10 Improvement

10.1 General
See ISO 9001:2015 requirements

10.2 Nonconformity and corrective action

10.2.1 and 10.2.2
See ISO 9001:2015 requirements

10.2.3 Problem solving
The organization shall have a documented process(es) for problem solving including:

a) defined approaches for various types and scale of problems (e.g., new product development,
current manufacturing issues, field failures, audit findings);
b) containment, interim actions, and related activities necessary for control of nonconforming
outputs (see ISO 9001, Section 8.7);
c) root cause analysis, methodology used, analysis, and results;
d) implementation of systemic corrective actions, including consideration of the impact on
similar processes and products;
e) verification of the effectiveness of implemented corrective actions;
f) reviewing and, where necessary, updating the appropriate documented information (e.g.,
PFMEA, control plan).

Where the customer has specific prescribed processes, tools, or systems for problem solving, the
organization shall use those processes, tools, or systems unless otherwise approved by the customer.

10.2.4 Error-proofing
The organization shall have a documented process to determine the use of appropriate error-proofing
methodologies. Details of the method used shall be documented in the process risk analysis (such as
PFMEA) and test frequencies shall be documented in the control plan.

The process shall include the testing of error-proofing devices for failure or simulated failure. Records
shall be maintained. Challenge parts, when used, shall be identified, controlled, verified, and calibrated
where feasible. Error-proofing device failures shall have a reaction plan.

10.2.5 Warranty management systems
When the organization is required to provide warranty for their product(s), the organization shall
implement a warranty management process. The organization shall include in the process a method
for warranty part analysis, including NTF (no trouble found). When specified by the customer, the
organization shall implement the required warranty management process.

10.2.6 Customer complaint and field failure test analysis
The organization shall perform analysis on customer complaints and field failures, including any
returned parts, and shall initiate problem solving and corrective action to prevent recurrence.

Where requested by the customer, this shall include analysis of the interaction of embedded software
of the organization's product within the system of the final customer’s product.

The organization shall communicate the results of testing/analysis to the customer and also within
the organization.

10.3 Continual improvement
See ISO 9001:2015 requirements

10.3.1 Continual improvement – supplemental
The organization shall have a documented process for continual improvement. The organization shall
include in this process the following:

a) identification of the methodology used, objectives, measurement, effectiveness, and
documented information;
b) a manufacturing process improvement action plan with emphasis on the reduction of process
variation and waste;
c) risk analysis (such as FMEA).

NOTE__Continual improvement is implemented once manufacturing processes are statistically capable and stable or when product
characteristics are predictable and meet customer requirements.