ISO 13485:2013

(ISO 13485:2013 starts form 6000/-.)

The ISO 13485:2013 Certification is used for implementation of a system that manages the quality of the devices that are manufactured in the company and ensures best quality of the products. The system ensures the manufacturers that the products they provide to the customers are of best quality and there is no chance of inducing any quality defects in the products.

When a company is granted the ISO 13485:2013 certificate, it is provided a complete set of instruction on how to ensure zero quality defects in the products as well as the manufacturing process for better quality assurance. The ISO 13485:2013 accreditation is necessary for the companies that are indulged in the manufacturing of high end medical devices so that they are able to provide the products with zero defects to the customers with better consistency.

Some of the Advantages of ISO 13485 are as follows

  • Improve customer satisfaction. The ISO 13485 standard is built on a set of quality management principles, one of which is ensuring customer satisfaction. This can be achieved by assessing customer needs and expectations, and striving to meet them. Customers know what they want, and what they need, and many of them will not even entertain a supplier that isn’t certified. Beyond that, ensuring the satisfaction of your existing customers keeps them coming back, and helps you sell your services to new customers. This translates directly to increased revenue.
  • Improve your processes. Using the process approach outlined in ISO 13485, it’s much easier to discover opportunities for improvements. You’ll be able to identify and eliminate waste within and between processes, reduce errors, and avoid rework—facilitating greater efficiency and cost savings.
  • Improve decision-making. Another quality management principle of ISO 13485 regards the use of evidence-based decision making. When you use facts and data to drive your decisions, those decisions tend to be better aligned with the strategic goals of your company. While “gut feelings” may be appropriate in some social situations, they can spell trouble in business. An added bonus is the increased insight into the health of your processes, and any improvements that are made, once you keep track of the data.
  • Create a culture of continual improvement. A third quality management principle making up the foundation of ISO 13485 is the concept of continual improvement. When adopted as the culture in your organization, management and staff will always be on the lookout for ways to improve on how things are done. By establishing systematic processes for reducing problems and mitigating their effects, everyone will spend less time cleaning up mistakes, and more time delivering quality products and services.
  • Better employee engagement. When employees are asked to help look for ways to improve their own processes, not only will they often provide the best insight – they will also be much happier and more invested in the success of the company. The more your employees understand their roles in delivering quality products and services, the more engaged they are, which leads to increased efficiency and productivity.

Documents required for ISO 13485

  • Incorporation Certificate of Organisation or GST Registration certificate
  • Scope of working
  • Copy of Invoices for any purchase or sale
  • Contact Details of owner 
  • Any other document as required time to time.

Steps for ISO 13485 Registration

  • Making an application to an accredited ISO certification body
  • Providing the required documents
  • Defining the certification scope
  • Initial assessment to verify that the basic structure of the management system is implemented.
  • Certification audit
  • Surveillance audits-it includes the verification of continuous improvement, closure of nonconformities from previous audits, conformance to the standards etc.
  • Re-certification after three years

Frequently Asked Questions

What is ISO certification?

ISO Certification is a seal of approval from a 3rd party body that a company runs to one of the internationally recognised ISO management systems. The certification can be used to tender for business as a proof of a company’s credibility but also to install confidence in the potential client that you will keep your promises.
The International standard supports its own benefits within every industry, however, the common benefits across the certifications include widened market potential, compliance to procurement tenders, improved efficiency and cost savings, a higher level of customer service, and therefore satisfaction, and heightened staff morale and motivation. By having a recognized management standard it tells your customers that you are serious about their needs.
On providing the correct documents and information of business you can obtain the final certificate within 2-3 working Days.
When you get ISO certified you will receive a certificate bearing a unique certificate number. Using such unique number over accreditation’s body website you can verify that your business is an ISO certified entity.
For customers, the worldwide compatibility of technology which is achieved when products and services are based on International Standards brings them an increasingly wide choice of offers, and they also benefit from the effects of competition among suppliers.
ISO 9001 is a quality management system that can be integrated into any business. It is focused on ensuring the business delivers a consistent level of quality to its customers by having well defined and regularly reviewed processes and procedures. The system fully integrates within the existing business procedures and becomes part of the culture within the organisation. Eventually a business will not perform a task to conform to the ISO 9001, it will perform the task for the good of the business. The system covers eight main business principles which are: Customer focus Leadership Involvement of people Process approach System approach to management Continual improvement Factual approach to decision making Mutually beneficial supplier relationships.
The system promotes efficient management of sensitive corporate information, highlighting vulnerabilities to ensure it is adequately protected against potential threats. It encompasses people, process and IT systems. An ISO 27001 certification can be achieved by any business of any size, in any given sector, which is looking to increase and enhance the company’s security of its data.
IAF stands for International accreditation forum which continuously monitors and improvises the international standards and it also educates accredited bodies about Standards. IAF ISO certifications are accepted worldwide.
ISO audit is the basic tool to check the quality process system to ensure that organisation is following the requirements as prescribed. Once you take an ISO certification, ISO audit needs to be done on an annual basis.
Definitely. The revised version of the standard is as relevant to small as well as large organisations. Irrespective of your size, it will enable you to drive improvement in your business and increase customer satisfaction.
ISO itself, does not issue any certificates. This task is performed by external certification bodies. Thus, start out by searching for certification bodies or you can contact us.
ISO certification costs differ based on the certification body, the size of the company and the level of its operations and proceedings. There are also audit costs in some cases. At Alonika.in ISO starts from Rs 2000/- only.
As business becomes ever more competitive, ISO Certification can be a cost-effective means to demonstrate to customers that quality assurance is of paramount importance to your organization. A recent study of various organizations’ with ISO Certification revealed an increase in turnover, sales, customer satisfaction and savings.
There are so many management standards, therefore finding the ones that are right for your business can sometimes be confusing. The best place to start is ISO 9001 quality management, as this is the core standard that most of the other well-known standards are based on. It’s focused on customer service and ensuring your customer receives the service they want, at a time that’s relevant for a cost that’s fair. Based on your company’s activities there may be additional ‘bolt on’ standards that might complement the business i.e. as waste and recycling company may benefit from the ISO 14001 environmental management as this is a fundamental element for their industry, or a manufacturing business might benefit from the ISO 45001 health and safety as they use lots of heavy machinery which could have risks associated. The best way to find out which standards are most relevant is to contact us today and let us know about your business. We can then send you the details of the standard/s most relevant to your company. We are here to solve it for you, contact us and we will let you know the appropriate ISO standard for you.