ISO 13485

Are your medical products ISO 13485 certified? Want worldwide recognition for your QMS? Get your ISO 13485 certification to save costs & secure your business.

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What is ISO 13485?

ISO 13485:2016 is the yardstick for Quality Management System otherwise known as QMS for the plan and assembling of the Medical gadgets. For organisations to get ISO 13485 authorisation, they are required to clear a program called MDSAP or Medical Device Single Audit Program. However, in many cases, ISO 13485 is considered equivalent to ISO 9001 with the additional acquisition of Medical Device Requirements.

While ISO 13485:2016 stays as an independent archive, it lines up with ISO 9001:2008 but not 2015. This is on the grounds that it doesn't follow the elevated level structure of Annexure “L” of the most recent adaptation of ISO 9001 (which is 9001:2015). Also, the documentation and wellbeing necessities are a lot more prominent under ISO 13485:2016, while ISO 9001:2015 puts its focal point around consumer loyalty and consistent advancement.

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What is the ISO 13485 certification?

So what does it mean when an organisation says it is ISO 13485 certified? ISO 13485 Certified signifies that an association or organisation has executed the procedures and processes involved in obtaining an ISO 13485 Quality Management System and has effectively met the entirety of the prerequisites in ISO 13485. ISO 13485 assesses whether your Quality Management System is fitting and powerful while stressing the security and adequacy of medical gadgets.

Benefits of having an ISO 13485 certification

When an organisation seeking ISO 13485, gets its certification, it enjoys the following benefits.

Ideally, from the time of getting certified as ISO 13485, it will be perceived by the Global Harmonization Task Force also known as GHTF and has also become the model of the QMS standard for the medicinal business. Additionally, ISO 13485 certification gives:


  • Worldwide Recognition – ISO 13485 Standard is perceived in significant markets in the world over such as,
    • United States of America
    • Australia
    • Japan
    • Canada
    • Europe
  • Meets lawful, administrative, legally binding, and showcasing prerequisites
  • In spite of the fact that it is not completely orchestrated, an ISO 13485 Quality Management System (QMS) is exceptionally close in terms of credentials to the Food and Drug Administration's (FDA) QSR principles.
  • It also gives improved item security

Very similar to ISO 9001, a strong QMS gives:

  • Expanded Efficiency
  • Cost-cutting
  • Increasingly Effective Risk Management
  • Improved probability of meeting Customer Requirements

ISO 9001:2015 versus ISO 13485:2016

Since ISO 13485:2016 depends on ISO 9001:2008 (and not ISO 9001:2015), there are contrasts between the two norms. A few organizations are keen on incorporating both Quality Management Standards into their business, and therefore along these lines, it is imperative to look at ISO 9001:2015 and ISO 13485:2016.

There are numerous distinctions and likenesses between ISO 9001 and ISO 13485, and it is good to know what they are. Since these are the two greatest quality benchmarks numerous associations have credentials from both. ISO 9001:2015 changes to another significant level unlike ISO 13485:2016, bifurcating both the standards. This dissimilarity has made plenty of associations worry about how to actualize these two measures together. Therefore, understanding the distinctions and similarities in-depth makes this procedure simpler.

ISO Audit checklist - Steps involved in getting an ISO 13485 certification

For an organisation to ace its review when the ISO body visits, it has to be equipped well in advance. Here is a thorough ISO audit checklist that details each and every thing that is needed.


