Quality Management System Certification

Valpas Certifications offers quality management system certifications for ISO 9001 and ISO 13485 standards.

Audit processes

Certification period starts

  • Voluntary preaudit
  • Initial audit step 1
  • Initial audit step 2
  • Certification (Certification period starts)

By the end of first year

  • First surveillance audit
  • Maintenance of certification

By the end of second year

  • Second surveillance audit
  • Maintenance of certification

By the end of third year

  • Re-certification audit step 1
  • Re-certification audit step 2
  • Re-certification

The certification cycle is three years as presented above. Before the certification activities are started, the client needs to contact Valpas Certifications and provide the necessary preliminary information about the client’s quality management system. After Valpas Certifications has reviewed the preliminary information, the client is guided to fill the Certification Application Form. The certification agreement is concluded between the client and Valpas Certifications after the information is evaluated to be appropriate and adequate by Valpas Certifications.

Valpas Certifications offers quality management system certifications for ISO 9001 and ISO 13485.

Valpas Certifications appoints an auditing team for each client considering the application information. The team consists of a lead auditor and one or more auditors. The client has the right to object any personnel appointed for the certification activities by Valpas Certifications. If any team members are objected with appropriate justifications by the client, Valpas Certifications appoints a different person for the position.

Audit duration is based on mandatory documents IAF MD 5:2009 for ISO 9001 and IAF MD 9:2011 for ISO 13485.

However, the audit duration audit duration may be reduced or increased because of factors such as complexity or results of previous audits. Audit duration is always justified and the justification is provided to the client in written form.

1. Initial Audit

Initial audit contains two phases and, according to the wishes of the client, of an additional voluntary preliminary audit.

The preliminary audit contains site inspection and quality management system documentation review to determine the readiness for Stage 1 and Stage 2 audits. During preliminary audits nonconformities are not documented.

Stage 1 audit contains assessment of readiness for certification. During Stage 1 audit Valpas Certifications performs an on-site audit and assesses quality management system documentation and business activities. Observations on possible nonconformities are identified. Observations are made on matters which may be classified as nonconformities during stage 2.

Stage 2 audit contains an on-site assessment for the quality management system in question. If found, nonconformities are identified, and a time frame is given for the corrective and preventive actions.

If the requirements for certification are met, the client is certified with a quality management system certificate after Stage 2 audit.

2. Surveillance Audit

Surveillance audits are carried out at least on a yearly basis. During surveillance audits a portion of the quality management system is evaluated. The evaluated areas of the quality management system are chosen according to their criticality.

If Valpas Certifications has certified multiple quality management systems for the client, the surveillance audits can be combined.

Reporting of surveillance audits are carried out the same manner as the initial certification audit. If major nonconformities are identified during the audit, Valpas Certifications makes a decision if any additional actions are carried out. These actions may be additional audit or withdrawal of certificate (temporary or permanent).

3. Recertification Audit

The recertification audit is carried out after two surveillance audits every 36 months. During the recertification audit a complete quality management system audit similar to initial audit is carried out. The recertification starts the three-year cycle from the beginning if all certification requirements are still met.

When scheduling the recertification audit date, the client is responsible for scheduling the date such that any possible corrective or preventive actions for nonconformities can be carried out before the certification period ends.

4. Additional unannounced audits

Valpas Certifications reserves the right to carry out additional unannounced audits. These audits are carried out if major changes in the certified organization or its procedures have taken place which may affect to the effectiveness of the certified quality management system. Unannounced audits may also be carried out due to a complaint received about the certified client.

5. Granting, maintenance, and withdrawal of certificate

The certification period starts from the initial certification audit. The granted certificate states the validity period of the certificate and all sites which the certificate covers. The default certification validity period is 36 months and the certification is renewed after recertification audits. The certification can be withdrawn based on the wishes of the client with a 3-month notice.

The certification automatically becomes unvalid after the certification period unless proper recertification activities are carried out. Valpas Certifications also reserves to right to withdraw the certificate in situations where

  • major nonconformities are identified during the surveillance audits
  • the client uses the certification in a misleading manner
  • the client has provided misleading or wrong information during audits
  • the client does not inform Valpas Certifications about major changes concerning the certified quality management system
  • the client does not carry out preventive and corrective actions during the period agreed with Valpas Certifications
  • the client does not pay the fees related to certification
  • the client goes bankrupt

If preventive and corrective actions can be carried out in a reasonable time, the withdrawal can be carried out as temporary. If Valpas Certifications uses temporary or permanent withdrawal of certificate, the justifications will be provided in writing.

For all permanent withdrawal cases the name of the certified client will be removed from the index of certified clients. For temporary withdrawal, a notice of the temporary withdrawal will be added to client information in the index. If the certification is withdrawn for any reason, the client is obligated not to use the certification or refer to it in any manner.

6. Use of certification mark

During the validity of a granted certificate, the client has the right to refer to the certificate and use the certification mark provided. All text linked to the certification mark must be used in English. The client also has to use the appropriate accreditation mark with the certificate. However, the client has to

  • use the exact mark provided by Valpas Certifications
  • use the name of organization with the certification mark
  • use the certificate according to its scope and not refer any products or activities not certified in a misleading manner
  • agree not using the mark in any product packaging in a misleading manner and use it in a manner that states which part of the product the certificate is linked to
  • agree not using the mark in any laboratory testing, calibration or inspection reports
  • stop using the mark immediately in case of withdrawal of certification