| TQAS is a consultancy based in Israel providing comprehensive RAMSQ-Reliability, Availability, Maintainability, Safety and Quality Assurance, engineering services and regulatory compliance solutions , with a primary focus on the high-tech, aerospace, defense, automotive and medical devices industries . TQAS is also marketing leading software solutions for software testing and quality management systems |
| Quality Management Systems |
| Consulting and training for the establishment, registration and maintenance of QMS (Quality Management Systems) per ISO9001and ISO 90003 (revision of ISO9000-3 for software) as well as per all the industry specific enhanced derivatives of ISO9001, such as : |
 | ISO/TS16949 (formerly QS9000) for the automotive and the Semiconductors industries (Per the Semiconductor Commodity Supplement SAC certification ) |
| TL 9000 for telecommunications, |
| AS9100 for aerospace and, |
| ISO13485 and/or the FDA's CFR 21 Part 820 Medical Device Quality Systems Regulation (CGMP) |
| ISO14001 Environmental Management (incl. integration with ISO9001 Quality Management System ) |
| Quality improvement methodologies such as: DMAIC-Define, Measure, Analyze, Improve, Control. |
| Incremental process improvement using Six Sigma methodologies. Specific quality improvement projects per customer requirements such as: process optimizations, reducing warranty and returned material costs, yield improvement, and waste reduction. |
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| Regulatory Compliance |
| CE Marking and Directives |
| Compliance with RoHS and WEEE directives |
| Medical Device Directive 93/42/EEC |
| Other Products requiring CE marking |
| Compliance with FDA regulations |
| FCC Part 15 and Part 76 Compliance |
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| SQA - ISO90003 and beyond: |
SRS-Software Requirements Specifications
| SDP- Software Development Plans |
| SDD- Software Design Documents (High and Low Level) |
| STP- Software Test Plans/Procedures STR- Software Test Reports |
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| Reliability Engineering |
| MTBF analytical predictions using 217 Plus, Telcordia ( Belcore) and other customer specified methodologies |
| Reliability Testing and Reliability Growth Highly accelerated testing- HASS and HALT FMEA |
| FMECA - for design and manufacturing processes |
| FRACAS-Closed loop Failure Analysis and Corrective Action System (for both hard and soft ware) |
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| Services for Electronics/Semiconductors |
| Compliance with EIA/JEDEC standards Device qualification testing |
| FIT calculation |
| Reliability monitor testing |
| AOQ-Average Outgoing Quality asessment |
| Marking and identification, moisture sensitivity classification |
| Compliance with the RoHS and WEEE directives |
| Validation and Environmental |
| qualification testing per Telcordia GR and NEBSTM requirements Qualification and production testing per military specifications and standards such as Mil-STD-810, MIL-T-28800 |
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| Safety and Risk Management |
Application Of Risk Management To Medical Devices TQAS provides manufacturers a methodology to identify hazards associated with a medical device (including IVD), to estimate and evaluate the risks associated with these hazards, control these risks, and monitor the effectiveness of that control, using EN ISO 14971 as a guide.
| Functional Safety Of Electronic/Programmable Electronic Safety-Related Systems-IEC 61508
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| Safety Assessment of Civil Airborne Systems and Equipment per SAE/ARP 4761 |
| Electrical safety of CPE (Customer Premises Equipment UL1459 |
| Medical Equipment Electrical Safety –IEC/ UL 60601-1 |
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| Software Marketing |
| TQAS markets, sells and provides local support for various software platforms and tools for software testing and QA management. Contact us for details |
| Representation |
| Second Party Audits, Assessments, Source Inspections , Test Witnessing and similar services on behalf of foreign companies doing business in Israel |