ISO 9001:2015 Quality Management System Standard
Deciding to implement a quality management system is a strategic decision for an organization as it helps improve the overall performance of the organization and lays a solid foundation for sustainable development initiatives. Implementing a quality management system based on the ISO 9001:2015 Quality Management System standard provides the following potential benefits to the organization:
Türkak ISO 9001 Certificate, namely ISO 9001:2015 Quality Management System standard, can be used by relevant internal and external parties.
The ISO 9001:2015 Quality Management System standard applies the process approach that includes the Plan - Do - Check - Take Action (PDCA) cycle and risk-based thinking. The process approach allows the organization to plan processes and their interactions. The PDCA cycle ensures that the organization is appropriately resourced for its processes, that its processes are managed appropriately, and that opportunities for improvement are identified and acted upon. Risk-based thinking enables the organization to identify factors that cause processes and the quality management system to deviate from planned results, implement preventive controls to minimize adverse effects, and make maximum use of opportunities as they arise.
Meeting requirements on a regular basis and determining future needs and expectations pose a threat to the organization in an increasingly dynamic and complex environment. ISO 9001 Certificate To achieve its goal, the organization may need to adapt different forms of improvement, such as major changes, innovation and organizational change, in addition to validation and continuous improvement.
Quality management principles
ISO 9001:2015 Quality Management System standard is based on the quality management system principles explained in ISO 9000. In the ISO 9001:2015 Quality Management System standard, these explanations include a sentence about each principle, a justification explaining why this principle is important for the organization, some examples of benefits related to the principle, and examples of typical activities to improve the organization's performance when applying the principle.
ISO 9001 Certificate quality management principles:
ISO 9001 Process Approach
ISO 9001:2015 Quality Management System Standard encourages the adoption of a process approach in establishing, implementing and improving the effectiveness of the quality management system in order to increase customer satisfaction by meeting customer requirements. Special conditions considered vital for the application of the process approach are included in Article 4.4 of the ISO 9001:2015 standard.
Understanding and managing interrelated processes within a system contributes to the effectiveness and efficiency of the organization to achieve intended results. Within the scope of the ISO 9001:2015 Quality Management System, this approach allows the organization to control the relationships and interdependencies between the processes of a system, so that the overall performance of the organization can be increased.
The process approach is the application of processes to achieve desired results according to the organization's quality policy and strategic direction.
It includes systematic identification, management and interaction with each other. Processes and system as a whole
management can be achieved using the PDCA cycle, which is a holistic focus of risk-based thinking that aims to take advantage of opportunities and prevent undesirable consequences.
Applying a process approach in the ISO 9001:2015 quality management system provides the following:
a) Understanding and maintaining the fulfillment of the conditions,
b) Considering the processes in terms of adding value,
c) Access to effective process performance,
d) Improving processes based on the evaluation of data and information.
The PDCA cycle can be briefly explained as follows:
- Plan: Establishing the purpose and processes of the system and the resources needed to obtain results according to customer conditions and organizational policies, identifying and determining risks and opportunities,
- Implement: Implementation of what is planned,
- Check: Monitoring, measuring (where applicable) and reporting results on processes and resulting products against policies, objectives, conditions and planned activities,
- Take action: Taking actions to improve performance when necessary.
Risk-based thinking
Risk-based thinking is essential to achieving an effective quality management system. The concept of risk-based thinking was partially included in previous editions of the ISO 9001:2015 Quality Management System standard, including, for example, taking preventive actions to eliminate potential non-conformities, analyzing any non-conformance that occurs and preventing its reoccurrence by taking actions appropriate to the impact of the non-conformity.
ISO 9001 Certificate To meet the requirements of the standard, the organization must plan and implement activities to identify risks and opportunities. Identification of risks and opportunities provides a basis for increasing the effectiveness of the quality management system, achieving improved results and preventing negative impacts. Opportunities may arise as a result of a positive situation to achieve an intended outcome; For example, it helps the organization impress customers, develop new products and services, reduce waste or increase efficiency. Activities to identify opportunities may also include assessments of associated risks. Risk is the effect of uncertainty, and such uncertainty can have positive or negative effects. A positive deviation from a risk may create an opportunity, but not all positive effects of the risk result in an opportunity.
The ISO 9001 Certificate sets requirements for understanding the context of the organization (see ISO 9001:2015 Clause 4.1) and assigning risks as a basis for planning (see ISO 9001:2015 Clause 6.1). This demonstrates the application of risk-based thinking to the planning and implementation of quality management system processes (see ISO 9001:2015 Clause 4.4) and helps determine the extent of documented information.
