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What is an ISO 9001:2015 Quality Management System?

Posted by Victoria Ontiveros in Blog, Home Page 02 Mar 2020

Introduction

Are you considering implementing an ISO 9001:2015 quality management system? Have you been asked by customers if you are ISO 9001 certified? This is not uncommon, as ISO 9001 certification is becoming an essential aspect of becoming an approved vendor or supplier. In fact, the ISO 9001:2015 quality management system standard (QMS), is one of the most popular international standards. In 2018 alone, the International Organization for Standardization (ISO) reported a total of 878, 664 of ISO 9001:2015 certificates issued (ISO Survey 2018). This article provides an overview of ISO 9001:2015, the benefits of the standard and how to become ISO 9001:2015 certified.

 

What is ISO 9001:2015 – Quality Management System?

ISO 9001:2015 is the quality management system (QMS) standard developed by the International Organization for Standardization (ISO). This standard helps organizations of any size in any industry increase consistency of quality products and services, improve customer satisfaction and reduce risks. This standard helps organizations of any size in any industry increase the consistency of their products and services, improve efficiency and continually improve customer satisfaction. The ISO 9001 quality management system standard does not outline requirements that specific products and services should conform to. Instead, ISO 9001 specifies the requirements for good management practices that should be followed to achieve quality, regardless of product or service. An ISO 9001 QMS provides a formalized and systematic approach to achieving organizational objectives.

In September 2015, ISO 9001:2015 officially replaced ISO 9001:2008. The revision helped the ISO 9001 standard be more applicable to organizations in different industries, beyond the manufacturing sector. Click here to learn more about the changes introduced by ISO 9001:2015.

The decision to implement ISO 9001 is a critical business strategy. This is why ISO 9001 should be considered much more than just a management system standard, or just “more paperwork”. Click here to learn more about how ISO 9001 can be used as a real business management tool.

 

Key Elements of ISO 9001:2015

Organizations that are new to ISO 9001 should be aware of the key elements of the quality management system standard:

  • The adoption of the Annex SL structure. This is the same high-level structure shared by other ISO standards, such as ISO 14001. This means that with the right expertise, ISO 9001 can be integrated into existing ISO management systems.
  • Context of the Organization. By assessing the overall context of the organization, companies will be able to clearly define who is affected by their work and their expectations.
  • Top Management’s leadership and commitment. ISO 9001 requires Top Management to move beyond commitment, and proactively engage employees and demonstrate leadership for the quality management system. Organizations will need to put more emphasis on the people that provide the products and services.
  • Quality Policy and Objectives. Organizations will need to establish a documented quality policy. The Quality Objectives will need to be measurable, and the method to achieve each of them must be defined.
  • Risk Based Thinking. Risk based thinking requires organizations to consider all of their processes and to determine probability impacts. They will then need to move beyond just thinking about risks, and start implementing preventive actions to control them. This includes establishing contingency plans in the event the mitigation controls fail.
  • Personnel Training and Competency. Organizations will need to ensure that employees are properly trained. Employees should then be able to demonstrate competency through tests or observations.
  • Control of Documented Information. ISO 9001 allows organizations to determine the necessary amount of documented information needed to demonstrate the effective planning, operation, control, implementation and continual improvement of the effectiveness of their QMS.
  • Operational Planning and Control. Regardless of their industry, organizations must ensuring that processes and documentation are established for the planning and controls of operational activities. This includes activities beyond manufacturing, including sales, design and development, delivery and servicing.
  • Management of Change. Changes that impact the QMS will need to be controlled in a planned manner. Changes should be requested, reviewed and approved. Risks that could be introduced with the change should be identified and addressed.
  • Control of Nonconforming Outputs. Organizations will need to establish, implement and maintain processes to determine and manage nonconformities. This includes nonconforming products, services and outputs. This means that organizations should put a focus on processes, not just the final output.
  • Design and Development. Organizations that are responsible for design and development will need to establish, implement and maintain design and development processes. This includes determining the required planning, inputs, controls, outputs and how to manage design and development changes.
  • Focus on Customer Satisfaction. Organizations should determine customer requirements, and focus on meeting the requirements to achieve customer satisfaction. Organizations should also work to receive customer feedback, for continual improvement.
  • Corrective Actions. A thorough root cause analysis should be conducted, to ensure corrective actions that address the root symptoms of issues are implemented.
  • Internal Audit Planning and Program. An internal audit will need to be conducted at planned time frames. An ISO 9001 internal audit will determine if the quality management system meets the requirements of the standard, and whether it has been effectively implemented and maintained.

Benefits of ISO 9001

When properly implemented and maintained, a good quality management system brings several benefits to organizations of all sizes, in all industries. Organizations that achieve ISO 9001 certification experience several benefits, including:

  • Attract new business opportunities
  • Meet customers’ requirements for ISO 9001:2015
  • Improve customer satisfaction
  • Enhance company reputation
  • Identify and eliminate organizational risks
  • Improve operations and reduce waste

How to Become an ISO 9001 Certified Company

Any organization in any industry has the ability to become ISO 9001:2015 certified. ISO 9001:2015 has been designed to be more inclusive of other organizations, beyond the manufacturing industry. The following are 7 steps organizations can take to start the journey towards ISO 9001 certification:

  1. Learn more about the requirements ISO 9001:2015 standard by reading the standard.
  2. Ensure adequate resources are in place to implement ISO 9001, including time and team members. Involve leadership in implementing the ISO 9001 management system.
  3. Perform an analysis of your organization’s operations, and identify gaps to ISO 9001:2015 requirements.
  4. Design and develop required ISO 9001:2015 management system documentation, including a quality policy, quality objectives and procedures. Our ISO 9001:2015 documentation package is a cost-effective solution to jumpstart your implementation.
  5. Work on ensuring the requirements of the ISO 9001 QMS are activity being implemented and complied with.
  6. Perform an ISO 9001:2015 internal audit. This may require employees undergoing additional ISO 9001 internal auditor training.
  7. Successfully undergo a certification body audit. Watch our webinar for key strategies on how to pass your certification body audit, stress-free.

Conclusion

ISO 9001:2015 is a quality management system standard that can be utilized by organizations of any size, in any industry, to become more efficient, improve operations and increase their profitability. By implementing an ISO 9001 QMS, organizations have the ability to focus on continual improvement and improve customer satisfaction, which in turn may mean repeat clients and increased business. Interested in becoming ISO 9001 certified? Our quality assurance and control consultants can help. Contact us to speak with an ISO 9001 management system expert.

 

Author

3 tips for preparing your team to undergo a certification body audit.

Victoria Ontiveros | Project & Office Coordinator 

Victoria focuses on creating quality educational content that provides value to current and potential clients. By collaborating with members of leadership and sales, she is able to develop informative articles that answer common questions and connect with current trends.

Victoria earned her Bachelor of Science in Sociology with an emphasis in communications from Texas A&M University.

  • Oscar Combs March 8, 2020 at 1:39 PM / Reply

    This is a great article. Very informative and provides key steps and reasons an organization should implement an ISO 9001 quality management system.

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