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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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How to Keep Your ISO 9001 Manual Relevant?

ISO 9001 manual

The first step in building an ISO 9001 Quality Management System is the creation of a “Quality Manual“. This is a separate and distinct step from developing quality procedures. The aim is to establish, in a short and concise format, the policies and objectives of the company required to achieve a desired level of quality for the organization or division.

ISO 9001 manual should be the document where the organization itself, its quality management system, and even his way of thinking and this quality management approach.

What should your ISO 9001 manual contain?

How you can define the contents of your ISO 9001 manual, include only what is useful for your company. So what should you write in the ISO 9001 quality manual? Add the information that will guide current and future employees as they build the business you imagined:

  • The objectives and vision of your company: To set the tone for your ISO 9001 manual, start with the answer to a question: Why does this company exist? Remember, your company does more than just making a product or providing a service. Its purpose involves improving people’s lives in a specific way. Figure out how, and write that down.
  • Products and services: For any product you create or service you fulfil, define the process behind it in the ISO 9001 manual. The quality depends to a large extent on consistency, therefore, clarify your expectations.
  • The definition of quality management system of your company: By itself, the word ‘quality’ is vague. Specifically define what is important to your client.
  • The relationship between different departments: Few products come from just one department. Be sure to define how different parts of your company work together. The easiest way to do this is with a clear flow chart.
 
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Posted by on August 31, 2018 in ISO 9001 Manual

 

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ISO 9001:2015 Internal Auditor Training and It’s Benefits

The internal audit is one of the most important tools for driving improvement in an ISO 9001 Quality Management System (QMS), it is vital that you have internal auditors who have the skills needed to properly review your processes and records and identify the strengths, weaknesses, and problems that are occurring in your organization.

In order to ensure this competence, it is important that you make sure your internal auditors are properly trained and experienced to do the job well. ISO 9001:2015 internal auditors training helps to provide the people conducting the internal audits in their firms to understand the process, follow the correct procedures, and lead auditing teams.

What does an effective ISO 9001:2015 auditors training should cover?

ISO 9001:2015 Auditor Training

Many companies offers ISO 9001 training course including training for ISO 9001 internal auditors. These courses include information on:

  • understanding the ISO 9001 quality management system standard, including the ISO 9001 requirements and structure
  • using the ISO 9001 standard for auditing management systems to assess company processes against requirements
  • role play of different auditing situations to enhance auditing skills

What are the benefits of ISO 9001:2015 auditor training?

After getting ISO 9001:2015 training, an internal auditor can be qualified internal auditor in the organization and it able to:

  • Understand the structure of QMS
  • Understand the processes involved in auditing
  • Plan, manage, and schedule an audit program
  • Develop a cost-effective and compliant audit system
  • Provide value addition to the system

Global Manager Group offers an extensive range of services to help with preparation for certification, maintaining compliance and ensuring improvement. One of our services is that of ISO 9001:2015 internal audit training. With various courses available, we enable your relevant employees to develop the needed skills to conduct such audits as required.

 
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Posted by on July 23, 2018 in ISO 9001 Training

 

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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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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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