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7.5.4 - customer property 8.2.2 - internal audits 8d problem solving 21 cfr part 11 - electronic records and signatures 21 cfr part 21 - protection of privacy (food and drugs) 21 cfr part 801 - labeling 21 cfr part 803 - medical device reporting 21 cfr part 812 - investigational device exemptions 21 cfr part 820 - med. device mfger. qsr requirements 510(k) 510(k) exempt device 2016 2017 2018 acceptance criteria accessories (product) accreditation bodies accuracy of a measurement device acronyms active medical device adhesives 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) aluminum alloy ams 2750 - pyrometric requirements anab (ansi-asq national accreditation board) anda (abbreviated new drug applications) andons annex v/vii annex x annual layout inspection 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) api q2 - oil and gas industry service suppliers 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 audit man-days audit nonconformances and findings audit observation auditor performance auditor qualification requirements and certifications auditor reporting auditors (general topics) auditor training audit plans and audit frequency audit questions audits and auditing audit scope australia australia tga authorized representative autoclaves automotive (general) automotive industry batch manufacturing (general) batch manufacturing records batch production battery (electric batteries) battery powered devices benefit(s) best practices bias study (measurement) bill of materials (bom) bioburden biocompatibility biocompatibility requirements biocompatibility testing birthdays boeing books brazil brazilian b-gmp (good manufacturing practices) regulations bribes brochures business development business processes business process maps cables (general) calibration (general topics) calibration (metrology) laboratories 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 cdsco (central drugs standard control organization) 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 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 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 (general) color measurement combination devices and related rules combination drug-device products communications community discussions company divisional differences company name change company policies company vision or strategy comparison matrix competence assessments competency complaint files and reports complaint handling process complaints (general) compliance (general) compliance to a standard components concessions connectors (electrical) construction company or industry consultants and consulting containment (related to nonconformances) contamination (also see fod - foreign object damage) context of the organization contingency plans continual improvement (also see continuous improvement) continuous improvement continuous process(es) contract audits and contract auditing contract manufacturing contract review and approval contracts and agreements (general) contract services control charts (general) controlled documents control limits control methods control plans controls convenience kits (medical device) copyrights corrective action (ca) corrective action request (car) corrective action systems correlation corrosion cots (commercial off-the-shelf) counterfeiting control counterfeit parts and products country specific standards and regulations 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 customer approval customer communication customer complaints and customer found nonconformance customer owned property customer property customer requirements customer satisfaction customer service customer specific requirements (csr) cycle time data (general) data (import from and export to applications) data analysis databases data collection and/or entry data control data integrity data security 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 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 detection ranking (fmea) deviations from a print or requirement device history file (dhf) device history record (dhr) device identification number (din) device master file 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 centers 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) dosimeter draft documents drawing (also see prints) drug master file (dmf) drugs (medicinal) easa (european aviation safety agency) easa part - 145 maintenance organisation approval effectiveness efficiency electrical safety electronic components parts assemblies and products electronic documents forms and templates electronic records electronic signatures and approvals elsmar elsmar cove tos and policies email (general) emc (electromagnetic compatibility) employee awareness employee development and motivation employees (general) employee training and qualifications en 60601 - medical electrical equipment endoscopic equipment energy sources engineering changes engineering company engineering drawings environment (environmental related) environmental management systems equipment qualification and validation equivalent medical devices 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 regulations and standards evidence evop (evolutionary operation of processes) examinations (course or certification tests) exam preparation question 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 processes external services faa (federal aviation administration) faa part 145 (certified repair station) faa regulations and requirements faa repair stations 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) first piece approval fixture(s) flowcharts fmea - failure modes and effects analysis fmea manual fmea rankings fod (foreign objects and debris) food (general) food safety football ford motor company foreign manufacturing formats and formatting forms and templates (general) formula (mathematics/statistics) for sale forum software (general) forum software instructions forum software problems forum suggestions (general) fraud functional requirements furls (fda's electronic registration and listing system) gage blocks gage r&r (repeatability and reproducibility) gages (measurement and monitoring devices) gamma irradiation sterilization gamp (good automated manufacturing practice) gap analysis gd&t (geometric dimensioning & tolerancing) gdpr (eu general data protection regulation) general motors (gm) 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 harmonization of standards hazard analysis hazard identification and risk assessment health (general) health canada health safety and environmental (hse) heat treatment hipaa (health insurance portability and accountability act) hipaa rules obligations requirements histogram history holes in parts - location(s) holidays and related occasions home healthcare hospitals hospital use human factors human tissues and organs humidity (general) humidity control humor 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 60335 - household electrical appliance safety iec 60601 - medical electrical equipment iec 60950 (information technology equipment - safety) iec 61010 - safety requirements for electrical equipment 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) immunity tests implantable medical devices (imd) implementation (general) 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-house calibration in-process inspection india indications for use information security information technology (it) department infrastructure injection medical 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) integrated management systems interaction of processes (see process interactions) interested parties internal auditors internal auditor training internal audits internal issues internal laboratory international standards internet (general topics and news) interpretations iran ishikawa diagram isms (information security management system) iso (int'l organization for standardization) iso/iec 15504 - software processes (spice) 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 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 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 26000 - social responsibility iso 27001 - information security management system (isms) iso 31000 - risk management iso 