This inspection gives a complete analysis of your organizations using ISO 9001 standards. Jurisdiction USA Publish Date Name Gap Analysis Checklist Item Number Question Yes No N/A Observations. Has the organisation established a process for an internal audit of the QMS? ISO 9001:2015 Internal Audit Checklist AC.9001-2015 R0 Page 5 of 14 The organization shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements. The organization shall ensure that the. Insert your company’s name or logo. ISO 9001:2015 Audit Checklist System & Process Compliance Auditing www.iso-9001-checklist.co.uk Page 4 of 78 This methodology should be uniformly applied to all types of internal audit (gap analysis, system audits and process audits) that your organization will likely.
What is an ISO Internal Audit? The purpose of an internal audit is to assess the effectiveness of your organization’s quality management system and your organization's overall performance. Your internal audits demonstrate compliance with your ‘planned arrangements’, e.g. the Quality Management System (QMS) and how its' processes are implemented and maintained.
'The most effective audits are those during which auditors simply talk with the auditees to learn everything they can about the process being audited.' Phillips, from ISO 9001:2015 Internal Audits Made Easy This checklist is designed as a supplement, and is not intended to replace ISO 9001. ISO 9001:2015 Requirements Leadership 5.1 Leadership and commitment 5.1.1 5.1.2 Customer focus 5.1.2 Are risks and opportunities that can affect conformity of products and services determined? Is the ability to enhance customer satisfaction determined and addressed? 5.2.1 Does it contain a commitment to satisfy applicable requirements?
Your organization will likely conduct internal audits for one or more of the following reasons:
| ISO 9001:2015 | ISO 9001:2008 | Summary of Changes | ||
| 9.2 | Internal Audit | 8.2.2 | ISO Internal Audit | This requirement is unchanged from the requirements of ISO 9001:2008 Clause 8.2.2 – Internal Audit. |
Auditing relies on a number of principles whose intent is to make the audit become an effective and reliable tool that supports your company’s management policies and policies whilst providing suitable objective information that your company can act upon to continually improve its performance.
Adherence to the following principles are considered to be a prerequisite for ensuring that the conclusions derived from the audit are accurate, objective and sufficient. It also allows auditors working independently from one another to reach similar conclusions when auditing in similar circumstances.
The following principles relate to auditors.
Competence level may be measured by training, participation in previous audits and experience in conducting audits. Auditors may be external or internal personnel; however, they should be in a position to be impartial and objective.
When internal personnel are selected to perform an audit, a mechanism needs to be established to ensure objectivity, for instance, a representative from another department may be selected to do the audit.
Audits are demanding and require various forms of expertise. The size of the audit team will vary pending the size of the organization, size and type of operations and the scope of the audit.
Before the audit, prepare thoroughly! Spending time in preparation will make you much more effective during the audit - you will become a better auditor. Auditors should not skip this step as it provides much needed value to the audit. Taking the time to prepare and organize actually saves time during the audit.
You should have an up-to-date audit schedule and a well defined audit plan for each process. Be sure to communicate the audit schedule to all parties involved as well as to Top Management as this will help reinforce your mandate.
Gather together all the relevant documented information that relates to the process you will be auditing. Look at process metrics, work instructions, turtle diagrams, process maps and flowcharts, etc. If applicable, collect and review any control plans and failure mode effects analysis work sheets too. Review these thoroughly and highlight the aspects that you plan to audit. Using the documented information in this way ensures they become audit records.
Your organization’s documented information may not cover all of the requirements that may be relevant to the process. If certain information is not available, it may become your first audit finding, not bad for the pre-audit review!
Certain information and linkages should be audited. Some are required and some are simply good audit practice. Putting these sections into a worksheet format gives auditors a guide to follow, to ensure the relevant links are audited.
Good auditors realize very early on that they are dealing with personalities as much as processes and systems. Whilst the intent of the audit a serious one, often light humor, politeness and diplomacy are the best ways to build rapport. It is vital every effort is made to reassure those being audited that the audit’s primary function is to drive improvement, not to name and shame.
If you are new to auditing, acknowledge this fact, be open and honest. It is also important to explain to the auditees that they are free to express their views during the audit. Remember that you, the auditor, are also there to learn.
Always discuss the issues you have identified with the auditees and always provide guidance on what is expected in terms rectifying any non-conformances or closing out observations you raised. Let the auditees know they are welcome to read your notes and findings; the audit is not a secret.
Try not to be drawn into arguments concerning your observations. It is never appropriate to directly name people in the audit report as this may lead to defensiveness which is ultimately counter productive.
'Internal auditing is an independent, objective assurance and consulting activity designed to add value and improve an organization’s operations. It helps an organization accomplish its objectives by bringing a systematic, disciplined approach to evaluate and improve the effectiveness of risk management, control and governance processes.'
Source: International Professional Practices Framework (IPPF), The Institute of Internal Auditors Research Foundation. Florida, USA, January 2011
Internal audits are commonly referred to as ‘first-party audits’ and are conducted by an organization to determine compliance to a set of requirements which might arise from standards like ISO 9001:2015, as well as customer or regulatory requirements.
There are common methods of internal auditing that may be used to determine compliance:
The system audits are best undertaken using the internal audit checklist. This type of audit focuses on the organization’s quality management system as a whole, and compares the planning activities and broad system requirements to ensure that each clause or requirement has been implemented.
The process audit is an in-depth analysis which verifies that the processes comprising the management system are performing and producing in accordance with desired outcomes. The process audit also identifies any opportunities for improvement and possible corrective actions. Process audits are used to concentrate on any special, vulnerable, new or high-risk processes.
The product audit may be a series of audits, at appropriate stages of design, production and delivery to verify conformity to any specified product requirements, such as dimensions, functionality, packaging and labeling, at a defined frequency.
So, how is an audit conducted?
An internal audit checklist will help you to determine the extent to which your organization’s quality management system conforms to the requirements by determining whether those requirements have been effectively implemented and maintained. The
Gather the whole audit package together, in an organized manner. The rest of the work instructions, flowcharts, notes and relevant papers should be gathered into the audit package as supporting records. All findings should also be documented on your corrective action forms. The audit summary and the corrective action forms should be attached to the audit package, which now becomes the audit record. Only the summary report and corrective actions need be given to the process owner.
These basic audit questions will help guide the audit in the right direction since the answers they provide often unlock the doors to information the auditor requires in order to accurately assess the particulars of a process.
Consider these common audit questions:
The audit schedule is divided up to reflect each section of ISO 9001 You should determine which of these sections are of greatest relevance to your business; in other words, which processes, should there be problems, will affect your customers the most. These are the processes that your company must make certain remain stable and consistent. You might wish to schedule these key processes for additional audits, perhaps two or even three times per year.
The audit schedule provides the following benefits:
You do not need a 'Certified Auditor' to undertake internal quality audits of your management system and its processes.
Certified Auditors normally work for external, third-party accreditation bodies such as DNV, UKAS, LRQA, who will perform the Certification Audit, that is, assess your organization's management system against the requirements of ISO 9001 and provide your certificate of compliance. They will also conduct Surveillance Audits to ensure that your certification is maintained. They would not be involved in day-to-day internal auditing operations.
Internal Auditors can be people from within your organization who posses the necessary competence and impartiality to undertake internal audits in order to ensure effective operation of your organization's processes. The Internal Auditors often report to the Quality Manager.