A Step-by-Step Guide to ISO Certification for Quality Management

ISO 9001 Certification

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ISO 9001 is an international standard that specifically lays out criteria and guidelines for quality management systems.

Standards like ISO 9001 fall under the ISO 9000 family of quality management criteria; specifically, ISO 9001:2015 is designed to help companies achieve and maintain a certain level of product or service quality. This, in turn, produces business benefits related to having an established quality management system (QMS), more consistent products, less effort spent on problem resolution, and overall, happier customers.

The ISO 9001 Quality Management Certification Process

For management professionals interested in optimizing product quality, an ISO 9001 certificate is one of the best quality management certifications available. And although the certification process is complex, the good news is that the quality management system standards are applicable to any organization, regardless of its size, purpose, or products. Any company can become certified to the ISO 9001 standard with some work.

1. Set Objectives and Select an Approach

What does your company hope to achieve by getting certified to ISO 9001?  Certification to the ISO 9001 standard can enhance an organization’s credibility by showing customers that its products and services meet expectations. In some instances or in some industries, certification is required or legally mandated. The first step of your certification should be a thorough audit of company goals, including what benefits you’re seeking and which implementation approach will work with your infrastructure. 

Organizations should consider the following as they begin preparing for an ISO 9001 quality management system certification:

  • Registrar’s costs for ISO 9001 registration, surveillance, and recertification audits
  • The current level of conformance with ISO 9001 requirements
  • Amount of resources that the company will dedicate to this project for development and implementation
  • Amount of support that will be required from a consultant and the associated costs

2. Prepare Documentation

Hopefully, your company point person will be familiar with the technical documentation required for an ISO certification in quality management. If not, expect to spend some time on this step learning and educating yourself before proceeding. You’ll need to line out the following details at a minimum to prove your company’s commitment to continuous improvement:

  • Quality management objectives
  • Internal policies and procedures to help achieve these objectives
  • Step-by-step work instructions for how policies are implemented to meet company goals

You’ll need to adequately describe your ISO certified quality management system, its procedures, and how they apply to the broader ISO framework. This can be a time-consuming task, and most companies rely on software that helps them automate template creation and documentation layouts to speed things along.

3. Applying Standards to Internal Processes

Armed with the above documentation, it’s time to begin implementing your plan. Though complicated in its own right, this step is made easier when you take a thorough assessment of your company, as defined in steps one and two. This process may take several forms, depending on your quality management system’s requirements:

  • Applying new specifications or process standardization to workflows
  • Having upper management disseminate information among staff
  • Updating documentation to reflect new approaches, processes, and procedures

Note that these workflows may change over time. During certification, staff may need to undergo re-training on these new procedures. However, if you document and establish repeatable frameworks for all operations, you’ll have an easier time onboarding new workers by preparing them with these ISO-based quality management principles.

4. Post-Implementation Audit

The only way to tell if you qualify for an ISO 9001 quality management certification (before you officially apply, that is) is to perform an internal audit. These audits can be split up into smaller reviews across products, processes, or departments – whatever makes sense for your business. The goal here is to demonstrate your company’s ability to consistently produce products that meet regulatory requirements.

Typically, the point person familiar with the ISO quality control management certification should be the one performing the audit, though it’s quite common for businesses to seek outside help in this area.

5. Get Certified by ISO Registrar

When all of the above steps are complete, you’ll be ready to work with a third-party certification body that can assess the legitimacy of your quality management ISO certification. This auditor will perform a similar assessment to your internal audit (often after several months of record collection) to verify that your new processes truly align with the ISO 9001 system.

This is the final step in your risk management certificate program, but make sure the registrar you choose is accredited by a national certification organization in your country.


Get Help With Your Quality and Risk Management Certification

The above framework will give you a good place to start, but ISO certification is just one of many standards that can help optimize your business. If you need help navigating this standard or others – such as the increasingly important ISO 14001 environmental standard – consider deploying a modern quality management system. A QMS can help streamline and simplify your ISO management. Contact us to connect with one of our configuration specialists for additional information about achieving ISO certification. We can walk you through the details.

To get a deeper insight into how Veeva's QualityOne can streamline your quality management, training, and HSE operations, we invite you to visit our product page.

Additional Reading:

Tools for Risk-based Thinking in ISO 9001:2015

Leadership and Performance Evaluation in ISO 9001:2015

Process Approach and PDCA in ISO 9001:2015

Veeva’s ISO 9001:2015 Certification



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