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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 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 2017 2018 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 active medical device address changes adhesives adverse event reporting aea - aerospace experience auditor aerospace (general) aerospace manufacturer aerospace standards and regulations aiag (automotive industry action group) aiag manual(s) aluminum (general topics) ams 2750 - pyrometric requirements anab (ansi-asq national accreditation board) andons annex x anodized surface 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 (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 qualification requirements and certifications auditors (general topics) auditor training audit plans and audit frequency audit questions audit reports audits and auditing audit scope australia australia tga authority and responsibility authorized representative autoclaves automatic test equipment (ate) automotive (general) automotive industry barcodes barcoding (upca - upce - ean8 - ean 13 - qr code) batch manufacturing (general) batch production battery (electric batteries) battery powered devices benefit(s) best practices bias study (measurement) bioburden biocompatibility biocompatibility requirements biocompatibility testing boeing books brazil brexit brochures bulk materials business processes business process maps cables (electrical and related such as signal carriers) cables (general) calculation formulas calibration (general topics) calibration (metrology) laboratories calibration interval (aka frequency) calibration past due date measurement equipment and gages 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) career changes careers cba (certified biomedical auditor) exam cdrh (center for devices and radiological health) 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 cleanroom classification cleanrooms clinical data management (cdm) clinical evaluations and reports clinical trials and studies and investigations cloud computing cmk cmm (coordinate measuring machine) cnc machine shop cnc machining coatings cofepris (mexico's medical device and ivd oversight) combination devices and related rules combination drug-device products communications community discussions company divisional differences company name change company organization company policies comparison matrix competence assessments competency complaint files and reports complaint handling process complaints (general) compliance (general) components concessions conformity assessment bodies 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 continuous improvement contract audits and contract auditing contract manufacturing contract review and approval contracts and agreements (general) contract services control chart limits control charts (general) controlled documents control limits control methods control plans controls convenience kits (medical device) conversion factors copyrights corrective action (ca) corrective action request (car) corrective action systems correlation cosmetics (parts and products such as painted surfaces) 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 cqi requirements (customer specific requirements) creepage distance critical characteristics critical parts and components critical suppliers customer approval customer complaints and customer found nonconformance customer requirements customer service customer specific requirements (csr) 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) declaration of conformity defects and defectives definitions dental topics design and development design changes design control design history file (dhf) design history record (dhr) design inputs and outputs design master records (dmr) design of experiments (doe) design validation design verification design verification testing (dvt - medical devices) deviations from a print or requirement device history record (dhr) device identification number (din) device listing device master record (dmr) dfars (defense federal acquisition regulation supplement) dfmea (design fmea) diagnostic devices (medical) diameter measurement dielectric strength differences (general) dimensional inspection dimensions displays (video monitors) disposable products 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 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 effectiveness efficiency electrical power cord(s) 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) embedded software emc (electromagnetic compatibility) employee awareness employee development and motivation employees (general) employee satisfaction employee training and qualifications endoscopic equipment engineering change request (ecr) engineering changes engineering company engineering drawings environmental management systems equipment qualification and validation equivalent medical devices essential performance 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 medical device directives (mdd) european union regulations and standards evidence examinations (course or certification tests) exclusions of clauses in a standard expiration date exports and exporting 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 fcc (federal communications commission) fda (food and drug administration) fda guidance fda news fda requirements final inspection and/or testing first article inspection (fai) first article inspection report (fair) flatness (general) 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 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 validation procedures gap analysis gd&t (geometric dimensioning & tolerancing) gdp (good documentation practices) gdpr (eu general data protection regulation) general motors (gm) germany ghtf (global harmonization task force) glp (good laboratory practices) gmdn (global medical device nomenclature) gmp (good manufacturing practices) go no-go gage gp-12 early production containment gs1-128 barcodes gtin (global trade item number) gudid (fda global udi database) guidance documents hardness measurement harmonization of standards hazard analysis hazard identification and risk assessment health (general) health canada heat treatment hipaa (health insurance portability and accountability act) history home healthcare hospital use human factors human resources (hr) human tissues and organs humidity control hurricanes 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 61000 - electromagnetic compatibility 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 a qms implementing iatf 16949 implementing iso 9001 imports and importation improvement in-house calibration in-process inspection india information security 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 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 investigational testing authorizations (ita) ishikawa diagram isms (information security management system) iso (int'l organization for standardization) iso 9001 - quality management systems iso 9001:2015 iso 10993 - biological evaluation of medical devices iso 11135 - medical device ethylene oxide sterilization iso 11137 - medical