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After the official release of the ISO9001:2015 standard in September 2015, enterprises can establish and implement a new version of the ISO9001 quality management system in accordance with the ISO9001:2015 standard.
So in accordance with the ISO9001:2015 standard to establish and implement the new version of the ISO9001 quality management system three months after the establishment and implementation of the new version of the ISO9001 quality management system, can you apply to the ISO certification company for ISO9001:2015 version of the certification, obtain ISO9001:
What about the new version of the 2015 version of the certificate? The answer is no, to implement the new version of ISO9001:2015 certification, the CNCA needs to formulate a new version of the certification implementation rules, certification bodies, auditors need to pass the new version of the identification, transformation before the implementation of ISO9001:
The 2015 version of the certification audit, and China's certification bodies, auditors identify, and transform are based on GB T standards, so it is necessary to transform ISO standards into national standards before starting this series of actions, which takes a long time. Although the CNCA has not yet announced a specific timetable, we can refer to the official implementation of ISO9001:2008 certification in China, and the fourth version of ISO9001 was released on November 15, 2008
2008 version, December 30, 2008 China released GB T19001-2008 version, implemented on March 1, 2009. According to the 08 version of the situation, we speculate that ISO9001: 2015 version of the September 2015 release, China will release the national standard in November (this time may be longer, 2000 version to 2008 version, the standard changes are very small, the 2015 version and 2008 version of the change is huge, it takes longer), in March 2016 officially implemented, it is estimated that the certification will also be around May 2016.
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On September 23, the new version of ISO9001:2015 standard was officially released! It is announced that the era of the third generation of management standards (G3) is coming as scheduled.
The new version of the standard released this time is a big change from the previous version. These questions about the new version of ISO9001:2015 are what you must know.
ISO 9001:2015 Variations.
1.Why was the decision to release a new version of ISO 9001?
Since the last major revision of ISO 9001 in 2000, business needs and expectations have changed significantly. These changes include more demanding customers, the emergence of new technologies, increasingly complex chains, and a growing awareness of sustainability initiatives.
Does it also apply to all organizations – large and small, different industries and different projects – products, services?
The concept of standards has not changed; The standard still applies to any organization, regardless of its size, type, or what its core business is.
3.What changes have been made to the structure of the standard?
The standard structure has been changed to align with the generic 10-clause high-level structure developed by ISO to ensure greater harmonization between ISO's many management system standards. The new version of ISO 14001 will also adopt this structure, which is built around the PDCA (Plan-Do-Check-Improve) sequence. Currently, all ISO management system standards are required to adopt this structure.
This change makes it easier for organizations to work in a single order.
1. Implement multiple ISO management system standards within the integrated system.
4.What are the main differences between the old and new versions?
The adoption of the standard for high-rise structures is set out in the SL Appendix to Part 1 of the ISO Directive;
There is a clear requirement for risk-based thinking to support and improve the understanding and application of the process approach;
fewer prescriptive requirements;
More flexibility in terms of documents;
improve the applicability of the Services;
Define the requirements for the scope of the management system;
increased organizational environment;
increased leadership requirements;
More emphasis is placed on obtaining the desired process results to improve customer satisfaction.
5.What are the changes to the documentation requirements?
No more reference to specific documentation procedures; Organizations are responsible for supporting their processes with their documentation information and retaining the necessary documentation information to demonstrate that the process has been implemented as planned. The extent to which documentation is required depends on the business environment.
6.If the standard does not mention a quality manual, is there a need for it?
The quality manual is no longer particularly requires. The new standard requires organizations to retain the necessary documentation for the effectiveness of their quality management system (QMS). There are many ways to meet this requirement, and the Quality Manual is just one of them.
This is of course perfectly acceptable if it is convenient and suitable for the organization to continue to describe its quality management system within the framework of the quality manual.
7.Why have management reviews been moved to the performance review section? (
The sequence of the new version of ISO9001 is based on the plan-implement-inspection-improvement cycle, and in order to evaluate the performance of the quality management system, it is necessary for the management review to follow the evaluation of the system performance.
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2. The development process of SO9000 family standards to the present has gone through 1987 version, 1994 version, 2000 version and 2008 version.
3. Compared with the ISO90012008 version, the 2015 version has been modified and improved in many aspects.
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The release time of the new version of the 2015 quality management system standard.
