GOOD INTERPRETATION OF THE MAIN CHANGES BETWEEN ISO 9001-2008 AND 2015 IS IMPORTANT.
Out of scope: (no longer available)
Management representative: No longer used as a concept. However, the condition that the duties and responsibilities of the management representative should be assigned still continues.
Documentation, Quality Manual, Documentation, Procedure Record: Documentation is called information.
Supplier: External provider
Purchased product: External products and services.
ISO 9001-2015 creates an advanced structure. EK SL is not a standard. It is a guideline for people and groups that write the standard and provides a common structure for the management system.
7.5 Article: Dokumante Information
Within the scope of this article, KEK and Compulsory Procedures have been abolished. According to the new revision, organizations will decide how much and how BİLGİ INFORMATION IN DOCUMENT ’will be formed according to the adequacy of the people according to the size of their activities and the interactions of the processes according to their products and service types.
So the documented procedure in 2008, NAMED NECESSARY REQUIREMENTS IN THE NEW REVISION ‘’ SUSTAINING DOCUMENT INFORMATION ’’.
The requirements of the ’REGISTRATION’ in 2008 are expressed as ASI STORAGE OF DOCUMENT INFORMATION ’.
PREVENTIVE ACTIVITIES AT ISO 9001-2015 REMOVED. However, the same subject ’İS RISK BASED THINKING’ ’Article-6.1 DE was asked to be evaluated. Therefore, it should not be forgotten that; The Concept of Risk at ISO 9001-2015 passes in 16 places. In other words, preventive activities have been activated under this heading.
This should not be forgotten. The standard has been revised, but the terms used have been changed and the processes have been added to the same line, effectively by placing risk items in 16 places.
Misunderstanding the words, removed from this standard yes removed but expanded further under the name of another CAKE got up but ‘BİLGİ DOCUMENT INFORMATION’ ’Brought. Content and Subject are detailed.
What is the Quality Manual? (Dokumante Information ’’
It is a type of document that presents the basic information about the organization, the organization chart, the quality policy, the services it provides, the basic commitments against the customers, the basic information about the quality system. The Quality Manual, which defines the Quality Management System Requirement and the Basic Processes and Interactions That Must be Defined Specific to the Organization, will be at the Top Level in the Document System and will provide guidance in your studies.
When reading standards or training, words, sentences should be read carefully, parts of which you do not understand should be asked in more detail. New system Standard is a high level.
KEK In the new system, BİLGİ INFORMATION IN DOCUMENT ’is evaluated within the concept.
The ISO 9001: 2015 Revision and the important changes make the documentation more flexible to use.
In the ISO 9001: 2015 standard, documented information concept has been introduced instead of document or record.
ISO 9001: 2008 Standard includes specific expressions such as üman document ”, ante documented procedure”, “quality handbook”, while ISO 9001: 2015 defines the conditions for muh preserving documented information ”.
The ISO 9001: 2008 Standard uses the word “records tanımla to describe the document to be supplied as proof of compliance with the requirements, whereas the ISO 9001: 2015 standard refers to the af storage of documented information”.
With the ISO 9001: 2015 Standard, the mandatory procedures have disappeared.
The organization will be able to define the document system to be created together with this standard as öngörülen the documents foreseen for the operation of the organization ”.
Please refer to the related document to learn the parts that are documented in ISO 9001: 2015 standard.
Risk Based Thinking
ISO 9001: 2015 Revision and one of the key applications that come up as important changes are the concept of risk-based thinking.
ISO 9001: 2015 Standard abolished the concept of “preventive action..
Risk-based thinking was presented in various ways such as the elimination of potential nonconformities and the analysis of nonconformities in ISO 9001: 2008 Standard.
In accordance with the requirements of ISO 9001: 2015, the organization is expected to plan and commission its activities in order to identify risks and opportunities.
Risk-based thinking also provides opportunities to identify opportunities.
There is no formal method or condition for risk based thinking. Organizations can apply various methods for this; however, the ISO 31000 Risk Management standard can be a good example for this.
ISO 9001: 2015 Revision and process changes as important changes.
The ISO 9001: 2015 Revision further clarifies the process approach.
Quality Management Principles
ISO 9001: 2015 Revision and major changes are the quality management system principles.
Understanding the Context of the Organization and the Needs and Expectations of Related Parties
ISO 9001: 2015 Revision and significant changes are the context of the organization.
The ISO 9001: 2015 Revision seeks to identify internal and external issues that relate to the purpose and strategic aspect of the organization and ensure that the targeted results of the quality management system are achieved.
As an external context, legal, technological, competitive, market, cultural, social and economic environment can be done by evaluating the issues arising.
The internal context can be made through an assessment of issues related to the organization’s values, culture, knowledge and performance.
The ISO 9001: 2015 Revision should also identify the parties involved and the requirements for the quality management system of those parties that influence the ability to provide products and services on a regular basis that meet customer and applicable primary and secondary regulatory requirements.
