Quality Management System

Paramit’s mission is to “DO IT RIGHT THE FIRST TIME” by establishing strong and long-term business relationships with our customers through consistent performance, superior technical support, exceptional customer service, and the ongoing development of custom solutions that simplify outsourcing complexity.

Paramit’s Quality Management System is based upon our understanding of the requirements stated in:

ISO 9001, ISO 13485,   cGMP/QSR/21 CFR 820, Japan PAL, and Korean GMP standards.

The application of a process approach gives us an understanding of the customer’s requirements relevant to Paramit’s business strategic direction.

Better than Best-in-Class Quality

Best-in-class mechanical assembly is considered 200 defects per million opportunities (DPMO). However, Paramit’s zero-defect approach to manufacturing has resulted in better than best-in-class quality at a virtually defect-free <1 DPMO, on average, for over four years. In surface mounted technology assembly (SMT), we’ve achieved 9 DPMO for over eight years, compared to best-in-class of 30 DPMO. Paramit takes an "own the outcome" approach to every product we manufacture, and the entire process takes place under one roof where we can control the quality for every aspect of production. We employ multiple defect prevention processes that include:

  • A Design for Manufacturability (DFM) review and a Failure Modes and Effects Analysis (FMEA) are performed during New Product Introduction (NPI) on every product.
  • Tightly controlled, closed-loop work cells and stop-on-defect processes that are key to quickly identifying and resolving all issues that impact product quality.
  • Design and execution of state-of-the-art test solutions to verify the integrity of PCAs, and our team of electrical engineers with design-level experience create functional tests and train operators to perform them.
  • Resolution of issues when they occur by manufacturing engineers in real time — on the spot. Paramit’s engineers are never more than a few steps away from the operators on the line, which allows for better communication and workflow.
  • Validations (IQ, OQ, and PQ) performed as part of our qualifications plan for PCBAs and instruments which have proven the highest quality level can be achieved consistently in the production phase.

vPoke Mechanical Assembly

Paramit builds all system subassemblies and completed systems using our patented computer-directed assembly technology called vPoke. vPoke controls all inputs into basic elements of work, forces conformance to established criteria and sequences, and automatically documents everything for easy future reference during internal reviews and external inquiries. This virtually eliminates all variability associated with the complex, error-prone manual assembly sequences commonly used in medical device and life science instrumentation manufacturing.

Certifications

DESIGN

  • FDA QSR
  • Design History File
  • Device Master Record
  • Human Factors Analysis
  • ISO 9001 Certified
  • Take product to CE mark
  • IEC 60601 and 61010
  • Documented Design Standards
  • ISO 13485

MANUFACTURING

  • ISO 9001:2015 – UL DQS Registration Number 10002924 QM15
  • ISO 13485:2016 – UL DQS Registration of Quality Systems for Medical Devices. Registration Number 10002924 MP2016
  • FDA/GMP – FDA Registered Number 3003537036
  • State of California – Medical Device Manufacturing License Number 50087
  • IPC Certification – Lead Free Electronics Assembly Process Capable
  • Product safety compliance with UL, TUV, CSA, ETL and NEMKO certification

Quality Council

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A cross-functional team that meets regularly and puts into practice the philosophy that “quality is everybody’s business.” A wide representation of members gives the Council expertise and authority to implement solutions to issues involving all aspects of the operations.

Facilitates QMS activities, such as ISO/Internal audits, Customer Complaints, Management Review, Quality Data Review, CAPA, Compliance program, Training, Process Improvement, and higher-level strategic initiatives.

Quality Council

Failure Modes & Effects Analysis (FMEA)

Paramit makes every effort to be proactive rather than reactive, preventing or reducing undesired effects and promoting continual improvement. Paramit promotes a risk-based thinking process and performs a systematic approach to risk rather than treating it as a single component of a quality management system.

Paramit utilizes the Failure Modes and Effects Analysis (FMEA) process to identify potential failures in the manufacturing process, determine their effect on the quality of the finished product, and then identify corrective actions to mitigate these risks. A key goal in the FMEA process is to reduce or eliminate complexities which drive manufacturing costs up or present potential quality concerns. Although it isn’t feasible to anticipate every possible failure, our Design for Manufacturability (DFM) review in combination with FMEA lets our manufacturing engineers create a prioritized action list which results in a much higher quality product.

FMEA exposes weaknesses and potential failures by assigning values to the severity of the failure should it occur, predicting the probability that the failure will occur, and then evaluating the likelihood that testing will detect the failure before the product advances to the next stage in the manufacturing process. Early and consistent use of FMEA in the DFM review process lets us and either the Lathrop or client engineering teams design out failures, reduce risks, and build reliable, safe, best-in-class products.