device radiation sterilization iso 13485 - medical device qms iso 13485:2016 iso 14001 - environmental management systems iso 14001:2015 iso 14155 - good clinical investigation practices iso 14644 - cleanrooms and controlled environments iso 14971 - medical device risk management iso 17025 - testing and calibration laboratories iso 19011 - quality (qms) and ems audits iso 27001 - information security management system (isms) iso 31000 - risk management iso 31010 - risk assessment techniques iso 45001 - occupational health and safety management standard israel itar (international traffic in arms regulations) 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 leak tester lean lean six sigma legacy products legal requirements level of concern (fda term) life cycle of a device or product lifetime (of a product) lithium ion batteries load cells low voltage directive 2006/95/ec machine shop machining processes maintenance management management representative management review manuals (misc) manufacturing (general term) 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) 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) medaccred industry program 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) monitoring monitoring and measurement 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) multiple business units multiple national or international locations multiple sites multiple standards in a company music nace codes nadcap (nat'l aerospace & defense contractors accred. pgm) nadcap ac7108 navistar ndt (non-destructive test) new processes news nhs (uk national health service) 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 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 planning operational qualification (oq) opportunities (general) opportunities for improvement (ofi) order processing 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 painted surfaces 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 personnel (also see employees and human resources) pfmea (process fmea) pharmaceuticals and pharmaceutical industry philippines pin gages plastic extrusion plastic injection molding plastic parts plastics plating & coatings pma (pre-market approval) pmda (japan) policies and policy statements policy documents 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) pre-control chart premarket review process premarket submissions presentations pressure gages preventive action (pa) preventive maintenance print (drawing) callouts prints (drawings or blueprints) private label manufacturer 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 performance process validation process verification and validation product audits product code production production line production processes product lifecycle management (plm) product limits product safety products and services professional certifications and degrees profile of a surface project management prototypes and prototype testing psw (part submission warrant) purchase orders purchasing purchasing controls purchasing department qms (quality management system) qualification of equipment and processes quality quality assurance (qa) quality control (qc) 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 system manuals 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 recertification (to a standard) record retention requirements records (evidence) and records control reference documents reference standards refurbishing registrar audits registrars (registration bodies) registration audits registration certificate registration requirements registration to a standard registration to multiple standards regression analysis (statistical technique) regrind material regulations and regulatory requirements regulatory affairs (ra) regulatory bodies regulatory compliance regulatory requirements relabeling (of products) 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 use only (ruo) device or software reselling residual risk resistance (electrical) resources response time responsibilities returned products and/or parts reusable medical devices revalidation of a process or product revision control revisions to a document or standard rework rework and repair procedures 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 run at rate s-charts safety (general) safety requirements and regulations sai salt spray testing samples (of a part product or service) samples (of a product or service for customer evaluation) samples and sampling plans sample size sampling plans for attribute data sanctioned interpretations sap erp (enterprise resource planning) saudi arabia scales and balances 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 calls service company or industry service life service providers service provisions severity ranking (fmea) shelf life signatures single use devices (sud) six sigma (general) small companies (small businesses) 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) spain spare parts spc (statistical process control) special characteristics special processes specifications (general term) spectrometer 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) 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 substantial equivalence supplier supplier audits supplier control and monitoring supplier corrective & preventive action supplier data supplier development supplier evaluation/rating/approval supplier nonconformances supplier performance supplier requirements suppliers (general topics) supplier selection qualification and approval 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 targets (aka objectives) taxes and taxation technical documentation technical files for medical devices temperature control and tolerances templates 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 plug gages and set plugs thread ring gages and setting plugs threads (of fasteners such as nuts and bolts) timelines and schedules tl 9000 tolerances (dimensional or other units) tooling control topical antiseptics top management torque wrench or tool 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 needs training records training requirements training sources and resources transition (between standards or revisions to a standard) transition audits transition period translations (languages) true position ts 16949 - automotive quality system standard ts 16949 4th edition turtle diagrams uae (united arab emirates) ukas (united kingdom accreditation service) uncertainty (aka mu - related to calibration) uncertainty budget (measurement) underwriters laboratories (ul) unique device identification (udi) united kingdom (uk) upper management upper management commitment usb port isolation usp (united states pharmacopeia) 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 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) vision system inspection (electronic) visual inspection voluntary consensus standards want to buy warehouse (general) waste (general) webinar websites weee (waste electrical and electronic equipment) weekend random topics welding wire wire harnesses work environment work instructions (wi) zero defects

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