ISO 9001 certification can be a total game-changer for your business.

So, what is ISO 9001?

ISO 9001 standards are designed to help life science companies develop high-quality products that are safe and effective for use. These standards help organizations get consistent results and continually approved processes. ISO 9001 is focused on the implementation of quality processes and standard operating procedures that make life easier for companies like yours.

Unfortunately, it's not enough to simply get ISO 9001 certified. After certification, most organizations make the mistake of ignoring standard operating procedures. For this reason, industry-leading life science organizations invest in enterprise quality management software (eQMS). By doing so, they get the peace of mind that comes with knowing products can be well-documented and organized, making the approval process easier on the back end.

10 ISO 9001 Quality Management System Requirements

Each of the following clauses contains individual processes and requirements in order to successfully attain ISO 9001 certification. The principles on our list aren't in priority order. The importance of each varies from organization to organization and can change over time.

With that in mind, here are the 10 ISO 9001 quality management system requirements:

1. Scope

The first three clauses of ISO 9001:2015 are scope, normative references, and terms and definitions. These are information clauses rather than clauses that outline particular actions or requirements.

This requirement highlights the basic tenets of great quality management systems. It encourages life science organizations to implement repeatable processes and procedures to ensure consistent products while retaining customer satisfaction throughout the product's entire life cycle.

2. Normative references

Normative references give users a better understanding of the terms used in ISO 9001:2015 through relatable comparisons.

3. Terms and definitions

Terms and definitions outline the basic vocabulary and definitions from ISO 9001:2015. Other related and applicable standards that you could refer to for vocabulary and definitions may include:

  • ISO 9004-2018 Guidance to Achieve Sustained Success
  • ISO 19011-2018 Guidelines for Auditing Management Systems
  • ISO 10004-2018 Guidelines for Monitoring and Measuring

4. Context of the organization

Context of the organization outlines the general requirements for the entire quality management system as a whole. There are four sub-clauses including:

  1. Understanding the organizational context
  2. Understanding the needs and expectations of relevant stakeholders
  3. Determining the scope of the management system
  4. The quality management system and its processes

5. Leadership

This requirement outlines the leadership responsibility as it pertains to the adoption of a quality management system. Creation of unity of purpose and direction and engagement of people enables the organization to align strategies, policies, and processes to achieve its quality management objectives.

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6. Planning

Planning addresses risks and opportunities. Determine, consider, and—where necessary—take action to address areas of high risk. By doing so, you can better identify areas of impact that might affect the quality management system's ability to perform as expected.

7. Support

Clause 7 of the ISO 9001:2015 requirements outlines the resources needed for the QMS—including the employee resources and documentation to support quality management system adoption, implementation, and management.

8. Operation

Clause 8 covers the plan and control processes needed to meet and/or exceed requirements for products and services—including design, development, external providers, production, and service provisions.

Sub-clauses include:

  • Control of external providers
  • Identification and traceability
  • Objects, outputs, products, and services

9. Performance evaluation

Performance evaluation requires organizations to monitor, analyze, and evaluate the quality management system. Additionally, sub-clauses provide a clear framework for planning and conducting internal audits.

10. Improvement

The final clause of ISO 9001:2015 standard focuses on improving the company. Your organization is required to enforce controls and correct non-conformity.

That way, you can determine whether your organization needs to make your QMS better or implement positive changes.

Achieve ISO 9001 Compliance with Qualio

Qualio has built an industry-leading eQMS for startups and scale-ups. There's a reason why a ton of life science leaders partner with us, but don't just take our word for it.

Just like with the ISO 9001 quality management certification, it's important to educate yourself before jumping in. To help you get started, we've assembled a free guide designed to give you the knowledge you need to determine what system will suit the unique needs of your business or organization the best.

To learn more, download our free guide: 12 Questions to Ask Before You Buy an eQMS.

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Published by Robert Fenton October 1, 2020
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