PLANNING AND CONTROL;

DEFINITION OF REQUIREMENTS FOR PRODUCTS AND SERVICES

QUESTION EVIDENCE FOLLOW- CAR #, IF
UP APPLICABLE
REQUIRED?
Operational planning and control—Clause 8.1
(this checklist is to be used in conjunction with
the “All Processes” checklist)
1. Describe how your organization defines and
documents requirements for products and
services. (Note: These may be requirements
from customers, regulatory bodies, industry
standards, and so on.)

2. (Review records for X new or changed products

or processes and verify the following:)

a. How were product or service requirements

defined? May I see them please?

b. How were current processes, acceptance

criteria, and resources evaluated to ensure
that they were suitable to meet requirements?
(Look for evidence that any identified action
items were completed.)

c. How did the organization implement control

of the processes in accordance with criteria?
(Review records to verify conformance.
Verify that control of processes included any
outsourced processes.)

d. Were any new records identified that would

Planning and Control; Definition of Requirements

 be necessary for these products, processes, or
projects?

Definition and review of requirements for

products and services—Clause 8.2

1. Does documentation (for example, customer

contracts, RFQs, RFPs, product specifications,
packaging standards, orders, and so on) clearly
and adequately define customer requirements
including delivery and post-delivery
requirements?

2. Do defined requirements include product-related

statutory and regulatory requirements? May I see
examples?

3. Do requirements include those considered

necessary by the organization?

4. (Review X examples of new products/customers

to verify conformance to questions 1, 2, and 3.
Note the orders reviewed to the right, along with
results.)

5. Who is responsible for reviewing customer

requirements prior to accepting the order to
verify that your organization has the capability
of meeting those requirements? (Verify that the
documents above contain evidence of review
and acceptance.)

6. If your organization cannot meet the customer’s

Planning and Control; Definition of Requirements

 requirements—including ship date—or if
requirements on the order are different from
those on the contract, how is that resolved with
the customer? By whom? What records are kept?
(Pull records to verify conformance.)

7. How are changes to customer requirements

reviewed? By whom? What records are
maintained? How are affected employees
notified of the changes? (Pull records to verify
conformance.)

8. Does communication with customers include:

a. Information related to products and
services?
b. Obtaining customer feedback, including
complaints?
c. Requirements for handling and
controlling customer property if
applicable?
d. Establishing requirements for
contingency actions, where relevant?

9. (Review the customer complaint file to look for

possible repetitive complaints that are the result
of unclear customer requirements or
requirements that your organization could not
meet. Be sure to include delivery and service
performance as well as product
nonconformances. Note any opportunities for
improvement to the right.)

Planning and Control; Definition of Requirements