Quality management systems in software development

Kapelan Bio-Imaging GmbH is a developer and distributor of software solutions for digital image analysis in laboratory diagnostics based in Leipzig, Germany. The software is used in scientific and medical research as well as in clinical laboratory routine or in the pharmaceutical industry and is marketed worldwide. However, increasingly complex global networking of different players in the laboratory routine inevitably leads to increased requirements for internationally valid certifications for companies in this industry. The processes of laboratory diagnostics must not only be of high quality, but above all must comply with globally valid standards in order to be equally transparent and reproducible. To ensure that Kapelan Bio-Imaging can demonstrably meet these requirements, the company has been working on the implementation of the new quality management system QMS since February

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Content:

• White Paper: Quality Management System for Software
• The process-oriented quality management software to achieve your quality goals.
• Software Testing – Quality Management Plan Template
• Quality Management System
• The difference between Quality Assurance and Quality Control in software development
• Quality Assurance vs. Quality Control: Key Differences Explained

White Paper: Quality Management System for Software

Kasve helps clients identify relevant legislation and standards, and collaborates with clients to design a quality management system that fulfils their needs. The resulting quality management system reflects the organisation and can be best incorporated into day-to-day operations. We are ready to roll up our sleeves and collaborate with you to find the best way for your organisation to fulfil requirements and help you draw up different levels of documentation to guide operations and indicate conformity.

Perhaps your organisation already has a quality management system you wish to update for the certification process or enable you to enter a new industry subject to new standard requirements. Kasve will assess what needs to be updated and prepare a plan that will allow you to meet your targets. Together with Kasve, Adamant Health built a quality management system on time to enable them to apply for the CE mark for their medical device. We help healthtech companies succeed in the international market.

Leverage our expertise and our comprehensive network! IEC is a series of technical standards that describes the requirements for the safety and essential performance of medical electrical equipment.

The ISO standard sets a frame for quality management systems for both medical device manufacturers and other organisations in the chain. The ISO standard for testing and calibration laboratories describes the general and technical requirements for the competent, impartial and consistent operation of laboratories.

IEC describes the processes for a manufacturer of medical devices to analyse, specify, develop and evaluate the usability of the medical device as it relates to safety. A turnkey solution for project and knowledge management in medical software product development. The Product Development Health Check will ensure that your product development project is appropriate and fulfils requirements.

With us, you will gain access to highly experienced specialists in regulatory affairs and their competence related to various regulatory challenges, such as obtaining a CE marking or FDA approval. Kasve enables its clients to prepare for entering the international market or expand their activities without a need to commit to permanent staff.

Kasve has helped numerous companies draw up materials for investors. We also perform technical Due Diligence audits. Update your QMS Perhaps your organisation already has a quality management system you wish to update for the certification process or enable you to enter a new industry subject to new standard requirements. See all. Quality Management and Regulatory Affairs. We launched the product as planned Together with Kasve, Adamant Health built a quality management system on time to enable them to apply for the CE mark for their medical device.

Rosa Tengvall Lead Quality Engineer. Do you need a qualified partner to support you? Contact us. IEC -standard IEC is a series of technical standards that describes the requirements for the safety and essential performance of medical electrical equipment. Read more. IEC -standard IEC defines the set of processes for life-cycle management of medical device software. ISO -standard The ISO standard sets a frame for quality management systems for both medical device manufacturers and other organisations in the chain.

ISO -standard The ISO standard for testing and calibration laboratories describes the general and technical requirements for the competent, impartial and consistent operation of laboratories. ISO -standard IEC describes the processes for a manufacturer of medical devices to analyse, specify, develop and evaluate the usability of the medical device as it relates to safety. ISO standard ISO is the globally well-known basis for effective quality management systems.

Quality Assurance and Regulatory Affairs. Software Life Cycle Management. Software Development Tools A turnkey solution for project and knowledge management in medical software product development.

Product Development Health Check The Product Development Health Check will ensure that your product development project is appropriate and fulfils requirements. Regulatory Affairs With us, you will gain access to highly experienced specialists in regulatory affairs and their competence related to various regulatory challenges, such as obtaining a CE marking or FDA approval. Business Development. Outsourced Business Development Manager Kasve enables its clients to prepare for entering the international market or expand their activities without a need to commit to permanent staff.

Investor Materials and Due Diligence Kasve has helped numerous companies draw up materials for investors.

The process-oriented quality management software to achieve your quality goals.

