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ISO 9001:2018 – What You Need to Know

Introduction

If you are looking for a way to improve the quality of your products and services, increase customer satisfaction, and gain a competitive edge in the market, you may have heard of ISO 9001. But what is ISO 9001 exactly, and how can you get certified to this standard? In this article, we will answer these questions and more, and provide you with a link to download a free PDF copy of the ISO 9001:2018 standard.

What is ISO 9001?

What is ISO 9001?

ISO 9001 is an international standard that specifies the requirements for a quality management system (QMS). A QMS is a set of policies, processes, and procedures that help an organization to ensure that it consistently meets the needs and expectations of its customers and other relevant stakeholders. ISO 9001 is part of the ISO 9000 family of standards, which are published by the International Organization for Standardization (ISO). ISO 9001 is the only standard in the family that can be used for certification purposes.

What are the benefits of ISO 9001 certification?

There are many benefits of implementing a QMS based on ISO 9001 and getting certified to this standard. Some of them are:

• Improved customer satisfaction: By meeting customer requirements and enhancing their satisfaction, you can build long-term relationships with your customers and increase their loyalty.
• Increased efficiency and effectiveness: By following a process approach and applying risk-based thinking, you can optimize your resources, reduce waste, prevent errors, and improve your performance.
• Enhanced credibility and image: By demonstrating your commitment to quality and continuous improvement, you can boost your reputation and trust among your customers, suppliers, regulators, and other stakeholders.
• Better market opportunities: By having a recognized certification, you can gain a competitive advantage in the market and access new customers and markets, especially in the public sector where ISO 9001 certification is often a requirement.

What are the requirements of ISO 9001:2018?

The requirements of ISO 9001:2018 are divided into seven sections:

1. Scope: This section defines the scope and applicability of the standard. It states that ISO 9001 can be used by any organization, regardless of its size, type, or activity.
2. Normative references: This section lists the normative references that are indispensable for the application of the standard. It refers to only one document: ISO 9000:2015, which provides the terms and definitions used in ISO 9001.
3. Terms and definitions: This section refers to ISO 9000:2015 for the terms and definitions used in ISO 9001.
4. Context of the organization: This section requires the organization to understand its internal and external issues, its interested parties and their needs and expectations, and its scope and boundaries. It also requires the organization to establish, maintain, and continually improve its QMS.
5. Leadership: This section requires top management to demonstrate leadership and commitment to the QMS by establishing a quality policy and quality objectives, ensuring roles and responsibilities are assigned and communicated, promoting a customer focus and a process approach, supporting risk-based thinking and continual improvement, etc.
6. Planning: This section requires the organization to plan actions to address risks and opportunities, changes, and quality objectives. It also requires the organization to determine how to measure and evaluate its QMS performance.
7. Support: This section requires the organization to provide adequate resources, competence, awareness , communication, documented information, and organizational knowledge to support the QMS.
8. Operation: This section requires the organization to plan, implement, and control its processes to meet customer and applicable statutory and regulatory requirements. It covers aspects such as operational planning and control, requirements for products and services, design and development, control of externally provided processes, products, and services, production and service provision, release of products and services, and control of nonconforming outputs.
9. Performance evaluation: This section requires the organization to monitor, measure, analyze, and evaluate its QMS performance and customer satisfaction. It also requires the organization to conduct internal audits and management reviews to ensure the effectiveness of the QMS.
10. Improvement: This section requires the organization to identify and implement opportunities for improvement, such as correcting nonconformities, preventing recurrence, addressing root causes, and enhancing customer satisfaction. It also requires the organization to consider innovation and continual improvement as part of its QMS.

How to get ISO 9001 certified?

