One of the most important factors consumers weigh when it comes to a product is its quality and reliability. These two factors can mean everything regarding a company’s reputation, and it's why so many manufacturers seek ISO certification for their offerings.

These certifications, offered by the International Organization for Standardization, ensure products can be traced and controlled throughout their development, thereby identifying any quality or compliance issues sooner. This post explains what an ISO Certification is, the benefits to ISO-certified manufacturers, and specifics on the ISO 13485:2016 certification that International Enviroguard holds for its garments.

What is an ISO Certification?

An ISO Certification is a designation that validates a manufactured product's quality and reliability. Governed by the independent and non-governmental International Organization for Standardization, ISO Certification ensures the product complies with quality, safety, efficiency, and other standards that have been created to ensure optimal quality. In a nutshell, ISO Certifications carry weight and credibility, and firms that have obtained such accreditation are largely viewed favorably.

The Purpose of ISO Standardization

ISO Certification is not mandatory in many industries. However, achieving it does come with a variety of benefits for manufacturers - and across a variety of industries, from medical device manufacturing to specialized garment manufacturing. Think of ISO Certification as somewhat of a rubber stamp or declaration that a status or event is the truth. Certification signifies that processes work efficiently and effectively, that all steps in the manufacturing process can be tracked, and that your product is “following the book” on best practices.

The biggest purpose of ISO Certification, however, is for a business to show its client base that it is building and selling products of high quality. This, in turn, can result in better business credibility and increased sales to consumers. ISO Certification shows a consumer several things, including:

  • The manufacturer’s products are manufactured according to the latest standards and regulations.
  • The manufacturer thoroughly understands the processes used to create its product.
  • The manufacturer is serious about product quality and improving the processes that are used to make the product.
  • The manufacturer is in compliance with any regulations that are required throughout the manufacturing process or materials-sourcing process.

Business Types Requiring ISO Certification

You can receive ISO Certification for a wide range of products spanning numerous industries, from construction to healthcare to engineering. Even colleges and universities have certain programs that are ISO-certified. Any business that's striving to stand out from its competitors on an international scale should strive to achieve ISO Certification in their field.

Some of the most common ISO Certifications that companies seek include the 900, 14001, 2700 and 5001 families. You can learn more about the various certifications at the International Organization for Standardization website at

Products that Require ISO Certification or Can be ISO-Certified

ISO Certification isn't mandatory in many industries, but there are some exceptions. For instance, medical manufacturers must obtain certain ISO certifications before their devices can be marketed and sold to ensure they're complying with international quality, risk management, and safety standards like sterilization procedures. Similarly, International Enviroguard has earned the ISO 13485:2016 certification for medical devices and protective clothing.

What is the ISO 13485:2016 certification?

This certification serves as verification that all steps of the making of a certain product - protective clothing in this case - adhere to existing safety standards. Similar to other types of ISO Certifications, the benefits of ISO 13485:2016 for manufacturers include establishing the high credibility of your company, gaining a competitive advantage over others in the industry, improving customer satisfaction and, ideally, increasing sales and revenue.

Getting ISO 13485:2016 Certified

All ISO Certifications have different requirements and timelines. As is the case with achieving any ISO Certification, manufacturers need to comply with the specific standard and its requirements to receive it. Once they are able to do this, it can take up to four months to officially obtain the certification.

However, if the 13485:2016 certification is the first one you receive, it may take up to 10 months due to enhanced analysis and auditing stages that may be required. However, these timelines should not be a deterring factor from seeking certification. All manufacturers should strive for ISO Certification for the benefits that such accreditation comes with.

Why Manufacturers Should Strive for ISO Certification

So why should manufacturers strive for ISO Certification? On the most basic level, ISO Certification tells a consumer that their product is following all the universally agreed upon international standards when it comes to making it. This can help instill confidence in the purchase and help provide a manufacturer with a key talking point to market to its current and potential clients.

Advantages of ISO Certification

  • To establish credibility
  • To gain a competitive advantage
  • To ensure customer satisfaction
  • To help protect against any legal issues (this is especially important in the healthcare industry where regulations and standards are inherently and understandably more stringent)
  • To increase sales and revenue

Disadvantages of ISO Certification

There's no real disadvantage to ISO Certification. When you achieve this certification, you're meeting an international standard set by a panel of experts to ensure that your product meets the latest requirements. The disadvantage of ISO Certification more or less involves the time and financial commitment that's required to achieve it. For instance:

  • Achieving ISO Certification can take several months to upwards of even a year, depending on the type of certification that is being sought. In other words, the process can be more than just lengthy, but complicated as well.
  • Getting certified also takes a lot of effort. Because manufacturers need to meet specific requirements throughout the entire manufacturing process, many firms may need to significantly change the way they operate in order to qualify for it.
  • The cost to achieve certification can be significant.

Despite some of these disadvantages, it's worth noting that the benefits almost always outweigh any of the disadvantages. There's a credibility aspect associated with achieving ISO Certification that carries significant weight, both when it comes to conveying the overall quality of the product and serving as a marketing tool. The bottom line is that ISO Certification is largely worth it, even if there's some upfront work and money involved in getting it.

If you're serious about your product's quality and reliability, then achieving ISO Certification should be on your priority list. Though it takes effort and some patience to acquire certification, the short-term legwork is often more than worth it in the long term. It can help elevate and take a product to the next level in terms of quality, reliability, and influencing purchase decisions.