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Certification Process

Certification Process

The ISO certification process typically involves gap analysis, documentation preparation, implementation, and audits by a certification body to assess compliance with ISO standards and ensure effective management systems.

It's important to note that the ISO certification process requires commitment, resources, and ongoing dedication to maintaining and improving the management system. While achieving certification demonstrates an organization's commitment to quality, it is just the beginning of a journey toward continual improvement and excellence.

The ISO certification process involves several key steps to assess an organization's compliance with a specific ISO standard and its ability to maintain a management system that meets the requirements of that standard. While the specifics can vary slightly depending on the certification body and the ISO standard being pursued.

  1. Gap Analysis: The organization conducts an initial assessment to identify any gaps between its current management system practices and the requirements of the ISO standard it intends to certify against. This step helps determine the scope of work needed to achieve certification.

  2. Documentation Preparation: The organization develops or updates its management system documentation, including policies, procedures, work instructions, and records, to align with the requirements of the ISO standard. Documentation should accurately reflect the organization's processes and how it meets the standard's requirements.

  3. Implementation: The organization implements the documented management system throughout its operations, ensuring that processes are followed, and employees are trained on their roles and responsibilities within the system.

  4. Internal Audit: The organization conducts internal audits to assess the effectiveness of its management system and identify areas for improvement. Internal audits are typically performed by trained personnel who are independent of the processes being audited.

  5. Management Review: Top management reviews the organization's management system to ensure its continued suitability, adequacy, and effectiveness. Management review meetings provide an opportunity to address any issues or concerns identified during internal audits and to make decisions regarding improvement initiatives.

  6. Stage 1 Audit (Documentation Review): The certification body conducts a Stage 1 audit to review the organization's management system documentation and assess its readiness for the certification audit. This audit verifies that the organization has addressed all the requirements of the ISO standard in its documentation.

  7. Stage 2 Audit (Certification Audit): The certification body conducts a Stage 2 audit, also known as the certification audit, to verify the organization's compliance with the ISO standard in practice. This audit involves onsite visits to assess the implementation and effectiveness of the management system against the standard's requirements.

  8. Certification Decision: Based on the findings of the Stage 2 audit, the certification body makes a certification decision. If the organization's management system meets the requirements of the ISO standard, it is awarded certification.

  9. Surveillance Audits: After certification, the organization undergoes periodic surveillance audits conducted by the certification body to ensure ongoing compliance with the ISO standard. Surveillance audits typically occur annually or semi-annually, depending on the certification body's requirements.

  10. Recertification Audits: Every few years (usually every three years), the organization undergoes a recertification audit to renew its certification. Recertification audits are similar to initial certification audits and involve a thorough assessment of the organization's management system against the ISO standard's requirements.

ISO Certifications

ISO 9001:2015

ISO 9001:2015 is an international standard that sets out the criteria for a quality management system (QMS).

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ISO 14001:2015

ISO 14001:2015 is an internationally recognized standard for environmental management systems (EMS)

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ISO 22000:2018

ISO 22000:2018 is an international standard that specifies requirements for a food safety management system (FSMS).

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ISO/IEC 27001:2022

ISO/IEC 27001 is an information security management system (ISMS) implemented according to this standard is a tool for risk management, cyber-resilience and operational excellence.

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ISO 45001:2018

ISO 45001:2018 is an international standard that specifies requirements for an occupational health and safety management system (OHSMS).

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ISO 13485:2016

ISO 13485:2016 is an international standard that specifies requirements for a quality management system (QMS) specifically tailored for the medical device industry.

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Ensuring quality is at the core of our mission

We adhere to the highest industry standards, ensuring that our processes, methodologies, and services consistently meet and exceed regulatory requirements and customer expectations. We believe in the power of continuous improvement. Through regular evaluations, feedback mechanisms, and ongoing training, we constantly refine our practices to optimize quality and efficiency.

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