The 5 most important elements of the ISO 9001 standard

    Are you preparing for ISO 9001 certification and are wondering about the most important elements of the ISO 9001 standard?

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    If so, it's important to remember that ISO 9001 nonconformance impacts thousands of life sciences organizations annually.

    According to recent studies, there are 878,661 organizations with valid ISO 9001 certificates operating in over a million certified sites. If your organization isn't one of those that are certified, you're missing out.

    The ISO 9001:2015 standard for quality management system requires organizations to define and conduct internal audits. As you know, a comprehensive internal audit is the final step toward achieving certification.

    Keep reading to learn more about ISO 9001 requirements to help your organization achieve rapid certification.

    5 Essential Elements of the ISO 9001 Standard

    Here are the key elements of the ISO 9001 standard that you need to consider as your organization prepares for ISO 9001 certification.

    Bonus: To kickstart ISO 9001 readiness, we recommend partnering with an eQMS partner purpose-built for medical device manufacturers, pharmaceutical companies, and biotech organizations. Qualio is trusted by founders working on breakthrough ideas to full quality assurance teams with multiple products.

    1. Scope

    The first three clauses of ISO 9001:2015 are scope, normative references and terms.

    These are information clauses rather than clauses that outline particular actions or major requirements. Additionally, these clauses highlight the basic tenants of a high-value quality management system.

    In this phase, organizations are encouraged to implement repeatable processes and procedures to produce uniform outcomes. Moreover, organizations are encouraged to work towards increased customer satisfaction throughout the product's entire lifecycle.


    2. Terms and Definitions

    The terms and definitions section outlines the rudimentary vocabulary and definitions from ISO 9001:2015.

    Terms that you'll need to know to fully understand the basics behind 9001:2015 include ISO, standards, asset inventory, management, management system, policy, process approach, and quality management, among others.

    ISO 9001:2015 defines eQMS as "an organization's system which implements policies and objectives into the processes that help improve a standard of quality."

    Some eQMS implementations include records, techniques, programs, rules, role distribution, and responsibility distribution.

    RELATED READING: The 7 Fastest Ways to Fail an ISO Audit


    3. Leadership

    This requirement outlines the roles and responsibilities of leadership as it pertains to the adoption and implementation of an eQMS.

    The purpose of this phase is to unify key stakeholders around key quality management objectives. In this stage, organizations can align strategies, policies, and processes to achieve comprehensive quality management adoption, implementation, and management.


    4. Planning

    This phase addresses risk and opportunity as it pertains to product development in conjunction with the quality management system.

    This allows organizations to address areas of high risk, and where applicable, activate risk prevention or mitigation activities. By doing so, your organization can better identify areas of impact that might adversely affect the quality management system's ability to perform as expected.

    RELATED READING: How Much Does an ISO 9001 Quality Management System Cost?


    5. Enforcement

    The last critical element of ISO 9001:2015 focuses on improving the company. Here, organizations should consider adopting and enforcing controls and correct nonconformities.

    At this point, you need to determine whether your organization needs to revaluate the effectiveness of your eQMS.


    Is your organization quality-driven?

    If you want to comply with ISO 9001, you need an eQMS that is purpose-built.

    The most effective eQMS implementations balance simplicity and customization. Every customization to the eQMS should provide clear value without complexity.

    The right QMS design is a mixture of flexibility and standardization. Organizations need enough standardization to produce consistent results and enough flexibility for continuous improvement to create a quality-driven culture.


    Fortunately, preparing for ISO 9001 doesn't have to be complicated. In this guide, you'll learn all you need to know about the seven steps leading life sciences companies take to prepare for and achieve rapid ISO 9001 certification.