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4.1 - general requirements 5s workplace organization methodology 7.5.2 - validation of processes 7.5.4 - customer property 7.6 - control of monitoring & measurement devices 8d problem solving 21 cfr part 11 - electronic records and signatures 21 cfr part 211 - finished pharmaceuticals cgmp 21 cfr part 801 - labeling 21 cfr part 803 - medical device reporting 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) accuracy of a measurement device acquisitions and mergers acronyms active medical device adverse event reporting 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) anda (abbreviated new drug applications) andons annex v/vii annex x anodized surface anova (analysis of variance) ansi z1.4 - inspection by attributes anvisa api (active pharmaceutical ingredients) api (american petroleum institute) api q1 - oil industry quality management system (qms) apple (the company) applicable clauses documents legal requirements etc. approvals 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 asean (the association of southeast asian nations) asia 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 audit checklist audit man-days audit nonconformances and findings auditor performance auditor qualification requirements and certifications auditor reporting auditors (general topics) audit plans and audit frequency audit questions audit reports audits and auditing audit scope australia authority and responsibility authorized representative automated measurement gages automotive (general) automotive industry aviation sector aws (american welding society) banks (financial) barcoding (upca - upce - ean8 - ean 13 - qr code) batch manufacturing (general) batch manufacturing records batch production battery (electric batteries) battery powered devices bcrp - business continuity & resiliency planning benchmarking bias study (measurement) bill of materials (bom) bioburden biocompatibility biocompatibility requirements biocompatibility testing birthdays blood glucose blood glucose meters and test strips boeing boeing d6-51991 bonus tolerance books brazil bribes brochures bs 25999 - business continuity (bc) business continuity business processes calculation formulas calibration (general topics) calibration (metrology) laboratories calibration data calibration interval (aka frequency) calibration procedures and methods calibration reports and certificates calibration standards and classes calibration verification calipers canada canada's sor 98-282 - complaint handling & problem reporting canadian medical devices canned procedure(s) and documentation capa (corrective and preventive action) capability study (measurement device) capability study (part dimensions from a process or machine) careers cba (certified biomedical auditor) cba (certified biomedical auditor) exam cdrh (center for devices and radiological health) ce mark and ce marking certificate of analysis (c of a) certificate of conformance (c of c) certificates (general) certification audits certification bodies (cb) certifications (to a standard) cfda (china food and drugs administration) change(s) (general) change control change management change notice (document or form) charts checklist or check sheet china chinese (language) classification(s) of parts or products class iii medical device class ii medical device class i medical device cleaning methods and processes cleanliness cleanrooms cleanroom validation clinical evaluations and reports clinical research clinical trials and studies and investigations cloud computing cmdcas (canadian med device conformity assmnt system) cmk cmm (coordinate measuring machine) cnc machine shop 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 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 computer viruses worms and related topics concessions 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 manufacturing contract research organizations (cro) contract review and approval contracts and agreements (general) contract services control charts (general) controlled documents control limits control of monitoring measurement & test equipment control of production equipment control plans conversion factors copyrights corrective action (ca) corrective action request (car) corrective action systems correlation study cots (commercial off-the-shelf) counterfeit parts and products cpk (related to process capability) cqe (certified quality engineer) cqe exam cqi 9 - heat treat cqi 23 - molding system assessment critical characteristics critical parts and components critical suppliers crossed gage r&r cross reference matrix customer approval customer communication customer complaints and customer found nonconformance customer documents customer owned property customer property customer requirements customer satisfaction customer specific requirements (csr) customer survey data (general) data (import from and export to applications) data analysis databases data collection and/or entry data control data security date of manufacture datum (gd&t) 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 history file (dhf) design history record (dhr) design inputs and outputs design of experiments (doe) design validation design verification destructive tests and testing detection controls detection ranking (fmea) deviations from a print or requirement device history file (dhf) device history record (dhr) device master file device master record (dmr) dfars (defense federal acquisition regulation supplement) dfmea (design fmea) differences (general) digital data dimensional inspection dimensional measurement dimensions disaster recovery distributors (distribution company) distributors (general) distributors (medical devices) dock audits dock to stock document classification document content & structure document control document control (electronic) document control software documented procedures (requirements for) document identification and numbering document references document retention document review(s) and approval(s) document revisions and changes documents and documentation (general) dod (department of defense) dose audit draft documents drawing (also see prints) drug devices drug master file (dmf) drugs (medicinal) due date easa (european aviation safety agency) easa part - 145 maintenance organisation approval ec certificate/certification education effectiveness efficiency egypt electrical safety electrocardiographs (general topics) electromagnetic compatibility electronic components parts assemblies and products electronic data (general) electronic documents forms and templates electronic records electronic signatures and approvals elsmar elsmar cove tos and policies elsmar improvements (general) email (general) emc (electromagnetic compatibility) employee awareness employee development and motivation employees (general) employee training and qualifications ems (environmental management system) en 980 (ifu graphical symbols) en 60601 - medical electrical equipment energy use and conservation engineering change request (ecr) engineering changes engineering drawings environment (environmental related) equipment qualification and validation equivalence studies equivalent medical devices erp software esd (electrostatic discharge) essential requirements checklist ethics ethylene oxide (eo) etl (intertek's edison testing laboratories) eto (ethylene oxide) sterilization europe european medical device regulations european union european union medical device directives (mdd) evop (evolutionary operation of processes) examinations (course or certification tests) exclusions of clauses in a standard exemptions expiration date exports and exporting external communications external document control external documents - prints standards etc. external processes faa part 145 (certified repair station) fasteners (category - nuts bolts and others) fda (food and drug administration) fda guidance fda requirements feedback field service final inspection and/or testing first article inspection (fai) first article inspection report (fair) fixture(s) flowcharts fmea - failure modes and effects analysis fmea manual fmea rankings fod (foreign objects and debris) food (general) food packaging food safety football ford motor company formats and formatting forms and templates (general) formula (mathematics/statistics) for reference only for sale forum software instructions forum software problems france fraud functional requirements functional safety furls (fda's electronic registration and listing system) furnaces 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) gdsn (global data synchronisation network) general motors (gm) germany glass measurement devices (thermometers beakers etc) glp (good laboratory practices) gmp (good manufacturing practices) goals (quality environmental and other measureables) go no-go gage gp-12 early production containment gs1-128 barcodes gtin (global trade item number) gudid (fda global udi database) guidance documents gum - measurement uncertainty document handling harmonization of standards hazard analysis hazardous substances health (general) health canada health safety and environmental (hse) hearing aids heat treatment height gages hibcc - health industry business communications council hipaa (health insurance portability and accountability act) histogram history holidays and related occasions home healthcare hospitals human factors human tissues and organs humidity (general) humidity control humor hypothesis test analysis iaf (international accreditation forum) iaqg (international aerospace quality group) iatf (international automotive task force) iatf 16949:2016 identification (products and parts etc) identification and traceability (general) iec (international electrotechnical commission) iec 60335 - household electrical appliance safety iec 60601 - medical electrical equipment iec 60950 (information technology equipment - safety) iec 61010 - safety requirements for electrical equipment iec 61508 - functional safety of electronic controls iec 62133 - secondary cells and batteries safety requirements iec 62304 - medical device software life cycle processes iec 62366 - medical device usability engineering iec 62366-1:2015 medical device usability iec 80002 - guidance on the application of iso 14971 imdrf (international medical devices regulators forum) imds (international material data system) implantable medical devices (imd) implementation (general) implementation of a standard in a company implementing a qms imports and importation improvement improvement plans and projects in-house laboratory incoming inspection (also see receiving inspection) india indian health ministry information security information technology (it) information technology (it) department infusion pumps and devices injection molding inks inputs (general) inspection (general) inspection devices tools and fixtures inspection methods and plans inspection records installation qualification (iq) instructions (general) instructions for use (ifu) integrated management systems intended use (medical devices) interaction of processes (see process interactions) interested parties internal auditors internal auditor training internal audits internal laboratory international standards internet (general topics and news) interpretations investigational use only (iuo) iran irca (int'l register of certificated auditors) ishikawa