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ISO 9001:2015

ISO; is abbreviation for International Organization for Standardization. Its a quality adminisration standard created by international standardization orgranization. ISO 9001 certificate assures the guarentee of the products and services Quality and permanence. Establishments take this certificate only if they can provide the conditions of the standards.The certificate shows the products and services are internationally appropriate. Standardization headquarters are in Geneva-Switzerland which more than 90 countries joined. Certification companies’ authorization is given to the accreditation committees of membered countries. Accreditation authority is holding by TURKAK in Turkey. In different countries those standards can be technical barrier for trade. ISO 9001’s quality management standards are internationally accepted and eliminates those types of problems.

WHAT IS ISO 9001?

Those standards issued by ISO to improve customer satisfaction. ISO certificate needs to be reviewed every 5 years and rearrange by the customers’s needs. ISO made a revision at 2008 and updated the standards. Its internationally accepted that our world’s resources are not infinite and every production and activity effects it not only by regionally but globally. This consciousness bring the need of restrictions of environmental effects are shouldn’t be controlled by laws but market forces. Being in global market is now valued by giving respect and worth for humanity. Nowadays consumers are in the expectation of seeing that respect and worth is been giving to the environment.

WHY ISO 9001?

  • Institutional structure,
  • Process and system focused effective management
  • More effective management with aim and data
  • Increasing on profit and yield
  • Increasing the trust for customers
  • Adopting a understanding of work focused to customer satisfaction
  • Quality certificate and market advantages
  • Decreasing the cost
  • Satisfaction of workers
  • Strenghten the image and quality of the establishment
  • Good relations with suppliers and satisfaction for both sides
  • Effective contact
  • Organizing the information flow and making it run appropriately
  • Effective management of the process
  • Decrease the returns
  • Noticing the problems faster and prevent
  • Decrease customer complaint

ISO 9001 2015 REVISION

In 3 June 2013 ISO TC 176 technical comitee made a comitee revision draft for ISO 9001 2015.There been some changes in ISO 9001 2015 and ISO 9001 2008 standards and drafts been published.This was ISO 9001 2015 draft’s first negotiations and there will be more changes.The date for next changes set for July 2014. The changes of July 2014 will be announced to public opinion as TQA.

Those changes will be in ISO 9001:2015 standars;

Authorization: Personnels need to assure their competency as the establishments work to get the Quality Management System. Authorization is the skills and capability to get the aimed results.

Documented Information ( Difference of Document and Record separation will cease)

ISO 9001:2008 instead of the terms of Document and Record, Documented Information phrase will be used.

Outsourcing of Products and Services (Outsourced Processes will now be controlled by a risk-based approach.)

An organization will need a risk-based approach to determine the type and degree of controls to be applied to  all types of products and services provided by external suppliers and external sources.(Where products and services are procured through procurement or procurement of processes and functions).

Exclusions

It is no longer necessary to define the requirements of the Quality Management System, which can not be implemented due to the nature of the work done by an organization.This is due to the different approach of the new version of the ISO 9001 standard, which means that it no longer meets all the requirements of an organization’s Quality Management System to meet all of the requirements of the future standard.

Goods & Services

References made in the ‘product’ (as specified in ISO 9001: 2008) are replaced by ‘goods and services’ statement.

Development

The term ‘continuous development’ will only be changed to ‘development’.

Related Party

An organization seeking to implement the Quality Management System will need to identify the ‘interested parties’ associated with its system.

Related party; (Defined as a ‘stakeholder’ at the same time), affected or perceived as affected by a decision or activity in which they have received the organization’s Quality Management System as a result of its implementation.

Preventive action (there will be no extra requirement for preventive action since the implementation of the Quality Management System itself is a preventive approach)

There will no longer be any specific requirements for ‘Preventive Action’. One of the main objectives of the Quality Management System is already being implemented as a preventive tool.

Process Approach

There will be a requirement for organizations to apply a process approach to their Quality Management Systems; There will also be a list of requirements that define the basic elements of such an approach.

Risks and Opportunities (Institutional risk management practices are introduced in the new standard.)

When planning their Quality Management Systems, organizations will need to determine what risks and opportunities need to be defined in order to ensure the creation of a quality management system that can achieve the intended outputs. In doing so, organizations will need to plan actions to identify these risks and opportunities, apply them to the processes of the Quality Management System, and assess the effectiveness of those actions.

ISO 9001:2015 Contents of standards:

1 SCOPE

2 STANDARDS CONSTITUTED

3 TERMS

4 ORGANIZATION STRUCTURE

4.1 Understanding organization and structure

4.2 Understanding the needs and expectations of interested parties

4.3 Determining the Scope of Quality Management System

4.4 Quality management system and processes

5 LEADERSHIP

5.1 Leadership and commitment

5.2 Quality Policy

5.3 Organizational roles, responsibilities and authorities

6 PLANNING OF QUALITY MANAGEMENT SYSTEM

6.1 Identification of Risks and Opportunities

6.2 Quality objectives and planning to achieve them

6.3 Planning Changes

7 SUPPORT

7.1 Resources

7.2 Qualifications

7.3 Awareness

7.4 Contact

7.5 Documented Information

8 PRODUCT AND SERVICE ACHIEVEMENTS

8.1 Operational planning and control

8.2 Determination of Product and Service needs

8.3 Design and Development of Products and Services

8.4 Control of External Products and Services

8.5 Provision of production and service

8.6 Release of Products and Services

8.7 Ineligible Process Outputs, Control of Products and Services

9 PERFORMANCE EVALUATION

9.1 Monitoring, measurement, analysis and evaluation

9.2 Internal audit

9.3 Management Review

10 IMPROVEMENT

10.1 General

10.2 Nonconformities and corrective actions

10.3 Continuous improvement