| 8.1 |
General requirements |
| previous: |
Elements 4.10/4.13/4.14/4.17/4.20 |
| new: |
Defining, planning, and
implementing or measurement, monitoring, analysis and improvement
processes to ensure that the quality management system, processes and
products and / or services are conform to requirements. |
|
The organization shall
identify and use appropriate statistical tools. |
|
The results of data
analysis and improvement activities shall be an input to the management
review process (see 5.7) |
| 8.2 |
Measurement and monitoring |
| 8.2.1 |
Measurement and monitoring of
system performance |
| previous: |
Element 4.17 |
| new: |
Determining and
establishing of processes for measurement of quality management system
performance. Customer satisfaction shall be used as one
measure of system output and internal audit shall be used as a tool for
evaluating ongoing system compliance. |
| 8.2.1.1 |
Measurement and monitoring of
customer satisfaction |
| previous: |
Monitoring of information on customer
satisfaction and / or dissatisfaction. The methods and measures for
obtaining and utilizing such information and data shall be defined. |
| 8.2.1.2 |
Internal Audit |
| previous: |
Element 4.17 |
| new: |
The organization may
carry out audits to identify potential opportunities for improvement. |
| 8.2.2 |
Measurement and monitoring of
processes |
| previous: |
Element 4.9 |
| new: |
The organization shall
apply suitable methods for measurement and monitoring of processes
necessary to meet customer requirements and to demonstrate the process's
continuing ability to satisfy its intended purpose. Measurement
results shall be used to maintain and / or improve those processes. |
| 8.2.3 |
Measurement and monitoring of
product and / or service |
| previous: |
Element 4.10 |
| new: |
The organization shall
apply suitable methods for measurement and monitoring of the
characteristics of the product and / or service to verify that
requirements for the product and / or service are met. |
|
Evidence of
implementation of required measurement and monitoring and conformance with
the acceptance criteria used shall be recorded. |
| 8.3 |
Control of nonconformity |
| previous: |
Element 4.13 |
| 8.3.1 |
General requirements |
| new: |
The organization shall
provide for identifying, recording and reviewing the nature and extent of
the nonconformity encountered. |
| 8.3.2 |
Nonconformity review and
disposition |
| new: |
No change |
| 8.4 |
Analysis f data for improvement |
| new: |
The organization shall
analyze applicable data to provide information on: |
|
a) process
operation trends, |
|
b) customer
satisfaction and / or dissatisfaction, |
|
c) conformance to
customer requirements. |
| 8.5 |
Improvement |
| new: |
The organization shall
continually improve the quality management system. The organization
shall establish a system level procedure which describes the use of
quality policy, objectives, internal audit results, analysis of data,
corrective and preventive action and management review to facilitate
continual improvement. |
| 8.5.2 |
Corrective actions |
| new: |
No change |
| 8.5.3 |
Preventive action |
| new: |
No modification |
