How to Get ISO 9001 Certified

What ISO 9001 certification means for a manufacturer

ISO 9001 certification means an accredited certification body has audited your quality system and confirmed that it meets the standard. For most shops and plants, the reason to get certified is a customer requirement. When a customer asks a supplier to get ISO certified, they almost always mean ISO 9001.

• A customer's supplier questionnaire or contract lists ISO 9001 certification as a requirement.
• Certification shows that you control the things that affect product quality: drawing revisions, material certs, inspection, calibrated gauges, nonconforming parts and corrective actions.
• Most small manufacturers take about 4 to 6 months from the first gap analysis to the certificate. The time depends on how much of the system already exists and how many hours someone can give the project each week.

The ISO 9001 certification process, step by step

The ISO certification process is similar for most management system standards. These are the steps most small manufacturers follow for ISO 9001. Steps 2 through 6 often overlap.

1. Gap analysis. Compare how the shop runs today against each clause of ISO 9001. The result is a list of what is in place, what is partial and what is missing, with a plan and a budget. For a small shop this usually takes one or two days of review plus a written report.
2. Write the quality system around how the work is actually done. Document the processes you already run: order review, purchasing, travelers, inspection, calibration, nonconforming parts and corrective action. A small shop usually needs a short quality manual, about a dozen procedures and the forms it already uses.
3. Run the system and keep records. Use the procedures on real jobs and keep the records they call for: travelers, material certs with heat lots, first article reports, calibration records by gauge ID and nonconformance reports. Most certification bodies want to see about three months of records before the Stage 2 audit.
4. Internal audit. ISO 9001 clause 9.2 requires internal audits at planned intervals. Before Stage 2, most certification bodies expect at least one internal audit that covers every process, done by someone who did not audit their own work. Findings should be closed with corrective actions.
5. Management review. Clause 9.3 requires top management to review the quality system. The review covers internal audit results, customer feedback, quality objectives and corrective actions, and the management review minutes should record the decisions and actions that came out of it.
6. Choose an accredited certification body. Get quotes from two or three accredited certification bodies, also called registrars. Most need several weeks of notice to schedule the first audit, so this step usually runs alongside steps 2 through 5.
7. Stage 1 audit. The auditor reviews your documents and checks whether you are ready for Stage 2. For a small shop, Stage 1 is usually about one day, on-site or remote.
8. Stage 2 audit. The auditor checks that the system is in use on the floor. They pick jobs, trace them through your records and interview the people doing the work. For a 10 to 50 person shop, Stage 2 usually takes 2 to 4 auditor days, set by headcount and scope.
9. Certificate issued. Major nonconformities from Stage 2 must be corrected and minor ones need an accepted corrective action plan. The certification body then makes its certification decision and issues the certificate, which is valid for three years.

How long does it take to get ISO 9001 certified

Step	Typical time for a 10 to 50 person shop
Gap analysis	1 to 2 weeks, including the written report
Write the quality system	4 to 8 weeks
Run the system and keep records	About 3 months, overlapping with the writing
Internal audit	1 to 2 weeks, including closing findings
Management review	One meeting, usually after the internal audit
Choose a certification body	2 to 4 weeks, alongside the steps above
Stage 1 audit	About 1 day
Time between Stage 1 and Stage 2	2 to 6 weeks
Stage 2 audit	2 to 4 days
Certificate issued	2 to 6 weeks after findings are addressed
Total	About 4 to 6 months

What the certification body checks at Stage 1 and Stage 2

Our ISO 9001 audit checklist follows the order auditors commonly use on the floor.

After certification: surveillance and recertification audits

The certificate is valid for three years, and the certification body audits you during that time to confirm the system is still working.

• A surveillance audit in year 1 and year 2. The first one is due within 12 months of the certification decision.
• A recertification audit in year 3, completed before the certificate expires.
• Internal audits and management review continue between visits, and corrective actions from each audit are checked at the next one.

Read more about ISO 9001 surveillance and recertification audits.

What ISO 9001 certification costs

The cost has three parts: consulting if you use it, the certification body's audit fees and your team's time. For shops and plants under about 50 people, initial certification audits typically cost $4,000 to $9,000, and surveillance audits about $2,000 to $4,000 a year. See the ISO 9001 certification cost breakdown for the details.

How to choose a certification body

• Accredited. In the US, look for a certification body accredited by ANAB, or by another accreditation body that is a member of the International Accreditation Forum (IAF). Customers often do not accept certificates from unaccredited bodies.
• Auditors who know your industry. The certification body has to be accredited for your industry's scope. Ask whether its auditors regularly audit manufacturers like yours.
• A quote for the full cycle. Ask for Stage 1, Stage 2 and both surveillance years in one quote, including travel, report and certificate fees, and compare quotes on the three-year total.

Common reasons ISO 9001 implementation takes longer

• No one has time set aside each week for the project.
• Documents were copied from a template and have to be rewritten to match how the shop runs.
• There are not yet enough records for Stage 2, such as three months of inspection, calibration or corrective action records.
• Gauges have no IDs or calibration history, so a full calibration cycle has to happen first.
• The internal audit or management review was skipped, or the internal audit was done by someone auditing their own work.
• A major nonconformity at Stage 2 needs correction and a follow-up visit.

How Qualent Advisory helps

We start with a fixed-price ISO 9001 gap analysis ($1,000-$2,500) that gives you a written roadmap and budget. Our ISO 9001 consulting service then builds the quality system around how your shop or plant already works and supports you through Stage 1 and Stage 2. For manufacturers that are already certified, we schedule and run internal audits with an experienced, independent auditor and help close the findings. Call (832) 905-1664 or book a call.

Common questions about ISO 9001 certification

How long does it take to get ISO 9001 certified?

Most small manufacturers take about 4 to 6 months from the gap analysis to the certificate. Shops and plants that already keep travelers, material certs and calibration records consistently can move faster. It takes longer when no one has time set aside for the project.

Can we get ISO 9001 certified on our own?

Yes. ISO 9001 does not require a consultant, and some manufacturers implement it themselves using the standard and a template kit. It usually takes longer, because the person leading the project has to learn the standard while doing their regular job.

Do we need a consultant?

Not always. A consultant makes sense when a customer has set a deadline or when no one in the building has been through a certification audit. A gap analysis shows how much work is involved before you decide.

What happens if we fail the Stage 2 audit?

Minor nonconformities need a corrective action plan that the certification body accepts. A major nonconformity has to be corrected first, and the certification body may need a follow-up visit to verify it before issuing the certificate. If the deadline it sets is missed, part or all of Stage 2 may have to be repeated.

How much does ISO 9001 certification cost?

For shops and plants under about 50 people, certification body fees for the initial audit typically run $4,000 to $9,000, plus about $2,000 to $4,000 a year for surveillance audits. Consulting and your team's time are separate. The ISO 9001 certification cost page has the full breakdown.