Certifications Quality - Medical Devices : CLOOS electronic

CLOOS electronic Certificates

This image displays a Rohde & Schwarz oscilloscope in a 19-inch rack, demonstrating compliance with ISO 9001 and 13485 certifications at Cloos Electronic. The high-quality measuring technology ensures precision and quality in electronics manufacturing.

ISO Certificates

ISO standards are crucial in electronic manufacturing, ensuring product quality, safety, and environmental sustainability. They provide guidelines for design, production, testing, and quality control, helping manufacturers meet global benchmarks for reliability and efficiency. Adherence to these standards facilitates international trade by instilling consumer and partner trust, as ISO is recognized worldwide. By following ISO standards, electronic manufacturers not only guarantee the safety and performance of their products but also support sustainable practices, contributing to a reduced environmental impact. This adherence promotes global market access and underscores a commitment to quality and ethical manufacturing.

ISO 9001 Certification of the Quality Management System

The ISO 9001 standard is an internationally recognized norm for quality management systems, aimed at helping organizations to continually improve the quality of their products and services. It defines the criteria for an effective quality management system and supports companies in increasing their process efficiency, improving customer satisfaction, and ensuring continuous improvement of their operations.

Our certification body for ISO 9001 is Bureau Veritas.

CLOOS electronic has been ISO 9001 certified since 1995.

Image of the ISO 9001 certification for CLOOS electronic, highlighting their quality management systems in electronic production and the manufacture of microtechnical systems for customers.

ISO 13485 Certification for Quality in Medical Technology

The ISO 13485 standard is an international standard specifically designed for the quality management system in the medical device industry. It establishes detailed requirements for manufacturers to ensure that their medical devices consistently meet current regulatory requirements and ensure safety and effectiveness for patients and users.

Our certification body for ISO 13485 is Bureau Veritas.

CLOOS electronic has been ISO 13485 certified since 2015.

Image oft the certificate ISO 13485 Certification for medical devices  for CLOOS electronic for the manufacturing and distribution of electronic cards, cables, and wiring harnesses, as well as medical devices and equipment in the medical field, including IoT and connected objects.

 

IPC Standards

IPC standards are essential for quality and safety in electronics manufacturing, setting clear requirements for the production of electronic components. Developed by the Association Connecting Electronics Industries, these guidelines ensure the reliability of electronics worldwide through detailed specifications for design, assembly, and testing.

Expert certification according to IPC standards is crucial as it provides professionals with the necessary knowledge to comply with these norms. These certifications demonstrate the ability to perform high-quality work, thereby enhancing product quality, reducing error rates, and increasing production efficiency. Investing in IPC certification for employees highlights our company's commitment to the highest standards and strengthens customer and partner trust in their products and services.

​​​​​​​​​​​​​​​​​​​IPC A-610-Standard

The IPC-A-610 standard, often known as 'Acceptability of Electronic Assemblies,' is an internationally recognized standard for electronic manufacturing that defines criteria for the acceptability of electronic assemblies. It provides detailed guidelines and accepted practices for the assembly and soldering process of electronic components to ensure the quality and reliability of the final products.

To consistently meet the highest standards, 7 certified IPC 610 experts work in the areas of quality control, production, and work preparation.

Image listing the IPC 610 experts at CLOOS electronic and their areas of expertise. These experts ensure the quality of SMD and THT assembly of PCBAs at CLOOS electronic by ensuring that all manufacturing processes comply with the high standards of IPC 610, enabling excellent product quality.

IPC A-620-Standard

The IPC/WHMA-A-620 standard, known as 'Requirements and Acceptance for Cable and Wire Harness Assemblies,' is an international standard that establishes requirements and acceptance criteria for cable harness and cable assembly in the electronics industry. This standard serves as a guide for quality assurance and ensures that cables and cable harnesses meet uniform and reliable quality standards, which is crucial for the functionality and safety of electronic systems.

