2. Verify conformity
Verify effectiveness
Show opportunity to improve
Meet regulatory requirements
2
Purpose of Auditing
Internal Audits - performed within an organization to measure
its own performance & determine conformance.
3. 3
Plan & Be Prepared
Quality Administrator will send out
1. Audit schedule at the beginning of each year
2. “Audit Plan” cover sheet at the beginning of each
audit quarter.
4. 4
Plan & Be Prepared
To access information needed for the audit:
•Use shortcut - Manufacturing-Distribution Home (Share Point), or
•Access page at: http://teamsites/supplychain/ManufacturingDistribution/SitePages/Home.aspx
•Go to panel on left side of screen & choose department you are auditing
5. 5
•Familiarize* with
list of documents for
department being
audited.
•Print & review
individual forms
(e.g., product
control plans, work
instructions)
Actions:
*Print as preference
6. 6
•Locate previous audit report in
same file under “Internal Audit”
•Print copy & review, especially
any identified issues, before audit
Actions Cont’d:
7. 7
•Locate the “Process Control Plan” by selecting
“Engineering” on left side of panel under the
“control plan” section.
•Choose the plans pertaining to the department to
be audited.
For Production Departments:
8. 8
•Locate, print, & use
the correct “Internal
Audit Checklist” for
the audit.
•Choose “Quality” on
the left side panel,
under the “forms”
section of Quality.
Production Departments Cont’d:
9. • Provide advanced notice (e.g., email) to associates involved
in audit to schedule & identify required support.
Provides time for them to prepare for the audit.
Confirms audit date is on their schedule.
• Define safety equipment requirements before the audit.
• Be respectful of associate time by completing efficient and
effective audit.
9
Planning For The Audit
10. • Use effective auditing strategies
Complete walkthrough before interview session.
Confirm priority checklist items during walkthrough.
Follow the product process flow from input to shipping.
Identify any issues for discussion during interview session.
Ensure you have complete understanding of process & controls by
asking for clarification.
10
•Conduct yourself in a professional manner
Use independent & unbiased judgment during audit.
Ensure no personal or professional involvement w/associates.
Auditor Requirements:
11. 11
Completing the interview session
State the purpose & objective of the audit.
Put associate at ease & treat w/respect.
Use checklist as your guide for questions.
Take accurate, precise & legible notes.
Identify important points (e.g., strengths, weaknesses).
Closing the interview session
Summarize audit findings & needed actions.
Provide overview of audit findings to associates.
End with “Thanks” for their cooperation & support
Auditor Requirements Cont’d:
12. 12
Practice Art of Listening
Eliminate distractions
Listen for content
Suspend judgment
Listening for themes
Seek clarification
Re-direct discussions as
needed to stay focused
Open-ended vs Closed-ended Questions
Open-Ended Questions Closed-Ended Questions
How do you record the test results? Do you record the test results?
What is the first thing you do? Do you set up the machine first?
What is the standard procedure for
responding to customer
complaints?
When a customer calls, do you have to
record the details?
What do you do with the finished
product?
Do you pack the finished product in the
box?
Auditor Guidance:
Ask Open-Ended Questions
13. 13
Product Sampling:
Complete random sampling due to limited time
Auditor should select the sample
Examine the sample in detail
Cover relevant period
Look @ control
• Verify Records & Documents
Procedures and work instructions should be current &
consistent w/processes
Records should be maintained, accessible, & sufficient
Auditor Guidance Cont’d:
14. 14
•Validate Findings
Ensure accuracy of information.
Ask for information in different way for collaboration.
Ensure evidence demonstrates activity performed as described.
Ask several people the same question, as needed.
Observe the activity in question being performed.
Review evidence such as procedures, instructions & records.
