The EN ISO 9001 standard has been created with the aim of support successful operation of any business organization, regardless of its size or operation area.
The EN ISO 9001 standard is a key member of the EN ISO 9000 series of standards.
A quality management system is the most effective way to make the use of processes, human and other resources optimal and to ensure high-level customer satisfaction.
Through our legal predecessors, NEOEMKI LLC. have outstanding experience in certification medical device manufacturers’ and distributors’ QM systems according to the EN ISO 9001 standard.
NEOEMKI LLC. is a certification organization accredited by the National Accreditation Authority. During the certification procedure we audit the manufacturer’s or distributor’s quality management system for compliance with the requirements of the EN ISO 9001 standard.
After a successful certification procedure NEOEMKI issues a QMS certificate to the customer. The certificate justifies that the QM system operated by the customer fulfils the requirements of the EN ISO 9001 standard.
The valid version of the EN ISO 9001 standard is the EN ISO 9001: 2015 Quality Management Systems. Requirements (ISO 9001: 2015).
Accreditation
The NEOEMKI LLC. is accredited by the National Accreditation Authority to certification of QM systems. The scope of accreditation is defined in the deed of accreditation. The up-to date accreditation status can be checked on the National Accreditation Authority homepage (www.nah.gov.hu).
Certificates
For detailed information on the validity of issued EN ISO 9001 certifications send an e-mail to titkarsag@emki.hu address.