Category Archives: ISO 9001

The Importance of an ISO 9001:2015 Internal Auditor

ISO 9001 states that the purpose of an ISO 9001 internal audit is to determine whether a quality management system of an organisation:

  1. Meets your requirements for a QMS, and the requirements of the standard; and
  2. Is implemented and maintained effectively.

ISO 9001 internal auditorThe most important task of the ISO 9001 internal auditor is to continuously monitor the effectiveness of the QMS and help senior staff determine whether the quality objectives are aligned with the organisation’s business objectives.

In smaller organisations, the internal auditor often helps to prepare for ISO 9001 certification or maintenance visit. Therefore, it is very useful to have a solid knowledge of the requirements and processes involved in the ISO 9001 certification audit.

The smaller organizations will probably only need an ISO 9001 internal auditor, but larger organizations often require multiple internal auditors to focus on different departments. Appointing internal auditors for different departments increases accountability and reduces the possibility of errors.

Their work, and the help they provide, isn’t finished after the QMS has been implemented and the audit has been completed. They will continue to monitor the QMS and make recommendations to maintain compliance.

The general auditing skills required to become an ISO 9001:2015 internal auditor can also be used in environments outside those related to the Standard. Furthermore, internal auditors are valuable to organisations that audit third-party suppliers, as they can check that suppliers have adequate security controls in place.

The E-learning course on ISO 9001:2015 Certified Internal Auditor Training gives you the knowledge and skills you need to audit against the standard effectively, driving the continual improvement of your organisation’s QMS. Those who pass the included exam will receive the ISO 9001:2015 certified internal auditor training certificate.

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Posted by on September 29, 2018 in ISO 9001, iso 9001 audit


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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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Why is ISO 9001:2015 Certification a Good Idea for Your Organization?

The benefits of ISO 9001 are not overstated; companies large and small have obtained great benefits from the use of this standard by discovering cost and efficiency savings. Here are the explanations of six main benefits and why they are important:

Improvement of your credibility and image – Because ISO 9001 is an internationally recognized standard, it has become the basis for creating a quality management system around the world. When a company is looking for a supplier, it is often necessary to have a QMS based on ISO 9001 to be considered. Getting ISO 9001:2015 Certification can be a powerful marketing tool.

Improvement of customer satisfaction – One of the principles of quality management that underlies the ISO 9001 requirements is to improve customer satisfaction by planning and trying to meet customer requirements.

Improve process integration – By observing the overall process interactions through the ISO 9001 process approach, improvements in efficiency and savings can be found more easily. This is done by eliminating the waste that might occur during the process transfer.

Improve your evidence for decision making – A second quality management principle of ISO 9001 is the need to use evidence-based decision making. In addition, by monitoring the process that is improving, you can see how much improvement has occurred based on the data.

Create a continual improvement culture – Continual improvement is a third quality management principle of ISO 9001. By adopting this culture to improve organizational processes and result, you will find efficiencies and cost savings, including the use of systematic processes in case of problems reduce the impact of the problem and increase the speed of recovery. By making this continuously, improving year after year, the company can see continuing benefits from this.

Employees Engagement – Employees who participate in the process improvements they work with are happier and more engaged. Engaged employees are more productive and will help the company better improve and save, especially when they understand how the quality of the process depends on them.

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Posted by on April 7, 2018 in ISO 9001


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Does ISO 9001:2015 Procedure Document Require for Addressing Risks and Opportunities?

With the release of ISO 9001:2015, there is a new requirement for the identification and assessment of risks and opportunities for the Quality Management System (QMS). These new requirements have created confusion not only about what should be done, but also about in ISO 9001:2015 documentation, what should be documented about risks and opportunities for your QMS. There are a few activities that must be carried out in relation to the risks and opportunities of the QMS:

  • Identify the risks and opportunities – what should be addressed to ensure that your QMS does what is necessary, is based on the desired results, prevents or reduces the results of the problem and obtains an improvement?
  • Plan your response – What actions should you take to address the risks and opportunities identified?
  • Integrate into your QMS – how can these plans be adopted and adapt to the usual activities so that they can happen easily?
  • Evaluate effectiveness – How will you know if your actions have worked, or need to be updated? This involves analyzing the information and management review to assess the effectiveness.

Do you need a document ISO 9001:2015 procedure?

It is important to note that there is no mandate for documented information for any of these steps. The standard itself does not state that it is necessary to document ISO 9001:2015 procedures that concerning risks and opportunities, just that you must perform the processes in the section above, as well as update the risks and opportunities as an outcome of process non-conformities.

