Ukrainian Certification Agency, certification authority accredited by National Accreditation Agency of Ukraine (NAAU), provides certification services for quality management systems for compliance with the requirements of various standards such as: ISO 9001: 2015 (DSTU ISO 9001: 2015) “Quality management systems. Requirements.”

Certification of quality management systems in accordance with ISO 9001

Accreditation Certificate No. 8О110

The main activity areas of Ukrainian Certification Agency in providing services on quality management system certification for compliance with the requirements of ISO 9001 are the following economic sectors:

• 13 pharmaceutics,
• 38 health and social work.

17 January 2014, the Order of the Ministry of Health of Ukraine No. 1116 of 20 December 2013 “On Amendments to the Order of the Ministry of Health of Ukraine of 14 March 2011 No. 142 “About improvement of state accreditation for health care institutions” came into force. The order amends the state accreditation for health care institutions (paragraph 4.2) “institutions that provide a secondary (specialized) medical care and tertiary (highly specialized) medical care can obtain highest qualification only if available certificate of conformance Quality management system implemented in this institution meets the requirements to DSTU ISO 9001 national standard”.

The ISO standards of the 9000 series address various aspects of quality management and include some of the most well-known ISO standards. These standards provide guidance and tools for companies and organizations that want their products and services to consistently meet customer requirements and the quality of their products and services to constantly improve.

ISO 9001 standard sets the criteria for the quality management system and can be applied by any organization, regardless of its field of activity. In fact, there are more than a million companies and organizations in over 170 countries certified to ISO 9001.

The ISO 9001 standard is based on seven principles of quality management:

• Customer orientation
• Leadership
• Personnel involvement
• Process approach
• Improvement
• Making decisions based on actual data
• Relationship management.

Advantages of ISO 9001certification:

The ISO 9001 certified QMS enables companies to stand out in the market, since effective quality management allows to:

• maximally effectively meet customer needs,
• more efficient use time and money resources,
• promptly eliminate errors,
• ensure personnel motivation and involvement to achieve a new level by contributing to the improvement of internal processes,
• obtain preferential credit terms,
• increase loyalty to the company by power structures, partners and customers,
• provide goods and services of better quality.

As a result, an enterprise lands more customers and expands its business opportunities, up to receiving state orders and contracts with foreign partners.

To obtain the ISO 9001 certificate at Ukrainian Certification Agency you need to:

1. Prepare an application and file a package of documents to the authority.
2. Sign the contract for certification and make a payment.
3. Undergo a certification audit.
   – Audit of the 1st stage (preliminary assessment)
   – Audit of the 2nd stage (final inspection / on-site audit);
   – Analysis of the results of verification and documentation of certification.
4. Obtain a certificate.

Rights and obligations of the applicant

The form of registration of complaints and appeals