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Manufacturing Compliance in 2020: FDA, ISO and More

11/23/2021
|
10 mins read
written by
Dhoof Mohamed

With 2020 just a month away, it’s time for manufacturing companies to review compliance within their organizations. Being compliant with the latest regulations allows companies to be competitive in addition to ensuring quality control. Although there are many regulations companies must comply with, two important regulations to note are FDA and ISO compliance. FDA and ISO compliance represent safety and confidence in a manufacturer’s product. By being certified in both, manufacturers can stay competitive while ensuring their products are safe to use by consumers worldwide.

In regards to ISO, there’s no major change coming during the 2020 calendar year. The current strategy that the ISO deploys is part of its 2016-2020 campaign. Following the end of the 2020 calendar year, ISO will revamp its strategies and make new guidelines for companies that want to remain ISO compliant. Although ISO has several quality management guidelines for many sectors, manufacturers should hone in on ISO 9001 specifically. ISO 9001 is what sets the standards for manufacturers who have global ambitions. Since the FDA is only regional to the U.S., ISO serves as an international standard that is recognized by most countries globally in regards to quality assurance. With ISO 9001 certification, your manufacturing organization is recognized for quality products and is cemented as a legitimate, international participant in the international domain.

In addition to ISO, your company must be FDA approved to succeed in 2020 and beyond. While ISO is the international standard for quality assurance, businesses are required to be FDA approved just to be in business in the U.S. With FDA compliance, your organization may need to be compliant with many guidelines depending on the products you manufacture. This can include labeling, nutrition, packaging and more. Also, the FDA doesn’t have a uniform guideline that applies to all manufacturing companies; there are certain guidelines that are revenue-based and dependent on the volume of products you produce annually. For example, the FDA implemented new guidelines for manufacturers selling over $10 million annually in food sales.

What can your company do to stay FDA and ISO compliant in 2020?

  • Fulfill ongoing state and federal filings: it’s important to review your annual filings to ensure all your information is up to date. Depending on the state your business is located in, you might need to have annual or semi-annual filings. This will help with making sure you’re up to date with federal and state taxes along with any other requirements.
  • Maintain and renew state and federal licensing and certifications: Before starting the new calendar year, renewing any licensing and certifications should be a priority. You can check with any local business filing office to see when your certifications expire. For some manufacturing businesses, you are not able to do business until your permit renews; it’s vital to ensure you’re staying compliant to avoid any legal ramifications.
  • Maintain virtual and manual copies of records: For all FDA and ISO filings, renewals and certifications it’s very important to keep at least one sort of digital or paper copy. This makes the process of renewal, customer support and other administrative tasks much easier. With multiple copies of records, there’s increased security and more backups.
  • Understand the consequences of non-compliance: Understanding the legal and business consequences of non-compliance is the best way to stay compliant. Many businesses fail to do this until there’s a point of no return. Educating your staff and senior members on the consequences of non-compliance will help your company as a whole stay on top of compliance.