ISO 9001:2015 Audit Checklist

Stay on track with your company with this ready-made ISO 9001 Internal Audit Checklist provided by SafetyCulture (iAuditor). Work across departments while recording and reporting results.

Support planning, auditing and record-keeping by providing a clause-by-clause checklist. Customize it easily for your own processes!

1. General Information
An ISO 9001 audit is an evaluation of your Quality Management System (QMS), to ascertain its compliance with international requirements for QMSs. An effective internal audit process will identify areas of non-compliance to ISO standards and offer opportunities for improvements.

This comprehensive audit checklist PDF, covering Clauses 4-10, can assist in conducting a systematic and in-depth audit. While not meant as an instruction script to follow verbatim, rather a guideline that ensures all key requirements are covered during an inspection process.

Launch your audit today by using SafetyCulture’s customizable internal audit templates and streamline your internal audits with QMS compliance in mind.

2. Normative References
Certification audits are inspections designed to evaluate how well your Quality Management System (QMS) conforms with ISO 9001 standards. They typically involve reviewing documentation, meeting with staff and evaluating performance; during which auditors should set clear expectations and deadlines for corrective actions to be completed by auditees.

An ISO 9001 certificate assures customers and other companies that your products and services meet international quality standards, while at the same time differentiating you from competitors. To prepare yourself for a successful audit process, use SafetyCulture internal audit software for successful outcomes.

3. Quality Policy
The Quality Policy serves as the cornerstone of your Quality Management System (QMS). It defines what an organization commits to doing and why, while simultaneously outlining vision and strategic direction. Furthermore, it serves as a basis for setting quality objectives while meeting ISO, customer and statutory/regulatory requirements.

An effective quality policy can serve as the cornerstone for change across your entire business, so be sure to communicate it and ensure everyone in the organization understands it.

Top management must regularly evaluate their Quality Management System (QMS), to make sure it still fits with business needs and the desired outcomes of QMS implementation. This often takes place during management review meetings.

4. Quality Objectives
ISO 9001 mandates companies create, implement and achieve quality objectives for an audit. Auditors look for documentation of such goals.

Corrective actions involve responding to deviations from established quality standards by identifying root causes and taking preventative steps against their recurrence.

Preventive action encompasses forecasting potential scenarios and analyzing historical data to detect any potential issues, and also involves determining whether your company has methods for monitoring customer perceptions and feedback.

The Smithers ISO 9001 Checklist is organized to match the plan-do-check-act (PDCA) structure of ISO 9001, making it simple for businesses to assess their status in relation to this requirement and identify and address any gaps which might hinder achieving certification.

5. Risk Assessment
Internal quality audits don’t need to be conducted by Certified Auditors; rather they can be provided through third-party ISO accreditation bodies like DNV, UKAS or LRQA which provide certification audits that establish compliance as well as subsequent Surveillance Audits to keep certification active.

As part of your internal audits, it is necessary to perform a risk analysis in order to identify those processes which have the most significant effect on customers and are in compliance with regulatory compliance obligations. You can do this using a gap analysis template; see the image below for reference.

The template provided below will assist in evaluating your existing system against the requirements of ISO 9001:2015 and will help identify areas in need of improvements.

6. Corrective Action
Corrective action is a proactive measure designed to address quality deviations and prevent their reappearance. With this audit checklist template, businesses can ensure their corrective actions have been implemented, documented, and assessed properly.

For an effective internal audit, it’s essential that all pertinent documentation related to the processes being audited be collected together in advance. This includes work instructions, turtle diagrams, flow charts and any other documents related to that particular process which help auditors gain a thorough understanding of how that particular process operates.

Our ISO 9001 audit checklist is structured using the PDCA management method for an intuitive experience and straightforward use. It breaks down each clause of ISO 9001 requirements so companies can assess whether they meet or don’t meet them, as well as whether certification may be possible in their organization.

7. Customer Feedback
ISO 9001 certification requires a robust customer feedback collection process. This system should demonstrate your business is focused on satisfying its customers, encouraging customer loyalty and driving overall business success.

This ISO 9001 internal audit checklist covers clauses 4 through 10, providing auditors with an efficient method to explore an organization’s quality management system. It features customizable forms to facilitate audit preparation and record keeping, with ample space provided for recording evidence of nonconformities as well as nonconformity logging. Furthermore, its use will aid both process auditing and clause-by-clause auditing and will ultimately assist your organization in attaining and sustaining ISO 9001 certification.