How to Implement ISO 9001: Step-by-Step Guide

ISO 9001 is the international standard that describes best practices for a QMS (quality management system). It contains seven principles that help organisations monitor and control their operations, while also benchmarking their performance and service.

Adopting a QMS is no easy feat, requiring you to rethink the way your business operates and what your strategic goals are. However, the benefits are numerous, from improving your ability to deliver quality products and services to widening your business opportunities.

More than one million organisations have already certified to ISO 9001, and in this blog we explain how you can join them using out 7-step guide.

1. Familiarise yourself with the ISO 9001 standard

Your first task should be to read copies of the ISO 9000 and ISO 9001 standards and familiarise yourself with their key concepts.

ISO 9000 provides an overview of the family of standards that includes ISO 9001 and ISO 9004. Meanwhile, ISO 9001 contains the requirements that must be met to achieve compliance.

Reading both standards will help you understand both the broad objectives of quality management and the specific actions that you must take to achieve compliance.

Although they are written in formal language and contain plenty of jargon, the clause titles in ISO 9001:2015 are self-explanatory, and with the help of ISO 9000 you will be able to follow its key points.

It’s important that you take this initial step rather than relying on general guidance related to the Standard, because the structure of ISO 9001 is flexible enough to be adjusted to any business.

By getting information directly from the source, you will learn how to best align ISO 9001’s requirements with your business needs.

2. Secure senior management buy-in

Once you have an idea of how ISO 9001 works and the ways it can help your organisation, you should seek the board’s approval to implement it.

The scale of the implementation project means you will need time and resources to complete the task, something that is only possible if you have the help of senior management.

When discussing ISO 9001, be sure to explain its purpose and the benefits that it will provide. From there, you can create a proposed implementation strategy, a timeline and an estimated budget.

You should also appoint a quality manager or management representative to oversee the project. This can be a full-time employee at a senior level with a strong understanding of your business.

3. Create an implementation team

The quality manager will need a team to help them implement ISO 9001’s requirements.

Your organisation must therefore assign relevant managers from different areas of the business to supervise the transition to your QMS.

4. Establish new roles and responsibilities

Every department within your organisation should contain people who are responsible for quality management tasks, including auditing, documentation maintenance and management reviews.

Depending on the size of your organisation, these could be the managers from your implementation team or additional employees for whom tasks are delegated.

5. Conduct a gap analysis of your current management system

A gap analysis is a process in which organisations review the effectiveness of their current practices and identify what improvements are necessary to achieve compliance.

For organisations seeking advice creating a gap analysis, there are a variety of tools that can help. IT Governance’s ISO 9001 Gap Analysis Tool is designed specifically for those tackling the project for the first time.

The self-assessment tool provides a clear, colour-coded report on the general state of ISO 9001 compliance.

6. Create your documentation

The next step is to create the documents for your QMS. This begins with the quality manual, which provides a top-level overview of your goals and objectives.

You should outline your quality policy and explain how your QMS system functions. This includes descriptions of the processes within your system and the ways they interact.

The quality manual should be complemented with procedure documents. These detail the individual business processes and how they operate. You should explain how each process is designed and controlled, including what checks are conducted to ensure that they work as intended.

After this, you should create work instructions documenting guidelines that employees should follow when performing organisational tasks.

Finally, you must document forms and records. These are used for collecting information about how the QMS is operates and whether it remains ISO 9001-compliant.

7. Involve employees and conduct regular staff training

Before you adopt your QMS, you must provide an introductory training session for relevant employees.

This ensures that anyone who will interact with the system understands how it works and what their requirements are. It also gives you an opportunity to answer any questions that employees have and identify knowledge gaps that need to be addressed further.

Employee engagement shouldn’t end here, though. You should encourage staff to raise any issues they have with the QMS to help you identify room for improvement. This should include further awareness training, as well as team reviews and dedicated sessions for feedback.

ISO 9001 documentation with IT Governance

Simplify your QMS implementation project with our ISO 9001 Documentation Toolkit. It contains more than 90 pre-written policies, procedures, work instructions and records, which you can tailor to your organisation’s requirements.

Developed by ISO 9001 auditors and enhanced by 20 years of customer feedback, this toolkit follows the ISO 9001 standard structure to help you map each clause for ease of use and simple implementation.