All About ISO
This is Field’s current ISO standard certification.
What is ISO 9001:2015?
My first audit (not prep) meeting should be set up with...
Functional Area Team Leader
ISO
What is International Organization for Standardization?
7.2 Competence
The organization shall:
b) ensure that these persons are competent on the basis of appropriate education, training, or experience;
d) retain appropriate documented information as evidence of competence.
Human Resources- Tina or Heather
Caliper FF-045 was found to have a label with a calibration due date of March 2023. The calibration log for this caliper shows a calibration due date of April 2023.
Yes!
7.1.5.2 states: The organization shall ensure that the resources provided:
b) are maintained to ensure their continuing fitness for their purpose.
The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources.
The first year Field was ISO Certified.
What is 1997?
The very first step in conducting an audit is....
Audit preparation.
8.2.2.1 IV. F.
Audit preparation shall be performed to review procedures and ensure compliance with the standard. Review of procedures and work instructions shall take place to ensure adequate detail is included in the documentation.
PRC
Print Revision Checklist
8.2.2 Determining the requirements for products and services
When determining the requirements for the products and services to be offered to customers, the organization shall ensure that:
a) the requirements for the products and services are defined, including:
1) any applicable statutory and regulatory requirements;
2) those considered necessary by the organization;
b) the organization can meet the claims for the products and services it offers.
Implementation Team- Aaron or Amber
or Sales- Brad
During your audit of the shipping process, a team member scans, pulls, counts, and labels.
YES!
PULL > SCAN > COUNT > LABEL is clearly defined in the 7.5.5.3 Distribution Process Flow Procedure to Pull, Pack an Order & Ship
The number of ISO certified Field COE’s.
What is five (5)?
DAILY DOUBLE
When is an audit considered closed?
8.2.2.1 IV. F. 5.
SDR
Supplier Deviation Report/Request
8.7 Control of nonconforming outputs
8.7.1 The organization shall ensure that outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery.
8.7.2 The organization shall retain documented information that:
Quality- Mike or Kristi
A survey was sent to selected customers to obtain feedback on our product and service performance. 25% responded.
NO!
8.2.1 states: Communication with customers shall include:
b) obtaining customer feedback relating to products and services, including customer complaints;
Field is exempt from this ISO clause in their certification.
What is Design; 8.3?
During the interview, I am auditing....
The process, not the person.
PDCA
What is Plan-Do-Check-Act?
9.3 Management Review Inputs and Outputs
Director of Quality- Chris Walls
While auditing the quality lab, Mike drops his micrometer. He picks it up and keeps checking the parts.
YES!
Field WI 7.6 III. C. states: If an inspection or measuring device is dropped or damaged notify a Quality Team Member as soon as possible. Upon review the assigned Quality Team member will coordinate the next steps required, which could include re-calibrating the device, or render it inactive.
This is Field’s ISO Registrar Company.
Who is Perry Johnson Registrars?
True or False
I should only ask the questions that are provided in "Questions to ask- EXAMPLES" folder.
FALSE!
Audits should be an evolving conversation that generate questions as you go. New questions should be thought of and asked during the audit.
IOP
Interaction of Processes
7.1.3 Infrastructure
The organization shall determine, provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services.
NOTE Infrastructure can include:
a) buildings and associated utilities;
b) equipment, including hardware and software;
c) transportation resources;
d) information and communication technology.
Operations- Site Leaders, Doug Warner.
While auditing account management, you find that nearly all of them enter orders the same way but the work instruction is not in perfect alignment with their steps.
NO!
Consistency is key in the process! As long as the WI and the actions taken by the AMs are similar, there is no finding. If the WI is vastly different than the steps being taken, then the WI needs to be updated and a finding documented.