ISO 13485: Quality management system for medical devices

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ISO 10002 is a standard that tells an organisation how to set up a customer satisfaction management system. The ISO 10002:2018 standard is called "Quality Management - Customer Satisfaction - Guidelines for Handling Complaints in Organisations." It explains what needs to be done to handle and solve customer issues in a way that makes customers happier and helps the organization's image.

Organisations that show they meet the standards of ISO 10002 are given the ISO 10002 approval. By getting this licence, a company shows that it is committed to giving great customer service and dealing with customer issues in a good way.

What its Cover

  • 1. Setting up a complaints management policy: Organisations need to outline their goals, responsibilities, and methods for dealing with complaints.
  • 2. Effective complaints dealing means setting up clear processes for getting complaints, writing them down, rating them, and finding solutions.
  • 3. Accessibility: Organisations should make sure that their complaint routes are easy to find and use to encourage customers to give feedback and file complaints.
  • 4. Objectivity and fairness: Complaints should be dealt with in a fair and objective way, with the goal of fixing them quickly and well.
  • 5. Continuous improvement: Organisations need to look at feedback data, find places where they can do better, and take steps to fix the problems so they don't happen again.

After a product has proven By getting ISO 10002 certification, a company shows that it is committed to customer happiness and improving how it handles issues all the time. It can increase customer trust, keep more customers, and set itself apart from competition by showing how committed it is to solving customer problems in an organised and effective way.


1.Better credibility and access to markets: ISO 13485 certification is often needed to sell medical products on global markets and get governmental approvals. It shows that a company has solid quality management practises in place and can meet customer and government standards.

2. ISO 13485 helps organisations set up effective ways to develop, make, and service medical equipment. This improves the quality, safety, and dependability of the product and lowers the chance of bad things happening to patients and health care workers.

3. Compliance with regulatory requirements: The standard is in line with regulatory systems around the world, such as the European Medical Device Regulation (MDR) and the US Food and Drug Administration (FDA) rules. Organisations that have ISO 13485 certification find it easier to meet these standards and keep up with new laws.

4. Processes that work well and are streamlined: Implementing ISO 13485 helps the whole organisation adopt processes that work well and are standardised. It helps find places to improve, cuts down on waste, and improves the general speed of operations.

Included in this Services

  1. Documents preparations
  2. ISO 13485 Certification
  3. Liasioning with the department
  4. 24*7 Mail Support


What does ISO 13485 mean?

ISO 13485 is an international standard that outlines the needs for a quality management system (QMS) in the medical device business. Its main goal is to make sure that medical device design, development, production, and service meet all regulatory standards and are of the best quality and safety.

Who needs to be ISO 13485 certified?

ISO 13485 certification is important for any business in the medical device market, including makers, suppliers, wholesalers, and service providers. It is especially important for businesses that want to show they are following the rules and get into foreign markets.

What are the advantages of being ISO 13485 certified?

ISO 13485 certification has a number of benefits, such as increased credibility and market access, better product quality and safety, compliance with legal standards, streamlined processes and increased efficiency, and a focus on constant growth. It helps organisations in the medical device business show that they care about quality and following the rules.

Does ISO 13485is mandatory?

Most countries don't have laws that say you have to get ISO 13485 approval. But regulatory bodies may require ISO 13485 compliance as a condition for approving a product or letting it on the market. Also, buyers usually expect and prefer ISO 13485 approval as a sign of quality and compliance with regulations.

How does a business get ISO 13485 certification?

An organisation needs to set up and use a quality management system that meets the standards of ISO 13485 in order to get ISO 13485 approval. This includes doing a gap analysis, putting in place the processes and paperwork that are needed, doing internal checks, and letting a certification group do an external audit.

What is different between ISO 9001 and ISO 13485?

Both ISO 13485 and ISO 9001 are standards for quality management systems, but they are different in what they try to do and what they need. ISO 13485 is for the medical device business and puts more stress on following rules, managing risks, and making sure the design is safe. ISO 9001 is a more general standard for quality control that can be used in many different businesses.

Does ISO 13485 cover complaint handling and post-market surveillance?

Yes, ISO 13485 has rules about post-market monitoring and how to deal with complaints. Organisations are needed to set up ways to track and analyse post-market information, such as customer feedback, and take the right steps to fix any problems that are found.

How often does ISO 13485 approval need to be updated?

Usually, ISO 13485 approval is good for three years. During this time, the certified organisation must go through regular surveillance checks by the certification group to make sure it is still following the standard. A recertification check is done to keep the licence valid every three years.

Can ISO 13485 be used with other standards for management systems?

Yes, ISO 13485 can be combined with other management system standards, such as ISO 9001 (Quality Management) and ISO 14001 (Environmental Management). Integration lets companies make a combined management system that streamlines processes and makes the best use of resources in many different parts of their business.

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