Many companies rely on quality management according to ISO 9001. The conformity of the QM system to standards must be checked at regular intervals through an internal audit. A company can't just introduce such a management system - it also has to maintain and develop it on a long-term basis. Non-conformities must be eliminated and improvements and their potential must be discovered and used. Trained internal auditors check the management system for compliance with standards and effectiveness. Conformity or non-conformity refers to compliance or non-compliance with the standard requirements of ISO 9001. The quality management system is based on these requirements. The process of self-verification of a management system is called internal audit.
The word “audit” comes from the Latin “audire,” which can be translated as “hear, listen, interrogate.” In general, an audit compares whether the current state corresponds to the specified target state, with which an ISO 9001 audit checks the requirements of the standard with the implementation in the company. What is often overlooked is that, in addition to looking for non-conformities, there is great potential in finding opportunities for improvement. In this way, many new impulses can be found for the management system. In order to achieve this, internal audits must be aligned with the target aspects within the company. The tool for this already exists - the audit program. Read below how you can plan and carry out an internal audit and, if necessary, realize additional economic benefits.
Your training as an internal auditor ISO 9001
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What are the objectives of an internal audit ISO 9001?
An internal audit in accordance with ISO 9001 serves to ensure that processes meet the requirements of the standard and internal quality standards. ISO 9001 is an internationally recognized quality management system standard that helps companies deliver consistent and high quality products or services.
The importance or objective of an internal audit according to ISO 9001 lies in various aspects. Above all, it aims to improve quality by uncovering weaknesses in the quality management system and identifying opportunities for improvement. Internal audits also help to identify possible risks and uncertainties in business processes. This allows appropriate measures to be taken to minimize or control these risks. A fundamental principle of ISO 9001 is continuous improvement. Internal audits are an integral part of this approach as they encourage companies to regularly review and optimize processes, procedures and results.
In summary, ISO 9001 internal audits play an essential role in ensuring the effectiveness of a quality management system. They promote quality, compliance, risk management and continuous improvement. This ultimately helps strengthen a company's competitiveness and long-term success.
What does strategy-oriented auditing mean?
A fictitious organization sets priorities in audit planning, building on the results of previous audits and the management review. The QMB reduces the scope of auditing of the “maintenance” process in favor of the “personnel development” process. The reason for this is the increasing number of complaints caused by inadequate qualifications. It actually sounds logical, but unfortunately it is still the case that an internal audit against the sawtooth effect is only perceived and used as a “dress rehearsal” for external audits.
This is a waste because the organization does not exploit the audit's potential for improvement as a contribution to the company's success. An internal ISO 9001 audit should therefore take into account the target aspects in the company by having the responsible person(s) derive the audit objectives from the company and (individually for each process and audit). Based on the audit objectives, the audit can then be individually defined and planned for the process/process chain.
Audit meaningful processes more clearly
The basic information on implementing internal audits according to the quality management standard ISO 9001 can be found in DIN EN ISO 9001. However, since these are very rudimentary, you should also use DIN EN ISO 19011 as a guide. This guide contains a lot of practical detailed knowledge about planning and carrying out your audits. Basically, like all audits, internal audits to support the corporate strategy require effort. Therefore, you should carefully consider which audits make sense.
The matrix shown above will help you with this consideration. You can use this matrix to work out which processes have the greatest influence on the successful realization of quality goals. From the perspective of DIN EN ISO 9001, these processes should be audited more frequently and more extensively due to their greater importance. You can implement these specifications in a planned and organized manner using an audit program (e.g. an annual audit plan).
Depending on the corporate culture, the internal auditor and process owner can coordinate the process of this checklist before the audit.
How is an internal audit planned?
As with all audits, the audit client (usually the top management in an internal audit for quality management according to ISO 9001) gives the starting signal by ordering the audits by releasing the audit program. You must then derive the audit objectives of the individual audits. The detailed audit objective sets the basic direction for each audit and determines the purpose of the audit. Therefore, individual audit goals should now be derived and specified for each audit from annual quality goals. The quality goal “reduce lead times” can be derived from the individual audits, as can be seen in the table above. For the process audit “Manufacturing, assembly and shipping” the derived audit objective is “Identify and reduce idle and waiting times, simplify and shorten routes”.
Once the processes and detailed audit objectives are known, qualifiedAuditorsfor one or more audit teams. If the audit team is divided into lead and co-auditors, the lead auditor should be a generalist, i.e. a professional in conducting audits. In this case, the co-auditor usefully complements the audit team with expert knowledge of the processes or areas being audited. The audit plan to be created should contain at least information about the processes, the process owners, auditors, the duration, the location and the references to the relevant standard specifications. The auditors must now identify the relevant documents (audit criteria) with those responsible for the process as a basis and preparation for the audit. This includes:
- Quality management manual, Q policy, Q goals,
- process descriptions,
- Work and test instructions,
- Key figures, ...
In order to create a strategy-oriented checklist, this documentation must be read, commented on and subjected to a general check from the perspective of the audit objectives. The process audit checklist consists of three parts:
- 1st part: Questions about the process environment (basic questions, relatively the same)
- 2nd part: Strategy-specific questions (developed individually, per audit and audit objective)
- 3rd part: Questions to determine standard conformity with regard to the corresponding management systems, e.g. DIN EN ISO 9001 (static, always the same).
Strategically align your audit goals with your company’s goals!
Your internal audit ISO 9001 should always take into account the company's goals in addition to the normative requirements. Therefore, the goals of the QM system should also be derived from the goals of your organization. Even if internal audits are mandatory, you should not see them as a necessary evil, but rather recognize the opportunities that an internal audit ISO 9001 offers you. The more the audits are aligned with the company's goals, they also create incentives for the application of the management system. This in turn improves your processes, saves time, reduces costs and permanently increases the quality of your products or services. The audit program is the ideal tool for implementation. The audit plan can also be aligned with it. The audit program is used for long-term planning and preparation of all audits, while the audit plan is the detailed description for a specific audit.