To guarantee these standards, at CLOOS electronic, 3 certified experts work in the areas of production and work preparation.

Image listing the IPC 620 experts in cable manufacturing at CLOOS electronic and their areas of expertise. These experts ensure that the cable assembly complies with the high standards of IPC 620, ensuring outstanding quality and reliability of the products.

 

​​​​​​​​​​​​​​​​​​​IPC A-600-Standards

The IPC A-600 standard, known as "Acceptability of Printed Boards," is an international standard that sets the quality criteria for printed circuits (circuit boards). It serves as a guide for assessing the acceptance criteria of circuit boards and includes guidelines regarding material quality, conductor path structure, solderability, hole metallization, and other critical factors that affect the performance and reliability of the finished circuits.

To ensure compliance with these standards in the design and procurement of PCBs, CLOOS electronic employs 3 certified IPC 600 experts in the field of quality assurance and work preparation.

Image listing the IPC 600 experts in PCBA manufacturing at CLOOS electronic and their areas of expertise. These experts ensure quality in PCB sourcing and qualify PCB suppliers to guarantee the highest standards in production and reliability of the final products.

IPC 7711/7721-Standards

The IPC 7711/7721 standard, known as "Rework, Modification and Repair of Electronic Assemblies," is an important standard that provides detailed procedures and guidelines for the revision, modification, and repair of electronic assemblies. It plays a crucial role in the electronics industry by establishing standards for the restoration and improvement of circuit boards and other electronic components, in order to prolong their lifespan and ensure their reliability.

To ensure full compliance in repair, modification, and rework, CLOOS electronic employs 4 certified IPC 7711/7721 experts.

Image listing the IPC 7711/7721 experts at CLOOS electronic and their areas of expertise. These experts ensure the highest quality in rework, modification, and repair of electronic assemblies, ensuring the longevity and performance of the products.

 

RoHS, REACH, UL Compliances

RoHS (Restriction of Hazardous Substances), REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals), and UL (Underwriters Laboratories) are key compliance standards that are of great importance to the electronics industry. RoHS restricts the use of certain hazardous substances in electrical and electronic equipment, while REACH regulates the production, sale, and use of chemical substances to protect human health and the environment. UL, an independent organization, ensures that products are tested and certified for safety.

Adhering to these standards is not only a legal requirement but also strengthens consumer confidence in the safety and environmental sustainability of products. For manufacturers, compliance with RoHS, REACH, and UL means taking their environmental responsibility seriously and ensuring the safety of their customers.

RoHS-Compliance

RoHS (Restriction of Hazardous Substances) is a directive from the EU that restricts the use of certain hazardous substances in electrical and electronic equipment. The aim of this directive is to reduce the environmental impact and health risks associated with hazardous materials such as lead, mercury, and cadmium. It ensures that electronic products are more environmentally friendly and safer for consumers.

CLOOS electronic provides Printed Circuit Board Assemblies (PCBAs) and systems that comply with RoHS, unless otherwise agreed.

Image de la compliance RoHS

REACH-Compliance

REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) is an EU regulation that aims to improve the protection of human health and the environment from the risks that can be posed by chemicals. It requires companies that manufacture, import, or use chemicals in the EU to ensure the safe handling of these substances by providing information about their properties and risks, and if necessary, implementing safety measures to minimize risks.

CLOOS electronic ensures a REACH-compliant organization in the manufacturing of PCBA (Printed Circuit Board Assembly) and systems.

Image de la compliance REACH

 

UL-Compliance

UL (Underwriters Laboratories) is an independent organization specialized in testing and certifying product safety. It establishes globally recognized safety standards for electrical appliances and components, and certifies products that meet these safety requirements, in order to provide consumers and manufacturers with confidence in the safety and reliability of the products.

CLOOS electronic provides all the necessary documents for traceability in procurement and assembly, to enable UL certification for the American market.

Image de la compliance UL

 

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