fbpx

Monthly Archives: April 2015

The Standards Institution of Israel (SII) awards Plastomold LTD two ISO quality certifications for Quality Management Systems in organizations and medical device companies.

HOLON, Israel (March 2015):

Plastomold LTD, the specialist in the development and production of plastic products and plastic injection molds in Israel and China, receives two quality certifications from The Standards Institution of Israel (SII):

 

ISO 9001: 2008 is an international standard that defines requirements for managing a quality system in companies.

 

ISO 13485: 2003 is an international standard for managing quality systems in companies in the medical field.

 

The SII certifications indicate that Plastomold has the ability to consistently supply a product that meets customer requirements and applicable statutory requirements, strives to increase customer satisfaction by effective application of the organization’s quality system, and implements processes to continuously improve the system by ensuring conformity to customer requirements and applicable statutory requirements.

 

ISO 13485, an expansion of ISO 9001, adds enhanced traceability across the entire supply-chain, risk survey, validation and more, and includes the majority of requirements of theU.S. Food and Drug Administration (FDA).

 

Boaz Zer, Plastomld’s CEO: "Receiving these certificates marks a major milestone in Plastomold’s operations in Israel and globally and is a testament to the quality we deliver to our clients, in product and process alike. The ISO certificates open new markets for Plastomold and allow us to offer our services to companies that are required to work with certified partners. We are very excited and look forward to expanding our client base locally and internationally.”

Our Projects

  • Fighter pilot combat device in

    Fighter pilot combat device includes handheld device, control panel and accessories. The client: A leading Israeli defense contractor. The challenge: A very complex product comprised of 15 plastic pieces, which also required delicate post-production processing and insertion of brass components. Due to the product's structure and intended use, it was...

    Read More

  • <!--:en-->Disposable component of a sophisticated hair removal device. <!--:--><!--:he-->חלק ממכשיר להסרת שיער באמצעות חום ואור<!--:-->

    Disposable component of a soph

    Disposable component of a sophisticated hair removal device. The client: Cosmetic equipment producer The challenge: The client came to us after four unsuccessful attempts at manufacturing the component. Although molds produced by our competitors made functional products, the quality of these was low due to a recurring problem with the...

    Read More

  • <!--:en-->Plastic parts for an electric screwdriver for surgical use.<!--:--><!--:he-->מכלול פלסטיק למברגה רפואית<!--:-->

    Plastic parts for an electric

    Plastic parts for an electric screwdriver for surgical use. The client: A developer of innovative equipment for cosmetic surgery. The challenge: We were requested to build a delicate surgical screwdriver, part of a very complex product for use in the OR. The product was being submitted for CE marking, and...

    Read More

  • <!--:en-->Connector for thermal insulation wall<!--:--><!--:he-->מחבר לקירות מבודדים<!--:-->

    Connector for thermal insulati

    Connector for thermal insulation wall The client A manufacturer and distributor of a fast and efficient solution for wall insulation. The challenge: Although the H-shaped connector may have seemed very simple at a first glance, our client came to us after developing an unsuccessful mold with another company in our...

    Read More

  • <!--:en-->Disposable parts for a medical device measuring the flow and quantity of urine of OR patients.<!--:--><!--:he-->חלקים חד פעמיים עבור מכשיר עזר רפואי לשימוש בחדרי ניתוח<!--:-->

    Disposable parts for a medical

    Disposable parts for a medical device measuring the flow and quantity of urine of OR patients. The client: Med Dynamics The challenge: Med Dynamics developed a device that measures the quantity and flow of urine in OR patients, giving surgical staffs a real-time indication of the patient’s condition during a...

    Read More

  • <!--:en-->Functional packing for beverage related product<!--:--><!--:he-->אריזה פונקציונלית למוצר בתחום המזון והמשקאות<!--:-->

    Functional packing for beverag

    Functional packing for beverage related product The client: R&D company that specializes in the food and beverage industry The challenge: Our client was interesting in testing the feasibility of replacing an aluminum wrap in the packaging of a commonly-used beverage related product with a plastic one. The plastic product had...

    Read More