One of the main purposes of a quality management system is to act as a preventive tool. Therefore, there is no separate article or sub-article regarding preventive action in the ISO 9001:2015 Quality Management System Standard. The concept of preventive action was expressed through risk-based thinking when establishing quality management system conditions. Risk-based thinking implemented in the ISO 9001:2015 Quality Management System Standard has helped to reduce some requirements containing mandatory provisions and replace them with performance-based requirements.
The ISO 9001:2015 Quality Management System standard covers the requirements that an organization's quality management system must meet in the following cases:
All conditions of the ISO 9001:2015 Quality Management System standard are general and are intended to be applied to all organizations regardless of their type or size or the products and services they supply.
Understanding the needs and expectations of interested parties
Article 4.2 of the ISO 9001:2015 Quality Management System Standard specifies the conditions for determining the relevant parties and the conditions of these relevant parties in compliance with the quality management system for the organization. However, ISO 9001:2015 Quality Management System Standard Article 4.2 does not indicate that the quality management system requirements go beyond the scope of this standard. As stated in the scope, an organization with ISO 9001:2015 Quality Management System standard; It can be applied if the customer wishes to demonstrate that he/she will regularly supply products and services in accordance with the applicable primary and secondary legislation conditions and aims to increase customer satisfaction.
In the ISO 9001:2015 Quality Management System standard, there are no conditions regarding where those who are decided as interested parties make decisions within the quality management system for organizations. It is up to the organization to decide whether a particular requirement of an appropriate interested party is relevant to the quality management system.
Applicability
The ISO 9001:2015 Quality Management System standard does not refer to “exclusions” regarding the applicability of the organization's quality management system requirements. However, an organization may consider the applicability of the terms; It can review the organization by taking into account its size or complexity, the management model it implements, the range of activities of the organization and the nature of the risks and opportunities it faces. Conditions for applicability are specified in Article 4.3 of the ISO 9001:2015 Quality Management System Standard (here it is described under which conditions the organization may decide that a requirement cannot be applied to the processes within the scope of the organization's management system). An organization may only decide that conditions that would not result in failure of products and services to achieve conformity are not applicable.
Documented information
As part of compliance with other management system standards, important information regarding “documented information”
A common clause (see ISO 9001:2015 Clause 7.5) with no changes or additions has been introduced. Where appropriate, this requirement is also applied in other texts in the ISO 9001:2015 Quality Management System standard. Therefore, “documented information” is used for all document terms.
Corporate information
Article 7.1.6 of the ISO 9001:2015 Quality Management System Standard specifies the need for the determination and management of the information maintained by the organization to ensure that its processes, products and services can achieve conformity.
Requirements are imposed on corporate information for the following purposes:
a) To protect the organization from information loss, for example:
- As a result of the change of employees,
- Lack of capturing and sharing information.
b) Encouraging the organization to obtain information, for example:
- Learning from experience,
- Mentoring,
- Benchmarking.
Control of externally supplied processes, products and services
Article 8.4 of the ISO 9001:2015 Quality Management System Standard specifies all kinds of processes, products and services supplied externally, for example through:
a) Purchasing from a supplier,
b) By agreement from an affiliated company,
c) By outsourcing the process to an external supplier.
Outsourcing is an outsourcing service because at least one activity takes place between the organization and its supplier.
It has a vital characteristic. The controls required in external procurement can vary widely depending on the nature of the process, product and service. The organization can apply risk-based thinking when assigning the type and extent of control to specific external suppliers and outsourced processes, products and services.
OTHER STANDARDS DEVELOPED BY ISO/TC 176 RELATING TO QUALITY MANAGEMENT AND QUALITY MANAGEMENT SYSTEMS
It was developed by ISO/TC 176 to provide supporting information to organizations implementing the ISO 9001:2015 standard and to provide guidance to businesses that choose to operate beyond the requirements of the ISO 9001:2015 standard.
- ISO 9000 Quality management systems – Basic principles, terms and definitions; It provides vital background for the proper understanding and application of this standard. Quality management principles are explained in detail in ISO 9000 and were taken into account in the development of this standard. These principles are not conditions alone, but they have shaped the formation of the conditions specified in this standard. ISO 9000 also defines the terms, definitions and concepts used in the ISO 9001:2015 standard.
- ISO 9001:2015- It specifies terms that aim to provide assurance for products and services supplied by an organization and thereby increase customer satisfaction. Proper implementation can also be expected to provide other benefits to the organization, such as improved internal communications and better understanding and control of the organization's processes.
- ISO 9004 Quality management approach – Management for the sustainable success of an organization; It provides guidance for organizations that choose to go beyond the requirements of this standard to identify a broader set of topics that could lead to improving the overall performance of the organization. ISO 9004 provides the organization with guidance on the self-assessment method to assess the maturity level of its quality management system.
