ISO 9001
Benefit from Our Experience
An ISO 9001 Internal Audit is
a systematic, independent, and documented review of your organization's Quality Management System. It ensures the QMS
conforms to ISO 9001:2015 requirements
is effectively implemented
is efficient
drives continuous improvement.
(616) 365-9822
Our Guarantee
"We offer a no cost, no obligation initial analysis as well as accomplishment Guarantees."
Brandon Kerkstra - President of MSG
ISO 9001:2015
is the world's most widely adopted Quality Management System (QMS) standard, certifying over 1.1 million organizations across 170+ countries.
Published by the International Organization for Standardization, it provides a flexible framework to ensure products/services consistently meet customer and regulatory requirements while driving continuous improvement.
Core Purpose
ISO 9001 applies to any industry—from metal stamping to software development. It focuses on 8 Quality Principles: customer focus, leadership, engagement, process approach, improvement, evidence-based decisions, relationship management, and systematic planning.
What Triggers an ISO 9001 Internal Audit?
| Requirement | Frequency | Scope | Typical Responsiblity |
| ISO 9001:2015 Clause 9.2 | Planned intervals (typically annual) | All QMS processes + risk-based | Management (delegates to auditors) |
| Certification Maintenance | Before external audit (6 to 12 months) | Full QMS | Internal Audit Team |
| Major Nonconformities | Immediate (within 30 days) | Affected processes | Root Cause Team |
| Process Changes | Post-change (within 90 days) | Modified processes | Process Owner |
Key Metric: Audits must cover 100% of QMS processes annually using a risk-based approach (focus 70% effort on high-risk areas like production vs. 30% on support functions).
Here are the most common triggering events:
Internal Audit Triggers by Clause and Process
| Trigger Event | ISO 9001 Clause | Associated Process | Reason for Audit Trigger |
| Scheduled audit (routine) | 9.2 Internal Audit | All processes | Required to verify conformity and effectiveness at planned intervals |
| Change in organizational structure | 4.4 QMS & its processes | Management, HR, Process Ownership | Changes may affect responsibilities, authorities, and process interactions |
| Introduction of new product or service | 8.3 Design & Development | Engineering, R&D, Production | Ensures new designs meet requirements and risks are controlled |
| New machinery or technology | 7.1.3 Infrastructure | Production, Maintenance | Audit verifies capability, equipment qualification, and calibration needs |
| Process change or re-engineering | 8.5 Production & Service Provision | Operations, Quality | Audit confirms control plans and SOPs are updated and followed |
| Recurring customer complaints or warranty returns | 9.1.2 Customer Satisfaction | Customer Service, Quality | Indicates process failure requiring focused audit |
| High scrap/rework rates | 8.7 Control of Nonconforming Output | Production, Quality Control | Evidence of process nonconformity triggering reactive audit |
| Corrective actions issued | 10.2 Nonconformity & Corrective Action | Any affected process | Audit required to verify effectiveness and closure of corrective actions |
| External audit findings (registrar or customer) | 9.2 & 10.2 | Audited process | Follow-up audits required to ensure issues are corrected |
| Changes in external requirements (legal or customer) | 4.2 & 5.1.2 Customer Focus | Regulatory Affairs, Quality | Ensures compliance to new or revised requirements |
| Supplier performance issues | 8.4 Control of External Providers | Purchasing, Supply Chain | Audit verifies supplier controls and incoming inspection |
| Management Review outputs | 9.3 Management Review | Top Management | If risks or trends are identified, management may mandate an audit |
| Risk increase identified | 6.1 Actions to Address Risks | Risk Management, Operations | High-risk processes must be audited to prevent nonconformities |
| Poor KPI performance | 9.1 Monitoring & Measurement | Any process with key metrics | Triggered when targets are not met, requiring audit investigation |
| Employee turnover in key positions | 7.2 Competence | HR, Production, Quality | Ensures trained personnel are competent and documented |
| New customer launch or PPAP requirement | 8.2 Requirements for Products & Services | Sales, Quality, Production | Customer-specific requirements trigger focused audits (critical for IATF) |
| Complaints from workers or internal feedback | 5.1 Leadership & 7.4 Communication | HR, Quality, Safety | Indicates disconnect requiring internal audit verification |
Management Solutions Group
Professional Services
Focused On
Our Clients
With a combined 100 years of experience in quality and process management systems, MSG presents practical solutions to companies that want help or are struggling to obtain their first certification or working to be certified or improve in new areas of business.
Copyright 2008 - 2021 Management Solutions Group, All Rights Reserved