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ISO 9001:2015 Audit Checklist: How to Create It for an Internal Audit for QMS

One of the most important checking tools in a Quality Management System (QMS), is the internal audit. The requirements of ISO 9001:2015 are very clear that this is a critical element of your QMS; and, as you want to know how your processes work, your internal audits become a key resource. ISO 9001:2015 Audit Checklist are a widely used and important tool to insure that when performing an internal audit.

What is the ISO 9001: 2015 standard required by the internal audit?

ISO 9001:2015 Audit ChecklistTo better understand the why and how of internal audit checklists, it is helpful to understand what the ISO 9001:2015 requirements state about why we do internal audits. The ISO 9001:2015 internal audit is there to perform two functions:

  • to make sure that the processes are meeting the planned arrangements that the company has identified for the process in the QMS and any requirements that the IOS 9001:2015 standard has in place for that process
  • to make sure that the process is effectively implemented and maintained

So, when creating ISO 9001:2015 audit checklists, you want to include the information needed to verify these two process results correctly.

How to create an ISO 9001:2015 Audit Checklists to check conformance?

An internal audit is there to witness the outcome of a process through a review of records or witnessing the actions of the employees, and to then compare this to the planned arrangements for the process to see if what is being done is what was planned. As can be seen above, there are two sets of planned arrangements to check: those required by ISO 9001:2015 and those that the company has put in place for their process to work.

An audit checklist is basically a set of questions that the auditor wants to ask, or activities that the auditor wants to witness, in order to verify the planned arrangements as above. The checklist is created by reviewing the ISO 9001:2015 standard and any documented procedures or undocumented processes for the activity to determine what should happen. The ISO 9001:2015 audit checklist could include questions on supplier evaluation and a review of the supplier audit reports that have been collected to see if they are done when determined by the QMS.

The checklist can include more than just questions; it can also include statements from the procedures that the auditor wants to check. The checklist is a tool for the auditor, and it is not something that the controlled entity should complete, so any format or questions and statements will be useful for the auditor to ensure that all the important parts of the process are checked will work.

 

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3 Tips to Ensure a Successful ISO 9001:2015 Audit

ISO 9001:2015 is a widely used standard for quality certification and also one of the most stringent. This standard ensures that all aspect of a contract manufacturer’s business are well-managed and continually improved, including key processes, management roles and responsibilities, ISO 9001:2015 documentation, customer satisfaction, employee training, vendor performance and internal audits.

Certification audits are used to evaluate the effectiveness of and assess conformity to documented Procedures and Work Instructions, and identify opportunities for improvement. During an ISO 9001:2015 audit, a manufacturer’s quality system is measured against the requirements of the standard. More than just a method of checking practice against procedure, audits are a powerful tool in manufacturing improvement processes. Below please find 3 tips to ensure a successful audit:

1. Review ISO 9001:2015 documentation: Ensuring that all company ISO 9001:2015 documentation, from packing slips to check sheets to invoices is thorough and accurate is essential to completing an audit successfully. Common elements to monitor include missing signatures, incomplete fields, and outdated revision levels. Also, check the handwritten notes on drawings and work instructions – these can be triggers that indicate a need for a new revision to the document.

2. Communicate: During the ISO 9001 audit, employees should answer questions openly and honestly. If they do not know the answer to a question, or if the question is not related to their role, they must inform the auditor. Referring an auditor to a Department Manager or referencing where the answer can be found is always acceptable. Providing misinformation under the guise of being helpful, or speculation on hypothetical situations, can potentially make things difficult for everyone involved. Employees should focus on answering the questions at hand.

3. Involve Everyone: Employees should be encouraged to contribute to the QMS and informed of improvements generated from their input. This is a powerful motivator and enhances a culture of employee engagement. When one has a stake in the success, they are more motivated to participate. It also makes one more knowledgeable of the QMS to enhance the processes in their departments.

ISO 9001:2015 certification requires manufacturers to constantly review, improve and document the processes in their facility to ensure that they are running at the highest standard possible. The main objective of ISO 9001:2015 certification audit is to enable manufacturers to evaluate their quality management systems, identify opportunities for improvement, and generate creative, effective and efficient solutions. Audits are performed to check practice against procedure, but the benefits to the manufacturer extend far beyond this objective. ISO 9001:2015 audits ensure that manufacturing companies are optimized, competitive, and deliver the highest quality and value to their customers

 
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Posted by on April 26, 2018 in ISO 9001 Certification

 

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Procedures ISO 9001 Internal Auditing

A regular internal audit may be a demand for all businesses if they need to realize ISO certification that may be a cluster of quality-control standards, aimed toward up product or service quality. ISO 9001 internal audit permits the corporate to assess and review their procedures and establish whether or not they square measure creating progress.

iso 9001 internal audit proedures

Management Commitment

The first factor that needs to take care while internal auditing for ISO 9001 is whether or not the creation and implementation of Quality Management System and procedures has the backing and support of upper management. While not this motivation and commitment, the implementation of those procedures can quickly fail. Management should designate somebody to manage the implementation of all processes and procedures, still as review them to confirm that they are up to this point which goals are met.

Quality Objectives

All company objectives relating to the standard of a service or product ought to be created in such the way that they’re measurable and it’s an interior audit procedure to spot and establish however this can be managed. Objectives ought to be tailored to the company’s resources to confirm that they’re possible and any goals or aims ought to be documented, with this info communicated to any or all staff.

Customer Focus

An auditor should have to establish however management ensures that ever client’s necessities are determined and met through the ISO 9001 procedures and processes place into place. Doing this can be determine areas at intervals the business wherever resources may be centered so as to best reach client satisfaction that may be a core goal of any organization.

Management Review

It is the responsibility of the board of upper management to frequently meet and review the progress and implementation of ISO 9001 quality standard procedures and systems and it’s an ISO 9001 internal audit procedure to spot whether or not this can be done and the way frequently it’s applied. Minutes and records of previous conferences ought to be filed therefore on be without delay on the market for reference and every meeting ought to follow a collection example or agenda, to spot whether or not progress is being created at intervals the standard system. This can be applied by examination current success or results against those recorded within the previous meeting.

 

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