Portfolio Detail

FAQ

What is ISO?
The International Organization for Standardization (ISO) was established in 1947 and is (currently) an association of approximately 157 members, which each represent their own country. ISO employs a system of Technical Committees, Sub-committees and Working Groups to develop International Standards. Besides the National Standards Bodies, ISO permits other international organizations that develop standards to participate in its work, by accepting them as Liaison members. ISO works in accordance with an agreed set of rules of procedure, the ISO/IEC Directives, which also include requirements on the presentation of standards.

What are the ISO 9000 Standards?
The ISO 9000 standards comprise a comprehensive collection of formal International Standards, Technical Specifications, Technical Reports, Handbooks, and web-based documents that pertain to Quality Management. This collection encompasses approximately 25 documents, with new or revised additions continually being developed. These standards serve as guidelines for organizations to establish and enhance effective Quality Management Systems.

Who is responsible for developing the ISO Standards?
The development of the ISO 9000 standards falls under the purview of ISO Technical Committee (TC) number 176, also known as ISO/TC 176, and its Sub-committees. These committees consist of quality and industry experts who are nominated by National Standards Bodies. The development process is based on achieving “consensus” among these experts, representing a wide range of interested parties. This approach ensures that the standards are shaped by the collective input and expertise of diverse stakeholders involved in quality and industry domains.

Where can copies of the standards can be obtained?
To obtain copies of the ISO 9000 standards, you have a couple of options. Firstly, you can contact your National Standards Body, which will have the standards available for purchase. Many National Standards Bodies offer the standards in different languages to cater to local requirements. You can find a list of National Standards Bodies and their contact details to identify the appropriate one for your region.

Alternatively, you can directly acquire the standards from the ISO Central Secretariat. This can be done through the ISO Store or by contacting the Marketing and Communication department at sales@iso.org. They will assist you in purchasing the specific ISO 9000 standards you need and can provide additional information regarding the process.

Where can copies of thr supporting ISO 9000 guidance notes or oter documents found?
There are a few options available for obtaining copies of the ISO 9000 standards. Firstly, you can choose to contact your National Standards Body, as they will have the standards available for purchase. Many National Standards Bodies offer the standards in different languages to cater to local needs. You can refer to a list that provides contact details for various National Standards Bodies to find the appropriate one for your region.

Alternatively, you have the option to directly acquire the standards from the ISO Central Secretariat. This can be done through the ISO Store, an online platform, or by getting in touch with the Marketing and Communication department at sales@iso.org. They will be able to assist you in purchasing the specific ISO 9000 standards you require and can provide additional information about the process.

Where can information be obtained on the ISO 9000 standards?
A wealth of information on the ISO 9000 quality management system standards can be found through various sources. ISO’s is an excellent resource that provides comprehensive details about the standards. It offers valuable insights and explanations on ISO 9000.
To obtain copies of the standards, your National Standards Body is a reliable option. They can provide the necessary documentation and offer guidance on implementation. Registrars and certification bodies can also assist with registration arrangements and provide expert advice throughout the certification process.
Furthermore, it is worthwhile to explore additional certifications that are relevant to your specific industry or field. These certifications can provide more detailed and specialized information relating to quality management systems and other pertinent areas.

Who is responsible for revising the standards?
ISO Technical Committee no. 176, Sub-committee no. 2 (ISO/TC 176/SC 2) holds the responsibility for revising the ISO 9000 standards. The revision process is conducted based on achieving consensus among quality and industry experts. These experts are nominated by ISO Member bodies and represent the interests of all stakeholders involved. Through collaborative discussions and deliberations, the committee ensures that the revision of the ISO 9000 standards reflects the collective agreement and input from a wide range of knowledgeable experts in the field of quality management.

Why are the standards being revised?
ISO has established a formal review process to maintain the currency of its standards. This process requires regular and continual reviews to ensure that standards remain up to date. Specifically, a review must be initiated within three years of a standard’s publication.

The review process incorporates various inputs from users and stakeholders. These inputs include:
Global User Questionnaire/Survey: ISO conducts surveys and questionnaires on a global scale to gather feedback and insights from users of the standards. This enables ISO to understand the experiences, challenges, and suggestions of the user community.