To get ISO 9001 certified, you need to follow these steps:

1. Understand the standard: You need to familiarize yourself with the requirements of ISO 9001:2018 and how they apply to your organization. You can download a free PDF copy of the standard from this link: ISO 9001:2018 free download.
2. Conduct a gap analysis: You need to assess your current QMS against the requirements of ISO 9001:2018 and identify the gaps that need to be addressed. You can use a checklist or a tool to help you with this task.
3. Implement the changes: You need to plan and execute the actions needed to close the gaps and improve your QMS. This may involve updating or developing policies, processes, procedures, documents, records, etc.
4. Train your staff: You need to ensure that your staff are aware of the changes and their roles and responsibilities in the QMS. You may need to provide training or coaching to help them understand and apply the requirements of ISO 9001:2018.
5. Audit your QMS: You need to verify that your QMS is implemented effectively and conforms to the requirements of ISO 9001:2018. You can do this by conducting internal audits or hiring an external auditor.
6. Choose a certification body: You need to select a reputable certification body that is accredited by an authorized accreditation body. You can search for certification bodies in your region from this link: ISO 9001 certification bodies.
7. Undergo a certification audit: You need to undergo a certification audit by the certification body. The audit consists of two stages: stage 1 is a document review and stage 2 is an on-site audit. The auditor will check your QMS documentation and records, interview your staff, observe your processes, and report any nonconformities or opportunities for improvement.
8. Get certified: If you pass the certification audit, you will receive a certificate that confirms that your QMS meets the requirements of ISO 9001:2018. The certificate is valid for three years, subject to periodic surveillance audits by the certification body.

Conclusion

Summary of key points

In conclusion, ISO 9001:2018 is an international standard that specifies the requirements for a quality management system. It helps organizations to improve their quality performance, customer satisfaction, and market competitiveness. To get certified to ISO 9001:2018, organizations need to understand the standard, conduct a gap analysis, implement the changes, train their staff, audit their QMS, choose a certification body, undergo a certification audit, and get certified. You can download a free PDF copy of ISO 9001:2018 from this link: ISO 9001:2018 free download.

FAQs

Here are some frequently asked questions about ISO 9001:2018:

• What is the difference between ISO 9001:2015 and ISO 9001:2018?

There is no difference between ISO 9001:2015 and ISO 9001:2018. They are the same standard with different publication dates. The latest edition of ISO 9001 was published in September 2015 and corrected in April 2018. The correction did not change any requirements or structure of the standard, but only clarified some wording and formatting issues.

• What are the main changes from ISO 9001:2008 to ISO 9001:2015/2018?

The main changes from ISO 9001:2008 to ISO 9001:2015/2018 are:

• The adoption of the high-level structure (HLS) that is common to all ISO management system standards, which makes it easier to integrate with other standards.
• The introduction of the context of the organization, which requires the organization to consider its internal and external issues and interested parties when establishing its QMS.
• The emphasis on risk-based thinking, which requires the organization to identify and address risks and opportunities throughout its QMS.
• The reduction of prescriptive requirements and documentation, which gives more flexibility to the organization to determine how to meet the requirements.
• The shift from quality assurance to quality management, which requires the organization to focus on achieving outcomes rather than following procedures.
• How much does it cost to get ISO 9001 certified?

The cost of getting ISO 9001 certified depends on various factors, such as the size, complexity, and maturity of your organization, the scope and duration of the certification audit, the certification body you choose, and the country you operate in. The cost can vary from a few thousand to tens of thousands of dollars. You can get a quote from different certification bodies to compare their prices and services.

• How long does it take to get ISO 9001 certified?

The time it takes to get ISO 9001 certified depends on how ready your organization is to meet the requirements of the standard. It can take from a few months to a few years, depending on how much work you need to do to implement and improve your QMS. The certification audit itself usually takes one or two days for stage 1 and two or three days for stage 2, depending on the size and complexity of your organization.

• How do I maintain my ISO 9001 certification?

To maintain your ISO 9001 certification, you need to:

• Ensure that your QMS continues to conform to the requirements of ISO 9001:2018 and is effective in achieving your quality objectives and customer satisfaction.
• Monitor, measure, analyze, and evaluate your QMS performance and customer feedback on a regular basis.
• Conduct internal audits and management reviews at planned intervals.
• Implement corrective actions and preventive actions to address any nonconformities or opportunities for improvement.
• Undergo surveillance audits by your certification body at least once a year.
• Undergo a recertification audit by your certification body before the expiry of your certificate (usually every three years).

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