ISO 9001 Audit Trail
A Practical Guide to Process Auditing Following an Audit Trail
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1.0 Introduction This is the second edition of ISO 9001 Audit Trail and the intention is to get “Back to Basics” and cover the importance of auditing the Primary and applicable Secondary Processes to ensure the specified requirements are being met. The first edition was produced following the publication of an article on “Audit Trail”, which was developed by David John Seear and has been accepted by the ISO 9001 Auditing Practice Group (APG). It has also been highlighted in his letter in Quality World November 2009 and in a 700 word article published in the December 2009 issue of IRCA Inform, all of which address the topic and emphasises the importance of the “Audit Trail”. This, the second edition, has been modified following a feed back request to include Secondary Processes and an example of auditing a service organisation. There have been only a small number of concerns over the general content of the first edition and therefore only minor clarification has been needed to improve the message and to illustrate how to audit a service organisation. This document has been developed to encourage audit improvement. ISO 9001 is a tool - not an Objective. It is a tool for the Organisation to ensure that it has the systems in place to enable them to consistently provide a product/service that meets the specified requirements. It is also the criteria used by the Auditors to measure whether the Organisations have the Management System Requirements, Management Responsibilities, Resource Management, Product Realisation and finally the Measurement Analysis and Improvement in place to allow them to meet specified requirements and move forward. 2.0 THE OBJECTIVE OF THE STANDARD It is important to remember the original and still stated purpose of ISO 9001 The ISO 9001 2008 international standard specifies requirements for a Quality Management System where an Organisation: - 1.1 a) Needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements. To achieve this the processes must be audited following an AUDIT TRAIL to demonstrate the organisations ability to meet those requirements. KEY 6: - From the above it is obvious that all auditing is about ensuring that the organisation can consistently meet the specified requirements. 3.0 BACK TO BASICS There are many “key” aspects to carrying out professional audits. There is the need to audit the process, defined in ISO 9000 as: - “3.4.1 Process set of interrelated activities which transforms inputs into outputs”. It is essential to fully understand the term Process when carrying out an Audit. A process is where you understand the input carry out an activity that then produces the desired output. If the process being audited is not understood then it is impossible to do a professional audit. There is however a critical omission to these defined Terms and Definitions and that is “Audit Trail”. This is one of the most important aspects of Auditing although it is not defined in ISO 9000:2005. It is this link between the two terms that enables the audit to be professional. 5.0 HOW TO START THE AUDIT Auditors should always remember why the audit is taking place. The primary purpose of an audit is to ensure that the processes being audited are capable of consistently meeting the specified requirements. It should be noted it is impossible for a 2nd or 3rd Party auditor to carry out a Professional Audit of an Organisation unless the auditor takes the time to understand the specification of the product/service required including any statutory and regulatory requirements that relate to the product/service itself. It is this Professional approach to Auditing that allows the auditor to identify the strengths and weaknesses in the process and decide if that Organisation is capable of consistently meeting those specified requirements. Internal audits should also follow an audit trail, however the audit scope is normally just a small part of the overall process. All of these audits need the auditor to know what the requirements are for the process being audited and should verify that the process with its controls and systems is able to achieve those requirements.
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About the Book
This book has been revised to coincide with the issue of the ISO 9001 Family of Standards by the same author. The intention is to improve the standard of auditing, especially audits carried out under the banner of the ISO 9001 standard. The ISO 9001 standard is quite capable of allowing organizations, certification bodies, and auditors to judge if an organization is capable of consistently providing product or service that meets the customer and applicable statutory and regulatory requirements. At the present time, however, there is no common understanding about what the ISO 9001 audit should achieve. The aim of this book is to explain what auditing is capable of achieving, in particular the method of carrying out audits. There is, however, a need to improve the understanding of the ISO 9000 Family of Standards, and to this end, appendix C contains the first five pages of that book. Auditing can be costly and time–consuming, and for it to be effective, it needs to give tangible benefits. This book will enable organizations and other interested parties to judge if their auditing activities are effective and beneficial. It enables them to examine their approach to audits and compare them with the techniques used within this book.
About the Author
David John Seear C.Eng CMarEng FIMarEST FCQI CQP is a Chartered Engineer who spent 12 years at sea ending up as Chief Engineer with a combined First Class Chief Engineers certificate before leaving and joining Shell. He left Shell U.K after 20 years service where he had been Head Of Quality and Performance for Shell UK Materials. One of the departments reporting to him was Quality Appraisal whose purpose was to carry out 2nd party audits for Shell UK and Shell den Hague. He represented the CBI on BSI QMS 22 for 6 years and represented the U.K. on ISO 9000 TC 176 for 3 years. He was a member of the Standards Development Group (SDG) in the U.K and attempted to encourage the SDG to justify the changes against the scope of the standard under review. Some recent changes to quality standards had no real justification for the changes that had been made. In fact some recent changes are now seen to be counterproductive. He has lived in Brunei and Abu Dhabi and carried out Audits and/or Training throughout the world including Africa, North and South America, Russia as well as the areas lived in namely the Far East (e.g. Singapore, Malaysia, Brunei) and was the regional manager for a Certification Body based in the Middle East working in UAE, Kuwait, Qatar, Bahrain to name just a few of the countries he was responsible for. He is an IRCA Principal Auditor of 25 years experience and runs PDQ Management Services that carries out Training, Auditing, Consultancy and Lecturing on various management issues including procurement and Improving Management Systems. email daveseear@btinternet.com