Tags Posts tagged with "9000"

9000

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No matter how many audits someone has gone through, knowing that someone will come and check your work always generates some tension and anxiety. Here are some recommendations to get rid of the fear and prepare for a successful ISO 9001 audit.

Prepare employees.

  • Refresh the quality policy and make sure everyone understands it. There is no need for workers to memorize it, but they should have a clear understanding of what the organization has committed to in terms of quality.
  • Refresh quality objectives. Workers should know what the organization’s quality objectives are and how they contribute in achieving them. They should know and be able to explain how their day to day activities can influence these objectives.
  • Ensure that everyone has been properly trained to perform their tasks.
  • Make sure everyone knows where to find procedures, work instructions and forms relevant to perform and record correctly a specific activity or process.
  • Let everyone know the scope of the audit, what will auditors be checking in their areas and when they will be audited.
  • Workers should have the confidence to answer what they know, and have the same confidence to say ‘’I don’t know” when they are not sure what they are going to answer.

Check all documented information.

  • Make sure document and record list has been updated.
  • Check that all documents have been reviewed, approved, communicated and followed by everyone involved in the process or activity.
  • Make sure no one is using obsolete documents.
  • Verify that all records are being used and that they are being filled out correctly.

Ensure all processes are being performed correctly.

  • Make sure that all the procedures (whether they are documented or not) are being followed.
  • Ensure that critical processes are being performed in the same way (correct way) by everyone.

Review the corrective and preventive action process.

  • Review the findings from previous audits and make sure they have been attended.
  • All nonconformities must be properly recorded, investigated and actions need to be in place or concluded by the time of the audit.
  • Corrective actions that have been executed and closed need to have a proper verification of its effectiveness.

Organize the workplace.

  • It is very hard for quality control and assurance to happen in a messy, dirty and unorganized workplace, and auditors know that. So, take time to organize the workplace (offices, desks, warehouses, workshop floor, etc.).
  • Make sure records, forms, procedures and any relevant documents are at hand and easy to find.

Prepare to have a nice and professional audit.

  • Make a good first impression. Treat auditors professionally and with respect from day 1.
  • Do not be predisposed. Auditors are not enemies, they will come to help the organization uncover their defects and weaknesses in order to take the necessary actions to improve.

Do not wait for the last minute to prepare for the audit.

  • Preparing for an audit takes time and effort. The sooner the organizations begins to prepare for their audit, the more successful it will be. So start soon!

 

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Effective Internal Audits

ISO 9001 and 9004 are both part of the ISO 9000 family of standards. These standards, even though they’re both about quality management systems (QMS), they have some important aspects that differentiate them. Many organizations, when seeking to establish or improve a QMS, tend to get confused about which standard to use or if they should use both. In exploring ISO 9001 vs 9004, the main differences between them will be highlighted.

Purpose.

  • ISO 9001 provides a framework for a systematic approach to managing an organization’s processes so that their products or services are consistent and meet client expectations. It also ensures the organization meets applicable laws, regulations and other requirements.
  • The ISO 9004 standard is intended to help organizations extend the benefits of their QMS to stakeholders and all other interested parties, helping to give sustained success.
Exploring ISO 9001 vs 9004: These standards complement each other, so they can be used simultaneously by an organization, and they can also be used independently.

Certification.

  • ISO 9001 is a requirements document. It is the only ISO 9000 family standard which an organization can be certified against in order to demonstrate conformance to its requirements.
  • On the other hand, ISO 9004 is a guidance document on how to achieve continuous improvement to get excellence for the organization. It is not intended for certification.

Focus.

  • ISO 9001 standard’s main focus is on customer requirements. This standard focuses on assuring conformance to defined customer requirements and ensure effective response to customer feedback.
  • ISO 9004 focuses mainly on meeting the requirements of customers and all other interested parties. It aims at balancing the needs of all stakeholders in order to achieve sustained success.

Continual Improvement.

  • In ISO 9001 continual improvement of the QMS is achieved mainly by performing management reviews, internal/external audits and corrective/preventive actions.
  • ISO 9004 promotes self-assessment in order for organizations to identify areas of strength or weakness and opportunities for either improvements or innovations, or both. It guides organizations on setting realistic and challenging improvement goals for their processes.

There are many other differences between both these standards; however, what is important to understand is that:

  • They are both intended to be used by any organization, regardless of their size and nature, to establish and improve their QMS;
  • ISO 9001 is intended for certification and ISO 9004 is not and;
  • ISO 9001 is focused mainly on customer satisfaction and ISO 9004 has a broader focus that include all stakeholders in order to achieve sustained success.

Many people believe that ISO 9004 is a guideline for the implementation of ISO 9001, however, this is not true. These standards complement each other, so they can be used simultaneously by an organization, and they can also be used independently. Some organizations decide to use ISO 9001 to establish and improve their QMS and then move on to ISO 9004 as a guide to obtain long term benefit from a more broad-based QMS.