• Skip to main content
  • Skip to secondary menu
  • Skip to primary sidebar
  • Skip to secondary sidebar
  • Skip to footer
  • Home
  • Resources
    • Calculators
      • ISO Certification Cost Calculator
      • Cost of Quality Calculator
    • Lowest Cost ISO Services Quote Program
    • Online Gap Checklists
      • ISO 9001 Gap Checklist
        • ISO 9001 Gap Checklist Overview
        • ISO 9001 Gap Checklist Sample
        • ISO 9001 Gap Checklist Dashboard
      • ISO 45001 Gap Checklist
        • 45001 Checklist Gap Checklist Overview
        • ISO 45001 Gap Checklist Sample
        • ISO 45001 Gap Checklist Dashboard
      • ISO 27001 Gap Checklist
        • ISO/IEC 27001 Gap Checklist Overview
        • ISO 27001 Gap Checklist Sample
        • ISO 27001 Gap Checklist Dashboard
    • White Papers
      • AI and Quality Management: Many Questions, Few Answers
      • A Guide to Quality Risk Management
      • ISO 9001 Updates FAQ
      • Integrating ISO 27001 and ISO 9001
    • Job Salary Reports
      • Quality Professionals Salary Report
    • Free Quality Ebook
    • Glossary
  • Articles
    • Environment
    • Cybersecurity
      • Artificial Intelligence
      • Automation
      • Career
      • Certification Management
      • Continuous Improvement
      • Documentation
      • ISO 27001
      • Information Security Mgt. Systems (ISMS)
      • Management
      • Regulatory
      • Risk Management
      • Software
      • Supplier Quality
      • Sustainability
    • Management Systems
    • Manufacturing
    • Quality
      • Artificial Intelligence
      • Automation
      • Career
      • Certification Management
      • Continuous Improvement
      • Cost of Quality
      • Documentation
      • ISO 9001
      • LEAN-6 Sigma
      • Product Safety
      • Quality Management
      • Regulatory
      • Risk Management
      • Root Cause
      • Skills
      • Software
      • Supplier Quality
      • Sustainability
    • Safety
      • Product Safety Certification
      • Risk Management
  • What We Do
    • About Conformance 1
    • Group Purchasing
    • Negotiated Discounts
    • Why Buy Through Us?
  • Products/Services
    • Name Your Fee Training
    • Registrar Directory
    • Software Directory
    • Consultant Directory
  • Online Gap Checklists
    • ISO 9001 Dashboard
    • ISO 45001 Dashboard
    • ISO 27001 Dashboard
  • Contact
    • General Inquiries
    • Ask an ISO Expert
  • Login
    • Login
    • Log Out
Conformance1

Conformance1

Tools for conforming to standards, goals and processes

The 7 Most Important ISO 9001:2015 Audit Questions

Leave a Comment Filed Under: Quality-ISO 9001

Audit Management of Life Science Manufacturers Improves with the Right QMS. - Dot Compliance
  • Preparing for ISO 9001:2015 audits requires understanding of what elements an extenal registrar auditor will ask in key areas such as organizational context, risks and opportunities, and how the QMS integrates with business processes.
  • Reading this article which provides advice for internal/external auditors can be helpful audit preparation.
  • It advises auditors to focus on how organizations manage changes, capture and use knowledge, and plan to achieve quality objectives.
  • In addition to audit preparation, answering these questions can also ensure that the QMS is not just a compliance tool but a strategic asset that drives continuous improvement and overall business success.

When preparing for an ISO 9001:2015 audit, auditors must focus on several critical areas to comprehensively evaluate an organization’s Quality Management System (QMS). One key question concerns the “context of the organization,” which involves understanding internal and external factors influencing the company’s strategy and goals. This context and identifying interested parties and their requirements form the foundation for assessing risks and opportunities, which is central to the ISO 9001:2015 standard.

Another essential aspect is how the organization plans and achieves its quality objectives. Auditors should examine the specific actions, resources, responsibilities, and timelines that have been put in place to meet these objectives. Additionally, understanding how the QMS is integrated into the broader business processes is crucial. This integration reflects the shift of ISO 9001 from a pure quality management standard to a strategic management tool that influences every part of the business.

Managing change and capturing organizational knowledge are also vital components of the audit. ISO 9001:2015 emphasizes proactive planning for changes and learning from past experiences to improve future outcomes. Auditors should seek evidence that changes are effectively managed and that lessons learned from successes and failures are documented and used to enhance the QMS. By focusing on these areas, auditors can help ensure that the QMS meets the standard’s requirements and drives continuous improvement and business success.

Key question areas are:

  • What can you tell me about the context of your organization such as goals, purpose, strategies, etc.
  • Who are your interested parties (i.e. customers, investors, communities in which you are based) and what are their requirements?
  • How do you capture and use knowledge to aid continuous improvement?
  • What risks and opportunities have been identified, and what are you doing about them?
  • What are your quality objectives and what plans are in place to achieve them?
  • How has your QMS been integrated into your operational/business processes?

Read the full article

Filed Under: Quality-ISO 9001

Reader Interactions

Leave a Reply

You must be logged in to post a comment.

Primary Sidebar

Search

Email Newsletter

News delivered to your inbox

Name(Required)
Newsletter Preferences(Required)
This field is hidden when viewing the form
This field is for validation purposes and should be left unchanged.

Related Items

Help us improve our tool

Have a suggestion for improving our ISO Gap Analysis Checklist? Let us know.

Secondary Sidebar

Categories

Recent Posts

  • Important Role of Thermal Imaging for Condition Monitoring
  • The Top 10 Security Awareness Training Solutions For Business
  • Improving Data Cleaning by Learning From Unstructured Textual Data
  • Operational Key Performance Indicators (KPIs) 2.0: A Smarter Way to Visualize and Use Your Metrics
  • Mastering the 8D Problem-Solving Methodology: A Guide to Root Cause Analysis in Manufacturing

Footer

Important Resources

Cost of Quality Calculator

ISO 9001 Online Gap Analysis

ISO Certification Cost Calculator

Free Quality Ebook

Process Improvement Survey

ISO 9001 Glossary

 

Recent Posts

  • Important Role of Thermal Imaging for Condition Monitoring
  • The Top 10 Security Awareness Training Solutions For Business
  • Improving Data Cleaning by Learning From Unstructured Textual Data
  • Operational Key Performance Indicators (KPIs) 2.0: A Smarter Way to Visualize and Use Your Metrics
  • Mastering the 8D Problem-Solving Methodology: A Guide to Root Cause Analysis in Manufacturing

Search

Contact Us

About Us

Privacy Policy

 

Copyright © 2025 · Conformance1 · Log in