ISO 9001 8.2.3 Audit Checklist Questionaire

Preparing for an audit by either an external certification body or internal quality audit requires thorough preparation. With this checklist in hand, it will allow you to examine key manufacturing processes and prepare for your audit with ease.

Process descriptions (commonly known as turtle diagrams) should be accessible, documented and controlled.

1. What is the purpose of the audit?
The ISO 9001 standards offer businesses guidance on how to produce and distribute their products efficiently, such as communicating with customers, assessing customer requirements, tracing product, etc. These requirements help minimize mistakes made during production or distribution that could potentially prove costly for companies.

An audit report can provide a useful way for stakeholders to evaluate a company’s records and processes, while increasing confidence in financial statements while mitigating investor risks. These reviews may also benefit shareholders, potential investors, lenders, etc. who review such reports regularly.

2. What is the scope of the audit?
No matter if an audit is being conducted externally by an independent certification body or internally by your organization, scoping early can greatly increase efficiency and effectiveness. An auditor plan or other planning documents should include an official statement of scope.

An auditor might opt to inspect all items with recorded values exceeding a certain threshold in order to ensure that every population of items have been checked and validated.

Audits may also be conducted specifically on one product or service. This approach can be useful when there are concerns regarding data integrity or product/service quality; doing so can reduce false positives while decreasing audit timeframes.

3. What are the objectives of the audit?
Clause 8.2.3 of ISO 9001 standards requires companies to establish and follow procedures for communicating with customers, including determining customer requirements and providing updates regarding products or services they’re ordering.

Under this requirement, businesses are also expected to monitor and analyze customer feedback regarding the quality of their products or services in order to identify areas for improvement within their organization.

Companies should maintain records of review outcomes in an organized fashion and ensure they can easily be accessed by employees who require them. This may involve using either document management software or physical files depending on your organization’s preferences, with retention periods established appropriately and keeping these documents secure from being lost or damaged.

4. What are the findings of the audit?
ISO 9001 standards strive to reduce errors when creating products or services, by outlining stringent guidelines on product design, development, manufacturing, distribution and customer communication. This allows companies to demonstrate they have established customer engagement methods.

This checklist covers the requirements of clauses 4 through 10, making it useful whether preparing for a surveillance audit from a certification body or conducting internal quality audit.

This document presents correlation matrices between the new ISO 9001:2015 standard and its predecessor (ISO 9001:2008) as well as details regarding any changes made to clause structure or terminology.

5. What are the recommendations of the audit?
Recommendations are an integral component of an audit and should encourage entities to take actions that will rectify root causes of issues or enhance operations. According to ANAO policy, recommendations must be specific enough for monitoring and assessment without being too prescriptive.

The Department of Health provides its responses to recommendations in a Recommendation Implementation Status Summary (RISS) document which is distributed after every audit report release. This RISS includes statements regarding whether or not the Department agrees with each recommendation, implementation status updates and, if necessary, reasons why certain recommendations cannot be implemented by explaining why the Department cannot support them.

Health’s Audit Committee periodically assesses implementation of all recommendations made by ANAO and internal audit, using iterative spreadsheets and email communication as tools.