An ISO 9001 gap analysis is the first step in the ISO 9001 certification process. To achieve ISO 9001 compliance, and ultimately ISO 9001 certification, your business must perform a comprehensive gap analysis of your current quality management system (QMS) against the ISO 9001 standard and identify areas of non-compliance. This gap analysis will inform the rest of your compliance and certification process so must be done properly the first time to avoid costly delays or inaccuracies.
What is an ISO 9001 gap analysis?
ISO 9001 is the International Organisation for Standardisation’s standard for quality management systems (QMS), one of the most popular standards in the world. There are a wide range of benefits to achieving ISO 9001 compliance including quality assurance, improved customer loyalty and increased efficiency.
An ISO 9001 gap analysis is the first stage in achieving ISO 9001 compliance. It involves conducting a thorough, objective evaluation of your business’s existing QMS system against the requirements set out in the ISO 9001 standard and identifying areas for improvement. This process can be done internally or can be outsourced to a professional ISO 9001 consultant.
What is the purpose of an ISO 9001 gap analysis?
The purpose of an ISO 9001 gap analysis is to assess the current state of your quality management system against ISO 9001 requirements and identify areas of noncompliance. This process will determine any issues, faults or potential risks which need to be rectified prior to applying for ISO 9001 certification.
How often should I perform an ISO 9001 gap analysis?
An ISO 9001 gap analysis should take place as the first step in your ISO compliance and certification process. ISO 9001 certification lasts for three years, so your gap analysis will need to take place at least every three years, or as needed for certification.
How to conduct a DIY ISO 9001 gap analysis
Before you begin your DIY analysis, it’s important to set goals around what you want to achieve from ISO 9001 certification and how you want it to benefit your business. Define the scope of your quality management system including which departments and locations of the business it will be responsible for.
One you’ve determined the scope of your QMS it’s time to conduct your gap analysis to find out which areas of the ISO 9001 standard you’re already compliant with and which aspects require improvement.
To conduct a DIY ISO 9001 gap analysis, compare your current QMS and your business practices against the requirements set out in clauses 4 -10 of the ISO 9001 standard.
Free DIY ISO 9001 gap analysis checklist PDF
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Disclaimer: Every business is different and your unique needs may impact the gap analysis process. This document is a guide only and we recommend seeking professional help to achieve ISO 9001 compliance.
I’ve completed my ISO 9001 gap analysis, what next?
Completing a thorough ISO 9001 gap analysis is the first step to becoming ISO 9001 certified. Once your analysis is complete you will need to take the following steps to become compliant:
Prepare compliance documentation – Prepare all necessary compliance documentation including but not limited to your quality policy, scope statement, quality objectives, policies and procedures, process maps and work process instructions.
Implement or update your ISO 9001 compliant quality management system (QMS) – Implement your new management system making sure to inform all staff members of the new processes and procedures, prepare workflow instructions, maintain records and continuously improve and update the system.
Conduct an internal audit and compliance verification – Before applying for certification conduct a thorough audit to check for ISO 9001 compliance. It’s best practice to outsource this task to a professional ISO 9001 consultant to ensure 100% compliance prior to applying for ISO 9001 accreditation.
Obtain ISO 9001 certification – Once you’ve achieved compliance head to the JAS-ANZ website to find a certifying body near you and apply for ISO 9001 certification.
Need help conducting your ISO gap analysis? Let us handle everything for you
At BusinessBasics we’ve helped countless Australian businesses achieve ISO 9001 certification and we can help you too. With an incredibly highly experienced team across a diverse range of industries from retail to construction to mining and manufacturing, we can help you achieve ISO 9001 compliance no matter your size, scope or sector.