{"id":5181,"date":"2018-06-30T08:09:36","date_gmt":"2018-06-30T08:09:36","guid":{"rendered":"https:\/\/amb.se\/?page_id=5181"},"modified":"2023-11-21T20:00:46","modified_gmt":"2023-11-21T20:00:46","slug":"quality-assurance","status":"publish","type":"page","link":"https:\/\/amb.se\/en\/quality-assurance\/","title":{"rendered":"Quality assurance"},"content":{"rendered":"
[vc_row full_width=”stretch_row” equal_height=”yes” content_placement=”middle” top_margin=”0″ bottom_margin=”0″ css=”.vc_custom_1509551730213{margin-bottom: -1px !important;padding-top: 30px !important;padding-bottom: 30px !important;background-color: #ffffff !important;}”][vc_column]
<\/div><\/div>[vc_column_text]\n

Quality assurance<\/h1>\n

What is quality assurance?<\/h2>\n

Quality assurance is the sum total of every action taken to achieve consistent product quality and delivery performance. It must prevent faults in manufactured products and preclude delivery related problems for the solutions and services we supply to our customers.<\/p>\n

Quality assurance is applied to physical products as early as the planning and preparation phase in order to verify what must be done to meet specifications and customer requirements. Accordingly, we work with a documented product development process (PDP) that governs our systematic work and which includes checklists to ensure nothing is forgotten. When the product is manufactured, out-turn samples and defined quality controls are used to verify that specifications are met. This may involve various measurements and also visual checks against a reference example.<\/p>\n

Everyone is involved<\/h2>\n

While quality assurance for AMB naturally involves meeting the conditions of our certification under ISO 9001, 14001 and 13485, it also involves constant dynamic quality efforts through our own quality mindset.<\/p>\n

Quality is created by the company\u2019s employees, and this requires insight, motivation, training and perseverance. Everyone in the company undergoes training and then works according to our watchwords Flexible, Professional and Committed, which are embodied in our 12 principles. In this way, quality assurance become second nature.[\/vc_column_text]

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\n\t\t\t\t\t\t\t<\/i>\n\t\t\t\t\t\t\tWhat is quality assurance?\t\t\t\t\t\t\t<\/i>\n\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t
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[vc_row][vc_column][vc_column_text el_class=”entry-content”]Quality assurance is a process that aims to systematically ensure that products or services meet the requirements and expectations of the customer. Quality assurance can include everything from developing and implementing quality control systems to conducting tests and evaluations of products and services.<\/span>[\/vc_column_text][\/vc_column][\/vc_row]\n<\/div>\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\t<\/i>\n\t\t\t\t\t\t\tWhat are outcome or acceptance tests within industrial contexts?\t\t\t\t\t\t\t<\/i>\n\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t
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[vc_row][vc_column][vc_column_text]Outcome testing in an industrial context is a method for testing and evaluating the quality of a product or process. This means taking a number of samples of the product or process and examining how they perform under different conditions. The results of outcome tests are used to assess whether the product or process meets set requirements and standards.<\/span>[\/vc_column_text][\/vc_column][\/vc_row]\n<\/div>\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\t<\/i>\n\t\t\t\t\t\t\tWhat is medical device quality management?\t\t\t\t\t\t\t<\/i>\n\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t
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[vc_row][vc_column][vc_column_text el_class=”entry-content”]Medical device quality management is a process that aims to ensure that medical device products and services meet high quality standards and are safe to use for patients and healthcare professionals. The process includes development of quality policies and procedures, risk management, quality control, validation of products and processes, and training of personnel.<\/span>[\/vc_column_text][\/vc_column][\/vc_row]\n<\/div>\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\t<\/i>\n\t\t\t\t\t\t\tWhat is a quality audit?\t\t\t\t\t\t\t<\/i>\n\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t
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[vc_row][vc_column][vc_column_text el_class=”entry-content”]A quality audit is a process in which an independent reviewer or auditor evaluates an organization’s quality system to ensure that it meets the necessary standards and requirements. The purpose of a quality audit is to identify any deficiencies or areas for improvement in the organization’s quality processes and systems and to make recommendations for improvements.<\/span>[\/vc_column_text][\/vc_column][\/vc_row]\n<\/div>\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\t<\/i>\n\t\t\t\t\t\t\tWhy should processes be documented?\t\t\t\t\t\t\t<\/i>\n\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t
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[vc_row][vc_column][vc_column_text el_class=”entry-content”]Documented processes ensure product quality through compliance with rules and standards. In addition, training and collaboration are facilitated and work is made more efficient.<\/span>[\/vc_column_text][\/vc_column][\/vc_row]\n<\/div>\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\t<\/i>\n\t\t\t\t\t\t\tWhen to document processes?\t\t\t\t\t\t\t<\/i>\n\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t
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[vc_row][vc_column][vc_column_text el_class=”entry-content”]Processes should be documented when they are established and when there is a clear structure for how they are to be carried out. It is also important to document changes or when there is a need to evaluate and improve the process. The documentation should be easily accessible to all involved and updated regularly.<\/span>[\/vc_column_text][\/vc_column][\/vc_row]\n<\/div>\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>
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Know more?<\/h3>Contacts<\/a><\/div><\/div>
<\/div><\/div>[\/vc_column][\/vc_row]\n<\/div>","protected":false},"excerpt":{"rendered":"

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Quality assurance is the sum total of every action […]<\/p>\n","protected":false},"author":1,"featured_media":335,"parent":0,"menu_order":2,"comment_status":"closed","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"footnotes":""},"class_list":["post-5181","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"\nQuality assurance - AMB<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/amb.se\/en\/quality-assurance\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Quality assurance - AMB\" \/>\n<meta property=\"og:description\" content=\"[vc_row full_width=”stretch_row” equal_height=”yes” content_placement=”middle” top_margin=”0″ bottom_margin=”0″ css=”.vc_custom_1509551730213{margin-bottom: -1px !important;padding-top: 30px !important;padding-bottom: 30px !important;background-color: #ffffff !important;}”][vc_column][vc_column_text] Quality assurance What is quality assurance? 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