What are the steps for preparing for an ISO 9001 quality audit?

It's important to review the standard and understand its interpretations. Every business is different, therefore understanding the standard, and how it impacts your scope of operations and then understanding the gaps are crucial.

I try to understand the client's business environment and their main competitors. Then, I read its website to see what kind of products and services the company provides. Its mission statement and business vision may already suggest its strategic direction. From there, I'll set up a road starting with how the company has linked the external and internal environments, looking at how their processes align with market demands. So, I follow the elements of ISO 9001 and connect them with what the company has idealised.

The first step for preparing for an ISO 9001 quality audit is indeed to review the ISO 9001 standard thoroughly. Here's how we can approach this step: 1) Acquire a Copy of the Standard 2) Understand the Requirements 3) Identify Applicable Requirements 4) Interpretation and Guidance 5) Document Review: 6) Gap Analysis 7) Documentation Updates 8) Training and Awareness "Preparing for an ISO 9001:2015 audit is not just about compliance; it's an opportunity to showcase our commitment to quality, excellence, and continuous improvement." Diamond Chan

Come?amos com um diagnóstico ou Gap Analysis onde identificamos o que a norma estabelece e a empresa tem (deixar como está), n?o tem nada (criar do zero) ou tem algo que atende parcialmente (aproveitar mediante ajustes). Desta forma valorizamos a cultura da empresa e o que tiver de práticas já adequadas, sem aquele efeito da consultoria que muda tudo do nada e gera mais resistência. Agora, um item inegociável é deixar claro que o SGQ deve ser totalmente apoiado pela alta dire??o e deve ser parte dos processos e da estratégia da empresa.

Ein Qualit?tsaudit nach ISO 9001 ist kein Sprint, sondern eine Reise – eine, die mit einer gründlichen Vorbereitung beginnt. Der erste und entscheidende Schritt? Sich mit der Norm selbst vertraut zu machen. Aber, wenn die Vorbereitung auf das Audit der erste Kontakt mit ISO 9001 ist, ist das viel zu sp?t. Ein effektives Qualit?tsmanagementsystem sollte von Anfang an in der DNA der Organisation verankert sein. Es geht nicht nur darum, die Norm zu erfüllen, sondern ein QMS zu gestalten, das Wert schafft. Und was die ISO-Begriffe angeht: Ja, man sollte sie kennen. Aber noch wichtiger ist, sie in eine Sprache zu übersetzen, die jeder im Unternehmen versteht. Denn ein QMS lebt von der Beteiligung aller – nicht nur der ISO-Expert:innen.

Initiating ISO 9001 compliance starts with a thorough gap analysis to identify discrepancies between current processes and ISO standards. For established systems, an effective internal audit process, scrutinized during external audits, is crucial. Both steps are key for compliance and continuous improvement.

Ideally, a mature system should never need preparation. If the system is functioning as intended the audit just becomes an exercise. What’s important is to have an audit plan and communicate effectively so people can be available to give candid input.

Fazer uma rigorosa auditoria interna, se possível mesclando auditores profissionais contratados com a equipe auditora da empresa. Em tese, a auditoria interna deveria ter 4 vezes mais rigor, tempo e capacita??o do pessoal do que uma auditoria de certifica??o. Ah, e claro, só vai ter sucesso se tiver o total apoio da alta dire??o e uma postura de transparência, lembrando que, o que tiver de n?o conformidade, que apare?a agora para ser tratada e n?o fique escondida para virar uma bomba-relógio para a auditoria externa.

Here is what I do when conduct an ISO9001:2015 self audit: 1) Understand the standard. 2) Review documentation. 3) Develop an audit checklist. 4) Conduct audits. 5) Document findings. 6) Evaluate compliance. 7)Develop action plans. 8) Implement corrective actions. 9) Document results. 10) Continuously improve. "Embrace the journey of self-audit, where introspection leads to improvement, and scrutiny paves the path to excellence. In the pursuit of ISO 9001:2015 compliance, every internal assessment is a step towards organizational maturity and sustainable success." Diamond Chan

Ein guter Start ist aus meiner Sicht ein internes Systemaudit. Zum einen, um die Unternehmensprozesse zu erfassen und zum anderen den Ist-Zustand mit den Anforderungen der ISO9001 abzugleichen. Im Folgeschritt kann dann eine erste Prozess-übersicht erstellt werden. Danach macht es Sinn, die einzelnen Prozesse durch Prozessaudits detaillierter zu erfassen, ebenfalls unter Anwendung der Norm. Dadurch entsteht eine GAP-Analyse (inkl. fehlender Prozesse) zur Norm, die dann einzelne Arbeitspakete für die Prozesseigner erzeugt. Normkonforme Ausgestaltung sowie Beschreibung der Prozesse erfolgt im Team. Sehr wichtig sind die Schnittstellen zwischen den Prozessen, die sehr sauber definiert und beschrieben werden müssen.