For instance, you could choose to assess your risks and opportunities at a management meeting, identify a risk, decide what you want to do and make sure that employees who are executing the QMS process are aware of what they need to do and you could then claim that you are compliant with the ISO 9001:2015 requirements, even if none of these are written.

Therefore, in accordance with ISO 9001: 2015, a documented procedure is not required, but your company may have a different need for documented information and records regarding QMS risks and opportunities.


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Objectives of ISO 9001 Quality Manual

An ISO 9001 quality manual is written to explain a company’s International Standards Organization quality management program. It’s many sections describing the scope, procedures, processes and news procedures of the program. The quality manual could be a handbook and reference for workers and managers concerned within the program.

Quality Management System

The quality management system section of the ISO 9001 manual provides general data regarding the company’s program. It includes ISO 9001 documents and descriptions the management of these documents. It conjointly includes news procedures.

Management Responsibility

The management responsibility section of the manual outlines the company’s commitment policy because it pertains to a quality management program. The section provides goals and objectives for the program. It conjointly outlines the responsibility of every management level.

Product Comprehension

The product realization section of the manual is a very important side of the program. This section explains the method of the product, the design, development, production, purchasing, delivery ways and also the client. The section outlines the controls and activity devices in situ to guide production.

Measurement, Analysis and Improvement

The activity and analysis section of the quality management manual includes product activity processes, client satisfaction, improvement processes, news and documents. It conjointly includes the inner audit method.


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A Short Explanation about ISO 9001 Procedure

When our company will implement Quality Management System, we should always prepare quality management system documentation that has documented statement of quality policy and quality objectives, a top quality manual, quality procedures and geographical point references or work directions to make sure the effective designing, operation, and management of company processes.

In regard with quality procedure, it ought to be established, documented, enforced and maintained. The ISO 9001 procedure is also completely different from one company to a different thanks to the dimensions of company and sort of activities, the quality of processes and therefore their interactions and the ability of their personnel.

In observe, format of ISO 9001 procedures may additionally take issue from one company to a different. For an organization that’s making an attempt to form their own quality procedures for the first time, Readymade sample ISO 9001 procedure will be terribly useful. It doesn’t mean duplicating the all sample procedures for the organization own use.

An ISO 9001 system procedure could encompass cowl sheet, multidimensional language, and procedure thoroughly. The quilt sheet contains name, title of procedure ISO 9001, sheet range, document range and revision record revision range, description of revision, date of revision and signature of the person to blame.

The multidimensional process explains step by step from the start however the ISO 9001 procedure flows. and therefore the procedure itself ought to a minimum of have associate objective, scope, general clarification, definitions employed in the procedure, content of the procedure, records used, connected documents and necessary attachments. The outline is started with the persons to blame and followed by clarification of their tasks or jobs as per the requirements.


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Key Benefits of ISO 9001:2008 Quality Management System Certification

The ISO 9001:2008 Certification for Quality Management System enable you to demonstrate your dedication to quality and client happiness, and additionally ceaselessly enhancing your company’s operations. The internationally recognized quality management system standard is certainly the well-liked resolution for about organizations in one hundred seventy five countries.

Overall, the consequence of the requirements of the quality would be to lower the instances wherever ISO 9001 documented procedures are obligatory and to permit the organization the liberty to determine the kind and extent of documentation required to secure the operation of the processes that comprise the standard management system.

Benefits of ISO 9001:2008

  • Establishes and streamlines processes through complete documentation
  • Improves and establishes coaching processes
  • Defines roles and responsibilities
  • Greatly will increase operational potency
  • Increases chance to troubleshoot
  • Develops and builds relationships to assist to retain existing client
  • Provide blessings over competitors that don’t seem to be certified ISO 9001:2008
  • Builds opportunities for world commerce with international recognition
  • Improves client relations
  • Improves relationships with suppliers ensuing from clear, epigrammatic production standards
  • Carefully planned enhancements, as made public by documentation and analysis
  • Provides for normal audits/reviews of performance
  • Increases productivity with maximizing quality
  • Increases revenue with Improves worker morale and satisfaction
  • Saves money
  • Enhances chance to draw in customers World Health Organization have adopted needs for certification
  • Improves responsibility of management
  • Increases employees’ information of their roles in success of their work similarly because the company
  • Creates bigger motivation and dedication.

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