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Explore Important Facts about ISO 9001 Quality Management & ISO 13485

ISO certification means a lot to the business owners regardless of their industry. An ISO certification assures customers that the products they are buying and the services for which they are paying are worthwhile. It makes customers come back to a certified business repeatedly. Iso standards have been classified into two categories. One is a generic category and the other one is specific to certain industries. Generic ISO standards include ISO 9001 quality management, ISO 14001 environmental management, ISO 45001 OHS management etc.

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Explore Important Facts about ISO 9001 Quality Management & ISO 13485

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  1. Explore Important Facts about ISO 9001 Quality Management & ISO 13485

  2. ISO certification means a lot to the business owners regardless of their industry. An ISO certification assures customers that the products they are buying and the services for which they are paying are worthwhile. It makes customers come back to a certified business repeatedly. Iso standards have been classified into two categories. One is a generic category and the other one is specific to certain industries. Generic ISO standards include ISO 9001 quality management, ISO 14001 environmental management, ISO 45001 OHS management etc. While standards such as ISO 13485 medical devices belong to the second group. Among all of these standards, some of the most popular ones are ISO 9001 and ISO 13485. Here, we will discuss these two vital ISO standards.

  3. ISO 9001 ISO 9001 is a generic standard that is applicable to every industry and organizations of all sizes. This standard encourages businesses to develop and maintain effective quality management systems that can save both time and money. Moreover, quality assurance systems improve the overall efficiency and customer relationships of an organization.

  4. ISO 9001 has multiple benefits, such as: Helps senior management build and maintain an effective quality management process • • Helps an organization identify areas of responsibility Encourages top management to consider improving processes by identifying, planning and implementing the most effective and efficient process for better quality outcomes. •

  5. ISO 13485 standard is developed for medical device manufacturing companies in particular. In other words, it is an industry-specific ISO standard. Certification to ISO 13485 provides all the aforementioned benefits of ISO 9001. The only difference is, it focuses only on a single industry- the medical device manufacturing industry. An organization dealing with medical devices should be compliant with the guidelines specified by ISO 13485, and should seek ISO certification to help improve their reputation and assure customers of compliance. Without ISO 13485 certification, you never know what opportunities you are missing out on. In many situations, ISO certification is a requirement, a ticket to working with a particular client or achieving industry acceptance or in some cases FDA compliance. If you need any help regarding ISO 9001 or ISO 13485 certification, please feel free to contact ComplianceHelp LLC.

  6. Business Name: Compliancehelp Consulting, LLC Phone No: 877-238-5855 E-mail Id: info@quality-assurance.com Website: https://www.quality-assurance.com

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