Quality management software QMS can help manufacturers measure and therefore improve the quality of their products and processes. This software category can refer to a broad range of applications that help manufacturers ensure quality across all supply chain activities—from design to production to distribution and eventually, service. Read more. Falcony is a cloud-based application fit for mobile and tablet use. It can be used by businesses of all sizes. It allows users to customise audit templates and score ran Orcanos is a cloud-based platform designed to help businesses of all sizes manage and automate all document workflows, from initial approvals to final signoffs.

Software Testing – Quality Management Plan Template

Software quality product is defined in term of its fitness of purpose. That is, a quality product does precisely what the users want it to do. For software products, the fitness of use is generally explained in terms of satisfaction of the requirements laid down in the SRS document. Although "fitness of purpose" is a satisfactory interpretation of quality for many devices such as a car, a table fan, a grinding machine, etc. Example: Consider a functionally correct software product. That is, it performs all tasks as specified in the SRS document. But, has an almost unusable user interface.

Quality Management System

Incorporating a Quality Management System QMS into your pharmaceutical company means investing in a commitment to your customers. The many features of a QMS include increased control, organized administrative archives, recall management, and more. Clients are provided with a streamlined platform for all their internal and external regulations. An electronically managed QMS encourages your company standards and procedures to stay consistent.

The difference between Quality Assurance and Quality Control in software development

A quality management system, or QMS, is a program designed to enforce and improve quality throughout a manufacturing or industrial system. Typical quality management software platforms are workflow-based and provide intelligent routing to move quality-related events through different areas of the business to ensure product or service quality. Most quality management software systems consist of document control, audit management, nonconformance tracking, corrective action, and employee training. However, more comprehensive QMS solutions will encompass critical processes like supplier quality, life sciences compliance and risk management. QMS software provides a centralized means of managing and tracking your quality management system.

Quality Assurance vs. Quality Control: Key Differences Explained

There is a growing realization in both public and private sectors that effective, continuous improvement requires efficient and effective information systems. O ne of the first comments from a company developing or using a quality system concerns the volume of paperwork involved. In fact, organizations must deal with two paper trails when initiating or maintaining an ISO or QS quality system. The first trail accumulates from the standard's requirement that the system be documented and quality records generated and maintained. The second occurs when the company or the standards change, when better practices are used or any other changes are made: All the existing documentation and paperwork must be changed, too. Document control software originally was developed to automate these processes. However, over the last five years, software has explored several other application areas. For instance, it's no longer necessary to document parallel definitions of an organization and its activities.

There are different ways companies can build required quality management systems, from using traditional paper-based solutions to deploying modern heavy-duty eQMS software. But what's the difference between these options? What's the best way to define and embed quality processes and procedures across your operations? A quality management system QMS is a formalised system that documents the processes, procedures, and responsibilities for achieving a company's quality policies and objectives.

The notion of "quality" is not as simple as it may seem. For any engineered product, there are many desired qualities relevant to a particular project. The section explains software quality fundamentals, including the main SQM processes: quality assurance, verification, validation, review, and audit. Software quality management SQM applies to all perspectives of software processes, products, and resources. It defines processes, process owners, and requirements for those processes, measurements of the process and its outputs, and feedback channels. Software quality management processes consist of many activities.

Skip to Main Content. A not-for-profit organization, IEEE is the world's largest technical professional organization dedicated to advancing technology for the benefit of humanity. Use of this web site signifies your agreement to the terms and conditions. Quality Management System Certification in the Russian Software Development Industry Abstract: ISO is the most widely recognized standard boasting the world economy development: more than countries are involved and over 1 million organizations are certified. ISO sets out requirements for quality management systems QMS and is applicable for all types of organization. QMS can bring significant benefits for organizations' competitiveness and success. The motivation for implementation mainly deals with changes and improvement, contribution to growing of sales, increasing of exports and reducing barriers to international trade due to improvements in product quality and differentiation, better market visibility.

Software Quality Management System refers to the activities used by companies to manage the delivery of high-quality products. It can be realized in various ways depending on organization and type of projects developed but it should support the whole software development life cycle: collecting the requirements, design the solution, solution implementation, change management, and closing project. To understand properly the Software Development processes it is important prior to get in touch with some close related concepts: Quality Assurance, Quality Control and Quality Plan. Quality Assurance QA refers to the process used to create the deliverables and can be performed by a manager, client, or even a third-party reviewer.