In the quality management system of a medical device manufacturer, a non-conformity refers to the non-fulfillment of a specified requirement; if it relates to a product, it is referred to as a non-conforming product. ISO 13485:2016, Section 8.3.1, requires that products that do not meet product requirements are identified and controlled to prevent their unintended use or delivery, and that a documented procedure defines the responsibilities for identification, documentation, segregation, evaluation, and disposition. The term describes a state and a duty to decide, not the downstream elimination of causes: the latter is covered by the entry Corrective and Preventive Action, while the procedural integration is covered by the entry Quality Management System. Records of the nature of the non-conformity, evaluation, investigation, and the rationale for decisions must be maintained. <\/p>\n
Non-conformities can occur during incoming inspection, manufacturing, final inspection, sterilization release, or labeling. The first step is the clear identification of the affected material or lot, followed by physical or system-based segregation, for example, through locked storage areas, block labels, and a status change that technically prevents picking. <\/p>\n
According to ISO 13485, the evaluation explicitly includes the question of whether an investigation is necessary and whether a responsible external party must be notified. Defective supplied parts therefore also trigger feedback to the supplier and, if necessary, a re-evaluation of their approval status. <\/p>\n
If the non-conformity is identified prior to delivery, ISO 13485 Section 8.3.2 provides three options for action: elimination of the identified non-conformity, measures that preclude the originally intended use, or release or acceptance under concession. A concession is the variant requiring the most justification: it is only permissible if a justification exists, authorization has been obtained, and applicable regulatory requirements are met; records must identify the authorizing person by name. <\/p>\n
A concession must never legitimize a deviation from the General Safety and Performance Requirements of Annex I of Regulation (EU) 2017\/745; it remains limited to cases where the deviation is demonstrably without impact on safety and performance. If residual uncertainty remains, scrapping with proof of destruction is the more robust path. <\/p>\n
If a non-conformity is only identified after delivery or the start of use, Section 8.3.3 requires measures appropriate to the actual or potential effects, as well as their recording. Additionally, a documented procedure for advisory notices that can be triggered at any time must be maintained. This is where the QMS process interfaces with the legal framework: if the findings lead to a Field Safety Corrective Action (FSCA), the reporting obligations under Article 87 of Regulation (EU) 2017\/745 apply, and the affected economic operators are obliged to cooperate under Articles 13 and 14. <\/p>\n
According to ISO 13485 Section 8.3.4, rework is only permitted according to documented procedures that take into account the potential adverse effects of the rework on the product; these procedures are subject to the same review and approval as the original procedures. After completion of the rework, it must be verified that the product meets the applicable acceptance criteria and regulatory requirements, and the rework must be recorded. <\/p>\n
In a narrow sense, a deviation is a departure from a specified procedure\u2014i.e., a process event that can leave behind a conforming product; non-conformity, on the other hand, concerns the result. A planned, pre-approved deviation from a specification is precisely not a non-conformity, but rather a changed requirement with a change assessment. <\/p>\n
A complaint is an external communication regarding an alleged deficiency of a product already delivered; it may uncover a non-conformity but is not one itself. An incident, by contrast, is an event-related regulatory term with its own reporting thresholds. A product is non-conforming even without any harm; conversely, an incident can occur with a fully conforming product, for example, as a result of a use error. <\/p>\n
In clinical trials of medical devices, the QMS term meets the investigational product context. Investigational products must correspond to the specifications described in the clinical investigation plan; a non-conformity identified in a test sample before shipment can affect the comparability of the collected data and the validity of endpoints. Therefore, release decisions, concessions, and rework on investigational products must be documented so that they remain traceable for an auditor or inspector years later, and product-related non-conformities must be linked to site and equipment management. <\/p>\n
Equally important is the clear separation of reporting paths: a non-conforming investigational product is initially a matter for quality management, but can simultaneously constitute a product deficiency that must be evaluated and, if necessary, reported according to the requirements for clinical trials. Full-service CROs like Mediconomics support sponsors and manufacturers in consistently describing these interfaces between product release, study documentation, and reporting processes and ensuring verifiable compliance throughout the study. <\/p>\n
Is every non-conformity reportable?<\/strong><\/p>\n No. Reporting obligations only arise if the evaluation results in a serious incident, a Field Safety Corrective Action, or a reportable trend. Non-conformities identified internally and eliminated before delivery remain subject to QMS documentation. <\/p>\n Must every non-conformity trigger a corrective action?<\/strong><\/p>\n No. What is required is a documented decision regarding the affected product as well as an evaluation of whether a root cause analysis is appropriate. A corrective action with an effectiveness check is only indicated when a systematic error or a cluster is recognizable. <\/p>\n How long must records of non-conforming products be kept?<\/strong><\/p>\n They follow the retention periods according to Article 10(8) of Regulation (EU) 2017\/745, i.e., at least ten years after the last product has been placed on the market, and at least fifteen years for implantable products.<\/p>\n In the quality management system of a medical device manufacturer, a non-conformity refers to the non-fulfillment of a specified requirement; if it relates to a product, it is referred to as a non-conforming product. ISO 13485:2016, Section 8.3.1, requires that products that do not meet product requirements are identified and controlled to prevent their unintended […]<\/p>\n","protected":false},"author":10,"featured_media":0,"parent":0,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"glossary-cat":[24],"class_list":["post-7763","glossary","type-glossary","status-publish","hentry","glossary-cat-medizinprodukte-ivd"],"acf":[],"related_terms":"","external_url":"","internal_reference_id":"","_links":{"self":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/7763","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary"}],"about":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/types\/glossary"}],"author":[{"embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/users\/10"}],"version-history":[{"count":0,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/7763\/revisions"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=7763"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=7763"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory References<\/h2>\n
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