31010 - risk assessment techniques iso 45001 - occupational health and safety management standard iso 62366 - medical device usability engineering israel ivd (in vitro diagnostic) devices and reagens ivdd ivdr (in vitro diagnostic regulations) j-std-001 japan job openings jobs (general) key performance indicators (kpi) key product or process characteristics (kpc) knowledge management korea kpi data labeling - eu labeling directive labeling content labeling requirements labels and labeling (general) label symbols laboratories (general) laboratory scope language requirements layout inspection lead auditor course leadership leakage current leak test lean lean six sigma legacy products legal requirements level of concern (fda term) liability insurance life cycle of a device or product lithium ion batteries load cells log books and log sheets low voltage directive 2006/95/ec machine shop machining processes maintenance malaysia management management representative management review manufacturing processes marketing (general) mathematical equations matrix mdd (medical device directive) mdd 93/42/eec mdel (medical device establishment license) mdr (medical device regulations) mdr (medical device reporting) mdr 745/2017 mds (material declaration sheet) mdsap (medical device single audit program) mds reporting mdvr - medical device vigilance report 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 method validation metrics (measurables such as for objectives) mhlw (japan's ministry of health labor and welfare) mhra (medical & healthcare regulatory agency) micrometers microsoft excel .xls .xlsx spreadsheet microsoft sharepoint software minitab (statistical analysis software) mmc (maximum material condition - gd&t) mobile medical devices and applications (apps) monitoring monitoring and measurement moop (means of operator protection) mop (means of protection) mopp (means of patient protection) moving to another location or facility mra (mutual recognition agreement- tga australia and eu) msa (measurement system analysis) msa manual msa study mtbf (mean time between failures) multiple national or international locations multiple sites multiple standards in a company nadcap (nat'l aerospace & defense contractors accred. pgm) nadcap ac7114 navistar ndt (non-destructive test) new location(s) 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 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 ojt - on the job training (also see training) online internet training courses and universities operational control operational planning operational qualification (oq) operator instructions 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 standards and specifications paper documents and records pcb (printed circuit board) pear (process effectiveness assessment report) pems (programmable electrical medical system) performance measureables performance qualification (pq) performance testing personal health information 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 post delivery activities post market activities (misc) post market clinical follow up post market surveillance ppap (production part approval process) ppk (related to process performance) pre-control chart premarket approval premarket notification premarket submissions presentations preventive action (pa) preventive maintenance print (drawing) callouts prints (drawings or blueprints) private label products problem solving procedure content procedure examples procedure format procedure pack (medical devices) procedures (general) process approach process audits process capability process changes and change notifications process controls and control plans process design and development processes (general) process flowcharts (process diagrams) process fmea process interactions process mapping process measurement and monitoring process validation process variation process verification and validation product audits product code production production processes product limits product realization product requirements product safety products and services professional certifications and degrees profile of a surface project management promotional materials proprietary information prototypes and prototype testing psw (part submission warrant) purchase orders purchasing purchasing controls purchasing requirements qms (quality management system) qualification of equipment and processes quality quality assurance (qa) quality control (qc) quality department quality management systems quality manuals (general) quality manuals - structure contents and examples quality objectives quality plans and quality planning quality policy quality records quality system manuals quality systems quotes (quotations for a service or product) radius measurement raps (regulatory affairs professionals society) raw materials raw material suppliers reach (ec 1907/2006) reach rohs recalls (general) receiving inspection record retention requirements records (evidence) and records control refurbishing registrar audits registrars (registration bodies) registration audits registration certificate 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 revalidation of a process or product revision control revisions to a document or standard rework rework and repair procedures 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) rta (refuse to accept) guidance rubber part or material russia 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 scales and balances scar (supplier corrective action request) scope (general term) scope of accreditation scope of certification (aka registration) scope of registration/certification changes scope of the qms scrap second party audit self declaration sequence and interactions of processes serial numbers service company or industry service exclusions service providers service provisions service realization severity ranking (fmea) 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 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 spain spare parts spc (statistical process control) special characteristics special processes specifications (general term) spectrophotometer spreadsheets sri lanka stability testing stainless steel stakeholders in a company standard deviation (stdev in statistics) standards (e.g. iso mdd ansi etc.) standards (measurement) startup business statistical analysis and studies statutory requirements stc (supplemental type certificate) sted (summary technical documents) sterile medical devices sterility and sterilization techniques sterilization (general) sterilization validation storage (general) strategic planning and objectives student questions subcomponents and sub-assemblies subcontracting and subcontractors substantial equivalence supplier 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 surface roughness 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 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 texas tga (therapeutic goods administration) thermocouples thickness meters third party audits and auditing thread inspection gages thread plug gages and set plugs thread ring gages and setting plugs threads (of fasteners such as nuts and bolts) tl 9000 tolerances (dimensional or other units) tools and tooling (general) top management torque wrench or tool touch current (tc) 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) travel true position ts 16949 - automotive quality system standard turtle diagrams tus (temperature uniformity survey) uncertainty (aka mu - related to calibration) uncertainty budget (measurement) unique device identification (udi) united kingdom (uk) upper management upper management support usability of a product user manuals validation (general) validation of machines equipment processes design etc. validation plan validation requirements validation testing variables data variation (measurement) vda 6.3 - process audit vda standards verification (general) video virtual manufacturing vision measurement systems (electronic) vision system inspection (electronic) visual inspection want to buy webinar weee (waste electrical and electronic equipment) weekend random topics welding wire wire harnesses work environment work instructions (wi) x-bar & r chart x-ray device(s) zero defects

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