Tag Archives: ISO 9001:2015 Documentation

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 Common elements to monitor include missing signatures, incomplete fields, and outdated revision levels.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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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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