ISO 13485 Certification - Medical Devices - Quality Management Systems

30 Oct 2017Posted By: chaman

ISO 13485 Certification - Medical Devices - Quality Management Systems

Medical services are the basic requirement which one needs one or other time in his life. There are a number of medical practitioners, hospitals, etc present in our society. Standardization of medical devices is very important from the safety point of view. As medical is the Nobel profession and is directly associated with one’s health and well-being, devices used need to have gone all through all the quality check. To give a solution to this, ISO 13485 which gives the guidelines for the standardization of medical; devices was published in 1996 for the first time. ISO 13485 gives you the guidelines for compressive quality management in order to design the medical devices.

Why we need ISO 13845?

It might come in your mind that if ISO 9001 is already presented which check the standardization and quality check then what was the need of ISO 13485? There are some differences between ISO 9001 and ISO 13485. ISO 9001 gives emphasis on that the organization needs to demonstrate continual improvement whereas ISO 13485 emphasizes that the quality system has been implemented or not.

ISO 13485 checks that the organizations have the ability to produce standard medical devices. It is used in the designing, production, and installation of medical devices in the Organization. ISO is reviewed after every 5 years and hence, ISO 13485 was reviewed in 2016. It emphasizes more on risk management involved in the medical devices and practices involved. It also includes technology and expectations which can meet the requirements of the customers. ISO 13485 is important for you if you are looking to work internationally as well as locally.

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01 Jan 1970Posted By: E-StartupIndia

5 Key Benefits of Udyog Aadhaar MSME Registration

MSMEs are indeed the precursors of economic growth in today’s globalized era. They account for over 99% of corporate taxpayers of India. Government has run several schemes for empowerment of the MSME sector due to its imperative role in the country’s economic growth. Very importantly, the key to access all the developmental avenues for MSMEs is the Udyog Aadhaar MSME Registration.

01 Jan 1970Posted By: E-StartupIndia

Why Tamil Nadu high court banned Rapido App?

The sincerely determined effort towards conforming the global quality standards ultimately helps any organization derive true customer satisfaction. This helps in attaining the desired level of growth. In order to raise the level of customer satisfaction, an organization must follow global benchmarks for quality. This can be attained with the ISO certification. However, in the absence

01 Jan 1970Posted By: E-StartupIndia

MSMEs shall get Reimbursement of ISO certification Fees

There is no doubt that the MSMEs are today the precursors of India’s economic growth. Today they account for nearly 99% of corporate taxpayers of India. The government has run various developmental schemes for empowerment of the evergrowing MSME sector, owing to its imperative role in the economic growth of India. However, the key to access all such developmental avenues is the Udyo

01 Jan 1970Posted By: E-StartupIndia

ISO Certification in Metal Fabrication Industry

It is beyond any doubt that the ISO 9001:2015 is an overall standard for impeccable Quality Management Systems (QMS). It lays out a well-defined structure for the redesigning of quality in all affiliations that are attempting to pass on the organizations that meet the necessities and wants for all customers and various accomplices, in the most achievable way. ISO 9001 certification is rea

01 Jan 1970Posted By: E-StartupIndia

Role of ISO Certification in the Transport & Logistics Sector

Transportation is indeed the lifeline of the Indian economy. A crucial tertiary sector activity, transportation & logistics provides a link between all other sectors of the economy. It promotes the easy exchange of commodities by breaking away all the barriers to domestic as well as international trade. Now, the transportation of merchandise all over the globe takes place through various chann

01 Jan 1970Posted By: E-StartupIndia

Importance of ISO certification in Private Security Services

In today’s bustling urban life private security has now become one of the dispensable needs for every household. In case you are living in well-occupied urban societies, you must be quite concerned about the security of your life and property. Here comes the job of the private security workforce. You may have met ordinarily with the private security monitor staff. These can be increasin

01 Jan 1970Posted By: E-StartupIndia

Role of ISO Certification for the Internal Security Mechanisms

The hustle & bustle of today’s frenzied urban life has necessitated the private security services for almost every household. The rising crime has now made private security one of the most indispensable needs for the busy metros. Very disgracefully, the national capital Delhi is also the crime capital of India, with the highest crime rate of 1050 per 100,000 persons (as per crime statist

01 Jan 1970Posted By: E-StartupIndia

Top 11 Benefits of Getting ISO 14001 Certification for Environmental Management?

Everybody knows about the way that the present age is of globalization, where there is an unbending challenge among every one of the rivals in the market. The most appropriate way to continue quicker than the kindred contenders is to convey incomparable quality administrations to the clients so as to make them completely fulfilled. Presently, this must be cultivated by utilizing the all-inclusive

01 Jan 1970Posted By: E-StartupIndia

How to make Smart & Energy Efficient Homes?

It is a well-known fact that the non-renewable energy resources are exhausting rapidly and are on the brink of depletion. Accordingly, the costs of the exhaustible power resources, such as coal, petroleum and other fossil fuels are soaring high. So we can clearly observe that all the organizations, in general, need to work upon upgrading their energy management framework as complete conservation o

01 Jan 1970Posted By: E-StartupIndia

How to enhance the Environmental Management System in an Organization?

