ISO 9001

What is special about ISO 9001:2015?

Using ISO 9001:2015 as a business management tool inevitably leads to success. ISO 9001:2015 is a standard for managing the business as a whole, not merely a quality management system standard. An important feature of the 2015 version of ISO 9001 is risk management.

This is a powerful instrument that helps solve one of the most pressing issues for manufacturers and businesses of any type: losses. Losses exist in every area of an organization's activity, including technology, production, environmental matters, information flows, and more.

By implementing risk management as a thoughtful and continuous activity, you gain a unified tool for managing production and business that is aimed at continual improvement and ongoing loss reduction.

Learning to manage risks means becoming more competitive and successful. By managing risks, you manage your business.

External reasons for implementing ISO 9001

• improving the company's image for foreign investors;
• entering European Union markets;
• the opportunity to participate in EU grant projects;
• meeting tender participation requirements;
• meeting the requirements of consumers or retail chains;
• competitiveness in domestic and foreign markets.

Internal reasons for implementing ISO 9001

• improving management of the company's organizational structure;
• raising the quality level of products or services;
• reducing costs, including production losses, defects, and claims;
• improving the existing management system;
• identifying the processes operating within the company and evaluating their effectiveness;
• improving supplier performance.

Main stages of ISO 9001:2015 certification

The management system pre-assessment stage:

The certification and certification audit stage:

1. prepare and submit the application to the certification body;
2. conduct a preliminary documentation review and a diagnostic audit of the management system;
3. sign an agreement for certification services;
4. develop the final management system assessment program with the audit team;
5. develop checklists for the audit;
6. hold the opening meeting and conduct the on-site certification audit;
7. prepare the report and receive the expert commission's decision;
8. issue nonconformity reports if minor nonconformities are identified;
9. receive a certificate valid for 3 years with annual surveillance audits.

Legislative framework

The modular concept of conformity assessment to EU Directives requires the implementation and certification of a management system. The international standard ISO 9001 is voluntary in application, and certification of the management system is also voluntary.

Answers to questions

Is a certificate for ISO management systems required to meet the requirements of EU Directives?

All EU Directives provide for modular conformity assessment (A, B, C, H, and others) of products in order to confirm compliance with European harmonized standards and the EU Directive as a whole. Module H provides for mandatory certification of the functioning management system at the enterprise.

The foundation of the modular concept and the manufacturer's compliance with EU Directive requirements is built on the implementation and functioning of the ISO 9001 management system concept, or ISO 13485 for medical devices and equipment, to confirm the stable release of products in accordance with European harmonized requirements.

EU Regulation 305/2011 for construction products requires the mandatory functioning of a factory production control system based on the principles of the ISO 9001 management system.