What is ISO 9001?

The ISO 9001 quality management system standards group consists of international standards that provide guidance for developing an effective quality management system. Regardless of the specifics of the products, these standards are applicable to both manufacturing and service industries.

Basic ISO standards

• ISO 9000:2015 - contains the principles and basic concepts of quality management, describes the content of the series of standards and contains a list of terms and their meaning in their use.
• ISO 9001:2015 – defines the requirements for quality management systems
• ISO 9004:2009 – management for the long-term success of any organization. ISO quality management approach
• 19011 – guidelines for auditing management systems (ISO 19011:2011).

Why do we certify ISO 9001 standard?

Businesses certify ISO 9001 for a variety of reasons. The decision to certify ISO 9001 may be based on objectives such as:

• satisfying the requirements of consumers looking for a high-quality product for the European Union market;
• competitiveness on the domestic and foreign markets;
• improvement of quality management systems;
• reduce and facilitate user audits;
• improving the organization of the work of all personnel in the company.

A simplified sequence on the path to certification

• Apply the requirements contained in ISO 9001
• determine the best working methods for you
• determine what and how you will do
• do what you said - back it up! Perfect it!
• The system should not be static. It must develop, and the main thing is to improve the quality of products and production processes. An effective approach can be to use the cycle: Plan - Do - Check - Improve. The quality objectives can become an instrument of such improvement.
• It is necessary to define and document quality objectives for process improvement. Objectives must be measurable and follow the company's quality policy.
• The objectives can be a separate document, they can be as a business plan of the Company or as part of the minutes of a management review.
• Objectives must be defined for all levels in the enterprise.
• The objectives may be included in the plans of individual structural units.

Distribute the responsibilities and powers in the enterprise!

Before the audit:

• Check that all requirements of the standard are met.
• Review all certification audit documents to ensure requirements are met.
• Consider the possibility of a pre-audit visit by the auditor. This is to determine your readiness for a certification audit.
• Hold a dress rehearsal.
• Prepare all associates in the enterprise how to answer the auditors' questions.

Control audits

Systems certified to ISO 9001 require periodic control to ensure that they continue to operate according to the requirements of the standard. The main objective of the auditors in the course of control audits is to verify compliance with the ISO 9001 standard. Auditors seek confirmation that the entire quality system is maintained, improved and, if necessary, corrected.