ISO 9001 compliance made practical

Achieving ISO 9001:2015 compliance requires the ability to translate regulatory requirements into structured processes, clear responsibilities, and auditable evidence across the entire Quality Management System. Without a centralized electronic Quality Management System, maintaining consistency, traceability, and control quickly becomes complex.

BPA Solutions simplifies this challenge through a clear standard-to-feature mapping that shows how each ISO 9001 clause is supported by concrete eQMS capabilities, from document control and risk management to audits, performance monitoring, and continuous improvement. Built on the Microsoft 365 ecosystem, BPAQuality365 and BPAMedical365 embed the Plan Do Check Act methodology into daily operations.

Download our ISO 9001:2015 guidebook to explore the full clause-by-clause mapping and understand how BPA supports efficient, sustainable compliance.

ISO/IEC 27001 made practical

Clause 4

CONTEXT OF THE ORGANIZATION

Understand the organization and its context, the needs and expectations of interested parties, while determining the scope of the QMS and its processes.

How BPA eQMS helps
  • List internal and external factors and create a formatted document in the compliance documents. Leverage the SWOT tool to list strengths/weaknesses for internal factors, and threats/opportunities for external ones

  • List stakeholders and create a formatted document in the compliance documents. Optionally maintain the stakeholder register directly in the Stakeholder Management module.

  • Define the scope of the QMS and create a formatted document in the compliance document. Leverage prebuilt workflow to approve and publish documents and collect collaborator training awareness.

  • Maintain a process-centered QMS by defining core processes and sub-processes, assigning process owners, and linking supporting documentation and performance indicators to each process. Use indicators and audit results to identify gaps and improvements, then update processes and documented information accordingly.

Concerned BPA modules and tools
  • Document Control

  • Stakeholder Management

  • Process Management,

  • Audit Management

  • Indicator Management

Clause 5

LEADERSHIP

Top management must ensure the effectiveness of the QMS by aligning quality policy and objectives with the organization’s strategy, promoting risk-based thinking and the process approach, providing resources, communicating requirements, and defining clear responsibilities.

How BPA eQMS helps
  • Define and maintain leadership commitments, policies, and responsibilities as controlled documents. Monitor customer-focused and QMS performance indicators, and use audit outcomes to confirm implementation and drive improvements.

  • Maintain the quality policy as a controlled document in compliance document, so the approved version is always available, traceable, and kept current.

  • Prepare and publish the organization chart including QMS responsibility, list and import plants/departments, list and import jobs, list and import collaborators.

Concerned BPA modules and tools
  • Document Control

  • Audit Management

  • Process management

  • Indicator Management

Clause 6

PLANNING

Identify and manage risks and opportunities affecting QMS performance and customer satisfaction, set and monitor measurable quality objectives aligned with the quality policy, and implement structured, controlled changes to ensure effectiveness and integrity of the QMS.

How BPA eQMS helps
  • With the prebuilt SWOT tool and risk module, you can manage strategical and operational risks. Mitigate risks with the controls and actions tools. Create a customer survey form with MS Forms, and leverage prebuilt workflows to collect customer feedback data in the eQMS. 

  • With the prebuilt objectives and indicators tools, you can measure key indicators periodically and track corrective actions.

  • Leverage the prebuilt change management module to track related corrective actions, update affected processes in Process Management and create CAPA Actions for required corrective actions and for tracking their effectiveness until closure. Assess change-related risks and mitigation actions in Risk Management.

Concerned BPA modules and tools
  • Document control

  • Risk Management

  • CAPA actions

  • SWOT

  • Customer Feedback

  • Indicators

  • Objectives

Clause 7

SUPPORT

Provide and manage adequate resources, ensure employee competence and awareness, define effective internal and external communication, and maintain controlled documented information to support the implementation, operation, and effectiveness of the QMS.

How BPA eQMS helps
  • Manage collaborators, equipment and organizational knowledge with BPA’s prebuilt modules and tools. Maintain competence and training records in to ensure required roles have appropriate skills and awareness.

  • Track collaborator’s training awareness for important documents. The lessons learned tool is key to highlight important facts and communicate them. Leverage task in MS Planner, discussion flows, and Teams to communicate around key QMS events.

  • Create/import/publish/update documents in the compliance documents module. Optionally use Purview to create classification rules and retention policies. Provide access to collaborators based on their roles and create the needed SharePoint groups for permissions.

