ISO 9001: QMS and PDCA

Source: ISO 9001:2015 — Quality management systems — Requirements. This page models the real standard content from clause 4 (Context of the organization) and the PDCA cycle described in the Introduction.

The standard

ISO 9001 is the world’s most widely used quality management standard. It defines a process-based QMS built on the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking.

The PDCA cycle applies to all processes and to the QMS as a whole:

• Plan: establish the objectives of the system and its processes, and the resources needed to deliver results
• Do: implement what was planned
• Check: monitor and (where applicable) measure processes and the resulting products and services against policies, objectives, requirements and planned activities
• Act: take actions to improve performance

Roles

role Org             { name "Organization" }
role TopManagement   { name "Top management" }
role QualityManager  { name "Quality manager" }
role ProductionDept  { name "Production department" }

Context of the organization (Clause 4)

4.1 Understanding the organization and its context

process DetermineContext {
  name "Understanding the organization and its context"
  actor Org
  modality SHALL
  validate_provision {
    Provision_4_1_a
    Provision_4_1_b
  }
}

provision Provision_4_1_a {
  condition "The organization shall determine external and internal
  issues that are relevant to its purpose and its strategic direction
  and that affect its ability to achieve the intended result(s) of its
  quality management system"
  modality SHALL
  reference { ISO9001-doc#4.1a }
}

provision Provision_4_1_b {
  condition "The organization shall monitor and review information
  about these external and internal issues"
  modality SHALL
  reference { ISO9001-doc#4.1b }
}

4.2 Understanding the needs and expectations of interested parties

process DetermineInterestedParties {
  name "Understanding the needs and expectations of interested parties"
  actor Org
  modality SHALL
  validate_provision {
    Provision_4_2
  }
}

provision Provision_4_2 {
  condition "Due to their effect or potential effect on the
  organization's ability to consistently provide products and services
  that meet customer and applicable statutory and regulatory
  requirements, the organization shall determine: (a) the interested
  parties that are relevant to the quality management system; (b) the
  requirements of these interested parties that are relevant to the
  quality management system"
  modality SHALL
  reference { ISO9001-doc#4.2 }
}

4.3 Determining the scope of the QMS

process DetermineScope {
  name "Determining the scope of the quality management system"
  actor Org
  modality SHALL
  validate_provision {
    Provision_4_3
  }
  output {
    ScopeDocument
  }
}

provision Provision_4_3 {
  condition "The organization shall determine the boundaries and
  applicability of the quality management system to establish its
  scope"
  modality SHALL
  reference { ISO9001-doc#4.3 }
}

4.4 QMS and its processes

process EstablishQMS {
  name "Quality management system and its processes"
  actor Org
  modality SHALL
  validate_provision {
    Provision_4_4_1
    Provision_4_4_2
  }
}

provision Provision_4_4_1 {
  condition "The organization shall establish, implement, maintain and
  continually improve a quality management system, including the
  processes needed and their interactions, in accordance with the
  requirements of this International Standard"
  modality SHALL
  reference { ISO9001-doc#4.4.1 }
}

provision Provision_4_4_2 {
  condition "The organization shall: (a) determine the inputs required
  and the outputs expected from these processes; (b) determine the
  sequence and interaction of these processes; (c) determine and apply
  the criteria and methods needed to ensure the effective operation and
  control of these processes"
  modality SHALL
  reference { ISO9001-doc#4.4.2 }
}

The PDCA cycle as nested processes

process QMS {
  name "Quality management system"
  actor Org
  modality SHALL

  process Plan {
    name "Plan: establish objectives and resources"
    actor TopManagement

    process DetermineContext {
      name "Determine external and internal issues"
      actor Org
    }

    process AddressRisks {
      name "Address risks and opportunities"
      actor QualityManager
    }

    process SetObjectives {
      name "Establish quality objectives"
      actor QualityManager
    }
  }

  process Do {
    name "Do: implement what was planned"
    actor ProductionDept

    process ControlProduction {
      name "Control production and service provision"
      actor ProductionDept
    }
  }

  process Check {
    name "Check: monitor and measure processes"
    actor QualityManager

    process AuditResults {
      name "Evaluate performance and effectiveness"
      actor QualityManager
    }
  }

  process Act {
    name "Act: take actions to improve performance"
    actor TopManagement

    process ContinualImprovement {
      name "Continually improve the QMS"
      actor TopManagement
    }
  }
}

Risk-based thinking

Risk-based thinking is essential for achieving an effective QMS. The standard requires organizations to plan and implement actions to address risks and opportunities:

provision Provision_6_1 {
  condition "When planning for the quality management system, the
  organization shall consider the issues referred to in 4.1 and the
  requirements referred to in 4.2 and determine the risks and
  opportunities that need to be addressed to: (a) give assurance that
  the QMS can achieve its intended result(s); (b) enhance desirable
  effects; (c) prevent, or reduce, undesired effects; (d) achieve
  improvement"
  modality SHALL
  reference { ISO9001-doc#6.1 }
}

What this demonstrates