Case study

ISO 9001:2015 Quality management system development and audit preparation


Situation Appraisal

A manufacturer of civil engineering and infrastructure products had an approaching ISO 9001:2015 audit by their certification body. The client suspected that their current management systems met neither the criteria of ISO 9001:2015 nor the organisation’s own documented management system which threatened their certification and business operations. In addition, the organisation had outstanding nonconformities from a previous audit that needed to be addressed before the scheduled audit.

The client’s original Quality Management System was never fully implemented or adopted by staff. Furthermore, the organisation had experienced significant growth and the existing systems were no longer effective in supporting the organisation.

The client got in touch to discuss how we could support them to prepare for the certification audit, and to identify and address areas that needed improvement.


  • We met with the client’s leadership and staff to understand the full scope of work required
  • We developed a plan and gave key staff an overview of the project, ISO 9001:2015 and the quality management principles
  • We performed a full system assessment to ISO 9001:2015 and the organisation’s own documented management system
  • We identified areas of conformity, nonconformity and any significant observations against the assessment criteria
  • We also identified opportunities for improvement within the scope of the assessment
  • We produced a gap analysis work document that showed areas of nonconformity and our recommended corrective actions
  • We produced a comprehensive audit report showing our assessment findings
  • We trained staff on ISO 9001 criteria relevant to their roles
  • We worked with leadership and staff to implement effective systems and address the nonconformities found
  • The client was aware that certain assessment criteria could not be fulfilled in the time available before their audit—in these instances, we helped them put a plan in place to demonstrate that the nonconformities were being addressed and that the correct resources had been made available
  • We participated in the certification body audit, helped the client answer audit questions and helped present evidence to demonstrate conformity


  • The client successfully passed the audit and retained their ISO 9001:2015 certification
  • Nonconformities that could not be addressed in the time available were known and understood. A plan was in place to address outstanding issues
  • The organisation had new processes in place to support operations and sales growth
  • Existing processes were better able to support the organisation
  • The organisation culture shifted towards continual improvement
  • Staff felt supported
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