{"id":6480,"date":"2011-09-06T09:17:55","date_gmt":"2011-09-06T09:17:55","guid":{"rendered":"https:\/\/2016.csoftintl.com\/?p=6480"},"modified":"2023-03-31T03:37:03","modified_gmt":"2023-03-31T03:37:03","slug":"csoft-international-renews-iso-quality-certifications","status":"publish","type":"post","link":"https:\/\/www.csoftintl.com\/cn\/news-events\/csoft-international-renews-iso-quality-certifications\/","title":{"rendered":"CSOFT International Renews ISO 9001:2008 and ISO 13485:2003 Quality Certifications"},"content":{"rendered":"

Beijing, China \u2013 CSOFT International, Inc.<\/a>, a leading provider of multilingual localization, testing, and software development services for the global market, announced today the successful renewal of two International Organization for Standardization (ISO) quality certifications, ISO 9001:2008 and ISO 13485:2003.<\/p>\n

“CSOFT constantly strives for continuous improvement in productivity, the quality of our deliverables, and overall customer satisfaction,” said Shunee Yee, CSOFT President and CEO. “These two ISO certifications highlight CSOFT\u00b4s dedication to the ongoing application and expansion of our documented Quality Management System in keeping with the exacting standards set forth by the International Organization for Standardization. They also serve as a promise to our valued clientele that CSOFT will continue to uphold strenuous, measurable quality standards for all of our translation, localization, and engineering work.”<\/p>\n

By clearly defining standards for management, traceability, and the regular re-evaluation of quality systems, the ISO 9001:2008 standard helps create a positive foundation for growth, transparency, better productivity and enhanced customer service. CSOFT also renewed its ISO 13485:2003 certification. This standard is similar to ISO 9001, but with a greater focus on risk management and corrective\/preventive action during the manufacture of medical devices and related services. In terms of localization, ISO 13485 certification is vital to mitigating communication risks when translating documentation for highly regulated organizations in the Life Sciences industry.<\/p>\n

In order to receive ISO certification, companies must be reviewed by a third-party auditing body. CSOFT\u00b4s audit was performed by the BSI (British Standards Institution) Group, a leading global organization that helps companies improve quality and performance by testing, developing, and certifying various sets of international standards.<\/p>\n

“CSOFT has proven once again its dedication to continuous quality improvement by passing the ISO audit without any non-compliance,” said Lane Ji, BSI China Lead Assessor, “demonstrating the effectiveness and depth of its quality management systems.”<\/p>\n

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About CSOFT Health Sciences<\/h3>\n

CSOFT Health Sciences, leaders in clinical trial localization, provides AI\/ML-enabled medical translation services for all phases of the drug and medical device product lifecycle, from development to post-launch. We also specialize in DCT solutions, linguistic validation, and CTD\/eCTD submissions with the FDA, EMA, and NMPA. Our operations are certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016, ensuring our customized solutions meet the rigorous regulatory requirements of MMA, NDA, CTA, and Medical Device Application submissions. www.csoftintl.com<\/u><\/a><\/p>\n \n <\/div>\n

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Media Contacts<\/h3>\r\n

Nikki Andrews (U.S.\/Europe)<\/h4>\r\n
Phone: +1 (617) 263-8950<\/div>\r\n
Email: nikki.andrews@csoftintl.com<\/a><\/div>\r\n \r\n <\/div>\n","protected":false},"excerpt":{"rendered":"

Beijing, China \u2013 CSOFT International, Inc., a leading provider of multilingual l …<\/p>\n","protected":false},"author":5,"featured_media":6481,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"pgc_sgb_lightbox_settings":""},"categories":[1],"tags":[],"_links":{"self":[{"href":"https:\/\/www.csoftintl.com\/cn\/wp-json\/wp\/v2\/posts\/6480"}],"collection":[{"href":"https:\/\/www.csoftintl.com\/cn\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.csoftintl.com\/cn\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.csoftintl.com\/cn\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/www.csoftintl.com\/cn\/wp-json\/wp\/v2\/comments?post=6480"}],"version-history":[{"count":2,"href":"https:\/\/www.csoftintl.com\/cn\/wp-json\/wp\/v2\/posts\/6480\/revisions"}],"predecessor-version":[{"id":189082,"href":"https:\/\/www.csoftintl.com\/cn\/wp-json\/wp\/v2\/posts\/6480\/revisions\/189082"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.csoftintl.com\/cn\/wp-json\/"}],"wp:attachment":[{"href":"https:\/\/www.csoftintl.com\/cn\/wp-json\/wp\/v2\/media?parent=6480"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.csoftintl.com\/cn\/wp-json\/wp\/v2\/categories?post=6480"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.csoftintl.com\/cn\/wp-json\/wp\/v2\/tags?post=6480"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}