In the audit plan you should then set priorities based on the company's goals, audit program and experiences from previous audits. An example: The scope of the audit of the maintenance process is reduced by the QM representative, but the “personnel development” process is audited in an expanded manner. Frequent customer complaints that indicate poor employee qualifications are the reason for this adjustment. Sounds logical, but unfortunately it is still the case that internal audits are often perceived and used as just a “dress rehearsal” for external audits. The improvement potential presented as a contribution to the company's success is not exploited - a clear waste. For this reason, it is important that internal audits are directly aligned with the company's goals. To do this, you must derive the goals from the targets for the company and for the individual processes. The derived audit objectives are then used to define the “audit route” individually through the process chain/process.
How are internal audits carried out?
After the opening discussion, the first impression that was derived from the documentation is randomly checked with those affected using concrete examples on site. Rule: The “strategic” introduction to the audit (e.g. by questioning the goals) is followed by the main part with the three-part question system. At the end of the audit, the strategic exit takes place (e.g. by asking the question: What should/will be different in a year?). During the audit, the rules of communication that promote the audit should be observed, for example by asking open questions in order to obtain as much information as possible. Closed questions are only useful for making a decision (e.g. necessary improvement measures).
Evaluate audits, create reports and determine benefits
At the end of an internal audit, findings must be made; the assessment of the questions should always be formulated openly and should be known to those being audited:
- Positive observations (= strength),
- Serious or critical deviation (= weak point),
- Minor deviation (= training point),
- Potential for improvement (= opportunity).
Auditors are consistent in appreciating strengths and identifying areas for improvement. Only identified potential for improvement brings long-term benefits to the company! All findings are included in the audit report. This is then distributed to the audit clients.
Your ISO 9001 audit template package
Templates/sample documents:Use ourAudit Package ISO 9001with all the necessary, directly usable audit templates and sample documents and carry out your next internal audit in your company efficiently! With our checklists, forms and guidelines, we provide you with comprehensive support in all areas of action. Immediately usable sample templates, checklists and work aids will help you with all aspects of your internal audit according to ISO 9001.
Check the effectiveness of the audit follow-up measures
The implementation ofAudit follow-up actionsAfter the audit, the change must be monitored and examined using ZDF (numbers, data, facts). The elimination of the non-conformity is only complete once the follow-up measures have passed the effectiveness test.
Who carries out an internal ISO 9001 audit in the company?
All companies that have an ISO 9001 quality management system or are in the process of implementing it are obliged to carry out regular internal audits to check the performance of the management system. The internal auditor is responsible for this. This person must have the appropriate specialist knowledge to audit according to the internal auditing guidelines, ISO 19011. This includes, for example, knowledge of audit principles and audit methods, but also knowledge of the company, the industry and the company's internal QM system. The number of internal auditors in the company depends on the size and complexity of the company.
You should specifically train individual employees in the area of internal audit ISO 9001. The auditor also checks their qualifications in the certification audit. This internal auditor is then explicitly familiar with the process of an ISO 9001 audit and is therefore a proven expert in his standard. An internal auditor in ISO 9001 quality management has different focus areas and different topic knowledge than, for example, an internal auditor according to IATF 16949 or ISO 14001.
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Als Experte im Bereich Qualitätsmanagement nach ISO 9001 kann ich Ihnen umfassende Informationen zu den in dem Artikel genannten Konzepten geben. Der Artikel beschäftigt sich mit dem Qualitätsmanagement nach ISO 9001, internen Audits und der Bedeutung strategieorientierten Auditierens. Lassen Sie uns diese Konzepte im Detail betrachten:
Qualitätsmanagement nach ISO 9001
Die ISO 9001 ist eine international anerkannte Norm für Qualitätsmanagementsysteme, die Unternehmen dabei unterstützt, konsistente und hochwertige Produkte oder Dienstleistungen bereitzustellen. Die Normkonformität des Qualitätsmanagementsystems muss regelmäßig durch interne Audits überprüft werden.
Ein internes Audit nach ISO 9001 dient dazu sicherzustellen, dass die Abläufe den Vorgaben der Norm und den internen Qualitätsstandards entsprechen. Es wird von ausgebildeten internen Auditoren durchgeführt, die das Managementsystem auf Normkonformität und Wirksamkeit überprüfen. Dabei werden Nichtkonformitäten abgestellt und Verbesserungsmöglichkeiten aufgedeckt.
Strategieorientiertes Auditieren bezieht sich darauf, dass interne Audits im Unternehmen gezielt auf die Zielaspekte ausgerichtet werden. Dabei sollten die Auditziele aus den Unternehmens- und Prozesszielen abgeleitet werden. Durch die Ausrichtung der Audits auf die Unternehmensziele können Verbesserungspotenziale identifiziert und genutzt werden. Dies trägt zur Stärkung der Wettbewerbsfähigkeit und des langfristigen Erfolgs des Unternehmens bei.
Zusammenfassend lässt sich sagen, dass interne Audits nach ISO 9001 eine wesentliche Rolle bei der Sicherstellung der Effektivität eines Qualitätsmanagementsystems spielen. Sie dienen der Verbesserung der Qualität, der Konformität, dem Risikomanagement und der kontinuierlichen Verbesserung. Durch strategieorientiertes Auditieren können Unternehmen zusätzlichen wirtschaftlichen Nutzen realisieren.
Bitte beachten Sie, dass die Informationen in diesem Artikel auf den angegebenen Quellen basieren.