What Is ISO Certification?

ISO certification means that a company’s quality management system (QMS) conforms with the requirements of the International Organization for Standardization (ISO). The most common reason for not attaining ISO certification is an inadequate document control system or quality management system.

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Benefits of Being an ISO Certified Company

An ISO certified company has demonstrated its commitment to providing quality products that go beyond consumer expectations. This provides a competitive advantage that non-certified companies lack. ISO standards are also used by regulatory bodies around the world, making the path to compliance simpler for companies that are ISO certified.

The FAQs of ISO Certification

  • What does ISO certification cost? ISO certification cost can vary widely based on certifying body, the size of the organization seeking certification, and the time involved.
  • How long does it take to become certified? Certification time can also vary widely based on certifying body and how much work the company has to do before it can meet the requirements. The more a company does beforehand, the shorter the certification process.
  • How can I get ISO certification? ISO itself does not offer certification. However, there are many certification bodies that do. When choosing a certification body, ensure they use ISO’s Committee on Conformity Assessment (CASCO) standards.
  • What ISO standards do I need? The ISO standards that apply to individual companies vary depending on the industry they’re in and the country or countries they operate in. Generally, ISO 9001 would be a good place to start because it relates to quality management.

ISO Accreditation vs. Certification

ISO certification is obtained by a certification body after a company demonstrates that it meets the requirements set forth by ISO. A certification body can obtain ISO accreditation from a third party as an independent verification of competence. ISO itself does not offer certification, but it does offer guidelines for selecting a certification body.

ISO Certification Process

  • Determine which standard you wish to certify in: The country your company operates in and the industry it belongs to will determine which ISO standard you should certify in.
  • Gain managerial support: Complying with an ISO standard requires vast organizational changes, and making these changes is impossible if you do not have the support of management.
  • Choose a certification body: As previously mentioned, ISO does not offer certification, but there are many certification bodies that do. When choosing a certification body, make sure they use CASCO standards.
  • Stage 1 audit: The purpose of the stage 1 audit is for the certification body to understand your business and make recommendations to improve your practices.
  • Stage 2 audit: The stage 2 audit verifies that the objectives of the stage 1 audit have been met.
  • Implement a management system: Based on what your company learns during the stage 1 audit, develop a management system that fulfills the requirements of the ISO standard in question.

Using MasterControl for ISO Certification

MasterControl helps companies obtain ISO certification by providing them with software solutions that are interconnected and keep all documentation in a centralized location. Different MasterControl modules help companies pass audits, disseminate training, track standard operating procedures (SOPs), and more.

MasterControl and The FDA

Organizations all over the world use MasterControl software solutions to ensure compliance – including organizations that enforce compliance. The U.S. Food and Drug Administration (FDA) became a MasterControl customer in 2009. Since then, the FDA has expanded its use and now multiple divisions of the agency use MasterControl software solutions.