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Sep 16 2014

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NEW VERSION of INTERNATIONAL STANDARD ISO 9001: 2015

Planned to release a new version of the standard ISO 9001: 2015 in 2015. Works on preparation of version of ISO 9001: 2015 started in June 2012. Nowaday create a version of the DIS (Draft International Standard) standard for quality management systems. In January, 2015, planned to prepare versions of FDIS (Final Draft International Standard) standard ISO 9001: 2015, and in September the adoption and approval of the final version.
In the new version of the standard warning actions are replaced by risk management. Thus, the key changes in the new version of ISO 9001: 2015 are requirements for risk assessment, as well as an approach based on risk management for the design and development of a management system.

STRUKTURE of ISO 9001: 2015 contains the following sections:
0 Introduction
1 Scope
2 Normative References
3 Terms and Definitions
4 Setting Organizations
5 Leadership
6 Planning
7 Ensure
8 Processes
9 Assessment
10 Improvements

OVERVIEW OF REQUIREMENTS ISO 9001: 2015
Section 0 Introduction. Provides general information about ISO, ISO 9000, process approach, cycle PDCA, risk management, the relationship of ISO 9001: 2015 standards to other management systems.
Section 1 Scope. This section contains the area of application ISO 9001: 2015. In comparison with the version of 2008 year area of application remained the same.
Section 2 Normative references. This section contains references to the relevant standards.
Section 3: Terms and definitions. This section contains terms and definitions used in the standard. A lot of the terms of the standard are included into a new version of ISO 9000:2014.
Section 4: Setting Organization

– 4.1 Understanding the organization and its setting. This section the standard requires to determine the internal and external conditions of work of the Organization (its setting) that influence to result of the work and the quality management system.
– 4.2 Understanding the needs and expectations of stakeholders. The organization needs to define stakeholders who influence on the quality management system, define the requirements of stakeholders and to implement regular monitoring of these requirements.
-4.3 Scope of quality management system. The Organization must determine the limits of application of the quality management system. The boundaries of application must be documented defined.
– 4.4 The quality management system and processes of the organization. This section is very similar to section 4.1 version of ISO 9001:2008. The organization must define the processes needed for the quality management system and to manage these processes. Extras organization must determine the risks and opportunities of each process.
Section 5: Leadership
– 5.1 Leadership and commitment. Section includes requirements for the senior management of the organization. Senior management must to demonstrate its leadership in quality management system and to commit themselves to the implementation and management of the system. Another component of the leadership and commitment of senior management is demonstration commitment to customer orientation.
– 5.2 Quality Policy. Similarly to the requirements of ISO 9001:2008 senior management must develop, review and revise the quality policy. The quality policy must be documented.
– 5.3 Roles, responsibilities and powers in the organization. The requirements of this section require senior management to determine responsibility and authority and spread the necessary roles in the organization for quality management systems, process execution, and fulfillment of requirements of consumers.
Section 6: Quality management system planning.
– 6.1 Actions to respond to the risks and opportunities. It is an essentially new unit of the ISO 9001:2015. Organization must define the risks and opportunities that able to influence on quality management system and results of the organization. Also need to create response plan in the risks and opportunities.
-6.2 Goals in the area of quality and planning of achieving the goals. The organization must establish the goals in area of quality for all levels, functions and processes. For achieving the goals must be developed plans and defined events.
-6.3 Planning changes. Such changes must be performed according to developed plans, if the organization determines the need for changes in the quality management system.
Section 7: Ensure
– 7.1 Resources. Section represents general requirements for resource management, requirements for human resource management, infrastructure and industrial environment, resources for monitoring and measurement, and the requirements for knowledge management.
– 7.2 Competence. In content, the requirements of this section are similar to the requirements of clauses 6.2 ISO 9001: 2008. It contains requirements for the competence of the staff of the organization.
-7.3 Awareness. ISO 9001:2015 sets requirements for the staff’s awareness about policy and and goals in area of quality, quality management system effectiveness and fulfillment of the requirements the quality management system.
– 7.4 Interactions. This part of ISO 9001: 2015 requires the organization to determine the external and internal interactions that may affect on the quality management system.
-7.5 documented information. ISO 9001:2015 introduces a new concept that replaces the term “documented procedure” and “records”. The section also contains general requirements for documented information, the requirements for its creation and updating and the requirements for management of documentary information.
Section 8 Processes
– 8.1 Planning and management processes. The organization must plan, implement and manage processes which necessary for the quality management system.
– 8.2 Determination of requirements for products and services. Organization must determine and establish the processes of interaction with customers, to determine the requirements related to products and services and to carry out regular analysis of the requirements associated with products and services. To fulfill this requirement must be identified and appropriate processes.
– 8.3 Development and design of products and services. This section describes the general requirements for the design and development, the requirements for the design and development planning, the design and development the input data, the design and development of control methods, the design and development of the output data, the design and development changes.
– 8.4 Managing the External providing products and services. Similarly to the requirements of section 7.4 of ISO 9001: 2008. The section contains general requirements for the management of external provision, the requirements to the form and degree of control of external provision, information management requirements for external provision.
– 8.5 Preservation of product and services. Contains requirements for the management of finished goods and services, the requirements for the identification and traceability, the conservation of the property of the customer or an external supplier, product protection and post-delivery activities and management of changes of products.
Section 9: Assessment
– 9.1 Monitoring, measurement, analysis and assessment. Includes general requirements for monitoring, measurement, analysis, and assessment, the requirements to the measurement of customer satisfaction and the requirements for analysis and assessment work of the organization and quality management system.
– 9.2 Internal Audit. Provides requirements for planning, organizing and conducting internal audits. In general, the requirements in this section are similar to the requirements of para. 8.2.2 of ISO 9001: 2008.
– 9.3 Analysis of system management. This section contains the requirements for the senior management of the organization. Senior management must to plan and regularly conduct analysis of the management system of the organization.
Section 10 Improvements
– 10.1 General requirements. Defines the requirements for the improvements in processes, products and servicesand of the quality management system.
– 10.2 Mismatches and corrective action. Here are the requirements for the actions of the organization in case of discrepancies. Also, this section identifies the need for corrective action.
-10.3 Continuous improvement. The requirements of this section obliges the Organization to use their capabilities to continuously improve performance and quality management system.
Attachment A
– A1. The application includes a description of the structure and terminology of ISO 9001 with indication of the relationship between the versions of the standard in 2008 and in 2015.
– A2. Includes explanations of the terms “products” and “services.”
– A3. Explanations of the term “environment of the organization.”
– A4. This application is provides an explanation for the approach based on risk management.
– A5. It explains in the applicability of the standard.
– A6. It explains by the new term “documented information.”
-A7. This annex contains explanations on the requirements related to knowledge management.
– A8. It explains in the requirements connected with the management of external providing products and services.
Appendix B
This application is includes 8 sub-sections. Each of the subsections clarifies the principles of quality management. Number of principles declined. No principle of “systemic management approach.”
– B1. Gives a description for clarification.
– B2. Explanation of the principle of “customer orientation”.
– B3. Explanation of the principle of “leadership.”
– B4. Explanation of the principle of “involvement of employees”.
– B5. Explanations on the principle of “process approach”.
– B6. Explanation of the principle of “continuous improvement.”
– B7. Explanation of the principle of “making decisions based on facts.”
– B8. Explanation of the principle of “mutually beneficial relationships with suppliers.”
Appendix C
Includes a list of related standards and their relationship with the parts of ISO 9001: 2015.
Bibliography
This section provides a list of documents which are interconnected with ISO 9001: 2015.

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