In May, ISO 9001:2015 DIS version was released.
In October, the new standard entered the FDIS stage.
In January, IAF officially released the "ISO9001:2015 Conversion Implementation Guide".
In May, the final draft international standard (FDIS) version of ISO9001 was released.
In July, the final draft of the ISO9001 international standard (FDIS) was released.
In September, the new version of ISO9001:2015 was officially released.
In September, all ISO9001:2008 certificates will be invalid and invalid during the three-year system conversion cycle.
ISO9001:2015 quality management system new version of the standard key changes:
1. Emphasize the establishment of a management system suitable for the specific requirements of each organization.
2. Require the top management of the organization to be involved and accountable, so that quality is compatible with the broader business strategy.
3. Risk prevention awareness runs through the entire standard, so that the entire management system is suitable for risk prevention and encourages continuous improvement.
4. Fewer prescriptive requirements for documents: Organizations can now decide for themselves what information needs to be recorded and what file format should be used.
5. Align with other major management system standards by using a common new high-level structure (Annex SL).
The revised ISO 9000 family of standards, which includes the key terms and definitions required to use ISO 9001, will be published at the same time as the new version of the ISO 9001 standard.
Enterprise transition schedule.
For ISO 9001 users and internal auditors, these basic steps need to be understood for the transition from ISO 9001: 2015 to system upgrades.
First of all, keep abreast of the dynamics, changes and requirements of the new version of the standard. It is recommended that you obtain a copy of the new version of the ISO 9001 standard as soon as possible after the publication of the new version of the standard to learn more about the requirements of the new version.
Secondly, it is necessary to carry out professional standard version change training or quality management system internal auditors, and organize different training courses that meet the requirements of the new version of the standard for all levels of the enterprise.
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The main modifications of ISO9001 2015 are:
1.The chapter framework of the standard has been changed from eight chapters in the 2008 edition to ten chapters (the same structure will be adopted in other ISO management standards in the future);
2.Learn from the new successful experience of quality management in recent years, such as performance management;
3.More easy-to-understand language to dispel some misunderstandings, such as no longer mentioning preventive measures and corrective measures;
4.More attention is paid to the conformity of products and services that emphasize the output of the organization;
5.Improved compatibility with other management standards.
In short, the 2015 version will place more emphasis on results-oriented, and the quality management standard should be a documented system, rather than a documented system.
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The general provisions of ISO9001:2015 "Quality Management System Requirements" stipulate that the quality management system of an organization shall include:
a)the information required to be documented by this International Standard; b) Documented information identified by the organization as necessary to ensure the effectiveness of the quality management system.
ISO9001:2015 clearly requires the formation of documents:
1. The scope of the organization's quality management system.
2. The quality policy in the article.
3. The quality objectives in the article.
Other documents are based on the needs of the organization.
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First of all, the 2015 version of ISO9001 has added 3 files compared to the 2008 version:
1) Knowledge management procedures.
2) Organizational environment and stakeholder requirements management procedures.
3) Risk and response management procedures.
In addition, the 2008 version of the document generally has these few.
1) Document and records management procedures.
2) Device management program.
3) Human resource management procedures.
4) Process management procedures.
5) Procurement management procedures.
6) Quality objective management procedures.
7) Continuous improvement of management procedures.
8) Management review management procedures.
9) Control procedures for customer-related processes.
10) Product development control procedures.
11) Nonconforming product control procedures.
12) Corrective Action Control Procedures.
13) Data analysis management procedures.
14) Monitor and measure device management procedures.
15) Internal audit management procedures.
16) Continuous improvement of management procedures.
17) Customer property, product protection, identification and traceability can also form program documents.
The above 2008 version can be corrected.
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1. ISO9001:2015 has been officially released and implemented on September 15, 2015, and the certification body can be certified according to the new requirements;
2. In August 2016, the collection of opinions on the draft of the standard for approval has been completed for the GB T19001 standard adopted in China;
3. Under normal circumstances, in 2016, the equivalent national standards will come out. It will not exceed 2017 at the latest, because the competent authority of national certification requires that the application for acceptance of certification according to the GB T19001-2008 version shall not be accepted before the end of December 2017;
4. Before the official release of the standard, you can refer to the draft for approval (which can be found in the National Standards Committee.
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