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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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How to Write a Good Quality Policy?

One of the first things to do when implementing a Quality Management System using the requirements of the ISO 9001:2015 standard is to write a Quality Policy for your company. Quality policy should be a brief statement that shows a commitment by top management to the quality management system.

One reason to create and implement a quality policy for your organization is to ensure that all staff are aware, aligned and supported their intentions on quality management. Another reason is because it is a requirement of ISO 9001:2015 Certification. In some ways, it seems a simple process; however, in other ways, making sure that the policy is effective in helping your company succeed can seem like an overwhelming task. You may be wondering: what are the important things to consider when creating the quality policy of our company?

Start with Customer Requirements

The key to starting any quality management system is to make sure that you understand customer requirements. If you want to successfully promote your QMS to improve customer satisfaction, it is essential to ensure that you understand all the requirements you need to meet to achieve it. These requirements may come directly from customer specification, through industry standards, or even through legal requirements related to their products or services. Making sure you have all these necessary inputs will help you ensure that your quality policy focuses on the important elements to achieve customer satisfaction.

Collect Inputs of Internal Parties

The quality policy is the main objective of the quality management system and is designed so that all employees can use it as a reference point for their work. In this case, it is important to gather input from all areas of the company to ensure that the Quality Policy is applicable to all those areas. In order to do this, it is important to get the input of people in the areas who will need to apply the policy.

Include Required Information of ISO 9001:2015

The standard does impose some requirements on the Quality Policy that are important to note. The quality policy must demonstrate the company’s commitment to meeting the requirements and improving the efficiency of the QMS.

Write and Communicate the Quality Policy

With all of this information in mind, you need to draft a policy that can guide the organization and provide direction to create quality objectives It is said that a good quality policy is simple, concise and easy to remember when under pressure. It is important that all employees not only know the policy, but also understand what it means and how their work supports compliance with the Quality Policy.

 
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Posted by on February 14, 2018 in ISO 9001 Certification

 

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Why Have Procedures? What are the Mandatory Procedures for ISO 9001:2015?

Why have procedures? Some would answer this question by providing very long lists of reasons why, these lists are sometimes not useful. They are too long to remember and absorb them, and there is too much overlap and redundancy. There are four very basic reasons that demonstrate why we should develop procedures to document important process.

  • Compliance
  • Operational Needs (i.e. consistency)
  • Manage Risks
  • Continuous Improvement

What to cover in Mandatory ISO 9001:2015 Procedures?

These mandatory ISO 9001:2015 procedures are specified by ISO 9001 and are included in quality manual template. There are the six procedures that are mandatory to be documented. Organization need to ISO 9001:2015 document these six procedures. This doesn’t mean simply will go away with just these six, the ISO 9001:2015 procedures you wish can abundantly rely upon the scale and complexness of your organization, these six but are those that you simply should have.

Six Mandatory ISO 9001:2015 Procedures

ISO 9001:2015 Mandatory Procedures

1. Control of Documents:

In this ISO 9001:2015 procedure, a written procedure to control the approval and re- approval of procedures and ensuring that the current revision status is displayed. It is the process to ensure that the obsolete documents are controlled and legible and that documents are intended for the external parties such as their clients or the process owner. The documents must be approved by senior management

2. Control of Records:

This is the procedure for checking the archiving of identification, protection, storage and deletion of records by the owner of the process and also keeping records in a specific location. The established records will be checked to provide confirmation of compliance with the requests and the effective functioning of the quality management system.

3. Internal Audit:

The purpose of the ISO 9001 internal audit is to assess the effectiveness of the quality management system and the organization’s overall performance. Your internal audits demonstrate compliance with planned arrangements, e.g. QMS manual, procedures or process maps and that the planned arrangements are implemented and maintained.

4. Control of Non-Conforming Product:

As regards the ISO 9001 standard, the documents are necessary and the records of the non-conformity problem are kept in order to identify them and act in this way. This is a procedure that ensures that the testimonial of the useless product and no action is performed and documented procedure is established to define the controls and the related responsibilities and authorities to deal with non-compliant products.