  • Leverage the prebuilt form module and automated workflows to manage forms and securely store their records. 

  • Implement Q-Pilot to allow collaborators to get instant answers to their quality-related questions.

Concerned BPA modules and tools
  • Competency Management

  • Equipment Management

  • Organizational Knowledge

Clause 8

OPERATION

Ensure controlled planning and execution of processes for delivering products and services, including customer requirements, design, supplier management, production, release, and nonconformity handling.

How BPA eQMS helps
  • Create/import operating procedures and documents in the compliance documents module and publish documents for further training.

  • Use the prebuilt supplier management module to manage, approve and evaluate suppliers as well as manage all their related documents.

  • Efficiently manage nonconformities and related corrective actions with the nonconformity management module.

  • Easily plan supplier audits leveraging the preconfigured audit form and workflow to alert auditees, provisioning audit questions, and collecting signatures, link findings and corrective actions. 

Concerned BPA modules and tools
  • Document Control

  • Change Management

  • Risk Management

  • Nonconformities management

  • CAPA actions management

  • Audit Management

Clause 9

PERFORMANCE EVALUATION

Monitor, measure, and analyze QMS performance and customer satisfaction, conduct planned internal audits, and perform regular management reviews.

How BPA eQMS helps
  • The eQMS includes preconfigured modules for managing clients with customer feedback and complaints with related actions. Customer feedback and complaints are created by using the nonconformity form, leveraging the prebuilt workflow for investigating, planning actions, and verifying effectiveness.

  • Leverage preconfigured modules to manage audits with related nonconformities and actions. Internal audits are planned leveraging the preconfigured audit form and workflow for alerting auditees, provisioning audit questions and collecting signatures. A Power BI report is available for monitoring audits.

  • Plan and run management reviews with related findings and actions, use prebuilt workflows for automated notifications, use prebuilt Power BI reports for QMS performance and generate review reports.

Concerned BPA modules and tools
  • Nonconformities management

  • Audit management

  • CAPA actions management

  • Power BI Extension

  • Stakeholder management

  • Management reviews

Clause 10

IMPROVEMENT

Identify improvement opportunities, address and prevent nonconformities, and continually enhance the effectiveness of the QMS using data, audits, and feedback.

How BPA eQMS helps
  • Create nonconformities by using the nonconformity form and leverage the prebuilt workflow for investigating, planning actions, and verifying effectiveness. Optionally, the nonconformity form can be leveraged to manage opportunities for improvement.

  • Create corrective actions by leveraging the action form, and the dedicated prebuilt workflow for tracking and monitoring actions.

  • Easily create a customer survey form with MS Forms, and leverage prebuilt workflows to collect and monitor customer feedback.

  • Leverage the management review module to verify eQMS efficiency and drive continuous improvement.

Concerned BPA modules and tools
  • CAPA Actions Management

  • Nonconformities management

  • Audit Management

  • Indicator Management

  • Management Reviews

  • Change Management

  • Risk Management

  • Document Control

ISO 9001:2026 readiness made simple

Early indications show that ISO 9001:2026 will continue to build on the solid foundations of the 2015 version. New drafts point toward modernizations that reflect today’s business environment and quality culture expectations, such as the need for enhanced risk-based thinking, digital transformation integration, sustainability and social responsibility, stronger stakeholder engagement and an evolving performance management.

Get our guidebook to learn how BPA’s eQMS helps organizations align with this updated standard and simplify certification readiness.

Reinforcing leadership and improvement cycles 

BPA Process Management helps organizations document how leadership influences improvement, accountability and performance

Updating audits and internal assurance

BPA Audit Management ensures that internal audits remain aligned with the new structure, effective and evidence driven

Ensuring full document traceability

BPA Document Control maintains complete traceability, version control and audit-ready documentation

Refreshing awareness and training

BPA Training Management allows teams to efficiently manage and track document training related activities

Reinforcing modern risk-based thinking

BPA Risk Management allows organizations to improve how risks and opportunities are identified, assessed and addressed

Strengthening sustainability and environmental considerations

BPA’s sustainability tools support environmental influence analysis and responsible business practices.

Download our practical guidebook to explore a detailed feature-to-standard mapping

and discover how ISO 9001 compliance can be embedded into daily operations, supporting certification, long-term compliance, and a stronger information security posture.