Gute Kommunikation mit dem Auditor oder der Auditorin im Vorfeld ist extrem wichtig. Kl?ren Sie die wichtigen organisatorischen Aspekte wie Besonderheiten, Logistik und so weiter. Erwarten Sie aber nicht zuviel bei der Vorabkommunikation: Organisatorisches, ja – eine inhaltliche Beratung werden Sie nicht erhalten. Auditor:innen sind neutral und ihre Aufgabe ist es, im Audit selbst die relevanten Fragen zu stellen und Bereiche zu evaluieren. Und - ganz wichtig: Sehen Sie den Auditor oder die Auditorin nicht als Gegner, sondern als Verbündeten. Eine offene und transparente Kommunikation kann helfen, den Boden für ein effektives Audit zu bereiten, das echte Verbesserungspotenziale aufzeigt.

Here's what I do on how to communicate with ISO 9001:2015 auditors: 1) Be open and transparent. 2) Answer questions honestly and accurately. 3) Provide relevant documentation promptly. 4) Listen attentively to auditor feedback. 5) Collaborate on finding solutions. 6) Maintain professionalism and respect throughout the process. "In the realm of ISO 9001:2015, effective communication is the bridge that connects compliance with excellence. Clear, transparent communication fosters understanding, collaboration, and continuous improvement, paving the way for organizational success." Diamond Chan

Key things I am going to do for our next ISO 9001 external audit: 1- Clearly show where we hold all of our documents, process, training material etc. 2- Accurately answer and discuss our solutions to problems with the auditor. 3- Remain positive. 4- Ask for feedback and areas of improvement. 5- Keep a record of everything that was discussed so you can reflect.

Try to have the audit plan few weeks ahead of the audit time so you'll be able to assign SME to each area. Be knowledgeable about findings and non conformities happened at least 2 audits prior to the coming one.

Bridge the Communication Gap: Contact your certification body: Understand their audit process, timeline, and expectations. Provide necessary documentation: Submit required documents like your Quality Manual, procedures, and records in advance. Maintain open communication: Clarify any doubts you might have and keep the auditor informed about any changes to your QMS.

Initiating training packages specific for each process to be audited is an important step during the preparation for the external audit. The training package may include the following: - Overview: What is ISO, Why do we need it, your current status, etc. - Focus areas where you review again the expected topics/questions to be discussed with the auditee according to their process. - Guidance slides to important portals or SharePoint where you have your documents placed. - One slide where you discuss the behavior in audits and the rules for the auditees.

Here's a some tips on how to train and inform my staffs about ISO 9001:2015: 1. Provide clear and concise training materials. 2. Offer interactive training sessions. 3. Emphasize the importance of ISO 9001:2015 compliance. 4. Encourage questions and discussions. 5. Reinforce learning through practical examples and case studies. 6. Ensure ongoing communication and support for staff throughout the implementation process. Let's get prepared....

I have setup up an internal "Information Centre" on our internal system, this essentially acts as a document library for all of our processes, documents, how-to guides, and training materials. All of this is accessible by all members of staff, who can record whether they have read the document. This has become a very helpful tool for new starts and sharing knowledge within the entire company. The information centre can be used in any aspect but will be pivotal when it comes to our external audit.

Ein entscheidender Schritt zur Vorbereitung auf ein Qualit?tsaudit ist die Schulung und Information Ihrer Mitarbeiter. Es geht darum, ihnen den Zweck und die Vorteile des Audits klarzumachen und sie auf ihre Rollen und Verantwortlichkeiten vorzubereiten. Ein gut informiertes Team ist selbstbewusst und kooperativ – und genau das macht den Unterschied. Erinnern Sie Ihre Mitarbeiter daran, dass ein Audit kein Test ist, bei dem es darum geht, "gut auszusehen". Es geht vielmehr darum, die eigene Arbeitsweise transparent zu machen. Wenn der Auditor eine Lücke findet, ist das weder ein Weltuntergang noch ein Beinbruch, sondern eine Chance, zu lernen. Erkl?ren Sie Ihrem Team, dass offene Fragen und Unsicherheiten Teil des Lernprozesses sind.

Ein zentraler Faktor für eine reibungslose ISO 9001 Audit-Vorbereitung? Ein grunds?tzlich gut organisiertes Dokumentenmanagementsystem. Die hektische Sortierung von Dokumenten im Vorfeld des Audits zeigt oft, dass das bestehende System nicht optimal funktioniert. Ein effektives System macht diese Last-Minute-Organisation überflüssig, weil es sicherstellt, dass alle Dokumente schon sortiert und auffindbar sind – genau nach der Logik Ihrer Organisation und nicht nach der einer Zertifizierung.

só atualizando o termo desde 2015 é informa??o documentada mantida e retida. Ainda vejo muita burocracia desnecessária tornando o sistema de gest?o pesado e lento. Recentemente em uma auditoria a empresa imprimia, fazia todos assinarem, escaneava e anexava a cada procedimento (os famosos "elaborado por, revisado por, aprovado por"), acreditem! E outro ponto: a velha mania de querer restringir o sistema a somente e exatamente o que a norma exige. O sistema deve ser adequado à realidade, complexidade dos processos e porte da empresa, ent?o, sim, haverá casos em que você sentirá necessidade de ter em seu sistema um documento que a norma n?o disse que é obrigatório, mas que para você operar facilita a sua vida.

