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8d problem solving 21 cfr part 11 - electronic records and signatures 21 cfr part 21 - protection of privacy (food and drugs) 21 cfr part 111 - dietary supplements (misc) 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 2019 aami (assn for the advancement of medical instrumentation) 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 address changes adverse event reporting advisory notices aea - aerospace experience auditor aerospace (general) aerospace standards and regulations 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) animal studies annex ii annex v/vii annex x annual layout inspection anova (analysis of variance) ansi y14.5 - dimensioning and tolerancing ansi z1.4 - inspection by attributes api (american petroleum institute) api q1 - oil industry quality management system (qms) app (mobile device software) applicable clauses documents legal requirements etc. approvals approved suppliers apqp (advanced product quality planning) aql (acceptable quality level) 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 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 audit reports audits and auditing audit scope australia tga authorized representative autoclaves automatic test equipment (ate) 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) bioburden biocompatibility biocompatibility requirements biocompatibility testing boeing books brazil brochures bulk materials business processes business process maps cables (general) calculation formulas calibration (general topics) calibration (metrology) laboratories calibration data calibration interval (aka frequency) calibration procedures and methods calibration reports and certificates calibration verification calipers canada capa (corrective and preventive action) capability study (part dimensions from a process or machine) career changes careers 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 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 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 coatings cofepris (mexico's medical device and ivd oversight) color (general) combination devices and related rules combination drug-device products communications community discussions 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 component manufacturers components computers concessions conformity assessment bodies connectors (electrical) construction company or industry consultants and consulting containment (related to nonconformances) contamination (also see fod - foreign object damage) contamination control context of the organization contingency plans continual improvement (also see continuous improvement) continuous improvement 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 correction and removal (fda term) 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) cqa (certified quality auditor) cqe (certified quality engineer) cqe exam cqi 9 - heat treat cqi 23 - molding system assessment cqi requirements (customer specific requirements) creepage distance critical characteristics critical parts and components critical suppliers cross reference matrix customer approval customer communication customer complaints and customer found nonconformance customer notification(s) 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 defects and defectives definitions delivery of products and services dental topics design and development design changes design control design exclusion design history file (dhf) design history record (dhr) design inputs and outputs design master records design of experiments (doe) design validation design verification design verification testing (dvt - medical devices) deviations from a print or requirement device master record (dmr) dfars (defense federal acquisition regulation supplement) dfmea (design fmea) diagnostic devices (medical) diameter measurement dielectric strength dies differences (general) dimensional inspection displays (video monitors) distribution centers distribution of products distributors (distribution company) distributors (general) distributors (medical devices) dock audits 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 revisions and changes documents and documentation (general) documents of external origin dod (department of defense) drawing (also see prints) drug master file (dmf) drugs (medicinal) easa (european aviation safety agency) easa form 1 easa part - 145 maintenance organisation approval ec certificate/certification education effectiveness efficiency egypt electrical power cord(s) electrical safety electromagnetic compatibility electronic components parts assemblies and products electronic documents forms and templates electronic records electronic signatures and approvals elsmar elsmar cove tos and policies emc (electromagnetic compatibility) employee awareness employee development and motivation employees (general) employee training and qualifications employee turnover ems (environmental management system) endoscopic equipment energy sources engineering changes engineering drawings equipment qualification and validation equivalent medical devices essential performance essential requirements checklist 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 medical device directives (mdd) european union regulations and standards evidence examinations (course or certification tests) exam preparation question exclusions of clauses in 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 repair stations failure modes fcc (federal communications commission) 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) fishbone diagram flammability flatness (general) florida flowcharts fmea - failure modes and effects analysis fmea manual fmea rankings fod (foreign objects and debris) food (general) ford motor company ford q1 foreign manufacturing formats and formatting forms and templates (general) formula (mathematics/statistics) for sale forum software (general) forum software problems forum suggestions (general) 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 gamp (good automated manufacturing practice) gamp validation procedures gap analysis gd&t (geometric dimensioning & tolerancing) gdp (good documentation practices) gdpr (eu general data protection regulation) general motors (gm) germany glp (good laboratory practices) gmdn (global medical device nomenclature) gmp (good manufacturing practices) 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 hazard identification and risk assessment health (general) health canada heat treatment hipaa (health insurance portability and accountability act) histogram history holidays and related occasions home healthcare human factors humidity control 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 - medical device usability engineering 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 iatf 16949 implementing iso 9001 imports and importation improvement improvement plans and projects in-house calibration in-process inspection india indications for use indonesia information 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) 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 interpretations interviews and interview questions 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 11137 - medical device radiation sterilization iso 13485 - medical