It can never be denied that environmental degradation is really a grave issue for the whole world. It must be dealt with utmost sincerity. With the ailing health of our planet, the requirement for a concrete and effective Environmental Management System is indispensable. Particularly if we talk about the corporate sector, it has a massive carbon footprint. The only way the corporate entities can p

01 Jan 1970Posted By: E-StartupIndia

Importance of ISO certification for sellers on Government e-Marketplace

We all know that in order to empower the small traders and manufacturers, the Indian Government has launched transparent e-Marketplace prominently known as GeM. Any small scale businessman or a manufacturer can get an easy GeM registration in its business name. A business would then be able to access the wide interface to sell its items and services to distinguished buyers from the Government s

01 Jan 1970Posted By: E-StartupIndia

ISO Certification for Water Treatment Plants

Water is indeed the most fundamental essentiality of the mankind. Besides it is the most valuable natural resource. It is a key indispensable element component for various sustainable energy, food processing and maintaining sanitation and overall wellbeing. Water must be considered as a global asset as well as a challenge for all. Today, the streams and rivers across national territories have b

01 Jan 1970Posted By: E-StartupIndia

How to start a Private Security Agency in India?

Running a Private security agency is indeed a very lucrative business idea that involves thorough planning and organizing. If you are planning to begin a security agency, you must not overlook the potential risks associated with the workforce i.e. security staff employed. Hence, providing assistance to the workforce is undoubtfully beneficial for your business concern and in turn favorable for the

01 Jan 1970Posted By: E-StartupIndia

How to use ISO 9001 efficiently in a business?

Each businessperson or merchant intends to extend his business with a gradual pace and by growing the trust among the clientele. The desired business growth is possible only with strong goodwill among the customers, which is only built through a desired Quality Management System (QMS). International Organization for Standardization or the ISO, a global autonomous body with 162 member nations as

01 Jan 1970Posted By: E-StartupIndia

ISO 14001 Certification for 11 Railway Stations in Palakkad Division

It is beyond any doubt that the Indian Railways have been the mainstay of the evergrowing Indian economy. Serving as the basis of the infrastructural advancement of the country, the Indian Railways Network has broken down all the barriers of language and culture. It is important to make sure that the Indian Railways that carry above 23 million passengers daily, must be equipped with eco-friendly a

01 Jan 1970Posted By: E-StartupIndia

ISO 50001 Energy Management Workshop held at Andhra Pradesh

We all know that non-replenishable energy resources are rapidly depleting. The global demand for energy is increasing, so is the costs of the energy sources, such as coal, petroleum and other fossil fuels. So we can clearly observe that all the business organizations in general, need to collaborate their efforts to conserve energy, for the coming future. There is a critical need for the adaptation

01 Jan 1970Posted By: E-StartupIndia

How to Combat Coronavirus with ISO 45001 Certification?

We all know that the world is struggling with the menace of Coronavirus disease, also called COVID-19. The number of casualties due to COVID-19 throughout the globe have reached an alarming rate. A number of countries are now witnessing complete deadlock due to the intensity of the disease. The infection can spread rapidly among the citizens if proper measures are not taken timely. This is why the

01 Jan 1970Posted By: E-StartupIndia

IAF gives More Time for Migration to ISO 45001 Certification amid COVID-19

Today, the entire world is battling with the Novel Coronavirus disease, better known as COVID-19. Total global cases of COVID-19 infection have gone beyond control. Various nations are currently under total lockdown because of the severity of the infection. The infection can spread rapidly among masses if safety measures are not taken. The only way to stop the spread is social distancing and self-

01 Jan 1970Posted By: E-StartupIndia

ISO Certification Standards Available for the Medical Equipment

Everyone knows that the Novel Coronavirus, better known as COVID-19, has influenced more than 110 countries of the world. Because of the number of deaths all through the globe coming about because of Coronavirus illness, various nations are presently on complete stop. In addition, the worldwide pandemic has additionally caused an overall monetary disturbance, remembering for India, where the admin

01 Jan 1970Posted By: E-StartupIndia

19 Andhra Pradesh Railway stations get ISO 14001 Certification

As we know that the entire world population is badly hit due to the Novel Coronavirus pandemic, or the COVID-19. A number of countries are now witnessing complete lockdown due to the severity of the infection. The fact can’t be negated that the lack of a healthy and safe environment paves way for the spread of epidemics like COVID-19. Hence, the significance of the environmental management s

01 Jan 1970Posted By: E-StartupIndia

Role of Effective Environmental Management System in Combating Coronavirus?

Today our home planet is trapped into the cobweb of Coronavirus pandemic, also known as COVID-19. Total deaths due to COVID-19 globally are increasing constantly. Despite a number of countries under complete lockdown, the infection can still persist among the citizens in the absence of proper measures even after lockdown. No doubt, diseases like COVID-19 can spread easily at the workplace

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