In ISO 9001:2015, clause 7.5.3 Control of documented information gives an idea about how to organize documents and record. For establishing and implementing a quality management system (QMS) and ISO 9001 certification, organizations should have four- a tier documentation structure: - Quality Policy, Quality Manual. - QMS Procedures and Quality objectives, Process Flow Charts etc. - Work Instructions, Standard Operating Procedures (SOP) etc. - Reports, Forms, Registers, Records etc.

Für eine einfache Auditierung ohne gro?e Probleme ist es meist von Vorteil die Dokumente durch die jeweiligen durchführenden zu prüfen und aktualisieren zu lassen. Dies entlastet zum einen den Qualit?tsmanager in der Vorbereitung und sorgt immer für genauere Prozessbeschreibungen und Arbeitsanweisungen. Im Audit selbst kennt der gefragte Mitarbeiter die Dokumentation dann genauer und kann genauer auf die Fragen des Auditors antworten.

Taming the Paper Tiger: Organize your documents: Create a clear and easily accessible system for storing your QMS documentation, records, and procedures. Ensure traceability: Link your documents and records to demonstrate their relationship to your QMS processes. Digitize wherever possible: Consider digital document management solutions for ease of access and efficiency.

Make a Good Impression: Prepare your facilities: Ensure your work areas are clean, organized, and reflect a commitment to quality. Have resources readily available: Make procedures, manuals, and relevant data easily accessible to the auditor. Project a positive attitude: Show enthusiasm and commitment to quality management throughout the audit process. Remember, preparation is key! By following these steps and demonstrating your commitment to continuous improvement, you can approach your ISO 9001 audit with confidence and achieve your certification goals.

Liebe Organisationen, denkt bitte auch eine ad?quate Verpflegung für alle Beteiligten. Denn nicht nur externe Auditoren, auch die eigenen Mitarbeiter sch?tzen sehr gerne Getr?nke wie Tee, Kaffee, Kakao, aber auch Wasser, Schorle, Cola u. ?. Eine kleine (!) St?rkung am Anfang und zu den Pausen sorgt für einen reibungslosen Auditverlauf. Eine Mittagspause von den berühmten 30 Minuten dürfen nicht von 10 Minuten Hinweg und 10 Minuten Rückweg gekennzeichnet sein. Vielleicht geht auch ein gut organisiertes Catering? So, nun viel Erfolg und guten Appetit.

uma excelente maneira de se preparar para uma auditoria e que sempre fa?o com meus clientes de consultoria é que cada um pegue a cláusula da norma que será de sua responsabilidade, marque os verbos "deve" e para cada verbo deve separe já previamente as evidências objetivas do atendimento. Além de já deixar tudo organizado para a auditoria, é um excelente exercício para verificar se algo n?o está faltando.

Considering the vision of the audited company, I understand that if everything maintained as an integral part of the management system means the essence of the company's management style, everyone will respond to the auditor more naturally because their routines are reality. Exaggerated preparations to receive external auditors reflect adaptations for the sole purpose of "passing the audit". It does cause concern, as it is hard to sustain false facts. It ends up being a theatre with evidence created for the auditors and not the actual results of the processes.

Preparing for an ISO 9001 quality audit involves reviewing documentation, training employees, conducting internal audits, implementing corrective actions, holding management reviews, preparing necessary documentation, communicating with employees, conducting mock audits, scheduling a pre-audit meeting, and ensuring facilities are organized and conducive to the audit process. By following these steps, organizations can demonstrate compliance with quality standards, identify areas for improvement, and ensure readiness for the external audit.

Um importante aspecto é refor?ar para que todos os auditados fiquem à vontade com o processo. Afinal, a auditoria é parte de um amplo processo de aprendizado organizacional. As perguntas dos auditores muitas vezes geram insights proveitosos para a organiza??o. Considerando que a auditoria será sobre o que a organiza??o (e suas pessoas) fazem e todos sabem o que fazem, podem ficar tranquilos e serenos e aproveitar o processo.

Internal audits are pivotal for ISO 9001 readiness, proactively spotting non-conformities prior to external scrutiny. These routine assessments ensure alignment with ISO standards, offering valuable insights for improvement. Leveraging audit findings drives corrective actions promptly, fostering a culture of continual enhancement in the quality management system. This iterative process not only meets ISO 9001 requisites but also showcases dedication to ongoing refinement, ensuring sustained adherence to quality standards and customer satisfaction.