device qms iso 13485:2016 iso 14001 - environmental management systems iso 14001:2015 iso 14155 - good clinical investigation practices iso 14644 - cleanrooms and controlled environments iso 14971 - medical device risk management iso 15223 - medical device label symbols iso 17020 - criteria for bodies performing inspection 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) japan job openings jobs (general) key performance indicators (kpi) 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 lcl (lower control limit) lead auditor course leadership leakage current lean lean six sigma leed environmental building program legacy products legal requirements life cycle of a device or product lithium ion batteries location lot numbering low voltage directive 2006/95/ec machine shop machining processes maintainability maintenance management representative management review management systems integration manuals (misc) 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) 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 equipment verification measurement systems measurement techniques and procedures measurement traceability 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) microbial count micrometers microsoft excel .xls .xlsx spreadsheet microsoft sharepoint software minimum requirements minitab (statistical analysis software) mmc (maximum material condition - gd&t) 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 multiple business units multiple national or international locations multiple sites multiple standards in a company music nadcap (nat'l aerospace & defense contractors accred. pgm) nadcap ac7108 ndt (non-destructive test) 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 nrtl (nationally recognized testing laboratories) 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 qualification (oq) operator error operator instructions opportunities (general) opportunities for improvement (ofi) order processing organization organizational knowledge orthopedic implants outputs (general) outsourced products and processes outsourced software 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) performance testing personal health information pfmea (process fmea) pharmaceuticals and pharmaceutical industry philippines pin gages planning plastic injection molding plastic parts plastics plating & coatings pma (pre-market approval) 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-clinical studies (medical devices) premarket notification premarket submissions presentations pressure (general) 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 line production processes product lifecycle management (plm) product limits product realization product safety products and services professional associations 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 qms (quality management system) qualification of equipment and processes quality assurance (qa) quality control (qc) quality control data quality department quality engineer(s) quality management systems quality manuals (general) quality manuals - structure contents and examples quality objectives quality plans and quality planning quality policy quality records quality systems quality tools quotes (quotations for a service or product) 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 requirements registration to a standard registration to multiple standards regression analysis (statistical technique) regrind material regulations and regulatory requirements regulatory affairs (ra) regulatory compliance regulatory requirements relabeling (of products) reliability (general) reliability analysis and testing relocation remote locations and sites repackaging repair and or overhaul required documents required procedures required processes requirements and specifications research and development (r&d) research thesis research use only (ruo) device or software reselling residual risk resistance (electrical) resources response time responsibilities returned products and/or parts reusable medical devices revision control revisions to a document or standard rework rework and repair procedures ring gage risk and opportunities risk based auditing 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 routers (process) rubber part or material s-charts safety (general) safety requirements and regulations sai salt spray testing samples (of a part product or service) samples and sampling plans sample selection (selection of samples) 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 approval scope of certification (aka registration) scope of registration/certification changes scope of the qms scrap second party audit sequence and interactions of processes service company or industry service life service providers service provisions shelf life shipping (general) and shipping requirements shop travelers signatures single fault condition single use devices (sud) six sigma (general) six sigma green belt small companies (small businesses) smed (single minute exchange of dies) software (general topics) software (off the shelf) software development software development life cycle (sdlc) software medical devices software tools (for qa statistics doc control etc.) software validation soldering 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) steel plating 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 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 requirements suppliers (general topics) supplier selection qualification and approval supply chain management 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 tc 176 (iso technical committee for iso 9000 documents) technical documentation technical files for medical devices temperature control and tolerances temperature gages and probes tensile strength and tensile strength testing test equipment testing (general testing topics) testing laboratories test methods and procedures and plans test reports texas 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) top management torque wrench or tool toyota tpm - total productive maintenance tqm (total quality management) traceability (misc) traceability of calibration (measurement) standards traceability of parts materials and products training (general) training (on-the-job) training effectiveness training materials training records training requirements training sources and resources transfer (general) 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) unique device identification (udi) united kingdom (uk) upper management upper management commitment upper management support usability of a product validation (general) validation of machines equipment processes design etc. validation plan validation requirements validation testing values value stream mapping (vsm) variables data variation (measurement) vda 5 - measurement system analysis vda 6.3 - process audit vda standards verification (general) verification of calibration verification testing virtual manufacturing vision measurement systems (electronic) visual inspection volkswagen want to buy waste (general) water (general) webinar weee (waste electrical and electronic equipment) weekend random topics welding wifi wireless rf transmission wire wire harnesses work environment work instructions (wi) x-bar charts zero defects

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