Market Justification Study: A market justification study is undertaken to evaluate the relevance and demand for a particular standard. This analysis takes into account industry trends, emerging practices, and evolving customer needs.

Suggestions from the Interpretation Process: Feedback and suggestions received during the interpretation process of the standard are considered. This allows users to seek clarification or guidance on specific aspects of the standard, leading to potential improvements.

Compatibility with ISO 14001: Opportunities for enhanced compatibility and alignment with ISO 14001, the environmental management system standard, are explored. This ensures harmonization and consistency across ISO management system standards.

The review process also aims to stay abreast of current trends in management system practices. This involves keeping up with the latest developments in the field to incorporate relevant advancements into the standards. By doing so, ISO ensures that the standards offer clarity, ease of use, and improved translation capabilities to meet the needs of a diverse global audience.

When will the revised standards be available?
The revised schedule for the ISO 9000 quality management system standards is as follows:
ISO 9000:2005: This standard has already been published, and no major changes are anticipated for 2009.

ISO 9001: An amendment with small changes to ISO 9001 is scheduled for publication in November 2015. These changes will be relatively minor in nature.

ISO 9004: A more significant revision of ISO 9004 is planned for mid-2009. This revision will involve substantial changes to the standard.

It is important to note that the provided schedule reflects the information available at the time, and it is recommended to consult the latest updates from ISO or the relevant standards bodies for the most current and accurate information on the publication and revisions of ISO 9000, 9001, and 9004 standards.

How much is the implementation of the new standard going to cost?
ISO/TC 176/SC 2 strives to create standards that minimize costs and facilitate a smooth implementation process. The goal is to ensure that any potential expenses incurred during implementation are seen as valuable investments. When developing ISO 9001:2015, a key focus was on limiting the impact of changes on users. The aim was to minimize any disruptions or challenges for organizations already using ISO 9001, ensuring a seamless transition and reducing the burden of implementing the updated standard.

Where can i obtain information of the revised standards?
For general information on the revision program, you can consult the ISO Catalog available on the ISO Online website. The catalog provides an overview of the revision process and other relevant details. To obtain more specific information, it is recommended to contact your National Standards Body. They will be able to provide additional guidance and resources related to the revisions. In due course, certification and registration bodies will also offer guidance on transitional arrangements. It is advisable to stay updated and maintain communication with these bodies to receive the latest information and support throughout the revision process.

Where can my organization go if it neds additional claeification or interpretation of the ISO 9001:2015 standard?
For any requests seeking interpretations of the ISO 9000 standards, individuals should contact their National Standards Body as the first point of contact. Direct requests for interpretations of the ISO 9000 standards cannot be accepted by ISO Central Secretariat or ISO/TC 176/SC 2 from individuals. ISO/TC 176 has a specific Working Group that exclusively handles formal requests for interpretations, which are accepted solely from National Standards Bodies. Therefore, individuals should approach their National Standards Body to seek official and accurate interpretations of the ISO 9000 standards.

Will my organization need full reassessement once the revised standards are available?
The issue of compliance with the ISO 9001:2015 standard primarily involves the relationship between your organization and your registration/certification body. ISO/TC 176 collaborates with the International Accreditation Forum (IAF) and ISO/CASCO (the ISO Policy Committee for Conformity Assessment) to ensure the timely dissemination of relevant information. ISO/CASCO oversees the standards that Certification Bodies adhere to, such as ISO/IEC 17021, while Accreditation Bodies are responsible for monitoring and approving the performance of Certification Bodies within their respective regions.

In terms of certification to ISO 9001:2015, it is expected that certification bodies will evaluate conformity during routine surveillance visits, and a full reassessment will typically occur upon the expiry of current certificates. However, it is important to note that ISO and the IAF have mutually agreed that all certificates to ISO 9001 should be transitioned to ISO 9001:2015 within two years of the amended standard’s publication. Therefore, it is expected that your organization has already completed the upgrade to the latest version of the standard by now.

Will the revise standards be available in my national language immediately after they are published by ISO?
The active participation of experts from various regions during the development of the new standards, coupled with the widespread distribution of draft standards, will facilitate the timely translation of the International Standards.

