Questions about ISO 9001 implementation

Planning achievement of the objectives means defining what actions will be take, what resources are needed, who is responsible and what is the deadline. For more information, see: How to Write Good Quality Objectives https://advisera.com/9001academy/knowledgebase/how-to-write-good-quality-objectives/

2. How does Top management design an action plan to address the identified risks and opportunities?

It can be done in the same way as plans for achieving the objectives. The top management needs to define actions, resources responsibilities and deadlines for each action. For more information, see: How to address risks and opportunities in ISO 9001 https://advisera.com/9001academy/blog/2016/06/21/how-to-address-risks-and-opportunities-in-iso-9001/

3. How does an organization determine the processes needed for the quality management system and their application throughout the organization?

The purpose of the QMS (Quality Management System) is to deliver quality produc ts and services and achieve customer satisfaction. All processes that contribute to this purpose are part of the QMS. The process are applied when they are carried out as planned and are monitored and measured for their performance.

4. How does an organisation get data and information to monitor the performance and effectiveness of the QMS and its processes?

The organization needs to determine what needs to be monitored in the processes. Values to be measured are some indicators that will show you whether the process is delivering what is expected or not. For more information, see: How to define Key Performance Indicators for a QMS based on ISO 9001 https://advisera.com/9001academy/24/define-key-performance-indicators-qms-based-iso-9001/-iso-9001/

5. Can a third party auditor carry out an audit before an ISO 9001 certification audit? is it compulsory for the internal audit process to be audited before a certification audit? if it is, who will carryout the audit of the
internal process, since an auditor cannot audit their work?

Yes, third party auditor can audit the system before certification audit. It is compulsory for entire QMS to be audited before the certification audit. By internal audit you will check whether your system is complaint with the standard or not. If you are a small company and have only one internal auditor, the certification body will probably turn a blind eye, but you can train couple of people so they can audit entire company. In this way you can avoid paying third party to perform internal audits. Here you can find our free ISO 9001:2015 Internal Auditor Course https://advisera.com/training/iso-9001-internal-auditor-course/

I look to hearing from you as soon as it is reasonably practicable.

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