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4.1 - general requirements 5s workplace organization methodology 7.5.2 - validation of processes 7.5.4 - customer property 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 2020 a2la (american association for laboratory accreditation) 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 adverse event reporting aea - aerospace experience auditor aerospace (general) aerospace auditor aerospace manufacturer aiag (automotive industry action group) aiag manual(s) alarp (as low as reasonably possible) aluminum (general topics) amdd - asean medical device directive ams 2750 - pyrometric requirements anab (ansi-asq national accreditation board) anda (abbreviated new drug applications) andons annex v/vii annex x anova (analysis of variance) anvisa api (active pharmaceutical ingredients) api (american petroleum institute) api q1 - oil industry quality management system (qms) 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) as9110 - aerospace maintenance quality systems as9120 - aerospace qms requirements for distributors 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 auditee audit man-days audit nonconformances and findings audit observation auditor performance 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 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 benchmarking benefit(s) best practices bias study (measurement) bill of materials (bom) bioburden biocompatibility biocompatibility requirements biocompatibility testing biological evaluations birthdays blood glucose meters and test strips boeing books brazil bribes brochures bs 25999 - business continuity (bc) business continuity business development cables (general) calculation formulas calibration (general topics) calibration (metrology) laboratories calibration data calibration interval (aka frequency) calibration of shop tools 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) 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 chrysler 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 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 comparison matrix competence assessments competency complaint files and reports complaint handling process complaints (general) compliance (general) compliance to a standard component manufacturers 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) 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 cross reference matrix customer approval customer communication customer complaints and customer found nonconformance customer feedback customer owned property customer property customer requirements customer satisfaction customer specific requirements (csr) customer survey cycle time 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 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 history record (dhr) 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 file device master record (dmr) dfars (defense federal acquisition regulation supplement) dfmea (design fmea) diameter measurement 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 draft documents drawing (also see prints) drug devices drug master file (dmf) drugs (medicinal) due date easa (european aviation safety agency) easa part - 145 maintenance organisation approval effectiveness efficiency egypt 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 company engineering drawings environment (environmental related) environmental controls 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 council directive on medical devices european medical device regulations european union european union regulations and standards evop (evolutionary operation of processes) examinations (course or certification tests) 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 part 145 (certified repair station) failure modes fda (food and drug administration) fda guidance fda requirements feedback final inspection and/or testing first article inspection (fai) first article inspection report (fair) 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 forum suggestions (general) fraud functional requirements functional safety furls (fda's electronic registration and listing system) furnaces gadsl - global automotive declarable substance list gage blocks gage r&r (repeatability and reproducibility) gages (measurement and monitoring devices) gamma irradiation sterilization gamma sterilization gap analysis gd&t (geometric dimensioning & tolerancing) gdpr (eu general data protection regulation) germany 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 haccp (hazard analysis & critical control points) hardness tester harmonization of standards health (general) health canada health safety and environmental (hse) hearing aids 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 factors human tissues and organs humidity (general) humidity control humor hurricanes 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 61326 - laboratory equipment emc requirements iec 61508 - functional safety of electronic controls iec 62133 - secondary cells and batteries safety requirements iec 62304 - medical device software life cycle processes imdrf (international medical devices regulators forum) imds (international material data system) immunity tests implantable medical devices (imd) implementation of a standard in a company implementing a qms implementing iso 9001 imports and importation improvement improvement plans and projects in-process inspection incoming inspection (also see receiving inspection) india indian health ministry information security information technology (it) information technology (it) department infusion pumps and devices injection molding inputs (general) inspection (general) inspection devices tools and fixtures inspection methods and plans inspection records installation qualification (iq) instructions for use (ifu) integrated management systems interaction of processes (see process interactions) interested parties internal auditors internal auditor training internal audits internal communications 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 22301 - societal security - business continuity requirements 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 iso 50001 - energy management systems israel 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 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 life cycle of a device or product lithium ion batteries load cells lot numbering low voltage directive 2006/95/ec machine shop mac os x maintenance malaysia management management representative management review manufacturing processes marketing (general) material testing and test reports mathematical equations matrix 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 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) mhlw (japan's ministry of health labor and welfare) mhra (medical & healthcare regulatory agency) microbial count micrometers microsoft excel .xls .xlsx spreadsheet microsoft sharepoint software 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 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) nested gage r&r new product introduction 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 control operational planning operational qualification (oq) operator instructions opportunities for improvement (ofi) optical comparators organization organizational knowledge orthopedic implants osha (occupational safety and health admin) outputs (general) outsourced calibration outsourced products and processes outsourced software 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 indicators performance measureables performance qualification (pq) personal health information pfmea (process fmea) pharmaceuticals and pharmaceutical industry philippines planning plastic injection molding plastic parts plastics plating & coatings pmda (japan) poka yoke policies and policy statements policy documents post market activities (misc) 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) privacy private label products problem solving procedure content 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 verification and validation product audits production 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 department purchasing requirements qms (quality management system) 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 recertification (to a standard) record retention requirements records (evidence) and records control reference documents 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 residual risk resistance (electrical) resources response time responsibilities returned products and/or parts reusable medical devices 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) safety (general) safety requirements and regulations salt spray testing 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 semiconductor manufacturing service company or industry service providers service provisions severity ranking (fmea) 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 spain spc (statistical process control) special characteristics special processes specification details specifications (general term) spectrophotometer sri lanka stability testing stainless steel stakeholders in a company stamps (e.g. inked document control stamps) standard deviation (stdev in statistics) standards (e.g. iso mdd ansi etc.) standards (measurement) statistical analysis and studies 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 sub-supplier 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) taxes and taxation 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 tga (therapeutic goods administration) thermocouples third party audits and auditing thread inspection gages thread ring gages and setting plugs threads (of fasteners such as nuts and bolts) timelines and schedules tl 9000 tolerances (dimensional or other units) tools and tooling (general) top management torque wrench or tool toyota tpm - total productive maintenance traceability (misc) traceability of calibration (measurement) standards traceability of parts materials and products training (general) training effectiveness training materials training needs 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 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 usp (united states pharmacopeia) validation (general) validation of machines equipment processes design etc. validation plan validation requirements validation testing values value stream mapping (vsm) vda 6.3 - process audit vda standards verification (general) verification of calibration 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 wire harnesses work instructions (wi) x-bar charts

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