Considering the global significance of the quality management system standards, many National Standards Bodies are already actively working on the translation process. While ISO will publish the new standards in English and French, it is anticipated that if your National Standards Body currently offers translations of the standards in your national language, they will have the translated versions of the revised standards prepared around the time of ISO’s publication or shortly thereafter.

For more detailed information, it is advisable to contact your National Standards Body. They will be able to provide specific details regarding the availability and timeline of translations for the revised standards.

Will my organization have to re-write all its documentation?
ISO 9001:2015 does not bring about major changes to the requirements when compared to ISO 9001:2000. However, to fully benefit from the improvements, it is advisable to become acquainted with the new version of the standard and the clarifications it offers. During your analysis of the clarifications, if you identify any discrepancies from your current interpretation of ISO 9001:2000, it is important to assess the impact on your existing documentation and make the necessary adjustments. The intention is for the amendment of ISO 9001 to have minimal or no impact on documentation, but it is crucial to evaluate and update as needed based on the clarifications introduced.

Will the revises standards address financial issues?
ISO 9001:2015, as a requirements standard, does not directly cover financial aspects. Its primary focus is on establishing the criteria and guidelines for implementing a quality management system. However, if you require guidance on the financial dimensions of quality management system implementation and improvement, there are other ISO standards available to address these aspects.

ISO 10014:2006 provides guidelines specifically for financial and economic considerations in the context of quality management. It offers insights on how to effectively allocate resources and optimize financial performance within the framework of a quality management system.

Additionally, ISO 9004:2000 serves as a guideline standard that complements ISO 9001 by providing broader guidance for performance improvement. It covers aspects beyond the requirements of ISO 9001 and includes considerations related to financial resources, helping organizations achieve sustainable success and enhance overall performance.

Therefore, if your focus is specifically on addressing financial resources in the context of quality management system implementation and improvement, ISO 10014:2006 and ISO 9004:2000 are valuable resources to consult.

What are the benefits of the revised standards?
ISO 9001:2015 offers several significant benefits, including:
User-Friendly and Simple Implementation: The standard is designed to be easy to use, allowing organizations to navigate the requirements and implement them effectively.
Clear and Understandable Language: ISO 9001:2015 employs clear and concise language, enhancing comprehension and minimizing confusion during implementation.
Translatability and Global Applicability: The standard is readily translatable into different languages, enabling its adoption and understanding across diverse regions and cultures.
Compatibility with Other Management Systems: ISO 9001:2015 is designed to be compatible with other management systems, allowing organizations to integrate quality management practices seamlessly with systems such as ISO 14001 for environmental management.
Regarding ISO 9004, it provides the following benefits:
Facilitation of Quality Management System Improvement: ISO 9004 offers guidance that assists organizations in improving their quality management systems, leading to enhanced performance and outcomes.
Value Creation for Customers and Interested Parties: The standard guides organizations in creating value for their customers through the products and services they deliver, while also addressing the interests and needs of other stakeholders.
Balanced Perspectives: ISO 9004 promotes the consideration of diverse viewpoints and interests of all relevant stakeholders, allowing organizations to achieve a balanced approach to quality management.
Guidance for Sustained Success: ISO 9004 provides guidance for managers on effectively leading their organizations towards sustained success in the long term.
Forward Compatibility and Building on Existing Systems: The standard supports forward compatibility, allowing organizations to build upon their existing quality management systems and adapt them to evolving requirements and practices.

What are the main change in ISO 9001:2015?
ISO 9001:2015 was developed with the aim of providing clarifications to the existing requirements of ISO 9001:2000 and enhancing compatibility with ISO 14001:2004. It is important to note that ISO 9001:2015 does not introduce any new requirements and does not change the fundamental intent of the ISO 9001:2000 standard.

Certification to ISO 9001:2015 is not considered an “upgrade.” Organizations that hold certification to ISO 9001:2000 should be treated with the same status as those certified to ISO 9001:2015. Annex B of the ISO 9001:2015 standard provides a detailed comparison of the changes between ISO 9001:2000 and ISO 9001:2015.

For more detailed information, you can refer to our other certifications, which provide comprehensive and detailed information on specific certifications, their requirements, and additional insights.