On the ISO9001: 2015DIS version of the most common 22 questions
ISO9001: 2015DIS version of what key points worthy of business focus, but also to the enterprise what kind of impact? With these questions, take a look at the 22 most common business concerns.
1, on the design and development of the relevant provisions of the merger that we usually do the need to change it?
A: In accordance with the provisions of the new version of the standard to change the original file, you can actually do what the contents of the document, continue to do, do not need to change.
2, ISO / TS16949 when the version?
A: There is no revision information, at least 2015 will not be revised.
3, cancel the manager's request how to understand?
A: The organization's top managers can personally participate in the planning, implementation and improvement of the system, you can not appoint managers on behalf of, of course, can also appoint managers on behalf of their implementation.
4, on the new version often referred to the "risks and opportunities", the need to reflect in the system documents?
A: Of course, for the quality system, "risk" can be understood as the possibility of quality failure, "opportunities" can be understood as opportunities for improvement, they can be in different documents (such as "external products and services Control "," product and service design and development "," production and service provision ").
5, on the design control, the new version is not deleted, the original design control for the deletion of enterprises, how to deal with?
A: You can change the production process, process change, proofing, work guide book development, service planning as "design and development" management object.
6, the new version of the knowledge mentioned in the part of how to achieve business?
A: This part is new, you can consider the organization in the new development of customers and products, open up the market, increase the share of customer purchases, etc., the current organization of knowledge is sufficient, whether the need to use external knowledge, and external cooperation.
7, ISO9001: 2015 mentioned the abolition of management manuals and managers on behalf of the enterprise that the corresponding documents to force the abolition of this document, such as reservations have an impact?
A: You can not cancel the original set of managers on behalf of the way, provided that this approach is applicable.
8, can suggest specific documents which need to be modified?
A: manuals, program files (all the new version of the standard and the old version of the corresponding provisions of the change, almost all of the 2008 version of the program files), operating instructions should not change, may add some new work instructions.
9, managers do not clearly put forward in the standard, follow-up enterprises can also appoint managers on behalf of it?
A: Yes
10, before the need for a new version of the internal trial?
A: At least one complete internal audit and management review should be conducted in accordance with the revised version of the revised version of the document prior to application for the 2015 edition.
11, can the transfer of internal auditor training in December 2015 before?
A: If the ISO9001: 2015 in June 2015 formally promulgated and implemented, the new version of the internal auditor training will be carried out after the promulgation of the standard.
12, our quality manuals are in accordance with the 08 version of the old structure to write the manual, 15 version must be updated?
A: The manual is a link between the standard and the company's quality management. It is written in accordance with the standard terms. The standard is updated and the manual must be updated.
13, the new standard must be established documents which?
A: 2015 version does not mention which documents must be established (2008 edition requires the preparation of manuals and 6 necessary program files), but in order to facilitate the use of the organization, the manual should have, other organizations need to set.
14, will the mail issued a controlled document, do not let the recipient confirmed that has been read?
A: Of course, if you can through the system to achieve (such as the file is click to open, the system is recorded) the best, if you can not achieve, you need to use other ways to confirm.
15,9001 Mandatory process and product review?
A: ISO9001 does not explicitly require the process and product review.
16,8.4.3 in the F, on the external supplier site verification planning is necessary? If the result of the plan is "the external supplier does not carry out the supplier site verification", this planning results can it?
A: Yes, but the organization should be careful, as may be possible to retain "in the external supplier of the place to verify."
17, after the revision and TL9000 structure is different, then how to do it?
A: In the TL9000 no revision before the need to do a ISO9001 and TL9000 of the table, if you want to write a combination of manual, can only be based on the provisions of ISO9001: 2015, TL9000 corresponding to the corresponding.
18, IS09001 in 2015 will release a new version, that TS16949 is not followed by the version update?
A: TS16949 will certainly be based on ISO9001: 2015 for the version, the specific timetable has not yet announced.
Does 19, 2015 require the use of FMEA?
A: No.
20, a good quality system, how to promote the company, with what method, so that we can quickly accept and use.
A: The use of good quality management of the basic principles, the company's requirements, regulations, assessment and other content of the use of quality management system to implement.
21, is our TS16949 has been, if the 9001: 2015 update, our 9000 need to re-certification is not?
A: If only TS16949 certification (not including ISO9001: 2008), then the ISO9001: 2015 version of the promulgation and implementation will not affect the original TS certification; if it is TS16949 + ISO9001 certification, there is ISO9001 requirements for the version.
What is the difference between the terms of use and the concession in the terms of paragraph 22 and 8.7?
A: "Authorization" of the authorization can come from the customer, such as the customer to provide the material; "concessions to accept" the authorization may be the organization of their own relevant staff of the approval.












