ISO 9001

ISO 9001

What is ISO 9001?

ISO 9001 is the most famous international norm that sets requests for establishing and maintaining the quality management system and is applicable to all type of organizations (profit/nonprofit, production/service-providing, small/medium/big).
It encompasses the basic processes inside the organization (sales, development, procurement, production/services, etc.) assuring hat through the activities these processes are led in controlled conditions, and, as such, comply with the requests of the relevant stakeholders:

• process description
•  setting measurable objectives of the processes on the basis of compared data and information
•  measuring and monitoring of the processes via key parameters
•  data analysis and reporting on the success of the processes
• improving the processes

The quality management system, pursuant to the demands of ISO 9001, today is used in the whole world and its certification is a generally accepted mode of proving the current and potential partners that the product or the service will meet their needs in terms of quality.

 A well developed and maintained quality management system has a positive contribution to the fulfillment of the objectives in the work, at the same time improving the:

    • buyers’ satisfaction and trust
    • overall results and abilities
    • better quality of products/services
    • better labor productivity
    • less mistakes
    • lower costs
    • timely delivery, etc.


Quality management system

The organization has to establish, document, apply and maintain the quality management system, and to continuously improve its efficiency pursuant to the demands of this international standard.

Introduction of a quality system

The Economic Chamber of Macedonia, more precisely the Center for the promotion of the quality in the production and services, which functions within the Chamber, works on introducing a quality management system pursuant to ISO 9001.

Dynamic/action plan of activities

• Structure of support/Action plan
• Analysis of processes and preparation of block diagrams
•  Programme for raising the awareness about quality
•  Development and preparation do documented information
• Internal checks
• Checking the quality system by the management 
• Pre-assessment
• Certification

Necessary documented information

The documented information that is to be prepared in order for the demands of the standard to be met is as follows:

1.  Quality manual
2. Procedures/diagrams for main processes
    Procedures/diagrams for additional processes
    Procedures/diagrams for systemic processes
3. Working guidelines for all critical and specific activities that are taking place within the defined process
4. Entries that generate information from all defined processes, as an impartial proof of the activity that has been performed
          4.1. Quality policy
          4.2.  General statement
          4.3.  Organizational scheme
          4.4.  Scope of the quality system
          4.5.  Quality aims

Internal checks

The organization has to implement internal checks in planned time spans, so that it confirms that the quality management system is established and harmonized with the planned activities regarding the demands of the standards, and that it is effectively implemented and maintained. There is a procedure for internal checks that outlines the course of the activities relevant in this process in detail:

• internal check planning
• making a team of persons responsible for the internal checks
• review of the documentation
• preparation of check lists
• notifications for those who have been checked
• holding an introductory meeting
• implementation of an internal check
• defining the findings
• holding a wrap up meeting
• issuing requests for corrective measures and a report

Corrective measures

The organization should conduct activities to eliminate the reasons that caused discrepancies with the objective to prevent their reappearance- a corrective measure. The organization should set activities that have an objective to eliminate the obstacles that would cause potential discrepancies in order to prevent their appearance. The procedure for a corrective measure describes in detail all necessary activities, relevant for this process:

• looking for discrepancies
• defining the reasons that caused the appearance of discrepancies
• assessment of the need of a measure that will prevent reappearance of discrepancies
• determining and implementing the necessary measure
• checking the corrective measure that has been undertaken

Pre-assessment of the quality system

The pre-assessment of the quality management system is the final stage of the project- introduction to a quality management system. About four to six weeks before the certification made by the Certifying Body, a full pre-assessment should be performed of the quality management system by the Economic Chamber of Macedonia. The pre-assessment is seen as an exercise for the “real” certification that follows.
At this level, it is not desirable for any major discrepancy to be detected, but the experience, including the communication with the persons who perform the check of the Certifying Body will be of great benefit, on the basis of which concrete corrective measures will be undertaken if certain discrepancies are to be found.

Contact address:
Economic Chamber of Macedonia
st. Dimitrie Chupovski, 13
1000 Skopje
Contact: Emilija Todorovska
Tel: ++ 389 2 3244047
Fax:++ 389 2 3244088

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