Auditor Guidance Cont’d:
15. 15
•Document Audit Findings
Positive findings/strengths
Opportunities for improvement/observation
Nonconformities- major/minor
Action items to be completed
Auditor Guidance Cont’d:
16. 16
•Nonconformances
Must be well-documented & have 3 parts
1. Requirement
2. Failure
3. Evidence
•Major Nonconformance
The absence or total breakdown of a system
Number of minor nonconformities against one clause
• Minor Nonconformance
Failure to meet one requirement of the standard, or single
lapse in following one item of a company procedure
Auditor Guidance Cont’d:
18. 18
Optional Content
• Summary of audit process
Identify uncertainties
Identify obstacles could affect results
• Confirm audit objective accomplished
• Recommend improvements
• Agree on follow up actions
• Identify action owners & targeted
closure dates
Not included in Audit Report
• Subjective opinions
• Deficiencies corrected during audit
• Specific names of associates
associated with the findings
Auditor Guidance Cont’d:
20. 20
4.0 Context of the Organization (Completely New Section)
• Organizations - required to identify any internal & external issues that
may impact their quality management system’s ability to deliver its
intended results known as Risk.
• A tool that helps with identifying risk is called a SWOT Analysis . It
identifies strength, weaknesses, opportunities & threats of
organization & strategic planning.
ISO 9001:2015
22. 22
4.2 Understanding Needs & Expectations of Interested Parties
Interested parties - any people or entities that believe they affect, are
affected, or could be affected by your organization
Examples - are customers, suppliers, employees, owners, community,
law enforcement, emergency responders & news media.
Attention - should be focused on those interested parties that can
impact the organization’s ability to consistently provide conforming
products and services.
ISO 9001:2015
23. 23
4.3 Determining the Scope of the Quality Management System (Expanded)
• Organization - shall determine boundaries & relevance of the QMS and what must be
considered.
4.4 Quality Management System & its Processes (Similar, but more
thorough)
•Organizations shall determine:
Inputs required & outputs expected
Measurements & related performance indicators
Responsibilities & authorities
Risks & Opportunities; plan & implement actions
ISO 9001:2015
24. 24
5.0 Leadership (Renamed from Management Responsibility)
• Top management - must manage quality, not delegate it.
• Removal - all references to role of ‘management representative.
• Quality management system - should be included in routine business
operations.
ISO 9001:2015
25. 25
5.1 Leadership & Commitment
5.1.1 General (Similar with added requirements)
• Top management - shall demonstrate leadership &
commitment to QMS by:
Ensuring policy & objectives are compatible with strategic direction
Ensuring the quality policy is communicated, understood & applied
Promoting awareness of the process approach
Supporting other relevant management roles to demonstrate their
leadership
ISO 9001:2015
26. 26
5.1.1 General Continued
• Top management is also required to ensure that:
Customer requirements are determined & met
Risks & opportunities that can affect conformity are determined & addressed
Meeting customer & applicable statutory & regulatory requirements
maintained
Focus on enhancing customer satisfaction is maintained
5.1.2 Customer Focus (Equivalent w/addition of risk & opportunities)
• Customer focus is the awareness of
who the customers are,
their strategic importance, and
their needs and expectations
ISO 9001:2015
27. 5.2 Policy (Equivalent with minor additions)
• The quality policy shall:
be available as documented information
be communicated within the organization
be available to interested parties, as appropriate
5.3 Organizational Roles, Responsibilities & Authorities (Equivalent)
• Top management - shall assign the responsibility & authority
27
ISO 9001:2015
28. 6.0 Planning (No equivalent)
• Risk-based thinking & management
• Required elements of successful quality management system plan
Measurement-based means to continually evaluate & update plan
Implementing plan based on fulfilling agreed upon customer
requirements, & supporting effort w/appropriate resources &
repeatable processes
Updating the plan based on measuring ongoing effectiveness & any
newly discovered risks or opportunities
28
ISO 9001:2015
29. 6.1 Actions to Address Risks & Opportunities (New)
• Will help the organization:
Achieve its intended results
Enhance a result
Prevent a result the organization doesn’t want to occur
Continually improve
29
ISO 9001:2015
30. 6.1 Actions to Address Risks & Opportunities - Continued
• Actions are to be implemented to evaluate their effectiveness
•Options can include:
Avoiding risk
Eliminating the risk source
Changing the likelihood or consequences
Sharing the risk
Retaining risk by informed decision
30
ISO 9001:2015
31. 6.2 Quality Objectives & Planning to achieve them (Equivalent
w/addition of achieving objectives)
• The organization shall establish quality objectives at
appropriate functions, levels and processes that are
measurable & monitored.
