| 5.1 |
General requirements |
| previous: |
Elements 4.1.1/4.1.2.2/4.1.3/4.2.1/4.3 |
| new: |
Awareness of the
importance to fulfill customer requirements. |
|
Ensuring the availability
of resources. (see 6) |
| 5.2 |
Customer requirements |
| previous: |
Element 4.3 |
| new: |
Determination of customer
needs and expectations and converting into requirements with the aim of
achieving customer confidence. (see 7.2.1) |
| 5.3 |
Legal requirements |
| new: |
Identify and have access
to legal requirements that are applicable to quality aspects of its
products and / or services. |
| 5.4 |
Policy |
| previous: |
Elements 4.1.1/4.1.3 |
| new: |
Commitment to meeting
requirements and continual improvement. |
| 5.5 |
Planning |
| 5.5.1 |
Objectives |
| previous: |
Element 4.1.1 |
| new: |
Consistency to continual
improvement. Objectives to meet also requirements for products and /
or services. |
| 5.5.2 |
Quality Planning |
| previous: |
Element 4.2.3 |
| new: |
Identify and plan the
activities needed to achieve quality objectives. |
|
Planning shall cover: |
|
- the processes required in the QM
System
|
|
- the realization processes and
resources needed, identifying quality characteristics at different
stages, to achieve the desired results
|
|
- the verification activities,
criteria for acceptability and the quality records needed
|
|
Ensure that the
organizational change is conducted in a controlled manner and that the
quality management system is maintained during the change. |
| 5.6 |
Quality management system |
| 5.6.1 |
General requirements |
| previous: |
Element 4.2.1 |
| new: |
Meeting its quality
policy, achieving its quality objectives and conformity of the products
and / or service to customer requirements. |
| 5.6.2 |
Responsibility and authority |
| previous: |
Element 4.1.2.1 |
| new: |
Organizational freedom
necessary to perform tasks that affect quality. |
| 5.6.3 |
Management representative |
| previous: |
Element 4.1.2.3 |
| new: |
Ensuring awareness of
customer requirements throughout the organization. |
| 5.6.4 |
Internal communication |
| new: |
Between the various
levels and functions regarding the QM System and its effectiveness. |
| 5.6.5 |
Quality Manual |
| previous: |
Elements 4.2.1/4.2.2 |
| new: |
Description of the
elements, their interaction and any reduction in scope of this
International Standard. Note: The quality manual need not to be a
stand alone document. |
| 5.6.6 |
Control of documents |
| previous: |
Element 4.5 |
| new: |
No modification |
| 5.6.7 |
Control of records |
| previous: |
Element 4.16 |
| new: |
No modification |
| 5.7 |
Management Review |
| previous: |
Element 4.1.3 |
| new: |
Includes review of
current performance and improvement opportunities related to: |
|
- follow-up actions from earlier
management reviews
|
|
|
|
The outputs from the
review shall include actions related to: |
|
- improvement of the QM System
|
|
- process, product and / or service
audits
|
|
|