  • Get the support of the board of trustees. This is a vital process as sans the support of the board members your ISO 13485 usage venture is bound to disappointment. Post this, you will have to create a well-considered introduction that sketches the advantages of your organization and can be executed through ISO 1348.
  • Define the degree. You need to abstain from applying the QMS to zones of your business that don't relate to quality, yet you would prefer not to make the degree so tight that the organization sees no advantage. At the point when you characterize your QMS scope, you will have a superior thought of what should be done, and the limits of your execution. Your best instruments to assist you with scope definition are the quality arrangement and quality manual, so these should be the principal records you produce for your QMS.
  • Identify prerequisites. The following basic procedure toward a fruitful execution is ensuring that you discover all the prerequisites you have to fulfil with your QMS. Such prerequisites normally incorporate lawful and administrative necessities, client necessities, and different necessities relying upon your organization's needs and culture.
  • Define procedures and techniques. The ISO 13485 standard characterizes certain obligatory strategies that must be a piece of your QMS, yet you will likewise need to figure out what procedures and systems inside your organization must be characterized so as to guarantee sufficient and steady quality. The primary activity is to characterize the entirety of your organization's procedures, and afterwards perceive how they communicate with one another. These correspondences are often where issues become clear.
  • Implement procedures and methodology. For most organizations, every one of those necessities to happen is the documentation of existing procedures and strategies to guarantee a steady quality that meets prerequisites. You don't need to archive each procedure, yet you do need to choose which procedures need a reported strategy so as to ensure consistency in the nature of items and administrations.
  • Programs for QMS Knowledge Acquiring. It is fundamental to the achievement of your Quality Management System that each worker in your association sees how the QMS functions, and where they fit in with the general mish-mash. All workforce should be prepared on the nitty-gritty of the ISO 13485 standard, so they are well aware of its goals and objectives. Additionally, they should know about any progress that has happened in the procedures.
  • Choose an accreditation body. The correct accreditation body can have a significant effect since this is the organization that comes in after your execution, to review your Quality Management System and decide if it fits in with ISO 13485 certification requirements. What's more? They will likewise choose how viable your QMS is, and whether it shows consistent improvement.
  • Measure the framework. This is the point at which you will gather the records that will be required in reviews to show that your procedures meet the necessities set out for them, that they are compelling, and that enhancements are being made in your QMS as required. Affirmation bodies need this to occur over a specific timeframe, which they will recognize, so as to guarantee that the framework is full-grown enough to show consistency.
  • Conduct inside reviews. After you have worked the QMS for the endorsed time allotment, yet before the accreditation body directs their review, you should play out an inside review of each procedure. This will disclose to you whether the procedures are proceeding as arranged, and if not, you'll have the chance to make a remedial move to determine any issues you find.
  • Take remedial activity. Here is the place you search for the underlying driver of the issues found during inner reviews, estimations, and the board survey, and afterwards make the important move to address the issues at the source. This is a vital advance in the constant improvement of the Quality Management System, which is a key point of ISO 13485.
  • Perform the stage 1 accreditation review. Right now is an ideal opportunity for the examiners from your picked confirmation body to audit your documentation and check that – at any rate on paper – the entirety of the ISO 13485 certification process prerequisites have been tended to in your QMS. You'll get a review report enumerating the regions where you are consistent, just as those in which you have issues. You will at that point be allowed a chance to execute the important remedial activities to determine the issues. This is regularly done during the equivalent time period given for the underlying activity of the Quality Management System.
  • Stage 2 accreditation review. During this review, the affirmation body will send inspectors to view the records you have gathered through the activity of QMS forms. These records will incorporate those from the executives’ survey, inner reviews, and remedial activities. At the point when the survey is finished, which regularly takes a couple of days, the inspectors will furnish you with a review report that layouts their discoveries, including their assurance about whether your QMS gives off an impression of being successful, and in the event that it agrees to the necessities of the ISO medical device standard. On the off chance that they find that your QMS meets the entirety of the necessities set out for it, the inspectors will prescribe you for affirmation. Suppose they have discovered any significant nonconformance, you will have a chance to execute remedial activity to ensure the issues are settled, and that you are prepared for accreditation.

ISO 13485 QMS - Quality Management System Documentation

To get your ISO medical device standard, you'll need a recorded Quality Management System (QMS) that agrees to the standard and all material administrative prerequisites. Besides the ISO has a set of guidelines for the recording or the documentation process as below,


  • Quality approach and destinations: Under this guideline, you will need to explain in writing that portrays your dedication to quality. Additionally, the point by point targets that will assist you with arriving at those objectives.
  • Quality handbook: Your quality handbook ought to incorporate QMS degree and references to recorded quality methodology.
  • PC programming approval method: The U.S. FDA or otherwise known as the Food and Drug Administration (FDA) requires medical gadget producers to approve any product utilized in the plan, packing, bundling, marking, stockpiling, establishment and adjusting of completed gadgets.
  • Quality systems and records: These need to cover all procedures, including methodology for report and record control.
  • Medical gadget record: This report alludes to the gadget master record just as its specialized documentation.

Frequently Asked Questions

This worldwide standard is obligatory in certain nations. In the U.S. the FDA has proposed a standard that would fit U.S. FDA 21 CFR 820 with ISO 13485:2016, making ISO 13485 the FDA's required QMS for Medical Devices. An ISO 13485 certification costs anywhere between five thousand to ten thousand. Here are some of the list of ISO 13485 certified companies in India.
  • Johari Digital Healthcare Limited
  • Denex International
  • Invent Bio-med
  • Sterimed Medical Services Pvt.Ltd and so on.
The new ISO 13485:2016 standard which has been published as of March 1st, 2016 is the current version of ISO 13485. However, the​​​​​​​​​ final date of the expiry of the previous standards namely the ISO 13485:2012 and ISO 13485:2003 will be 28th of February, 2019.
ISO stands for International Standard Organisation and FDA stands for The Food and Drug Administration. Both these certifications can be availed for Medical gadgets and devices. In order for the Medical gadget manufacturers to regularly provide and meet the apt demand, requisites, and guidelines, the Food and Drug Administration (FDA) has established quality systems to benefit and promote the same. ISO 13485 Certified implies that an affiliation or association has executed the techniques and procedures engaged with acquiring an ISO 13485 Quality Management System and has successfully met the total of the requirements in ISO 13485. ISO 13485 evaluates whether your Quality Management System is fitting and ground-breaking while at the same time focusing on the security and suitability of the medicinal devices.

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