The new standard ISO9001: 2015 has been officially released in September 2015, then our old version of ISO9001: 2008 and the new version of ISO9001: 2015 What is the difference between the specific!

The new requirements in ISO 9001: 2015 include: Section 6.3 "Planning for Change", 8.1 "Operational Planning and Control", 8.3.6 "Changes in Design and R & D" and 8.5.6 "Changes to Control".

1, the new requirements described below are quoted from ISO 9001: 2015

(A) 6.3 changes in the planning

Such changes should be planned and implemented systematically when the organization determines that changes to the quality management system are required (see 4.4).

The organization shall take into account:

(1) the purpose of change and its potential consequences;

(2) the integrity of the quality management system;

(3) the availability of resources;

(4) Assignment or redistribution of liability and authority.

(2) 8.1 Operation planning and control

The organization shall control the changes to the plan, review the consequences of the unintended changes, and, if necessary, take measures to eliminate the adverse effects.

(Iii) 8.3.6 Design and development changes

The organization shall identify, review and control changes in product and service design and development and subsequent changes in order to avoid adverse effects and ensure compliance.

(D) 8.5.6 change control

The organization shall conduct the necessary review and control of changes in production and service provision to ensure that the requirements are met in a stable manner.

The organization shall retain information on the formation of documents, including those relating to changes in the results of the review, authorization of the changes and the necessary measures taken in accordance with the review.

Footnotes: Other references to changes can be found in clause 4.4 / 5.3 / 9.2 / 9.3 / 10.2.

2, the purpose of the new requirements

One of the goals of ISO 9001: 2015 is to strengthen the positioning requirements for system and operational level changes.

The requirements of ISO 9001: 2015 provide a strong business management system to support the organization's strategic direction.

Once the organization identifies its environment and the parts of interest, and identifies processes that support these consortia, positioning changes become increasingly important components of continued success.

Once the process is identified, the organization needs to identify the risks and opportunities associated with the process. Once you have identified the risks and opportunities, you need to make changes to get the benefits associated with it. Changes are linked to the elements of the process, such as input, resources, human, activity, control, measurement, and output. Changes are made for the benefit of the organization, need to be implemented in accordance with the organization's intentions, and require new risks and opportunities to be taken into account.

In order to combine benefits with changes, the organization needs to take into account all types of changes that may occur. Give an example of how several changes may occur:

(1) process;

(2) the formation of documents of information;

(3) Tools;

(4) equipment;

(5) employee training;

(6) supplier selection;

(7) supplier management;

(8) and others.

The successful management and control of these changes has become a core requirement within the organization's quality management system.

3, the implementation of the new requirements of the change need to consider the issue

Here are some of the triggers that could lead to changes in the quality management system:

(1) customer feedback;

(2) customer complaints;

(3) failed product;

(4) employee feedback;

(5) innovation;

(6) decision-making risk;

(7) decision-making opportunities;

(8) internal audit results;

(9) management review results;

(10) recognition does not meet;

(11) and others.

Note: These recommendations are not intended for use by all types of organizations.

Background: Some changes need to be carefully managed, and some can be safely ignored. In order to distinguish, the organization needs to consider sorting by priority.

In order to determine the priority, the organization needs to take into account the following:

(1) the consequences of the change;

(2) the likelihood of the consequences;

(3) the impact on the customer;

(4) the impact on the relevant parties;

(5) the impact on quality objectives;

(6) the effectiveness of the process within the quality management system;

(7) other.

4, the implementation of the typical steps of change

(1) define the characteristics of the need to change the object;

(2) planning (tasks, timetables, responsibilities, authorizations, budgets, resources, required information, others);

(3) the appropriate participation of other personnel in the process of change;

(4) to develop communication planning (the appropriate staff within the organization, customers, suppliers, stakeholders, and may need to inform the object);

(5) the use of cross-functional grouping audit to provide planning and related risks related to the provision of feedback planning;

(6) trainers;

(7) measure the validity.

5, may need to do what changes?

(1) process changes (input, activity, output, control, etc.);

(2) customer communication;

(3) supply chain communication;

(4) the process of increased control;

(5) inspection;

(6) employee training;

(7) implement a new process;

(8) to provide information on the formation of documents;

(9) to change the existing information on the formation of documents;

(10) to enhance the ability of employees;

(11) external resource processes;

(12) and others.

6, other considerations

(1) the organization shall consider unintended results prior to the change;

(2) after the change, the organization should monitor the changes to determine their effectiveness and identify other possible additional problems;

(3) As part of the quality management system, some changes need to be recorded.

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