Quality Management System

ISO 9000 Series Standards were developed by ISO (International Organization for Standardization) to define requirements for international quality management systems ISO 9001:2015 Quality Management System Standard; It is a standard that ensures quality by meeting the expectations and requirements of the customer in every process from the production of a product or service delivery to the place where it reaches the customer, and prioritizes customer satisfaction in all these processes.

ISO 9001:2015 REVISION PROCESS:

• All ISO standards are reviewed every five years in terms of changing conditions and updated when necessary.
• The ISO/TC 176/SC2 Committee is responsible for the revision of the ISO 9001 standard.
• The revision studies of the ISO 9001 standard have been continuing since 2012.
• Studies on the draft standards continued for almost 3 years and the final version of the standard was published by ISO in September 2015.

ISO 9001 HISTORY

MAJOR CHANGES IN TERMINOLOGY

STANDARD ITEMS

• Scope
• Referenced Standards
• Terms and Recipes
• Context of the Organization
• Leadership
• Planning
• Support
• Operation
• Performance evaluation
• Improvement

COMPARISON OF QUALITY MANAGEMENT PRINCIPLES

ISO 9001:2015 PUKO CYCLE

ISO 9001:2015 RISK-BASED APPROACH

• Introduction – Concept of risk-based thinking explained
• Clause 4 – The organization should identify the required Quality System processes and identify the risks and opportunities for these processes
• Clause 5 – Senior Management; It should support risk-based thinking and identify and identify risks and opportunities that affect product and service compliance.
• Article 6 – The organization should identify and identify risks and opportunities that affect the performance of the QMS and initiate appropriate actions.
• Article 7 – The organization must identify and provide the necessary resources.
• Article 8 – The organization must manage the necessary operational processes. (The concept of Risk is included in the definitions of “appropriate” in Articles 7 and 8.)
• Article 9 – The organization should determine the necessary monitoring, measurement, analysis and effectiveness evaluation activities for risks and opportunities.
• Article 10 – The organization shall correct, prevent or reduce undesirable consequences and improve its QMS; update risks and opportunities.

Benefits of ISO 9001:2015

• Increasing the company's market reputation
• Increasing quality awareness in employees
• Increasing competitiveness by providing differentiation from competitors in marketing activities
• Benefiting from the commercial advantages of acquiring an internationally valid quality certificate
• Adopting a customer and process oriented approach
• Increasing customer satisfaction and customer loyalty
• Reduction in error rates, waste, rework
• Effective input, production and final controls
• Understanding the systematic approach and process approach
• Facilitating the selection, evaluation and follow-up of suppliers
• Facilitating the determination and distribution of in-house authorities and responsibilities
• Providing trust to the companies and customers we work with by proving that the business is managed within the framework of a Quality Management System
• Creation of documentation (infrastructure) that will standardize business activities
• Establishing the infrastructure to ensure that historical records are kept regularly
• To be able to make situational analyzes in line with data and statistical measurements and to use these analysis results in future decisions
• An important step towards institutionalization