Other Important Changes
Leadership has taken its place among the articles of the standard.
He was dismissed as Management Representative. At this stage, the organization will have to appoint a representative, but may be this person or persons.
The framework of customer expectations has been expanded and evaluated as a whole not only for the intended function and performance but also for the quality of products and services for perceived value and benefit.
The way to achieve quality objectives is clearly defined.
Awareness was considered as a separate item and the importance of employee awareness was emphasized.
External communication material was added to the existing communication material and the methods of this communication were clarified.
With ISO 9001: 2015 Corporate Information, organizations want to identify the information necessary for the operation of processes, management of the organization, the realization of the provision of products and services, and more importantly, to make this information sustainable and measurable.
ISO 9001: 2015 Corporate Information
ISO 9001: 2015 has added as new requirement in Article 7.1.6. ISO 9001: 2015 Corporate Information will increase the awareness of organizations about information management. ISO 9001: 2015 Corporate Information is an enterprise-specific knowledge and is usually gained with experience. This is the information that the organization uses and shares to achieve its objectives.
Purpose of corporate information
In every unit of the organization’s developing activities, the project, to make a process better to observe the stages, to avoid the source of information from employees, to prevent the occurrence of mistakes foreseeing again, the next business process more efficient, accurate and unnecessary time-cost is to support completion without loss.
ISO 9001: 2015 Corporate Information can be sourced internally or externally;
The competence, experience, knowledge, knowledge, skills, experiences, past successes, failures, all improvement results, experiences, value-creating information of the employees in all positions within the organization constitute internal resources.
All kinds of standards, academic studies, information obtained from customers or external suppliers, web and databases, independent researches, conferences and meetings are external sources.
The corporate information of an organization should be sustainable and appropriately accessible. In other words, how the corporate information should be updated and by whom it should be maintained should be determined within the organization.
Determination of QMS scope (4.3)
QMS and QMS Processes (4.4.2)
Quality Policy (5.2.2)
Quality Objectives (6.2.1)
Operational Planning & Control (8.1)
Design and Development Planning (8.3.2)
Control of Product and Service Provision (8.5.1)
Documented information indicating that ISO 9001: 2015 Quality management system processes are implemented as planned (see 4.4),
ISO 9001: 2015 Periodic maintenance, repair and calibration records of monitoring and measuring devices (see 188.8.131.52),
ISO 9001: 2015 Basic standards or standards used in calibration of monitoring and measuring instruments (see 184.108.40.206),
ISO 9001: 2015 Quality management system required to perform product and service personnel and company competency records (see 7.2),
ISO 9001: 2015 Records of review of the conditions for product and service realization (see 8.2.3),
ISO 9001: 2015 Records of new conditions that may occur in product and service realization (see 8.2.3),
Records indicating that ISO 9001: 2015 Design and development needs have been met (see 8.3.2),
Records showing ISO 9001: 2015 Design and development inputs (see 8.3.3),
Records indicating that ISO 9001: 2015 Design and development records have been checked (see 8.3.4),
Records of design and development outputs of ISO 9001: 2015 (see 8.3.5),
ISO 9001: 2015 Reviews and records confirming the necessary changes as a result
Records of approvals of ISO 9001: 2015 reviews and consequent amendments as required, records of changes to design and development, including the implementation of necessary activities (see 8.3.6),
ISO 9001: 2015 Supplier evaluation selection performance check (audit records) periodic reassessment and quality records indicating that all supplier activities are followed (see 8.4.1),
The required product and service traceability records in accordance with ISO 9001: 2015 Quality Management System (see 8.5.2),
ISO 9001: 2015 Non-conforming product and service follow-up control records (see 8.5.3),
ISO 9001: 2015 Records of various and revisions that may occur during product or service realization processes (see 8.5.6),
ISO 9001: 2015 Quality control check lists to be made before delivery of production and services to customers, quality control check lists (see 8.6),
ISO 9001: 2015 Monitoring records that will enable the identification of persons who demonstrate the application of all approvals and decisions made by the enterprise on the basis of who, when and on what evidence (see 8.7),
Records relating to activities carried out to monitor the performance of ISO 9001: 2015 Quality management system (see 9.1.1),
ISO 9001: 2015 Internal audit plans, application records and report records (see 9.2.2),
ISO 9001: 2015 ROI “management review” records (see 9.3.3),
ISO 9001: 2015 Records to ensure that nonconformities are traceable together with nonconformity monitoring and process structure (see 10.2.2),
ISO 9001: 2015 Corrective action records and finalized corrective action records (Article 10.2.2). Internal Audit (9.3.3)
Nonconformity and Corrective Actions (10.2.2)
What is EK SL?
Appendix SL provides a new high-level structure for ISO management systems standards – replacing the historic ISO Guide and expanding the already implemented base structure.
It was created to introduce the same basic text and common terms and definitions. This will:
To promote standardization
Facilitate the integration of management systems