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5 whys (problem solving method) 7.5.4 - customer property 8.2.2 - internal audits 8d problem solving 21 cfr part 11 - electronic records and signatures 21 cfr part 801 - labeling 21 cfr part 807 - establishment registra. & device listing 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 accelerated life and stability testing acceptance criteria accessories (product) accreditation bodies accuracy (general term) accuracy of a measurement device acronyms action plans active medical device adverse event reporting advisory notices aea - aerospace experience auditor aerospace (general) aerospace standards and regulations 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) andons annex ii annex v/vii annex x anova (analysis of variance) ansi y14.5 - dimensioning and tolerancing ansi z1.4 - inspection by attributes anvisa 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) as9104 - aerospace qms registration requirements as9110 - aerospace maintenance quality systems as9120 - aerospace qms requirements for distributors asl (approved supplier list) aspects and impacts (environmental) 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 auditors (general topics) auditor training audit plans and audit frequency audit questions audits and auditing audit scope australia australia tga authority and responsibility authorized representative autoclaves automated measurement gages automatic test equipment (ate) automotive (general) automotive industry aws (american welding society) barcoding (upca - upce - ean8 - ean 13 - qr code) batch manufacturing (general) batch production battery (electric batteries) battery powered devices benefit(s) best practices bioburden biocompatibility biocompatibility requirements biocompatibility testing boeing books brazil bribes brochures business processes cables (general) calculation formulas calibration (general topics) calibration (metrology) laboratories calibration interval (aka frequency) calibration procedures and methods calibration reports and certificates calibration software calibration verification calipers canada capa (corrective and preventive action) capability study (measurement device) capability study (part dimensions from a process or machine) careers cba (certified biomedical auditor) cba (certified biomedical auditor) exam ce mark and ce marking certificate of conformance (c of c) certificate of free sale certificates (general) certification audits certification bodies (cb) certification certificate (content) 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 change notice (process or product) aka pcn charts checklist or check sheet china chinese (language) class i exempt medical device 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 cnc software 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 audit 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 of production equipment control plans controls convenience kits (medical device) conversion factors 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) cqa (certified quality auditor) 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 owned property customer property customer requirements customer satisfaction 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 history record (dhr) design inputs and outputs design of experiments (doe) design validation design verification 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 dielectric strength dies differences (general) dimensional inspection dimensions 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 revisions and changes documents and documentation (general) documents of external origin dod (department of defense) draft documents drawing (also see prints) drug master file (dmf) drugs (medicinal) due date easa (european aviation safety agency) easa form 1 easa part - 145 maintenance organisation approval education effectiveness efficiency egypt electrical components parts and products electrical safety electronic components parts assemblies and products electronic documents forms and templates electronic records electronic signatures and approvals elsmar email (general) embedded software emc (electromagnetic compatibility) employee awareness employee development and motivation employees (general) employee training and qualifications en 60601 - medical electrical equipment end of life program for devices endoscopic equipment engineering change notice (ecn) engineering changes engineering drawings environment (environmental related) 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 medical device regulations european union european union medical device directives (mdd) european union regulations and standards evidence evop (evolutionary operation of processes) examinations (course or certification tests) exclusions of clauses in a standard exclusions of product lines in registration to a standard exemptions expiration date exports and exporting external audits and auditors external communications external document control external documents - prints standards etc. external issues external laboratories (including calibration and testing) external processes external services faa (federal aviation administration) faa part 145 (certified repair station) faa repair stations failure modes fda (food and drug administration) fda guidance fda requirements feedback final inspection and/or testing financial (finance) departments first article inspection (fai) first article inspection report (fair) first piece approval fishbone diagram flammability florida flowcharts fmea - failure modes and effects analysis fmea manual fmea rankings fod (foreign objects and debris) food (general) food safety ford motor company ford q1 foreign manufacturing formats and formatting forms and templates (general) formula (mathematics/statistics) for sale forum software (general) forum software instructions forum software problems fraud furls (fda's electronic registration and listing system) gage blocks gage r&r (repeatability and reproducibility) gages (measurement and monitoring devices) gamma irradiation sterilization gap analysis gd&t (geometric dimensioning & tolerancing) gdp (good documentation practices) gdpr (eu general data protection regulation) general motors (gm) germany gmdn (global medical device nomenclature) gmp (good manufacturing practices) goals (quality environmental and other measureables) go no-go gage gp-12 early production containment gs1-128 barcodes gudid (fda global udi database) gui (graphic user interface) guidance documents handling harmonization of standards hazard analysis hazard identification and risk assessment health (general) health canada heat treatment high level structure (hls) hipaa (health insurance portability and accountability act) hipaa rules obligations requirements history holidays and related occasions home healthcare human factors human tissues and organs humidity (general) humidity control humor 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 61326 - laboratory equipment emc requirements 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 implementing a qms implementing iatf 16949 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) department infrastructure infusion pumps and devices injection molding innovation inputs (general) inspection (general) inspection devices tools and fixtures inspection methods and plans inspection records inspectors 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 communications internal issues internal laboratory international standards internet (general topics and news) interpretations interviews and interview questions 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 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 15223 - medical device label symbols 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 26000 - social responsibility iso 27001 - information security management system (isms) iso 31010 - risk assessment techniques iso 45001 - occupational health and safety management standard isolation israel ivd (in vitro diagnostic) devices and reagens ivdd ivdr (in vitro diagnostic regulations) japan japan - ministry