5. Corrective Action:

A corrective action should be considered as a reactive response to a problem since it is taken when a non-conformance is detected or upon receipt of a customer complaint or other event. Your organization should first contain the problem and then determine its root cause in order to take appropriate corrective action to prevent the problem’s recurrence.

6. Preventive Action:

The Preventive actions are pro-active – something could go wrong and these are actions taken to prevent it from happening, or to prevent it from becoming too severe. If something has already gone wrong, it is a non-compliance that is addressed with corrective actions. ISO 9001: 2015 requires documenting the preventive action procedure. Furthermore, it is necessary to keep a record of the identified preventive actions and actions taken.

 
 

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ISO 9001:2015 Consultant – What Services Can Offer to Your Business?

Do you know the importance of having an experienced ISO 9001 consultant? In real terms, ISO 9001:2015 consultant services help a business to save both money and time, thereby helping your organization to gain an edge over the competition together with several other advantages to seek as well.

An ISO company ensures ISO 9001 quality management system (QMS) which can be very helpful in improving your company’s prospects. To achieve advantages of ISO 9001:2015 Certification, a business should have the knowledge to implement the ISO 9001 in right manner. ISO 9001 Consultant offers a number of services.

What Services ISO 9001:2015 Consultant Provide?

ISO 9001:2015 consultanting services benefited the most in terms of speed of implementation, effectiveness and payback. Let us check out some of these so that you can determine what selection of services would best suit your company:

ISO 9001 Standard Interpretation

The ISO 9001 quality management system standard can be a hard document to understand. It is written in quasi-legal language and points out requirements in very general terms. This is deliberately so, as it is meant to be applicable to all types of business activity. Quite a few companies have issues interpreting it to their organizations. An experienced ISO 9001 consultant can help you apply the standard to your specific business processes.

ISO 9001 Gap Audit

Before applying the ISO 9001 standard to your business, you need to know what is missing between your existing business practices and controls relative to ISO 9001. The ISO 9001 consultant will provide you with a detailed verification report that shows gaps in your company, along with their recommendations.

ISO 9001 Project Planning and Organization

Depending size and complexity of your company, your ISO project needs to well-planned in terms of how much time and various resources needed specific activities to be carried out, training, dealing with problems, etc. An ISO 9001 consultant can be a valuable aid to help a company with this important activity

ISO 9001 System Development and Implementation

The main emphasis of the ISO 9001 standard is on effective planning, operation and control of thrust all relevant quality management system processes. This is probably the longest and most challenging part of any ISO implementation project. Here is where using external ISO 9001 consulting will significantly help in answering these questions, provide required focus and facilitate implementation.

ISO 9001 Management System Documentation

The latest ISO 9001:2015 standard reduces the attention on documentation and maximizes its attention on effective planning and control. Sufficient ISO 9001:2015 documentation is however needed for many business processes in order to ensure consistent application of effective controls. An export ISO 9001 consultant can help your organization determine where it is needed, how much and how it should be documented.

ISO 9001 Training

ISO 9001 Consultancy services often offer a number of training alternatives. These include

  • ISO 9001 awareness training to employees at all levels
  • An executive overview of the ISO standard to top management
  • Process identification, mapping, analysis and improvement
  • ISO project management
  • ISO documentation and implementation
  • Internal audit
  • Use of problem-solving tools

Develop and Maintain your ISO 9001 Internal Audit Program

To be certified and remain so, the ISO 9001 Standard requires your organization to plan and conduct an internal audit program of its quality management system. In these days, many organizations are short on resources, internal audit expertise and employee availability outsource the upkeep of their internal audit programs to ISO 9001 consulting firms.

ISO 9001 Continual Improvement Process

The ISO 9001 standard expects your quality management system to be dynamic and work towards continually improving the effectiveness and efficiency of your organization and enhance customer satisfaction. Many ISO 9001 consulting firms have diversified skills and experience in strategies and methods of continuous improvement.

 
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Posted by on January 9, 2018 in ISO 9001 Certification

 

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