ISO 9001 certification is a baseline requirement for most manufacturers, yet maintaining compliance consumes a disproportionate amount of quality team resources. The annual surveillance audit cycle, preparation, evidence gathering, gap remediation, audit execution, and corrective action follow-up, can dominate quality department calendars for weeks. BPA Solutions eQMS on Microsoft 365 is designed to make compliance a byproduct of daily operations rather than a periodic scramble.
Synesis International has helped dozens of manufacturers achieve and maintain ISO 9001 certification using BPA Solutions. Drawing on our 20-year partnership and deep understanding of manufacturing quality requirements, we configure the eQMS platform to align with each clause of ISO 9001:2015, ensuring that the evidence auditors need is generated automatically through normal business operations.
Mapping BPA eQMS to ISO 9001:2015 Clauses
The power of BPA Solutions lies in how naturally it maps to ISO 9001 requirements. Document control (Clause 7.5) is handled natively through SharePoint's version management, approval workflows, and controlled distribution. Nonconformance output (Clause 10.2) is tracked through structured workflows with mandatory root cause analysis and corrective action. Internal audit management (Clause 9.2) uses built-in scheduling, checklist templates, finding classification, and CAPA linkage. Management review (Clause 9.3) is supported by automated data aggregation from all quality modules into executive dashboards.
What makes this approach different from paper-based or generic software compliance is traceability. Every action in the eQMS is timestamped, attributed to a specific user, and linked to the relevant quality record. When an auditor asks for evidence that a procedure was approved, distributed, and read by the required personnel, the system generates that proof instantly, no searching through email archives or training folders.
Automating the Compliance Lifecycle
Document Review Cycles
Power Automate triggers periodic review notifications based on document classification. Reviewers approve or request changes directly in Teams.
Audit Scheduling & Execution
Annual audit plans are configured with automatic scheduling, auditor assignment, and checklist deployment via Power Apps on mobile devices.
Training Compliance
When a procedure is revised, training assignments are automatically generated for affected personnel. Completion is tracked and reported in real time.
Management Review Data
Power BI dashboards automatically aggregate quality KPIs, NC trends, CAPA status, audit findings, customer complaints, for management review meetings.
AI-Enhanced Compliance with Q-Pilot
BPA Solutions' Q-Pilot AI assistant adds another layer of compliance support. Quality managers can ask Q-Pilot to verify whether their documented procedures cover specific ISO 9001 requirements. The AI can cross-reference quality records to identify potential gaps before an audit occurs. For training management, Q-Pilot automatically generates competency quizzes based on procedure content, verifies employee answers, and records training completion, all without manual administration.
This proactive approach to compliance represents a fundamental shift from traditional audit preparation. Instead of assembling evidence in the weeks before an audit, the eQMS continuously maintains audit-ready documentation. The quality team's role shifts from reactive evidence gathering to strategic quality improvement.
Beyond ISO 9001
BPA Solutions supports a wide range of quality and compliance standards relevant to the industries Synesis serves. The platform can be configured for IATF 16949 (automotive), ISO 13485 and FDA 21 CFR Part 11 (medical devices), ISO 22000 and FSSC 22000 (food safety), AS9100 (aerospace), and ISO 14001 (environmental). Synesis consultants have implementation experience across all of these frameworks.
Simplify Your ISO Compliance
Whether you are pursuing initial ISO 9001 certification or looking to reduce the burden of maintaining compliance, Synesis International and BPA Solutions can help automate your quality workflows. Contact us for a compliance readiness assessment.