of health labour and welfare job openings jobs (general) key performance indicators (kpi) korea kpi data labeling - eu labeling directive labeling content labeling requirements labels and labeling (general) label symbols laboratories (general) laboratory scope language requirements lead auditor(s) and related topics lead auditor course leadership leakage current leak test lean lean six sigma 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 lot numbering low voltage directive 2006/95/ec machine shop machining processes maintenance malaysia management management representative management review manufacturing planning manufacturing processes manufacturing site marketing (general) marking (general such as labeling) mathematical equations matrix mdd (medical device directive) mdd 93/42/eec mdr (medical device regulations) mdr (medical device reporting) mdr 745/2017 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) metal forming and stamping method validation 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 minimum requirements minitab (statistical analysis software) mmc (maximum material condition - gd&t) mobile medical devices and applications (apps) molds and molding monitoring monitoring and measurement moop (means of operator protection) mop (means of protection) mopp (means of patient protection) mra (mutual recognition agreement- tga australia and eu) msa (measurement system analysis) msa manual msa study msds (material safety data sheet) mtbf (mean time between failures) multiple national or international locations multiple sites multiple standards in a company nace codes nadcap (nat'l aerospace & defense contractors accred. pgm) nadcap ac7108 navistar ndt (non-destructive test) 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 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 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 ojt - on the job training (also see training) online internet training courses and universities operational control operational planning operational qualification (oq) opportunities (general) opportunities for improvement (ofi) order processing organization organizational knowledge orthopedic implants outputs (general) outsourced products and processes outsourcing ovens packaging (general) packaging labeling and related requirements packaging sealing packaging standards and specifications paper documents and records pcb (printed circuit board) pdca cycle (plan do check act) pear (process effectiveness assessment report) pems (programmable electrical medical system) performance measureables performance qualification (pq) personal health information personnel (also see employees and human resources) pfmea (process fmea) pharmaceuticals and pharmaceutical industry philippines pin gages planning plastic injection molding plastic parts plastics plating & coatings pmda (japan) policies and policy statements policy documents polymers post market activities (misc) post market clinical follow up post market surveillance ppap (production part approval process) ppap review and approval ppk (related to process performance) ppm (parts per million) precision machining premarket approval premarket submissions presentations pressure gages preventive action (pa) preventive maintenance print (drawing) callouts prints (drawings or blueprints) private label manufacturer problem solving 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 verification and validation product audits product code production production control production processes product limits product requirements product safety products and services professional associations professional certifications and degrees profile of a surface project management proprietary information prototypes and prototype testing psur (periodic safety update report) 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 manuals (general) quality manuals - structure contents and examples quality objectives quality plans and quality planning quality policy quality records quality system manuals quotes (quotations for a service or product) raps (regulatory affairs professionals society) raw materials raw material suppliers reach (ec 1907/2006) reach certification recalls (general) receiving inspection record retention requirements records (evidence) and records control refurbishing registrar audits registrars (registration bodies) registration audits registration requirements registration to a standard registration to multiple standards regression analysis (statistical technique) regulations and regulatory requirements regulatory affairs (ra) regulatory compliance regulatory requirements relabeling (of products) reliability analysis and testing remote locations and sites repackaging repair and or overhaul required documents required procedures required processes 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 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 rubber part or material s-charts safety (general) safety requirements and regulations salt spray testing samples and sampling plans sample size sampling plans for attribute data sanctioned interpretations sap erp (enterprise resource planning) saudi arabia 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 self declaration sequence and interactions of processes service company or industry service providers service provisions service realization severity ranking (fmea) sheet metal shelf life shipping (general) and shipping requirements signatures 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 quality assurance software tools (for qa statistics doc control etc.) software validation soldering sole source supplier sop (standard operating procedure) sorting out nonconforming material or goods spain spare parts spc (statistical process control) special characteristics special processes specification details specifications (general term) sri lanka stability (of a product) 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) startup business statistical analysis and studies statistical analysis tools statutory requirements sted (summary technical documents) sterile medical devices sterile packaging sterility and sterilization techniques sterilization (general) sterilization validation storage (general) strategic planning and objectives student questions subcontracting and subcontractors supplier supplier audits supplier control and monitoring supplier corrective & preventive action supplier development supplier evaluation/rating/approval supplier nonconformances supplier performance supplier quality supplier quality engineer (sqe) supplier requirements suppliers (general topics) supplier selection qualification and approval supply chain management support processes surface finish measurement surgical products surveillance audits surveys (general) sustainability swot (strengths weaknesses opportunities and threats) symbolization for devices symbols (general) taguchi designs and analysis tape measure 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 tga (therapeutic goods administration) 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) timelines and schedules tolerances (dimensional or other units) tolerances (process) 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 (on-the-job) 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 uae (united arab emirates) uncertainty (aka mu - related to calibration) uncertainty budget (measurement) underwriters laboratories (ul) unilateral dimensional tolerances unique device identification (udi) united kingdom (uk) upper management upper management commitment upper management support 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 value stream mapping (vsm) vda 6.3 - process audit vda standards verification (general) verification of calibration verification testing version changes and change control video virtual manufacturing vision measurement systems (electronic) visual inspection want to buy warranties (general) webinar weee (waste electrical and electronic equipment) weekend random topics welding wire wire harnesses work instructions (wi) x-bar & r chart zero defects

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