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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 806 - reports of corrections and removals 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 acronyms active medical device adverse event reporting aea - aerospace experience auditor aerospace (general) aerospace manufacturer aerospace standards and regulations 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) 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 approved suppliers 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 (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 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 aviation sector batch manufacturing (general) batch manufacturing records batch production battery (electric batteries) battery powered devices bcrp - business continuity & resiliency planning 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 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 canada's sor 98-282 - complaint handling & problem reporting canadian medical devices canned procedure(s) and documentation capa (corrective and preventive action) capability study (part dimensions from a process or machine) careers catheters 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 cgmp (current good manufacturing practices) change(s) (general) change control change management 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 cleanliness cleanrooms cleanroom validation 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) color measurement combination devices and related rules combination drug-device products communications community discussions company divisional differences 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 components computers 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 research organizations (cro) contract review and approval contracts and agreements (general) control charts (general) controlled documents control limits control plans controls conversion factors copyrights corrective action (ca) corrective action request (car) corrective action systems correlation study corrosion 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 notification(s) customer owned property customer property customer requirements customer satisfaction customer specific requirements (csr) customer survey 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 defect rate defects and defectives definitions dental topics design and development 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 ranking (fmea) deviations from a print or requirement device history file (dhf) device history record (dhr) device identification number (din) device master record (dmr) dfars (defense federal acquisition regulation supplement) dfmea (design fmea) diameter measurement differences (general) dimensional inspection dimensions displays (video monitors) distribution of products distributors (distribution company) distributors (general) distributors (medical devices) dock audits dock to stock 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 education effectiveness efficiency egypt electrical safety electronic components parts assemblies and products electronic data (general) electronic documents forms and templates electronic records electronic signatures and approvals elsmar elsmar cove tos and policies 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 use and conservation engineering change request (ecr) engineering changes engineering drawings environment (environmental related) environmental controls equipment qualification and validation equivalent medical devices erp software essential requirements checklist ethylene oxide (eo) etl (intertek's edison testing laboratories) eto (ethylene oxide) sterilization eu 2017/745 europe european council directive on medical devices european medical device regulations european union european union regulations and standards evidence 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) failure modes fda (food and drug administration) fda guidance fda requirements feasibility analysis and review feedback final inspection and/or testing first article inspection (fai) first article inspection report (fair) first piece approval fixture(s) 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 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 software questions fraud functional requirements functional safety furls (fda's electronic registration and listing system) gage blocks gage r&r (repeatability and reproducibility) gages (measurement and monitoring devices) gamma irradiation sterilization gamma sterilization gamp validation procedures 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 gs1-128 barcodes gtin (global trade item number) gudid (fda global udi database) gui (graphic user interface) guidance documents harmonization of standards hazard analysis 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) hipaa rules obligations requirements history holidays and related occasions home healthcare hospitals hospital use human factors human tissues and organs humidity (general) humidity control humor 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 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 62366-1:2015 medical device usability imdrf (international medical devices regulators forum) imds (international material data system) implantable medical devices (imd) implementation of a standard in a company imports and importation improvement improvement plans and projects incoming inspection (also see receiving inspection) india indian health ministry indications for use information security information technology (it) information technology (it) department infrastructure injection molding inputs (general) inspection (general) inspection devices tools and fixtures inspection methods and plans inspection records inspectors installation qualification (iq) instructions (general) instructions for use (ifu) 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 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 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 45001 - occupational health and safety management standard iso 50001 - energy management systems israel itar (international traffic in arms regulations) ivd (in vitro diagnostic) devices and reagens ivdr (in vitro diagnostic regulations) japan japan - ministry of health labour and welfare job descriptions 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 issues language requirements laser micrometer layout inspection lead auditor course leadership leakage current lean leed environmental building program legacy products legal requirements level of concern (fda term) life cycle of a device or product listing number lithium ion batteries load cells low voltage directive 2006/95/ec machine shop mac os x maintainability maintenance malaysia management management representative management review manufacturing location change manufacturing planning manufacturing processes marketing (general) material testing and test reports 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 equipment verification 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) 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) 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 nadcap (nat'l aerospace & defense contractors accred. pgm) nadcap ac7108 ndt (non-destructive test) nested gage r&r new product introduction 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 nuclear (general) oasis (online aerospace supplier information system) oasis database objective evidence 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 organization organizational knowledge orthopedic implants osha (occupational safety and health admin) outputs (general) 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) performance testing personal health information pfd (probability of failure on demand) pfmea (process fmea) pharmaceuticals and pharmaceutical industry philippines planning plastic injection molding plastic parts plastics plating & coatings poka yoke policies and policy statements policy documents polymers post delivery activities 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) pre-clinical studies (medical devices) 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 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 processes (general) process flowcharts (process diagrams) process fmea process interactions process mapping process measurement and monitoring process performance process validation product audits product code production product limits product requirements product safety products and services professional associations professional certifications and degrees 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 control data 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 quality tools quotes (quotations for a service or product) raw materials raw material suppliers reach (ec 1907/2006) reach certification reach rohs recalls (general) receiving inspection recertification (to a standard) record retention requirements records (evidence) and records control red (radio equipment directive) reference dimensions 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 reportable event reporting (medical devices) reports (general) required documents required procedures requirements and specifications research and development (r&d) research use only (ruo) device or software 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) root cause failure analysis rpn (fmea risk priority number) safety (general) safety requirements and regulations salt spray testing 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 semiconductor manufacturing sequence and interactions of processes serial numbers service company or industry service exclusions 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 business qualification and certification small companies (small businesses) smed (single minute exchange of dies) software (general topics) software (off the shelf) 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) south africa spanish spare parts spc (statistical process control) special characteristics special processes specifications (general term) spectrometer spectrophotometer sri lanka stability testing stainless steel stakeholders in a company stamps (e.g. inked inspection stamps) standard deviation (stdev in statistics) standards (e.g. iso mdd ansi etc.) standards (measurement) statistical analysis and studies statutory requirements stc (supplemental type certificate) sterile medical devices sterility and sterilization techniques sterilization (general) sterilization validation storage (general) storage requirements and specifications strategic planning and objectives student questions sub-supplier 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 surgery products surgical products sustainability swot (strengths weaknesses opportunities and threats) symbolization for devices symbols (general) taguchi designs and analysis tape measure taper gages targets (aka objectives) taxes and taxation technical documentation 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 thermocouples third party audits and auditing thread inspection gages thread plug gages and set plugs threads (of fasteners such as nuts and bolts) 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 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 matrix 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) uncontrolled documents unilateral dimensional tolerances unique device identification (udi) united kingdom (uk) upper management usability of a product validation (general) validation of machines equipment processes design etc. validation plan validation requirements validation testing values variables data vda 6.3 - process audit vda standards verification (general) verification of calibration video virtual manufacturing vision measurement systems (electronic) visual inspection volkswagen want to buy webinar websites weee (waste electrical and electronic equipment) weekend random topics welding white papers wifi wireless rf transmission wire wire harnesses work instructions (wi) youtube videos zero defects

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