What is ISO 9001?
ISO 9001 is the world's most widely used standard for quality management systems. It describes how an organisation plans, runs and improves its processes so that it consistently delivers products and services that meet customer and legal requirements.
The current edition, ISO 9001:2015 (with Amendment 1:2024 on climate change), is built on the process approach, risk-based thinking and the PDCA cycle. Certification is issued by an accredited certification body after a two-stage audit and is valid for three years with annual surveillance audits.
Who needs ISO 9001 certification?
- Manufacturers and suppliers in B2B supply chains
- Companies taking part in public procurement and tenders
- Construction, engineering, logistics and trading companies
- IT and service companies that want to prove stable, repeatable delivery
- Any organisation that wants a structured basis for other standards such as ISO 14001, ISO 45001 or ISO 27001
What the ISO 9001 self-assessment checks
- Context of the organisation, interested parties and QMS scope (clause 4)
- Leadership, quality policy and responsibilities (clause 5)
- Risks, opportunities and quality objectives (clause 6)
- Resources, competence, awareness and documented information (clause 7)
- Operation: customer requirements, design, purchasing, production and service delivery (clause 8)
- Customer satisfaction, internal audit, management review and continual improvement (clauses 9–10)
Typical gaps before an ISO 9001 audit
- Processes work in practice but are not described, and their interactions are unclear
- Quality objectives are not measurable or are not monitored
- Supplier evaluation is informal and not recorded
- Customer feedback and complaints are not analysed
- No internal audit or management review before the certification audit
From self-assessment to certification
The self-assessment shows where you stand today. Use the gap report to plan the work, prepare documents and evidence, and then run a practice interview in the BALTUM AI audit simulator. The certification itself is carried out by an accredited certification body of your choice.