Quality Management System (ISO 9001) Certification

ISO 9001 is a quality management system standard showing that an organisation can consistently provide products and services conforming to customer requirements and applicable legislation. The certificate does not approve the product itself; it shows that the system to produce quality has been established and works. The current version is ISO 9001:2026.

• Organisations bidding on public tenders where the specification requires a quality certificate
• Manufacturers within scope of major buyers' supplier-approval process
• Growing organisations wanting to standardise their processes and become more corporate
• Those wanting to build the foundation before moving to a sector scheme (IATF 16949, ISO 13485, AS9100)
• Every organisation regardless of size or field of activity, including the service sector

Not legally mandatory. The requirement in practice arises contractually: public tender specifications, major buyers' supplier-approval criteria, and some sector legislation require an ISO 9001 certificate. Most sector schemes (IATF 16949, AS9100, ISO 22163) build on ISO 9001 and add further requirements.

• Clause 4 — Context of the organisation: internal and external issues, the requirements of interested parties, the QMS scope and processes
• Clause 5 — Leadership: top management commitment, customer focus, the quality policy, roles and authorities
• Clause 6 — Planning: actions to address risks and opportunities, quality objectives, planning of changes
• Clause 7 — Support: resources, monitoring and measuring resources, competence, awareness, communication, documented information
• Clause 8 — Operation: customer requirements, design and development, control of externally provided processes, production and service provision, control of nonconforming outputs
• Clause 9 — Performance evaluation: monitoring and measurement, customer satisfaction, analysis, internal audit, management review
• Clause 10 — Improvement: nonconformity and corrective action, continual improvement

1. 1ApplicationThe organisation's field of activity, headcount, number of sites and scope boundaries are determined. The number of audit days is calculated from this information.
2. 2Document Review (Stage 1)The management system documentation, scope definition, risk assessment and internal-audit/management-review records are examined; readiness for the on-site audit is assessed.
3. 3Certification Audit (Stage 2)It is verified on site that the system is implemented and effective. Findings are classified as major/minor nonconformity or observation.
4. 4Closing NonconformitiesThe organisation submits a root-cause analysis and corrective action plan. The certificate is not issued until major nonconformities are closed.
5. 5Issuing the CertificateThe certificate is issued after review by an independent decision-maker. The audit team cannot make the certification decision.
6. 6Surveillance AuditsA surveillance audit is carried out at least once a year during the certificate's validity. The first surveillance cannot exceed 12 months from the last day of Stage 2.
7. 7RecertificationAt the end of three years, the entire system is re-audited; it must be completed before the certificate expires.

Management system certificates are valid for three years. At least one surveillance audit is carried out per year during this period; the certificate is suspended if surveillance is not carried out. A recertification audit is completed at the end of the third year.

• Trade registry record and operating licence
• The organisation's organisation chart and headcount
• The list of sites/branches within scope
• The management system manual or process documentation
• Internal audit and management review records
• Legal permits, licences and operating documents, if any

There is no fixed list price; the cost is calculated based on the following variables and provided in writing in the quote.

• The headcount within scope (directly determines the number of audit days)
• The number of sites and branches; whether multi-site sampling applies
• The activity's risk level and process complexity
• The number of standards to be certified — an integrated audit reduces the number of days
• The three-year cycle: certification + two surveillance audits

Management system certification is carried out within the scope of ISO/IEC 17021-1. The certification body is accredited by an accreditation body party to the IAF multilateral recognition agreement (IAF MLA); This agreement establishes a chain of international recognition that ensures that a document issued in one country is accepted in other countries. EUROLAB has internationally recognized accreditation from IAF member accreditation bodies within the scope of ISO/IEC 17021-1.

The scope under which this scheme can be offered varies according to your product and activity; it is confirmed in writing at the quote stage.

• ISO 10002Customer Satisfaction and Complaint Management
• ISO 10004Customer Satisfaction Monitoring and Measurement
• ISO 10012Measurement Management System
• ISO 13485Medical Device Quality Management
• ISO 15378Pharmaceutical Primary Packaging Quality Management
• ISO 17034Reference Material Producers
• ISO/IEC 17025Testing and Calibration Laboratories
• ISO 21001Educational Organizations Management