diagram iso (int'l organization for standardization) iso/iec 15504 - software processes (spice) iso 9001 - quality management systems iso 9001:2015 iso 10993 - biological evaluation of medical devices iso 11135 - medical device ethylene oxide sterilization iso 13485 - medical device qms iso 13485:2016 iso 14001 - environmental management systems iso 14001:2015 iso 14644 - cleanrooms and controlled environments iso 14971 - medical device risk management iso 15197 - in vitro glucose monitoring systems iso 15223 - medical device label symbols iso 15378 - primary packaging materials for medicinal products iso 16269 - statistical interpretation of data iso 17025 - testing and calibration laboratories iso 22000 - food safety management systems iso 27000 series - information technology security iso 27001 - information security management system (isms) iso 31010 - risk assessment techniques iso 50001 - energy management systems israel italy itar (international traffic in arms regulations) ivd (in vitro diagnostic) devices and reagens ivdd japan japan - ministry of health labour and welfare job descriptions job openings jobs (general) kaizen key performance indicators (kpi) key product or process characteristics (kpc) knowledge management korea labeling - eu labeling directive labeling content labeling requirements labels and labeling (general) label symbols laboratories (general) laboratory scope language issues language requirements laser measurement equipment laser micrometer layout inspection lead auditor(s) and related topics lead auditor course leadership leakage current lean leed environmental building program legacy products legal requirements level of concern (fda term) linkedin lithium ion batteries load cells log books and log sheets lot numbering low voltage directive 2006/95/ec machine shop maintenance malaysia management management review mandatory documents and procedures manufacturing (general term) manufacturing planning manufacturing processes marking (general such as labeling) material changes material testing and test reports mathematical equations matrix mdd (medical device directive) mdd 93/42/eec mdr (medical device regulations) mdr (medical device reporting) mds (material declaration sheet) mdsap (medical device single audit program) measureables (also see metrics) measurement (general) measurement and monitoring and test devices measurement equipment resolution and tolerances measurement equipment verification measurement systems measurement techniques and procedures measurement uncertainty (mu) meddev - ec guidelines on medical devices medical device accessories medical device company or industry medical device electronics and electrical equipment medical device file medical device licensing medical device listing codes and classifications medical device parts and components medical device registration medical device repair and servicing medical device reports including incident reporting medical devices medical devices (disposable) medical device safety medical device software medical device standards and regulations medical equipment (general) metal forming and stamping metrics (measurables such as for objectives) mhra (medical & healthcare regulatory agency) microbial count micrometers microsoft excel .xls .xlsx spreadsheet microsoft sharepoint software minitab (statistical analysis software) mmc (maximum material condition - gd&t) mobile medical devices and applications (apps) molds and molding monitoring and measurement moop (means of operator protection) mop (means of protection) movies mra (mutual recognition agreement- tga australia and eu) msa (measurement system analysis) msa manual msa study multiple business units multiple national or international locations multiple sites multiple standards in a company nadcap (nat'l aerospace & defense contractors accred. pgm) nadcap ac7108 nested gage r&r new products and new product requirements news nhs (uk national health service) 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 oasis (online aerospace supplier information system) oasis database objectives (quality environmental and other measureables) obl (own brand labeling) occurrence ranking (fmea) oem (original equipment manufacturer) off the shelf (ots) equipment or parts or software ohsas 18000 & 18001 & 18002 online internet training courses and universities operational planning operational qualification (oq) operator instructions opportunities for improvement (ofi) optical comparators organization organizational knowledge osha (occupational safety and health admin) outputs (general) outsourced products and processes outsourcing ovens over the counter (see otc) packaging (general) packaging labeling and related requirements packaging standards and specifications panama paper documents and records particulates pcb (printed circuit board) pems (programmable electrical medical system) peppol (pan-european public procurement online) performance measureables performance qualification (pq) personal health information pfh (probability of dangerous failure per hour) pfmea (process fmea) pharmaceuticals and pharmaceutical industry philippines planning plastic injection molding plastic parts plastics plating & coatings pma (pre-market approval) pmda (japan) poka yoke policies and policy statements policy documents post delivery activities post market clinical follow up post market surveillance powder coat paint ppap (production part approval process) ppk (related to process performance) ppm (parts per million) pre-clinical studies (medical devices) precision machining predicate devices and parts premarket approval premarket notification premarket review process premarket submissions presentations