ISO 9001: Quality Management

Orion is an experienced ISO 9001 certification company who can help with the audit. Our team has worked with thousands of companies and maintains an overall satisfaction rate over 99%. We are the only certification body to proudly say that we have never lost a client to a competitor due to quality issues. Let our team guide you through the process.
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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 99% 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.

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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.

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Breakdown of the ISO 9001 Standard

ISO 9001:2015 specifies requirements for a quality management system when an organization:

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Needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements; and

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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

Orion Assessment Service can assist your organization in achieving certification from the initial application request, and through to the required stages which include:

Sign the Agreement

1

Sign the Agreement

Orion must provide a quote for all ISO standards. The terms and conditions must be signed and returned to Orion along with any required deposit.
1

Perform GAP Audit (optional)

2

Perform GAP Audit (optional)

Prior to your Stage 1 or Stage 2 audit, Orion can perform a gap audit to identify major gaps in meeting the requirements of the standard. This independent review will identify strengths, weaknesses, and opportunities for improvement. Many companies prefer undergoing a preliminary gap audit to ensure they fully understand the standard’s requirements prior to their actual certification audits.
2

Perform Stage 1 Audit:
Readiness Review

3

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)

3

Perform Stage 2 Audit:
Certification Audit

4

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.
4

Finalize Audit Report
and Receive Certificate

5

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.

5

Perform Surveillance
or Recertification Audit

6

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.

6

Sign the Agreement

1

Sign the Agreement

Orion must provide a quote for all ISO standards. The terms and conditions must be signed and returned to Orion along with any required deposit.
1

Perform GAP Audit (optional)

2

Perform GAP Audit (optional)

Prior to your Stage 1 or Stage 2 audit, Orion can perform a gap audit to identify major gaps in meeting the requirements of the standard. This independent review will identify strengths, weaknesses, and opportunities for improvement. Many companies prefer undergoing a preliminary gap audit to ensure they fully understand the standard’s requirements prior to their actual certification audits.
2

Perform Stage 1 Audit:
Readiness Review

3

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)

3

Perform Stage 2 Audit:
Certification Audit

4

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.
4

Finalize Audit Report
and Receive Certificate

5

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.

5

Perform Surveillance
or Recertification Audit

6

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.

6

Sign the Agreement

Orion must provide a quote for all ISO standards. The terms and conditions must be signed and returned to Orion along with any required deposit.
1

Perform GAP Audit (optional)

Prior to your Stage 1 or Stage 2 audit, Orion can perform a gap audit to identify major gaps in meeting the requirements of the standard. This independent review will identify strengths, weaknesses, and opportunities for improvement. Many companies prefer undergoing a preliminary gap audit to ensure they fully understand the standard’s requirements prior to their actual certification audits.
2

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)

3

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.
4

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.

5

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.

6

Schedule a Consultation

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