreadsheet microsoft sharepoint software microsoft software minimum requirements minitab (statistical analysis software) mmc (maximum material condition - gd&t) molds and molding 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 mtbf (mean time between failures) multiple business units multiple national or international locations multiple sites multiple standards in a company music nace codes nadcap (nat'l aerospace & defense contractors accred. pgm) nadcap ac7114 navistar nested gage r&r new products and new product requirements news nist (nat'l institute of standards & technology) non-destructive testing 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) 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 organization organizational knowledge orthopedic implants osha (occupational safety and health admin) outputs (general) outsourced products and processes outsourced software outsourcing ovens packaging (general) packaging labeling and related requirements packaging standards and specifications painting 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) performance testing personal health information pfh (probability of dangerous failure per hour) pfmea (process fmea) pharmaceuticals and pharmaceutical industry philippines planning plastic injection molding plastic parts plastics plating & coatings pma (pre-market approval) policies and policy statements policy documents post market clinical follow up post market surveillance ppap (production part approval process) ppk (related to process performance) ppm (parts per million) pre-control chart predicate devices and parts premarket approval premarket review process premarket submissions presentations pressure gages preventive action (pa) preventive maintenance print (drawing) callouts printers and printing equipment prints (drawings or blueprints) privacy private label products problem solving procedure examples procedure format procedures (general) process approach process audits process capability process changes and change notifications process controls and control plans process design and development process documentation 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 product limits product requirements product safety products and services professional certifications and degrees project management prototypes and prototype testing psur (periodic safety update report) psw (part submission warrant) purchase orders purchasing purchasing controls purchasing requirements qms (quality management system) qs-9000 qualification of equipment and processes quality quality assurance (qa) quality control (qc) quality department quality management systems quality management system software 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) raw materials raw material suppliers reach (ec 1907/2006) reach rohs recalls (general) receiving inspection record retention requirements records (evidence) and records control reference documents reference standards refurbishing 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 remote locations and sites repackaging repair and or overhaul reports (general) required documents required procedures 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) rohs 2 directive root cause failure analysis rpn (fmea risk priority number) rta (refuse to accept) guidance safety (general) safety requirements and regulations samples (of a part product or service) 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 certification service company or industry service providers service provisions severity ranking (fmea) sfda (saudi food and drug administration) sheet metal shelf life shipping (general) and shipping requirements shop travelers 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 spc (statistical process control) special characteristics special processes specification details 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 sterile medical devices sterile packaging sterility and sterilization techniques sterilization (general) sterilization validation storage (general) storage requirements and specifications strategic planning and objectives student questions subcomponents and sub-assemblies subcontracted goods processes and services subcontracting and subcontractors substantial equivalence supplier audits supplier control and monitoring supplier corrective & preventive action supplier data supplier development supplier evaluation/rating/approval supplier nonconformances supplier performance supplier quality supplier requirements suppliers (general topics) support processes surgery products surgical products surveillance audits surveys (general) sustainability swot (strengths weaknesses opportunities and threats) symbolization for devices symbols (general) taguchi designs and analysis tape measure targets (aka objectives) technical files for medical devices temperature (general) temperature control and tolerances tensile strength and tensile strength testing terminology testing (general testing topics) testing laboratories test methods and procedures and plans test reports texas thermocouples third party audits and auditing thread inspection gages thread ring gages and setting plugs threads (of fasteners such as nuts and bolts) tl 9000 tolerances (dimensional or other units) tolerances (process) tools and tooling (general) top management torque wrench or tool touch current (tc) toyota tpm - total productive maintenance traceability (misc) traceability of calibration (measurement) standards traceability of parts materials and products tracking (general) training (general) training effectiveness training materials training plan and training matrix training records training requirements training sources and resources 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) unique device identification (udi) united kingdom (uk) upper management usability of a product user manuals validation (general) validation of machines equipment processes design etc. validation plan validation requirements validation testing vda 6.3 - process audit vda standards vdmax25 sterilization validation 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 webinar weee (waste electrical and electronic equipment) weekend random topics welding white papers wire harnesses work environment work instructions (wi)

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