ISO 9001 is a standard that defines the requirements for a Quality Management System (QMS). A QMS is a set of policies, processes, and procedures that help organizations ensure they can consistently meet customer and regulatory requirements, as well as improve customer satisfaction. Want to know more? Check out this article by GIAYCHUNGNHAN!

1. What is the current ISO 9001 standard?

The current revision of the standard is ISO 9001:2015. The ISO 9001 2015 standard, sometimes called ISO 9001 revision 2015, was released in October 2015 and replaced the previous revision ISO 9001:2008. This updated revision includes many of the processes from the previous revision of the standard, with a greater focus on risk-based thinking and understanding the context of the organization. To support this change, there was a major structural change from the ISO 9001:2008 standard – the main clauses of the standard are different between the 2015 and 2008 revisions.

2. Who should use the ISO 9001:2015 revision?

ISO 9001:2015 applies to any organization, regardless of size or industry. More than one million organizations from more than 160 countries have applied the ISO 9001 standard requirements to their quality management systems.

Organizations of all types and sizes find that using the ISO 9001 standard helps them:

• Organize processes
• Improve the efficiency of processes
• Continually improve

All organizations that use ISO 9001 are encouraged to transition to ISO 9001:2015 as soon as possible. This includes not only organizations that are certified to ISO 9001:2008, but also any organizations involved in training or certifying others.

As of September 14, 2018 organizations that are currently registered to ISO 9001:2008 should have transitioned to the 2015 standard.

Guidance on transitioning from ISO 9001:2008 to ISO 9001:2015 can be downloaded from the International Accreditation Forum (IAF).

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3. How can an organization implement ISO 9001 QMS?

To implement ISO 9001 QMS, organizations typically follow these steps:

• Gap Analysis: Assess current processes and identify gaps relative to ISO 9001 requirements.
• Plan: Develop a plan for implementing the QMS, including setting quality objectives and defining roles.
• Training: Train staff on the ISO 9001 standard and QMS procedures.
• Process Documentation: Document key processes, policies, and procedures.
• Internal Audits: Conduct internal audits to verify compliance.
• Management Review: Management reviews the QMS performance to ensure it aligns with goals.
• Certification Audit: Have an external certification body audit the system to achieve ISO 9001 certification.

For more information on ISO 9001 design and development, check out this article!

4. What are ISO 9001 documented information requirements?

• ISO 9001 requires organizations to maintain certain documents and records, which are referred to as documented information. These include:
  • The scope of the QMS.
  • Quality objectives and policies.
  • Process documentation: Describing key processes and their controls.
  • Records of activities, such as inspection logs, audit reports, and corrective action records.
• These documents help ensure that processes are followed, and they provide evidence of compliance.

5. Questions 

What is the process approach in ISO 9001 QMS?

• The process approach involves managing an organization’s activities as interconnected processes that function as part of a system. By understanding how processes interact, organizations can optimize performance, improve efficiency, and ensure product or service consistency.

What is the role of top management in ISO 9001 QMS?

• Top management plays a crucial role in implementing ISO 9001 QMS. They are responsible for:
  • Defining the organization’s quality policy and objectives.
  • Ensuring the QMS aligns with the organization’s goals and strategy.
  • Providing resources and support for the QMS.
  • Promoting a culture of quality and continuous improvement throughout the organization.

What is the role of internal audits in ISO 9001 QMS?

• Internal audits are conducted regularly to assess whether the QMS conforms to the requirements of ISO 9001 and is effectively implemented. Internal audits help:
  • Identify non-conformities and areas for improvement.
  • Ensure that processes are followed as documented.
  • Provide data for management review to help drive continuous improvement.

How does ISO 9001 QMS handle non-conformities?

• When non-conformities are identified (i.e., failures to meet specified requirements), ISO 9001 requires organizations to take corrective actions. This involves:
  • Identifying the root cause of the non-conformity.
  • Implementing actions to correct and prevent the issue from recurring.
  • Verifying that the corrective action was effective.

The above article provides information about ISO 9001 quality management system. GIAYCHUNGNHAN hopes this article will be helpful to you. If you have any questions, please don’t hesitate to contact us for advice and support.”