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.

Certified companies are required to create formal, documented procedures, ensure that team members follow the procedures and undergo regular checkups by internal, as well as third-party auditors. ISO 9001:2000 is the quality standard selected by the information technology industry and has been adopted by more than 50,000 American companies and more than 610,000 companies worldwide. It has become the recognized standard for business around the world and is increasingly appearing as a requirement on bid requests.

ISO Certificates - Sassenheim

ISO Certificates - Beverly (PDF)
ISO Certificates - Redmond (PDF)

Scope of Registration

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.

ISO 9000 and ISO 14000 families are among ISO’s most widely known standards. The requirements for control of design and development activities contained in ISO 9001:2000 go beyond the production, installation and servicing requirements contained in the less rigorous and older ISO 9002 standard used by other technology providers. By getting the most comprehensive registration possible, Sensitech exceeds customer expectations and demonstrates its commitment to continuous improvement in the quality of its solutions.

What ISO 9001:2000 Means to You

	Peace of mind knowing you receive service from a company that has made a commitment to quality
	Satisfaction because products and services are selected and designed to meet your unique business needs
	Confidence from partnering with a company that measures its success on how well it meets your expectations
	Consistency in products and services resulting from our use of documented procedures, which meet internationally accepted quality standards
	Reliability because you know that independent quality auditors are continually monitoring our products to ensure quality processes are followed. Management reviews, and corrective and preventive actions provide a closed loop for continuous improvement.

At Sensitech, we genuinely value customer input. Part 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 provide comments that allow us to evaluate ourselves and continually evolve our quality systems to better meet our customers’ expectations. In the last few years alone, Sensitech has been successfully audited by 13 different 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, as well.

Sensitech has participated in 20 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

	Confidence that your data instrument will function properly in the environment in which you use it
	Assurance that if you are exporting products to the EU, your products will not be rejected because the third-party monitoring equipment you are using is not CE certified
	Satisfaction that you are partnering with a company that, like you, is dedicated to quality products, services and systems

EN12830:1999, EN13485:2001, EN13486:2002

EN12830:1999

EN13485:2001

EN13486:2002

EN certificate Sensitech

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.

	Confidence that Sensitech has a standardized way in which we test our products, guaranteeing you that each product meets specifications
	Assurance that your products are accurate and have been manufactured under quality processes, and that Sensitech’s test equipment meets NIST standards

Policy

Sensitech shall pursue excellence and leadership in its markets through a reputation for Quality. Our Quality programs will be consistently applied, continuously measured and rigorously enforced. The company will continuously 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 empower our employees to provide the highest possible return to our shareholders, while pursuing profitable growth for our company, customers, 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.

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