• The organization shall determine what will be done, what
resources will be required, who will be responsible, when it
will be completed & how the results will be evaluated.
31
ISO 9001:2015
32. 6.3 Planning of Changes (Equivalent with additional
requirements)
•Consider:
The purpose & potential consequences
The integrity of Quality Management System
The availability of resources
Responsibilities and authorities
32
ISO 9001:2015
33. 7.0 Support Processes
7.1 Resources (Equivalent)
• For the purpose of establishing, implementing, maintaining, &
continual improving of the Quality Management System, they are:
•People needs
•Infrastructure, like buildings, utilities, equipment, hardware, software,
transport & communication
•Process environment-the conditions of the workplace
•Monitoring & measuring resources
•Organizational knowledge
33
ISO 9001:2015
34. 7.2 Competence (Equivalent)
• Determine the necessary competence of person doing work
on the basis of appropriate education, training, or experience
• Take actions to acquire the necessary competence, &
evaluate the effectiveness
• Retain appropriate documented information as evidence of
competence
34
ISO 9001:2015
35. 7.3 Awareness (Equivalent with minor additions)
•Persons doing the work should be aware of:
the quality policy
relevant quality objectives
their contribution
implications of not conforming
35
ISO 9001:2015
36. 36
ISO 9001:2015
7.5 Documented Information (Renamed from
documents & records)
• Document: Living information that is used for
decision making or performing tasks.
Subject to revision.
Such things as, procedures, policies, instructions,
and blank checklists.
• Records: Historical information about things that
have already happened.
Not subject to change.
37. 37
7.5 Documented Information ….continued
•Ensure the following are present when creating & updating
documented information:
Identification: titles, document numbers, or something that
represents identity
Format: must be appropriate to the purpose and users, & the
media must be accessible & understandable.
Review & Approval: signatures, initials, email approval,
electronic signatures, meeting minutes or click-box approval is
acceptable
ISO 9001:2015
38. 38
ISO 9001:2015
8.0 Operation
8.1 Operational Planning & Control (Equivalent)
Determine requirements
Establish the processes & acceptance criteria
Determine resources needed
Implement control
Retain documented information
Plan Output in a suitable form
Plan for expected & unexpected changes
Control of outsourcing
39. 39
ISO 9001:2015
8.2 Requirements for products and services (Equivalent)
• Customer Communication should be effective at all times
• Customer Requirements defined
• Customer Requirements how to meet them & reviewing them
40. 40
ISO 9001:2015
8.3 Design & Development of products & services
(Equivalent)
The organization shall:
Establish, Implement & Maintain
Plan by determining the stages & controls
Determine Inputs
Document Outputs
Identify, review & control (verify & validate) Changes
41. 41
ISO 9001:2015
8.4 Control of externally provided processes, products & services
(Equivalent)
•This is basically concerning Purchasing which include:
Raw Materials
Products that a supplier provides directly to your customer
Processes provided by subcontractors
42. 8.5 Production & Service Provision (providing)
Control
Availability of specifications
Availability & use of verification equipment
Implementation of monitoring & measurement
Effective infrastructure & environment
Selection of competent people
Validation of processes when outcomes cannot be verified
Actions to remove human error
Release, delivery & post-delivery activities
ISO 9001:2015
42
43. 43
ISO 9001:2015
8.5 Production & Service Provision……continued
Identification & Traceability- most common types are labels,
stickers, tickets, bar codes, tags, serial numbers, travelers & work
orders & location identification
Must control the processes that produce your goods & services
Property belonging to customers & external providers
Preservation-during handling, packaging & storage
44. 44
8.5 Production & Service Provision…….continued
• Post-delivery activities covering
associated risks(potential problems),
statutory & regulatory requirements,
application & lifecycle,
customer requirements & customer feedback
• Control of changes includes,
results of reviewing the changes,
who authorized the change and
any necessary action from the review- go back to the old way or
establish the change as the new benchmark
ISO 9001:2015
45. 45
ISO 9001:2015
8.6 Release of Products & Services (Equivalent)
• Before releasing something: test, inspect, review, patrol, examine or
assess.
