Quality Certifications
Quality Management System
Our Quality Management System is at the heart of Sensitech® and drives everything we do. This commitment to quality is our core differentiating factor among cold chain service providers. We deliver comprehensive cold chain solutions and take pride in our technological leadership. We have a long-standing record of innovation, quality initiatives, proven product performance, and the highest level of customer service.
As a supplier of “critical components,” our hardware and software products are designed and tested against rigorous standards. Validation protocols are adhered to and quality control is enforced at every level.
Sensitech cares as much about protecting your product quality as you do. That is why choosing the right partner with a commitment to excellence and quality ensures increased control and understanding of the condition of your products, wherever they are in the supply chain.
At Sensitech, we genuinely value customer input. A major segment of our 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 90 companies or divisions representing the world’s largest food and pharmaceutical corporations. We’re proud of the high-quality standards we’ve set and appreciate that our customers recognize and value 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.
Quality 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 profitable growth for our company, employees, suppliers, partners and community.”
Dave Ray, Senior Director of Quality Assurance
Customer Audits
The regulatory agencies, and subsequently, our customers, have come to characterize temperature dataloggers and the software systems that manage cold chain data as “critical components” of a pharmaceutical manufacturer’s supply chain. Sensitech addresses this classification though an extensive Quality Management System that has withstood rigorous auditing by the pharmaceutical manufacturing industry.
The increasing importance of cold chain monitoring to protect patient safety, ensure product efficacy, and comply with regulatory and standards-based guidance, has increased the importance of a pharmaceutical manufacturer’s audit program. As a result, Sensitech strongly encourages and welcomes customer audits. Over the past ten years, Sensitech has been successfully audited in excess of 80 times–never failing an audit. Every year the number of audits increases indicating the importance of audit-ability for a supplier of cold chain critical components.
The audit is an opportunity for our customers to validate and understand Sensitech’s quality procedures. In addition, we often gain insights into our customers’ needs which help us maintain a market leadership position. An audit provides us with valuable feedback from customers regarding our quality systems and procedures. We welcome this input, listen carefully to the customer, and strive to consistently improve our own processes.
Sensitech has participated in over 90 supplier audits since 2001 with the leading major pharmaceutical and biotechnology companies. As the industry leader, ISO 9001:2008 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.
Our commitment to quality is exemplified by our numerous certifications and our industry-leading expertise.
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National Institute of Standards and Technology (NIST®) |
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ISO 9001:2008 |
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Expanding ISO 9001:2008 to incorporate elements of Current Good Manufacturing Practices (cGMP) |
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Validation of Hardware |
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Validation of Software |
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CE Mark |
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EMC (Electromagnetic Compatibility) |
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Federal Aviation Administration (FAA) and Electromagnetic Interference (EMI) Compliance |
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Lithium Battery Transportation Approval |
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Transportation Security Administration (TSA) Screening Methods Testing |
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Global Support and Customer Service |
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Leading Industry Expertise |
ISO 9001:2008 Certification (Beverly and Redmond facilities)
The International Organization for Standardization (ISO) is a worldwide federation of national standards bodies from more than 160 countries including the United States. ISO 9001:2008 promotes the creation of worldwide quality standards in order to facilitate international cooperation in the exchange of goods and services. ISO 9001:2008 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 and third-party auditors. ISO 9001:2008 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 (PDF Documents)
Scope of Registration
Sensitech ISO 9001:2008 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 9001:2008 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 9001:2008 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.
CE Certification
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
NIST (National Institute of Standards and Technology) Traceability
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 9001:2008 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