ISO certifications: How to Avoid Lethal Recalls

After the pandemic impacted the world, people began resorting to self healing strategies like natural herbs and supplements. The supplement industry experienced a major spike in sales in 2020 and as a result, the FDA has enacted more strict guidelines for supplement brands to protect consumers. “That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations.” (8). The best way to avoid a costly recall is to work with a contract manufacturer that is certified according to the International organization for Standardization also known as ISO. International standards help to keep a level playing field in the supplement industry to maintain consistency and quality across industries and countries. ISO is an independent, international organization that develops standards to ensure the quality, safety, and efficiency of products, services, and systems. ISO standards are in place to ensure consistency. Each certification has separate standards and criteria and is classified numerically.

Why does it Matter?

Certifications can be a useful tool to add credibility by demonstrating that your product or service meets the expectations of your customers. Having your certification allows your customer to trust that you are putting out quality products. Certifications are important for many reasons. When choosing a certification body, You should evaluate several certification bodies and see which one best serves you and your customers.

Each ISO certification has its own benefits. Here’s the list of ISO certifications and its benefit:

  • ISO 9001 – The international standard for a quality management system. Helps put your customers first. The standard is used by organizations to demonstrate their ability to consistently provide products and services that meet customer and regulatory requirements and to demonstrate continuous improvement.
  • ISO 27001 – It shows that your business keeps information assets secure by protecting your systems, data and reputation. According to IT Governance USA website, the ISO 27001 “provides a management framework for implementing an ISMS (information security management system) to ensure the confidentiality, integrity, and availability of all corporate data (such as financial information, intellectual property, employee details or information managed by third parties).”(3).
  • ISO 14001 – Reduces your environmental impact. ISO 14001 sets out the criteria for an environmental management system. The ISO website says that the ISO 14001 standard “provides assurance to company management and employees as well as external stakeholders that environmental impact is being measured and improved.” (4)
  • ISO 45001 – Offers a single, clear framework for all organizations wishing to improve their Occupational Health and Safety performance. This certification is  issued to protect employees and visitors from work-related accidents and diseases. This certification was designed to reduce any factors that can cause employees and businesses irreparable harm.

ISO 22301 – Also known as the Business Continuity Management System standard. This certification is designed to ensure that a robust business continuity management system has been established, and that internal staff

  • members are fully aware of their role within the system should an incident occur. According to the BSI group, The ISO 22301 “helps organizations put business continuity plans in place to protect them, and help them recover from disruptive incidents when they happen. It also helps you to identify potential threats to your business and to build the capacity to deal with unforeseen events.”(5)

 If you are a brand owner on Amazon, you have most likely heard about the ISO certification. According to the ISO Quality Services LTD, “ISO certification is a seal of approval from a third party body that a company runs to one of the international standards developed and published by the International Organization for Standardization (ISO).”(1).

What is an ISO Certification?

ISO certification is a seal of approval from a third party body that a company runs to one of the international standards developed and published by the International Organization for Standardization (ISO).  According to ISO Quality Services ltd, “The ISO is an independent, non-governmental international organization who brings together experts to share knowledge and develop international standards that support innovation and provide solutions to global challenges.” (2).

ISO certification process and what does it mean to you

All types of businesses can get an ISO certification. Adopting international standards is an important strategic tool that can help your company tackle some of its more pressing challenges. Obtaining an ISO certification requires an investment not only in money, but time, and effort as well. However, with this investment, your brand will benefit from improved processes and controls while providing you with additional credibility with customers. Obtaining the ISO certification is simple, but not easy. It takes time developing a system of operations that meets the international standards. Here are 4 very simple steps to become certified.

  1. Develop your management system
    1. Identify your core business processes
    2. Document your process with the involvement of employees
    3. Review, approve, and distribute the documents to those who need access to the information.
  2. Implement your system
    1. Ensure procedures are being performed as they are described in your documentation.
    2. Ensure employees are trained properly for the tasks they are performing.
    3. Create effective reporting systems to cover inspection, testing, corrective actions, preventive actions, management review meetings, monitoring of objectives, statistical techniques and so on.
    4. Monitor the effectiveness of your processes through the use of measurable data, where possible.
    5. Review and take action to improve in the areas required.
  3. Verify that your system is effective
    1. Conduct the audit and review the processes and system for compliance and effectiveness. Observe, interview people and look at sample records.
    2. Identify and report strengths and weaknesses of the management system.
    3. Take corrective or preventive action as required.
  4. Register your system
    1. Select the appropriate auditing body for external registration.
    2. Submit your management system documentation for review to ensure it complies with the applicable standard.
    3. Prepare for review by an external auditor to confirm that the system’s requirements are being satisfied and that the management system is implemented effectively. (6)

When choosing an ISO Certified Manufacturer, it is important to choose the right manufacturer. There are several factors that every business owner must take into consideration. The first factor is to consider why certifications are important in the first place. We covered that earlier in this article. Another factor to consider is if the certified manufacturer utilizes the latest, most relevant standards as well as being accredited. The level of preparation you do as the business owner will only benefit your brand as you grow and scale your business.

The California Manufacturing Network website does an excellent job in describing the benefits of being ISO Certified. These Benefits are:

  1. Boost Employee Performance and Productivity
  2. Define Your Company’s Quality Control Processes
  3. Reduce Waste and Improve Efficiency
  4. Provide an Improved Customer Experience
  5. Increase Confidence in your Manufacturing Business (7)

There are some dangers to beware of in the supplement industry. When supplement brands sell their product to consumers, they are held to rigorous standards in the industry because the products are ingested by consumers and can impact their health. Failing to hire an insured, licensed, and ISO certified contractor could potentially cost you everything you own. Lethal recalls happen every year, devastative smaller companies that are unable to recover from major losses in revenue. Brands spend years building trust to their customers and can lose it all on one lawsuit if the brand owners are not careful. So always do you research when choosing your contract manufacturer.

If you are a brand owner looking for a trusted Contract Manufacturer then look no further than Pure NSM. We have over 25 years of experience with an expert team to provide customer support every step of the way.

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Key Words:

ISO Certification, Supplements, Contract Manufacturer,

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