8.7 Control of nonconforming outputs (Equivalent)
• Identification of nonconforming product or service
• Controlling nonconforming outputs
• Nonconforming outputs detected after delivery or use
• Dealing with nonconforming outputs
• Re-verifying after correction
• Retained documented information
• Connection to corrective action
46. 46
ISO 9001:2015
9.0 Performance Evaluation
9.1 Monitoring, measurement, analysis and evaluation (Equivalent)
• What needs to be monitored & measured?
• What method will be used?
• When will it be performed?
• When will results be analyzed & evaluated?
• Evaluate the performance & effectiveness of the QMS
• Retain documented information
• Customer satisfaction
• Analysis and evaluation of data
47. 47
9.2 Internal Audit
The organization shall conduct internal audits at planned
intervals to provide information on whether the quality
management system:
• Conforms to the organization’s own requirements for its
quality management system
• The requirements of this international standard are
effectively implemented and maintained.
ISO 9001:2015
48. 48
9.2 Internal Audit….continued
The organization shall:
• Plan, establish, implement and maintain an audit program including
frequency, methods, responsibilities, planning requirements and
reporting, which shall take into consideration the importance of the
processes concerned, changes affecting the organization, and the
results of previous audits
• Define the audit criteria and scope for each audit
• Select auditors and conduct audits to ensure objectivity and the
impartiality of the audit process
ISO 9001:2015
49. 4
9
9.2 Internal Audit….continued
• Ensure that the results of the audits are reported to relevant
management
• Take appropriate correction and corrective actions without undue
delay
• Retain documented information as evidence of the
implementation of the audit program and the audit results
ISO 9001:2015
50. 50
9.3 Management Review
• Requirements
External & internal issues relevant to QMS & strategic direction
• Information on the quality performance, including trends & indicators for:
Monitoring & measurement results
Issues concerning external providers and other relevant interested
parties
Adequacy of resources
Effectiveness of actions taken to address risk & opportunities
ISO 9001:2015
51. 51
10 Improvement
• General
• Implement actions to meet customer requirements and
enhance customer satisfaction, by:
Improving processes to prevent nonconformities
Improving products and services to meet known and
predicted requirements
Improving quality manage system results
May include breakthrough improvements, innovation,
transformation etc.
ISO 9001:2015
52. 52
10 Improvement…..continued
• Nonconformity and corrective action
• When a nonconformity occurs, the organization shall:
React to the nonconformity, and as appropriate
• Take action to control and correct it and
• Deal with the consequences
Evaluate the need for action to eliminate the causes of the
nonconformity, in order that it does not reoccur or occur
elsewhere, by:
• Reviewing the nonconformity
• Determining the causes of the nonconformity and
• Determining if similar nonconformances exist, or could
potentially occur
ISO 9001:2015
53. 53
10 Improvement…..continued
• implement any action needed
• review the effectiveness of any corrective action taken,
and
• make changes to the quality management system, if
necessary
• Consider outputs of analysis and evaluation, and outputs
from management review, to identify areas of
underperformance or opportunities for improvement
• Select and utilize appropriate tools and methods for
investigation of the causes of underperformance and for
supporting continual improvement
ISO 9001:2015