{"id":3245,"date":"2025-12-08T10:37:27","date_gmt":"2025-12-08T01:37:27","guid":{"rendered":"https:\/\/ir.test.kitazato.co.jp\/ja\/?page_id=3245"},"modified":"2026-02-04T16:47:49","modified_gmt":"2026-02-04T07:47:49","slug":"quality","status":"publish","type":"page","link":"https:\/\/www.kitazato.co.jp\/en\/corporate\/fertility\/quality\/","title":{"rendered":"Reliability Assurance"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\">Basic Policy<\/h2>\n\n\n\n<p>As a provider of products essential to reproductive medicine, Kitazato consider the assurance of the highest levels of quality, safety, and reproducibility across all products and services to be our top priority.<\/p>\n\n\n\n<p>Fully recognizing our responsibility in handling technologies that support the beginning of life, we have established a robust reliability assurance framework based on stringent international standards.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Quality Assurance Philosophy<\/h2>\n\n\n\n<ol start=\"1\" class=\"wp-block-list\">\n<li>Establishment of a quality assurance system based on international standards<\/li>\n\n\n\n<li>Fostering a quality-driven culture in which every employee contributes to quality<\/li>\n\n\n\n<li>Ensuring safety and reproducibility based on scientific evidence<\/li>\n<\/ol>\n\n\n\n<h2 class=\"wp-block-heading\">Quality Assurance Framework<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Operating a company-wide Quality Management System (QMS) in strict accordance with ISO 13485 standards.<\/li>\n\n\n\n<li>Rigorous inspection and record management at each stage of the manufacturing process<\/li>\n\n\n\n<li>Thorough implementation of manufacturing environment monitoring, raw material control, validation, and pre-shipment testing<\/li>\n\n\n\n<li>Continuous improvement through internal and external audits<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Product Safety and Risk Management<\/h2>\n\n\n\n<p>In reproductive medicine, even minor differences can affect treatment outcomes; therefore, we conduct rigorous evaluations.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Biocompatibility testing<\/li>\n\n\n\n<li>Stability testing<\/li>\n\n\n\n<li>Component-level quality control testing<\/li>\n\n\n\n<li>Product-specific risk assessments<\/li>\n\n\n\n<li>Post-market analysis of safety information<\/li>\n<\/ul>\n\n\n\n<p>In the event of any nonconformity, we implement immediate root-cause analysis and proactive corrective actions.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Supply Reliability Initiatives<\/h2>\n\n\n\n<p>To ensure uninterrupted product availability at clinical sites, we regard stable supply as a core corporate responsibility.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Securing multiple sourcing routes for raw materials<\/li>\n\n\n\n<li>&nbsp;Strengthening our Business Continuity Planning (BCP) through equipment redundancy and strategic inventory management.<\/li>\n\n\n\n<li>Leveraging our operational expertise gained through serving more than 110 countries worldwide.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Collection of Safety Information and Continuous Improvement<\/h2>\n\n\n\n<p>Feedback from medical institutions is actively collected and utilized for product improvement.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Post-Market Surveillance<\/li>\n\n\n\n<li>Interviews with healthcare professionals<\/li>\n\n\n\n<li>Sharing and analyzing clinical data to enhance performance.<\/li>\n\n\n\n<li>Updating educational materials and Instructions for Use (IFU)<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Compliance with International Regulations<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>CE marking<\/li>\n\n\n\n<li>Regulatory submissions to the FDA and other authorities<\/li>\n\n\n\n<li>Compliance with medical device regulations in various countries and regions (including MDR, TGA, NMPA, etc.)<\/li>\n\n\n\n<li>Export control and preparation of regulatory documentation<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Basic Policy As a provider of products essential to reproductive medicine, Kitazato consider the assurance of  [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":3219,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"fix\/corporate_block_common.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-3245","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.kitazato.co.jp\/en\/wp-json\/wp\/v2\/pages\/3245","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.kitazato.co.jp\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.kitazato.co.jp\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.kitazato.co.jp\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.kitazato.co.jp\/en\/wp-json\/wp\/v2\/comments?post=3245"}],"version-history":[{"count":2,"href":"https:\/\/www.kitazato.co.jp\/en\/wp-json\/wp\/v2\/pages\/3245\/revisions"}],"predecessor-version":[{"id":5205,"href":"https:\/\/www.kitazato.co.jp\/en\/wp-json\/wp\/v2\/pages\/3245\/revisions\/5205"}],"up":[{"embeddable":true,"href":"https:\/\/www.kitazato.co.jp\/en\/wp-json\/wp\/v2\/pages\/3219"}],"wp:attachment":[{"href":"https:\/\/www.kitazato.co.jp\/en\/wp-json\/wp\/v2\/media?parent=3245"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}