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Showing posts from February, 2021

ISO 27001 Compliance

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  The International Organization for Standardization (ISO), the global body that published various standards for disciplines. In today's digital world, more and more people have emphasized the usage of technology for their requirements to avoid any consequences. It’s easy to imagine the consequences for an organization if its information is lost, destroyed, corrupted, or misused. So many industries are now reliant upon the internet and digital networks, for the quick and paperless process.   In particular, ISO 27001 is designed to function as a framework for an organization’s information security management system (ISMS) for implementing, managing, and maintaining information security. ISO 27001, often as an umbrella demonstrates that their Information Security Management Systems (ISMS) is compliant with the requirements of ISO/IEC 27001. This includes all policies and processes relevant to guide the selection of adequate and proportionate controls to protect information. ISO 2

ISO 13485: Medical Devices QMS

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ISO 13485 is an international standard for a medical device's system for an organization to develop and demonstrate a quality management system that consistently meets customer and applicable for regulatory requirements. The safety and quality of the public cannot be kept at risk. In order to demonstrate continual improvement and maintain the new adoption of the technology in devices is accepted to upgrade the organization with new medical devices. ISO 13485 standard is an effective solution to meet the comprehensive approach to a QMS is ad hoc. It places a more significant focus on regulatory compliance of the standard with less flexibility in the process of the organization.   ISO 13485:2016 introduces some changes from ISO 13485:2012. The major focus of ISO 13485:2016 Certification is a host of subtle, yet detailed, changes requiring more thorough documentation and records on risk management, the work environment, design control, and regulatory requirements to get fulfilled

What is Quality Management System (QMS)?

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  Quality Management System is the overall concept of all activities and tasks that must be accomplished to maintain a desired level of excellence. It provides your company with a set of principles that ensure a common-sense approach to the management of your business activities. This helps in the consistent achievement of customer satisfaction while standardizing your processes and continually improving the effectiveness of the business processes and approach.   The four main components of QMS are quality planning, quality assurance, quality control, and quality improvement. Implementation of these four components helps in maintaining and balancing the Total Quality Management (TQM) of an organization. This helps in the formalized system of document policies, processes, and procedures for achieving quality policies and objectives. Quality management aims to ensure that all organization’s stakeholders employees and clients are satisfied and work together to improve the company’s proc

CE Marking

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  CE Marking is the product Certification for placing the product in the EU Nations. CE Marking Certification is a mandatory certificate required by the manufacturer for ensuring the compliance of EU Directives and Legislations. CE Mark is a product New Approach Directive and Global Approach Directive to clear the technical barriers in the territory of the European Union. CE Marking is the manufacturer's declaration and is responsible for placing the CE Mark on the products. This mark has its described specifications and dimension to get it placed. Any breach of the dimension is considered void and does not fulfil the EU Directives.   CE Marking came into force from the year 1985, published by the European Economic Area (EEA). This represents that the product products comply with the EU’s New Approach Directives. There are EU requirements that each product needs to pass for affixing the CE Mark. These Directives are have been assessed to meet high safety, health, and environmen

What are the requirements of the ISO 27001 Information Security Management System?

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Companies in the past few years have been brought down to their knees because they have not taken the right measures to secure, maintain their clients' valuable information. Understanding the most important assets of your company is a must for evaluating. Many companies work on databases and their main assets are the clients' information. For instance, securing Information is a crucial point as they are paid for it. Having your data and information protected is vital for your company and this is where ISO 27001 Certification comes in. An Information Security Management System (ISMS) is a systematic approach to manage risks of manipulation of information and adopt ways to establish, implement, operate, monitor, review, maintain, and improve information security.   When you have such a standard implemented in your organization, you can rest assured that your data will be protected from any possible security threat. For this, the management comes with new technologies and techni

ISO 20000-1 Information Technology Service Management System

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  This standard ISO 20000-1 was designed to deliver valuable managed IT services to customers and maintain those standards over time. ISO/IEC 20000-1:2018 is an international standard for IT Service Management System. ISO/IEC 20000-1 helps organizations to ensure that your day to day service delivery is carried out in a way that drives customer satisfaction. ISO 20000-1:2018 is the first internationally accepted standard for IT service management.ISO 20000-1 promotes provider to plan, establish, implement, operate, monitor, review, maintain and improve the service management system.   ITSMS implementation in an organization is considered as the outline to be a bedrock upon which to build continually improving service management systems. As in today's era of technology, the IT sector in every organization is considered the left hand of each organization. Given how vital IT is to organizations, your internal and external IT services need to meet the customers and business needs.

CE Marking

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  Conformitè EuropĂ«enne (CE Marking) is the mandatory requirement for European Union (EU Nations) to get entry into the European market. European Nations have stated and made obligatory to fulfil EU Directives  and Legislations  for the products to legally distribute the products to the general public ensuring their safety concern. CE Marking affixed on the product compliance with the regulation and legislation of EU Directives. CE Marking has its unique shape and size which decides its originality. The CE marking for Restriction of Hazardous Substances is managed by Directorate-General for Environment. Comprehensive guidance on the implementation of EU product rules can be found in the so-called Blue Guide.   CE the marking indicates that the product fulfils the requirements of EU Directives and is considered safe from any threat. Whether the manufacturer, distributor, or retailer is wholly responsible for the product published in the European Nation. Further, this mark also indicat

GMP Certification

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  Good Manufacturing Practice GMP helps in ensuring the system that products are consistently produced to maintain the quality standard. It is designed to minimize the risks and enhance your food safety management system. The main aim of GMP is to see quality assurance to ensure that a food or drug product is safe for human consumption.   GMP guidelines are not instructions on how to manufacture products for utilization after the outcome. It states certain guidelines that talk about the quality assurance approach. Many countries have legislated and made it mandatory that food, pharmaceutical, and medical device manufacturers should follow GMP certification procedures and create their GMP guidelines that correspond with their legislation.   GMP is initiated by the WHO. GMP Certification can be obtained by the manufacturer or the retailer dealing and manufacturing in the pharmaceuticals, food, and cosmetics. Compliance with GMP requirements in the industry means that companies have i