ISO 9001 Quality Management System

ISO 9001 Quality Management System is a standard that defines the quality management system conditions that businesses operating in both production and service sectors must comply with at a minimum. ISO 9001 is not a product or service standard, but a management system standard.

What are the ISO 9000 series standards?

        – ISO 9000 Quality Management Systems – Fundamentals, Terms and Definitions

        – ISO 9001 Quality Management Systems – Requirements

        – ISO 9004 Quality Management Systems – Guide to Performance Improvement

There are 3 standards. Of these standards, only the ISO 9001 standard is subject to certification, and the other 2 standards have been prepared as support for businesses that want to implement the ISO 9001 standard.

History of the Standard;

        – ISO 9001:1987 Documentary approach.

        – ISO 9001:1994 Documentary approach. (ISO 9001, ISO 9002, ISO 9003)

        – ISO 9001:2000 Process approach. Partial documentation.

        – ISO 9001:2008 Process approach. Partial documentation.

        – ISO 9001:2015 Risk-based process approach. Documented information.

When the history of the standard is examined chronologically, it is seen that there is a transition from the documentary approach to the process approach. In summary; The “WRITE WHAT YOU DO, DO WHAT YOU WRITE” approach has been replaced by the “MEASURE and IMPROVE” approach and the PDCA (Plan Do Check Act) cycle has become a part of the standard.

Where should I start for the ISO 9001:2015 Standard?

The biggest problem of businesses that want to establish a Quality Management System according to the ISO 9001:2015 standard is that they do not know where to start.

As a business, the first thing to decide is whether to receive consultancy support to establish a system.

If Counseling Support will not be received, at least the following steps should be followed;

  • First of all, the appointment of a person who has knowledge of the processes of the enterprise as responsible for establishing the system
  • Establishment of the Quality Team with the participation of a representative from all units under the leadership of the person appointed as the Quality Officer.
  • Receiving ISO 9001:2015 Basic, Process Management and ISO 9001:2015 Documentation Trainings. (At this stage, the experience of the person who will give the training must be questioned and practical training must be obtained)
  • Preparation of Process Inventory (Input, Output, supplier, customer, performance criteria…)
  • Preparation and publication of the Organization Chart (Job definition and competency definition can be made for each task in the chart)
  • The Senior Management prepares the Quality Policy and Targets and announces them to the employees with the participation of the employees.
  • Risk analysis for processes
  • Preparation of action plan according to risk analysis
  • Creation of a documented list of information that needs to be prepared
  • Preparation of Machine Equipment List (Machine operation and maintenance instructions can be determined according to this list if needed)
  • Preparation of the list of measuring devices (Device usage, calibration instructions and plans can be determined according to this list, if needed)
  • Preparation of Basic Input (Raw material, packaging, service) lists (Purchasing specifications, input quality plans can be determined according to this list)
  • Preparation of product service lists (Product quality plans and specs can be determined according to this list)
  • Receiving ISO 19011:2018 Internal Auditor Training. (At this stage, the experience of the person who will give the training must be questioned and practical training must be obtained)
  • Preparation of Annual Training, Calibration, Maintenance, Internal Inspection Plans
  • Implementation of the system
  • 1 internal audit and 1 management review
  • Correction of detected nonconformities

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.