ISO 9001 Quality Management System

Good quality products and services are essential for achieving economic success in today’s global market. Product and service characteristics that are stated through internationally recognized quality terms such as complying with the requirements of ISO 9000 on quality management systems shall form an important basis for market negotiations. All manufacturers, distributors, sellers, subcontractors, retailers and consumers shall need to have a common understanding on what quality is and how it is achieved.

What is ISO 9001?

ISO 9001 is an international standard that specifies the conditions required for establishments that desire to establish and implement the Quality Management System. The first version of the standard was published in 1987 and the latest version was published as ISO 9001:2015 in September, 2015.

The Standard defines the Quality Management System processes that must be followed by an establishment at minimum level. ISO 9001 Standard is not a product standard, but it is a standard for the Quality System of an establishment.

The Standard is still implemented by many establishments all over the world and constitutes the foundation of several management systems with regard to its general structure.

How Has Been ISO 9001 Standard Developed?

The Technical Committee 176 was established  in 1979 in order to reveal the quality principles that would meet the need for a minimum international standard (ISO 9000) and that demonstrate how manufacturing companies would constitute their quality control methods.

20 countries and 10 observing countries gathered and created unanimously the series of quality management standards that were called ISO 9000 and published in 1987 so as to achieve this objective. These standards were prepared based on the British standard BS 5750 published in 1979. Furthermore, we can summarize the chronological development of the standard as follows;

  1. The US Ministry of Defense published MIL-Q 9858 (Quality Management Program) in 1959.
  2. MIL-Q 9858 was revised and published in 1963.
  3. NATO adopted the MIL-Q 9858-A as Allied Quality Assurance Publication / AQAP-1 in 1968.
  4. The British Ministry of Defense adopted AQAP-1 as the Management Program Defense Standard DEF/STAN 05-8 in 1970.
  5. The British Standards Institution (BSI) developed the first commercial Quality Management Standards – BS 5750 in the light of AQAP in 1979.
  6. A great majority of BS5750 was cited in the same manner and ISO9000 was created in 1987. Then BS5750 and ISO9000 were harmonized and became an equivalent standard.
  7. The American Society for Quality Control (ASQC) and the American Standards Institute (ANSI) published the Q-90 equivalent to ISO9000 in the same year.
  8. The Turkish Standards establishment – TSE published the ISO9000 as TS6000/ISO9000 series in 1988.
  9. The European Organization – EO adopted the ISO9000 as the European Norm-EN29000 in 1989.
  10. The number of TS6000 was changed as TS-ISO 9000 in 1991.
  11. The US Ministry of Defense adopted the ANSI/ASQC Q-90 series and ISO9000 series standards to be used in contracts with US Companies and Foreign Companies in 1992.
  12. The first revision of ISO 9000 standards was published as ISO 9001, ISO 9002 and ISO 9003 in 1994.
  13. The second revision of the standard was published as ISO 9001:2000 in December, 2000.
  14. The third revision of the standard was published as ISO 9001:2008 in 2008.
  15. The fourth revision of the standard was published as ISO 9001:2015 in September, 2015.

What Are The Benefits of ISO 9001 Certificate?

Today, the main reason of the fact that establishments request to obtain the ISO 9001 is related to the market. The standard is a prerequisite for doing business with several customers. ISO 9001 also provides benefits towards implementation. The surveys conducted among the certificated establishments show that ISO 9001 has provided increase in sales at the rate of 15-20%.

The reasons for purchasing ISO 9001 are stated as;

  • Strengthening the market image,
  • Ability to respond to customer expectations,
  • Efficacy of the management,
  • Efficacy of the audit,
  • Preparation for total quality
  • and Conditions of EC legislation as the results of the surveys.

establishments request ISO 9001 to gain advantage or equalize the advantages of their competitors. Several companies act, when they hear that their competitors have started to prepare for ISO 9001 or when their customers demand it.

Benefits of ISO 9001

  • Strengthening the establishment’s image,
  • Customer satisfaction,
  • Increase in the number of customers,
  • Increase in competitive power,
  • Better supplier relations,
  • Increase in efficiency of management,
  • Positive cultural change,
  • Development of quality consciousness,
  • Better documentation,
  • Becoming systematic,
  • Standardization and consistency,
  • Increase in efficacy and productivity,
  • Reduction of costs.

ISO 9001 certification process can be compared to a medical examination. The examination does not heal you, but tells you what you should do to recover.

How Does The Process of ISO 9001:2015 Certification Proceed?

First of all; the certificates that you have obtained are required be issued by an Accredited establishment, the organization that the establishment from which you have obtained the certificate is accredited with must be an IAF member and authorized in the relevant standard so as for these certificates to be internationally valid.

Firstly, the process begins through application to the certification body and a two-stage audit plan is done following the approval of the proposal for certification. The current status, processes, legal conditions and document structure of the establishment are subjected to desk-based examination in the field of establishment or office environment at Phase 1 audit and Phase 2 audits are conducted  in the field of establishment, after the noncorformities detected in the Phase 1 are removed.

Process audit reports on removal of nonconformities detected in the audits are submitted to you. You must send us the correction and corrective activities you have planned for nonconformity within 180 days for minor nonconformities and must completely remove the nonconformity within 180 days for major nonconformities so as for the certificate to be issued or maintained as required by the QSI procedures.

Decision on certification will made as a result of the examination that will be carried out by the Certification Committee and the certificate will be published, after the report prepared by the audit team leader is sent to QSI.