Ready to get started with ISO 9001 certification?
The good news is that you don’t need everything in place before you start the certification process. It will highlight any areas that need improvement—think of it as a learning journey.
Here’s what you need to know to get started.
1. Prepare Your Team
At this stage, you will need someone who has experience in implementing Quality Management Systems and knows what’s needed to achieve ISO 9001 certification. This can be someone on your team or an external consultant.
Don’t worry if you don’t have an employee with this knowledge or expertise—there are free ISO 9001 training courses available to get you and your team up to speed.
2. Enlist the Support of Top Management
The support of top management is essential—leaders are a vital part of driving the ISO 9001 implementation process. They also keep your quality objectives in line with your organization’s business strategy. Their commitment will also help to empower your team.
3. Create Your Implementation Plan
It’s essential for your organization to have clear objectives and understand the benefits of achieving ISO 9001 certification—be ready to weave the QMS into every part of your business. Plus, make sure everyone knows what’s expected of them and what their responsibilities are.
A gap analysis—which assesses current practices against ISO 9001 requirements—will identify areas of your existing system that need improvement. You’ll then need an implementation plan that outlines your goals, timelines and everyone’s responsibilities.
This is your roadmap to success!
Download our free ISO 9001 checklist.
4. Define Your QMS
Defining your QMS is a vital team effort that involves all departments. Here’s what you’ll need to do:
- Establish who the ‘customers’ are for each department. For example, the sales team focuses on external clients, while your IT department serves internal teams.
- Document what happens in each area to ensure you meet the ISO 9001 requirements. You’ll need to include all critical processes and interactions.
- Identify any problem areas and fix them. Remember to make adjustments along the way, as they help build an effective system.
Discover ISO 9001 software for a smoother certification process.
5. Support and Train Employees
Establish training programs for your team, so that they feel engaged and understand the QMS. Your employees should understand the quality objectives and know their individual responsibilities. Everyone should recognize the part they play in the QMS.
Track their experience, education and training to understand their capabilities. Then, plan for future training needs and any new skills you’ll need as your business evolves.
Find out more about ISO 9001 training.
6. Document Your QMS
A well-documented QMS is essential, along with the necessary policies and procedures. This setup will define:
- How your organization is structured
- Who’s responsible for recording information and what gets recorded
- Employee responsibilities
- Communication lines throughout the company
- Required actions
- How to keep things running smoothly as team members change
7. Manage Your Documentation Effectively
Make sure everyone understands the importance of keeping accurate records and using the right documents.
Set up a system to control documents, making sure that only the latest versions are used. Decide which records are crucial for ISO 9001 compliance and running your business effectively.
You’ll need to provide your auditor with several documents to show that your QMS is effective. These include your quality policy, the scope of the QMS and your quality objectives (plus how you will meet them). Having everything organized will make this step easier.
Find out more about ISO 9001 requirements.
8. Correct and Prevent Issues
Sometimes things go off track, and that’s OK. What’s important is having a process to fix problems and understand what caused them, so they don’t happen again.
Keep a record of any actions taken and try to identify potential issues before they happen—these processes should be integrated into the QMS for ongoing improvement. Think of challenges as opportunities to improve your system.
9. Conduct Regular Internal Auditing
Regular internal quality audits can help to make sure everything’s on track. Have independent team members carry out these audits to check that procedures in the Quality Manual are being followed. Set up a procedure for how audits are planned, conducted, and recorded.
Management reviews can assess your audit findings and the performance of your QMS.
If your QMS is considered to be effective, it’s time for your certification audit—ask an accredited certification body to perform this for you. This is the time to be proud of how far you’ve come.
10. Time for the Audit Process—Stage 1 and Stage 2
Once you’ve laid the groundwork and completed your ISO 9001 Quality Manual, you’ll be ready for the Stage 1 assessment—which focuses on reviewing documentation.
The assessor will need to verify that your documented QMS meets the ISO 9001 standards and aligns with what you’re actually doing, pointing out any areas for improvement.
After making any necessary changes, get ready for the Stage 2 certification assessment, which assesses implementation and effectiveness. This should be done by an independent third party, accredited by bodies like ANAB.
Successfully achieving certification will be a mark of all your hard work so far.