CONTROL OF EXTERNALLY PROVIDED PRODUCTS AND SERVICES

QUESTION
EVIDENCE
FOLLOWCAR #, IF
UP
APPLICABLE
REQUIRED?
Control of externally provided products and
servicesClause 8.4 (this checklist is to be used
in conjunction with the All Processes checklist)
1. Describe the purchasing process. How are
suppliers of quality-related goods and services
evaluated and approved? (Note: Suppliers here
can mean a provider of goods and services used
by the organization, a provider of goods and
services provided by the organization directly to
the customer, or a contractor performing a
process or a part of a process.)
2. Are evaluation and selection criteria for new
suppliers and contractors clearly defined? May I
see them please? (Pull X current supplier records
and verify that they provide evidence of
conformance to requirements. If any suppliers
have been approved in the past year, review their
records to verify that they met requirements.)
3. How are suppliers and contractors re-evaluated?
(Review records to verify conformance to
specified requirements. Where records show
evidence of poor performance, follow through to
ensure that corrective action has been initiated.)
4. How is supplier and contractor performance
monitored? Who is responsible for gathering and

Control of Externally Provided Products and Services

analyzing this information? What actions are

taken based on these data? How is performance
information communicated to the supplier?
(Review records and verify conformance.)
5. (Review X purchase ordersor the
organizations purchasing documentsand
verify the following:)
a. Were they issued to suppliers and/or
contractors that have met the selection and
evaluation criteria?
b. Were the products or services being ordered
clearly defined in purchasing documents
along with, as applicable, required delivery
dates, any required quality system standards,
applicable approval requirements, personnel
qualifications, and any verification or
validation activities that the organization or
its customer plans to perform at the
suppliers facilities?
6. How does the organization define the level of
supplier/contractor control? May I see it?
(Verify that the decision considers the potential
impact of the process, product, or service
provided as well as the effectiveness of controls
provided by the supplier.)
7. (Using samples reviewed in Question 5, verify
that defined controls were implemented. These
controls may be those applied to the supplier or

Control of Externally Provided Products and Services

those applied to the process, product, or service

provided.

Control of Externally Provided Products and Services