The 2015 version of the quality management system mainly changes in eight rhetorical aspects, which are specially listed in the appendix of the new version of ISO9001:2015. The rhetoric itself is not very special or difficult to understand, but there are some profound considerations behind it, and some flexibility in application. Here, we also make some brief explanations. Welcome to inquire: Miss Luo 13798904733

1) Product:

The 2015 edition now replaces the old term "product" with "products and services".

The purpose of listing the services is to highlight the differences in the application of certain standards for products and services, so as to facilitate the understanding and application of service-oriented industries. Now, the term "product" no longer includes all output types, but only includes the three forms of hardware, software, and process materials, and services are listed separately. A service is characterized by at least part of its output being realized at the interface with the customer.

As stated in the MSS Higher Order Structure stage, if an organization has become accustomed to using the term "product" to encompass all output types, it may, at its discretion, retain such use as long as it does not cause misunderstanding or ill effects. It is not necessary to revise the QMS to modify the expression of products to the expression of products and services just to align with the standard. Welcome to inquire: Miss Luo 13798904733

2) Deletion clause:

When ISO9001 was revised in 2000, the three certification standards at that time, namely ISO9001, ISO9002 and ISO9003, were merged into one, namely ISO9001. At this time, in order to facilitate the good adaptation of organizations that initially applied different certification standards, the standard has specially set up an arrangement to delete clauses, namely clause 1.2. When it was revised in 2008, it was only an editorial revision of the standard, so this The setting of the abridged clause is retained.

Now that the presentation of the standard has been improved and the ability of the organization to understand and apply the standard has been enhanced, there should no longer be a technical reason why an organization cannot meet some of the requirements of the standard, so it is appropriate to remove the exclusion clause.

Of course, for some organizations it may be necessary to review the applicability of certain requirements of the standard, and this consideration is set out in clause 4.3 of the standard. The organization may decide that a requirement is not applicable only if it does not result in a failure of conformity of the products and services. Also, although not expressly stated in the standard, requirements that are generally not applicable may only be those in Part D of the PDCA cycle, i.e. requirements within Clause 8 of the standard.

3) Management representative:

The new version of the standard no longer requires a management representative, which is consistent with the idea of giving top management a more active role. Of course, this does not mean that organizations cannot appoint management representatives. The point is that top management needs to be involved in, support and lead the activities of the QMS, whether or not a management representative is appointed, as well as obtain reports on the performance of the QMS and need to substantiate this.

Of course, the standard has clearly expressed that these responsibilities and authorities of the management representative must be specified. At the same time, it also means that the management representative is not a person, but may be the person responsible for each process has the responsibility to ensure quality management The planning, establishment, maintenance and continuous improvement of the system.

4) Documents, quality manuals, documented procedures, records:

"Documented information" replaces the old term for documents, records. When the standard refers to "maintaining documented information", it means creating a document; while it refers to "retaining documented information", it means keeping records. This use is also a requirement from Annex SL, which is one of the requirements of the MSS higher order structure, mainly for consistency with other management systems.

As with the aforementioned 1) product terminology, it is up to the organization to retain past habits or use new rhetoric.

Quality manuals and procedural documents are no longer mandatory, which means greater flexibility in the organization's document structure and degree of documentation. It is of great significance for some service-oriented organizations, small organizations, and organizations with specific functions. For most traditional manufacturing organizations, the traditional pyramid-like file structure and degree of documentation in the past are still valuable. Organizations can explore and try, and the key is to ensure that the QMS results are effective.

Although the standard does not refer to quality manuals and procedural documents, definitions are retained in terms and terms. See nouns and terms 3.8.5, 3.8.8

5) Working environment:

The process runtime environment now replaces the work environment rhetoric.

There are some processes, such as the customer waiting process in the service area, where the contact with the customer and the service may not have started, and it cannot be called a work environment. However, the customer waiting process may still affect customer satisfaction, and proper consideration and control of such an environment may be necessary or even critical. Such as proper space, adequate seating, comfortable temperature, etc. Thus, consideration of the extension of the environment is expanded.

On the other hand, the standard has also expanded the consideration of the connotation of the environment through the annotation, in addition to the physical factors of the past, social and psychological factors have been added.

This extension of the extension and connotation of environmental factors is aimed at making the process effective and ultimately enhancing customer satisfaction.

6) Purchased products:

The term “externally provided products and services instead of procured products” is used to collectively refer to products and services obtained from external organizations through various forms of outsourcing, outsourcing, or outsourcing. Correspondingly, these external organizations are collectively referred to as external suppliers.

This is due to the fact that the above process now applies the requirements of Standard Clause 8.4 uniformly.

7) Supplier:

Same as above.

8) Monitoring and measuring equipment:

For some service processes, such as guided tours, the organization still needs to implement appropriate monitoring, or measurements, to verify that service requirements have been met, including obtaining information on customer satisfaction. In this case, the usual tangible monitoring and measurement equipment may not be used, but methods such as questionnaires, telephone interviews, and Internet surveys may be used. At this point, these questionnaires, telephone interview systems, and web survey systems are a monitoring and measurement resource.

The language of using resources instead of equipment actually expands the means of monitoring and measurement available, which is beneficial to the understanding and application of service-oriented organizations, and also meets the actual needs.

Welcome to inquire: Miss Luo 13798904733