ISO 9001: Quality Management
Why Work with Orion on ISO 9001?
Orion has performed thousands of ISO 9001 audits and is a trusted partner you can rely on for your quality management certification needs.
We are currently the only firm endorsed by three industry associations to audit their members, and we reward this trust by only using auditors that have an overall customer satisfaction rating of 98% or better. Our auditors have over 15 years of auditing experience, making them seasoned and proven professionals.
Our vast experience means that we truly know and understand the ins and outs of quality management, including its typical processes, software, and terminology. As a result, our auditing services are efficient and effective, and we will work with you to establish mutual goals up front to make sure your needs are fully met. If you are looking to certify to multiple standards, we also provide integrated audits so you can achieve certification to multiple standards in one audit (e.g. ISO 9001 / ISO 14001 / ISO 45001 / R2), ultimately saving you both time and money.
About ISO 9001
This international standard applies to any organization that produces a product or delivers a service. ISO 9001 certified organizations are required to continually improve performance and customer satisfaction, while addressing a number of requirements, including consumer needs and industry regulations. This is achieved through applying a consistent framework to all processes to create a dependable result for all the organization’s customers.
Breakdown of the ISO 9001 Standard
ISO 9001:2015 specifies requirements for a quality management system when an organization:
Needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements; and
Aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
The 7 Quality Management Principles of ISO 9001:2015 are:
- Customer focus
- Leadership
- Engagement of people
- Process approach
- Improvement
- Evidence based decision making
- Relationship management
Overview of the Audit Process
Sign the Agreement
Sign the Agreement
Perform GAP Audit (optional)
Perform GAP Audit (optional)
Perform Stage 1 Audit:Readiness Review
Readiness Review
This review is conducted to determine whether your organization is ready to move to Stage 2 Audit (Certification Audit) by confirming that:
- The management system addresses all the requirements of the standard.
- The management system has been implemented and the client is ready for the Stage 2 Audit (Certification Audit).
Note that a full management review and internal audit must occur prior to conducting the Stage 2 Audit (Certification Audit)
Perform Stage 2 Audit:Certification Audit
Certification Audit
This onsite audit is conducted to ensure that the processes and documents examined during the Stage 1 Audit (Readiness Review) are in use and that the system is implemented according to the requirements of the standard.
The key deliverables from this stage include:
- An audit report detailing positive aspects, issues for resolution (non-conformances), and areas for improvement.
- A recommendation regarding your registration.
Finalize Audit Report and Receive Certificate
Finalize Audit Report and Receive Certificate
The results from the Stage 1 and Stage 2 audits are reviewed to ensure that all Orion accreditation requirements have been met and a proper recommendation made. At this point, approval is given to either certify, seek clarification, or not certify.
Perform Surveillanceor Recertification Audit
Perform Surveillance or Recertification Audit
Registration is based on a 3-year cycle. To maintain your certification, your organization must participate in an onsite review each year. The first two are surveillance audits and only look at a portion of your system, whereas the third-year review (re-certification) is a more comprehensive audit and looks at your overall system for continued effectiveness.
Sign the Agreement
Sign the Agreement
Perform GAP Audit (optional)
Perform GAP Audit (optional)
Perform Stage 1 Audit:Readiness Review
Readiness Review
This review is conducted to determine whether your organization is ready to move to Stage 2 Audit (Certification Audit) by confirming that:
- The management system addresses all the requirements of the standard.
- The management system has been implemented and the client is ready for the Stage 2 Audit (Certification Audit).
Note that a full management review and internal audit must occur prior to conducting the Stage 2 Audit (Certification Audit)
Perform Stage 2 Audit:Certification Audit
Certification Audit
This onsite audit is conducted to ensure that the processes and documents examined during the Stage 1 Audit (Readiness Review) are in use and that the system is implemented according to the requirements of the standard.
The key deliverables from this stage include:
- An audit report detailing positive aspects, issues for resolution (non-conformances), and areas for improvement.
- A recommendation regarding your registration.
Finalize Audit Report and Receive Certificate
Finalize Audit Report and Receive Certificate
The results from the Stage 1 and Stage 2 audits are reviewed to ensure that all Orion accreditation requirements have been met and a proper recommendation made. At this point, approval is given to either certify, seek clarification, or not certify.
Perform Surveillanceor Recertification Audit
Perform Surveillance or Recertification Audit
Registration is based on a 3-year cycle. To maintain your certification, your organization must participate in an onsite review each year. The first two are surveillance audits and only look at a portion of your system, whereas the third-year review (re-certification) is a more comprehensive audit and looks at your overall system for continued effectiveness.
Sign the Agreement
Perform GAP Audit (optional)
Perform Stage 1 Audit:Readiness Review
This review is conducted to determine whether your organization is ready to move to Stage 2 Audit (Certification Audit) by confirming that:
- The management system addresses all the requirements of the standard.
- The management system has been implemented and the client is ready for the Stage 2 Audit (Certification Audit).
Note that a full management review and internal audit must occur prior to conducting the Stage 2 Audit (Certification Audit)
Perform Stage 2 Audit:Certification Audit
This onsite audit is conducted to ensure that the processes and documents examined during the Stage 1 Audit (Readiness Review) are in use and that the system is implemented according to the requirements of the standard.
The key deliverables from this stage include:
- An audit report detailing positive aspects, issues for resolution (non-conformances), and areas for improvement.
- A recommendation regarding your registration.
Finalize Audit Report and Receive Certificate
The results from the Stage 1 and Stage 2 audits are reviewed to ensure that all Orion accreditation requirements have been met and a proper recommendation made. At this point, approval is given to either certify, seek clarification, or not certify.
Perform Surveillanceor Recertification Audit
Registration is based on a 3-year cycle. To maintain your certification, your organization must participate in an onsite review each year. The first two are surveillance audits and only look at a portion of your system, whereas the third-year review (re-certification) is a more comprehensive audit and looks at your overall system for continued effectiveness.