The international standards outlined below can provide assistance as organizations establish or seek to improve their management systems, processes and activities.
- ISO 10001 Quality management - Customer satisfaction - Guidelines for the rules to be followed in organizations; It provides guidance in determining whether the organization's customer satisfaction requirements meet customer needs and expectations. The use of this standard can increase trust in the organization and improve customer understanding of what the customer expects from the organization, thereby reducing the likelihood of misunderstandings and complaints.
- ISO 10002 Quality management - Customer satisfaction - Guidelines for handling complaints in organizations; It provides guidance on processes for recognizing and identifying the needs and expectations of complaints and handling complaints in a manner that resolves any complaint received. ISO 10002 provides a clear, effective and easy-to-use complaints-handling process, including training of individuals. It also provides guidance to small businesses.
- ISO 10003 Quality management - Customer satisfaction – Guidelines for external dispute resolution to organizations; Provides guidance for effective and efficient external dispute resolution for product-related disputes. If the organization cannot resolve a complaint internally, dispute resolution leads to redress. Most complaints can be resolved within the organization without adversarial procedures.
- ISO 10004 Quality management - Customer satisfaction – Guidelines for monitoring and measuring; Provides guidance for increasing customer satisfaction and identifying opportunities for improvement of products, processes and customer-valued aspects. These activities can increase customer loyalty and retain customers.
- ISO 10005 Quality management systems – Guidelines for quality plans; It provides guidance on the creation and use of quality plans as a means of relating process, product, project or contract terms to work methods and practices that support product realization. Benefits of preparing a quality plan; It provides increased assurance that conditions will be met, processes are under control, and motivation for those involved.
- ISO 10006 Quality management systems – Guidelines for quality management in projects; It can be applied to all projects, from small to large, from simple to complex, from a single project to part of a project portfolio. ISO 10006 is applied to organizations managed by individuals that want to ensure that they implement the practices included in the ISO quality management system standards.
- ISO 10007 Quality management systems – Guidelines for configuration management; It is to assist organizations implementing configuration management for technical and administrative aspects throughout a product's lifecycle. Configuration management can be used to meet the product identification and traceability requirements specified in this standard.
- ISO 10008 Quality management – Customer satisfaction – Guidelines for transactions from business to customer in electronic commerce; It provides guidance on how the organization can implement effective and efficient business-to-customer transactions (B2C ECT) in electronic commerce, thereby providing the customer with a basis for increased trust in B2C ECT, increasing the organization's customer satisfaction and helping to reduce complaints and disputes.
- ISO 10012 Measurement management systems – Necessary conditions for measurement processes and equipment; It provides guidance for managing the verification that measurement processes and measurement equipment used to demonstrate and support compliance comply with metrological requirements. ISO 10012 provides quality management criteria to ensure that a measurement management system meets metrological requirements.
- ISO/TR 10013 Guide for quality management system documentation- provides guidance for developing and maintaining the documentation required for a quality management system. ISO/TR 10013 can also be applied to management system documentation other than ISO quality management system standards, for example, environmental management systems and safety management systems.
- ISO 10014 Quality management – Guidelines for the realization of financial and economic benefits- is for top management. It provides guidance for the realization of financial and economic benefits as a result of the implementation of the quality management system. This standard assists in the application of management principles and the selection of methods and tools that will assist in the sustainable success of an organization.
- ISO 10015 Quality management – Guide for training- Provides guidance to assist the organization in determining training-related issues. ISO 10015 can be used whenever guidance is required when referring to "instruction" and "training" in ISO quality management system standards. Any reference to “education” includes all types of education and training.
- ISO/TR 10017 statistical techniques guide- Describes statistical techniques that track observable variations in the behavior and results of processes (even under conditions that are clearly in equilibrium). Statistical techniques enable better use of existing data to aid decision-making, thereby helping to continuously improve the quality of products and services to achieve customer satisfaction.
- ISO 10018 Quality management – Guide for the contribution and competence of people- for the contribution and competence of individuals
provides guidance. A quality management system depends on the contribution of competent people and how they are introduced and integrated into the organization. Determining, developing and evaluating the required knowledge, skills and working environment is critical.
- For the selection of ISO 10019 Quality management system consultants and the services they will provide
Guide- It provides guidance on the selection of quality management system consultants and the use of the services they will provide. This standard provides guidance on the process for assessing the competence of a quality management system consultant and assurance that the organization's needs and expectations from consulting services will be met.
- ISO 19011 Management systems audit guide - It provides guidance for the management of the audit programme, planning and execution of a management system audit, including the qualification and evaluation of the auditor and audit team. ISO 19011 is intended to be applied to auditors, organizations that implement management systems, and organizations that need to perform management system audits.
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