ISO audit always worries you, especially when you are appointed as ISO in-charge person in the company.
I know your feeling …
I’ve been there too …
You don’t know what questions the external ISO auditor will ask you …
You don’t know what records they will check …
You scare you can’t pass the ISO certification audit!
It was my situation when I was preparing for my first ISO 9001 certification audit.
If you don’t want to FAIL your ISO audit, make sure you do these 4 things before your ISO audit days.
Must-Do 4 Things in Preparing ISO 9001 Audit
Fail in ISO audit, meaning the audit team does not recommend your company for granted the ISO 9001 certificate. Or suspend your certificate in surveillance audit during the ISO audit closing meeting.
These can happen if the auditor issues any MAJOR non-conformance findings. Non-conformance (NC), also known as CAR (Corrective Action Request).
1. Risks Assessment
Risks assessment clauses are newly introduced in ISO 9001: 2015 revision.
The clauses are:
4.1 Understanding the organization and its context
4.2 Understand the needs and expectations of interested parties and
6.1 Actions to address risks and opportunities
The organization will do a risk assessment to set the scope of QMS and integrate the action into the QMS processes when preparing ISO documentation.
Company first time applying for ISO 9001 certificate:
You need to conduct a risk assessment. If you are not, MAJOR non-conformity will be an issue during your ISO certification audit.
The company already have ISO 9001 certificate:
You need to ensure your risk assessment is up to date. How to do it? Review and update what you have written in your QMS manual or procedure.
You will receive MAJOR or MINOR non-conformity if you don’t update your risk assessment.
2. Internal Quality Audit (IQA)
Internal audit helps you self-check your QMS is implemented effectively in the company.
Everyone has followed ISO procedures. ISO records are in place. Correction and corrective action are taken for all the non-conformity internal audit findings.
The ISO 901:2015 clause is:
9.2 Internal audit
You are wasting your time and company money if you arrange for an external ISO audit without conducting your internal ISO audit.
An internal audit is also known as a first-party audit. You can do it by
- Appoint internal staff to form an internal ISO audit team to do IQA. External ISO auditor will check their competency. So, send them for ISO 9001 Internal Audit Training or get a qualified trainer to train your staff.
- Appoint external ISO audit services to help you conduct an internal audit. Reminder to review auditor CV to check they are competent to do ISO 9001 audit.
Once you complete your internal audit, you can know how far you’re ready for an external ISO audit based on the audit result. Fix all the non-conformities and plan the corrective action that will make you good to go for an external ISO audit.
3. Management Review Meeting
It is a mandatory ISO 9001 requirement.
The boss or management team needs to know the company’s QMS implementation status. Provide adequate resources to ensure QMS effectiveness and align with company direction.
Examples of topics discussed in the meeting include:
- changes in nature of business
- add a new process
- adopting new technology
- expanding new market
- customer satisfaction
- audit results
- business challenges
- new customer requirements
- quality policy, and quality objectives achievement
External ISO auditor will check your management review meeting minutes. And interview the boss, management team, or quality management representative (QMR) to verify the content in the meeting minutes.
The ISO 901:2015 clause is:
9.3 Management Review
As mentioned, management review is mandatory. You need to conduct a management review meeting and get meeting minutes ready. Else, MAJOR non-conformity will be issued.
4. Quality Objectives
ISO 9001 is a Quality Management System (QMS). You must have a written quality policy and quality objectives.
You need to update your quality objectives achievement status. ISO auditor will check it and ask you questions about your action plan for any unachieved objectives.
The ISO 901:2015 clause is:
6.2 Quality objectives and planning to achieve them
This clause is unlikely to have MAJOR non-conformance unless you ignore it and take no action.
Will You Pass the ISO audit if You've Done All These 4 Things?
The above 4 Must-Do things are straightforward; you will fail your external ISO audit if you do not do them.
If you have done it, you probably wouldn’t have any issues passing your external ISO audit.
However, you may be ready for any MINOR non-conformity. Don’t feel worried when you get MINOR non-conformity. Get it fixed, and it will not affect your ISO 9001 certification.
Nothing is perfect. MINOR non-conformity (NC) doesn’t mean your QMS is terrible and you’re not doing a good job.
It’s common to get MINOR NC in external ISO audits during the first few years of an audit. MINOR NC helps you to improve and make your QMS more perfect.
Be relaxed, and I hope you sleep well 🙂
ISO 9001 ISO Audit
Recommended Course
