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ISO 9001

What is ISO 9001?

The ISO 9001 quality management system standards consist of international standards that provide guidance for the development and implementation of an effective quality management system. Regardless of the specific nature of the products, these standards are applicable to both the manufacturing and service sectors.

Key ISO Standards

  • ISO 9000:2015 – contains the principles and fundamental concepts of quality management, describes the content of the standards series, and includes a list of terms and their definitions used within the standards.
  • ISO 9001:2015 – specifies the requirements for quality management systems.
  • ISO 9004:2009 – provides guidance for achieving the sustained success of an organization through a quality management approach.
  • ISO 19011 – provides guidelines for auditing management systems (ISO 19011:2011).

Why implement the ISO 9001 standard?

Organizations implement ISO 9001 for various reasons. The decision to implement ISO 9001 may be based on objectives such as:

  • meeting the requirements of customers seeking high-quality products;
  • accessing the market of the European Union (EU);
  • improving competitiveness in both domestic and international markets;
  • enhancing quality management systems;
  • reducing and facilitating audits conducted by customers;
  • improving the organization of work for all personnel within the company.

A simplified sequence on the path to certification

  • Apply the requirements contained in ISO 9001.
  • Determine the working methods that are most suitable for your organization.
  • Define what you will do and how you will do it.
  • Do what you have defined – and confirm it.
  • Improve it! The system should not be static. It must evolve, with the main goal being the continuous improvement of product quality and production processes. An effective approach is the use of the Plan – Do – Check – Act (PDCA) cycle. Quality objectives can serve as a key tool for such improvement.

It is necessary to define and document quality objectives aimed at improving processes. These objectives should be measurable and aligned with the organization’s quality policy.

The objectives may be documented separately, included in the company’s business plan, or incorporated into the minutes of a management review.

Objectives should be defined at all levels of the organization.

They may also be included in the plans of individual organizational units.

Clearly define and distribute responsibilities and authorities within the organization.

The Role of the Consultant:

Some organizations achieve ISO 9001 certification without involving external consultants, but the assistance of external specialists can often be highly valuable and may be a wise decision.

If consultants with knowledge and experience in your organization, who are familiar with the ISO 9000 series standards, are engaged, they can become a valuable resource.

They often help to properly plan and implement the Quality Management System, conduct training, and support preparation for the audit. Additionally, they are comfortable with the audit process, as they work daily according to the standard’s requirements.

Before the Audit:

  • Check that all recommendations provided by the consultants have been implemented.
  • Review all documentation for the certification audit to ensure that the requirements are being met.
  • Consider a pre-audit visit by the auditor. This is not a consulting visit, but an assessment of your readiness for the certification audit.
  • Conduct a full rehearsal.
  • Prepare all employees on how to respond to the auditors’ questions.

Before the Audit:

  • Verify that all recommendations provided by the consultants have been implemented.
  • Review all documentation for the certification audit to ensure that all requirements are being met.
  • Consider arranging a pre-audit visit by the auditor. This is not a consulting visit, but an assessment of your readiness for the certification audit.
  • Conduct a full-scale rehearsal.
  • Prepare all employees on how to respond to auditors’ questions.

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Tel.: +359 32 624 243
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