It seems like there might be a slight confusion in your question. ISO 22000 and ISO 13485 are two different standards with distinct focuses.
- ISO 22000: This standard pertains to food safety management systems. If you are seeking ISO 22000 certification in Australia, you need to follow the guidelines and requirements specified in ISO 22000 for ensuring food safety in your organization. Certification is typically issued by accredited certification bodies or registrars.
- ISO 13485: This standard, on the other hand, relates to quality management systems for medical devices. If you’re looking for ISO 13485 certification, it means your organization is involved in the design, development, production, installation, or servicing of medical devices. The certification process involves demonstrating compliance with the ISO 13485 standard.
To obtain ISO certification, including both ISO 22000 and ISO 13485, organizations typically follow these general steps:
- Understand the Standard: Familiarize yourself with the specific requirements of the chosen ISO standard. This includes understanding the principles, processes, and documentation needed.
- Implementation: Implement the necessary systems and processes within your organization to meet the requirements of the chosen ISO standard. This may involve training employees, updating procedures, and making organizational changes.
- Documentation: Maintain documentation that proves your compliance with the standard. This often includes creating a quality manual, procedures, and records.
- Internal Audit: Conduct internal audits to ensure that your organization’s processes align with the requirements of the standard. This helps identify areas for improvement.
- Certification Body Assessment: Choose an accredited certification body to assess your organization’s compliance with the ISO standard. This involves a thorough audit of your processes and documentation.
- Certification Issuance: If your organization successfully passes the assessment, the certification body will issue the ISO certification.
Make sure to choose an accredited certification body, as this ensures that the certification is recognized internationally and holds credibility. Accredited certification bodies are recognized by accreditation bodies that assess their competence and impartiality. In Australia, JAS-ANZ (Joint Accreditation System of Australia and New Zealand) is a well-known accreditation body.
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