pressure gages preventive action (pa) preventive maintenance print (drawing) callouts prints (drawings or blueprints) privacy problem solving procedure examples procedure format procedures (general) process approach process audits process capability process changes and change notifications process controls and control plans process design and development process documentation 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 equipment production processes 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 qms (quality management system) qualification of equipment and processes quality quality assurance (qa) quality control (qc) quality department quality management systems quality management system software quality manuals (general) quality manuals - structure contents and examples quality objectives quality plans and quality planning quality policy quality records quality system manuals quality systems quality tools raw materials raw material suppliers reach (ec 1907/2006) reach certification recalls (general) receiving inspection record retention requirements records (evidence) and records control red (radio equipment directive) reference dimensions reference documents refurbishing registrar audits registrars (registration bodies) registration audits registration requirements registration to a standard regulations and regulatory requirements regulatory affairs (ra) regulatory requirements relabeling (of products) reliability (general) reliability analysis and testing remote locations and sites repackaging repair and or overhaul reportable event reporting (medical devices) reports (general) required documents required procedures requirements and specifications research and development (r&d) 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 based compliance risk based thinking (rbt) risk management and analysis risk register robotics rohs (restriction of hazardous substances) root cause failure analysis routers (process) rpn (fmea risk priority number) safety (general) safety requirements and regulations sample frequency samples (of a part product or service) samples and sampling plans sample size sampling plans for attribute data sampling plans for variables data sap erp (enterprise resource planning) saudi arabia scales and balances scar (supplier corrective action request) scope (general term) scope of certification (aka registration) scope of registration/certification changes scope of the qms scrap second party audit self declaration service company or industry service providers service provisions severity ranking (fmea) shelf life shipping (general) and shipping requirements signatures single fault condition single use devices (sud) six sigma (general) six sigma black belt small business qualification and certification 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 tools (for qa statistics doc control etc.) software validation soldering sole source supplier sop (standard operating procedure) south africa spanish spc (statistical process control) special characteristics special processes specification details specifications (general term) spectrophotometer sri lanka stability testing stainless steel standalone software standard deviation (stdev in statistics) standards (e.g. iso mdd ansi etc.) standards (measurement) statistical analysis and studies statutory requirements stc (supplemental type certificate) sterile medical devices sterile packaging sterility and sterilization techniques sterilization (general) sterilization validation storage requirements and specifications strategic planning and objectives student questions subcontracted goods processes and services subcontracting and subcontractors substantial equivalence supplier audits supplier control and monitoring supplier corrective & preventive action supplier data supplier evaluation/rating/approval supplier nonconformances supplier quality supplier quality engineer (sqe) supplier requirements suppliers (general topics) 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 targets (aka objectives) taxes and taxation technical files for medical devices temperature (general) temperature control and tolerances tensile strength and tensile strength testing terminology testing (general testing topics) testing laboratories test methods and procedures and plans test reports texas thermocouples thermometers and thermostats thickness meters third party audits and auditing thread inspection gages 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 trade names training (general) training effectiveness training materials training needs 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 matrix transition period transition training translations (languages) transportation (general) true position ts 16949 - automotive quality system standard turtle diagrams tus (temperature uniformity survey) uncertainty (aka mu - related to calibration) uncertainty budget (measurement) uncontrolled documents unilateral dimensional tolerances unique device identification (udi) united kingdom (uk) upper management usability of a product user manuals 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 vda 5 - measurement system analysis vda 6.3 - process audit vda standards vdmax25 sterilization validation verification (general) verification of calibration veterinary medical devices virtual manufacturing vision measurement systems (electronic) visual inspection want to buy warranties (general) webinar weee (waste electrical and electronic equipment) weekend random topics welding white papers who (world health organization) wifi wireless rf transmission wire work instructions (wi) youtube videos zero defects

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