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Quality Certifications TUV Recertifies Sensitech to ISO 9001
The International Organization
for Standardization (ISO) is a worldwide federation of national standards
bodies from more than 160 countries including the United States. ISO 9001:2000
promotes the creation of worldwide quality standards in order to facilitate
international cooperation in the exchange of goods and services. ISO 9001:2000
standardization ensures conformity to quality standards for business processes
used to produce products and services.
ISO
Certificates - Beverly
Sensitech ISO 9001:2000 registration
applies to the provision of national and international solutions, including
design, development, configuration and distribution of temperature and
humidity monitors and systems. What ISO 9001:2000 Means to You
At Sensitech, we genuinely value customer input. A major segment of our Life Science customer base falls under FDA guidelines and cGMP standards. As part of our continuous improvement process, our customers periodically perform assessments of our quality system. These assessments allow us to evaluate ourselves and continually improve our quality systems to better meet our customers’ needs and expectations. Sensitech has been successfully audited by over 30 companies or divisions representing the world’s largest pharmaceutical corporations. We’re proud of the high-quality standards we’ve set and appreciate that our customers recognize those standards, as well. As part of our overall services, Sensitech has participated in several legal claims as an independent third party supplier of temperature monitors for the food and pharmaceutical vertical markets. The data derived from Sensitech temperature monitors and strip chart recorders can help assist in identifying temperature abuse and may be useful in supporting insurance claims.
Sensitech has participated in over 30 supplier audits since 2001 with the leading major pharmaceutical and biotechnology companies. As the industry leader, ISO 9001:2000 certification provides Sensitech with a distinct competitive advantage. Our documented quality management system allows us to actively engage in pharmaceutical markets, which requires and maintains stringent quality-control standards.
What is CE? CE is mandatory for a wide range of products that will be sold or imported into the European Union (EU). The CE marking regime requires companies to ensure that their products comply with the mandatory health and safety regulations spelled out in EU directives. Without a CE mark, exporters could lose access to the EU market. Products that do not meet CE requirements may be held at EU member state borders for failure to have the CE mark. Thus, products may be rejected and not allowed into that country. Scope of CE Certification Sensitech has CE certified its products to ensure acceptance of use within the EU. Our products meet the most inclusive directive, the Electromagnetic Compatibility (EMC) directive. This means our products will continue to function properly in environments that are exposed to electronic emissions, such as around forklifts, radios, cell phones, generators, RF, EMI and ESD, CBs and other electronic equipment. What CE Means to You
Sensitech products are traceable to NIST, as stated on our accuracy certifications. That means all the referencing equipment used to validate our products must satisfy NIST standards. What is NIST? NIST, formerly the National Bureau of Standards (NBS), is an organization established by congress in 1901 to support industry,commerce, scientific institutions and all branches of the government. Its purpose is to work with industry and government personnel to advance measurement science and develop standards. The NIST was established to assist industry in the development of technology needed to improve product quality, to modernize manufacturing processes, to ensure product reliability and to facilitate rapid commercialization of products based on new scientific discoveries. What Does NIST Traceability Mean to You? As previously stated, Sensitech has traceability to NIST through accuracy certifications. All of Sensitech’s referencing equipment used in critical measurements must satisfy NIST standards. The standards state that all referencing equipment must be calibrated on a routine basis by qualified personnel. These items must have visible evidence of that calibration. Sensitech personnel must be specially trained to perform these functions. Sensitech has a documented plan, Measurement and Test Equipment Procedure, to cover NIST issues. This plan is audited semiannually under our ISO 9001:2000 certification.
Policy Sensitech shall pursue excellence and leadership in its markets through a reputation for Quality. Our Quality program will be consistently applied, continuously measured and rigorously enforced. The company will continually improve its ability to meet or exceed customer expectations, providing products and services that conform to all user requirements and strictly adhere to Quality standards. In this way, we will provide the highest possible return to our shareholders while pursuing profitable growth for our company, employees, suppliers, partners and community. This policy is posted throughout the company and is embraced by all of our employees. As a result of our focus on quality, Sensitech has earned its ISO 9001:2000 Certification for both the Beverly and Redmond manufacturing facilities. We have also earned the Massachusetts Quality Award, and both TUV Certification and the CE Mark Registration on many of our products. Download Quality Brochure (PDF Document; 224 KB)
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Copyright © 2008 Sensitech. All Rights Reserved. Sensitech is a business unit of Carrier Corp. |
