1. ISO 9001 Auditor Training Rita D’Angelo AFDO San Diego, March, 2015
D’Angelo Advantage LLC Consulting
D'Angelo Advantage Consulting LLC 1

2. Description of the Course
This course will provide the learner an overview and a “hands on” approach to perform an audit, verify compliance and/ or non-conformances and provide a report to leadership within your organization.
D'Angelo Advantage Consulting LLC

3. Learning Outcomes
The participant will:
Understand the ISO 9001 Quality Management System requirements , definitions, terms and ISO 9001 standard
Understand the process approach to auditing
Apply principles learned to define the objectives, scope and criteria of the audit
Verify the conformity of the known standard against the current process
Prepare audit reports
D'Angelo Advantage Consulting LLC

4. Definitions
Audit: The on-site verification activity, such as inspection or examination, of a process or quality system, to ensure compliance to requirements. An audit can apply to an entire organization or might be specific to a function, process or production step
Nonconforming record (NCR): A permanent record—made in writing—for accounting and preserving the knowledge of a nonconforming condition for the purposes of documenting facts or events
Nonconformity: The nonfulfillment of a specified requirement
Preventive action: Action taken to remove or improve a process to prevent potential future occurrences of a nonconformance.
Quality audit: A systematic, independent examination and review to determine whether quality activities and related results comply with plans and whether these plans are implemented effectively and are suitable to achieve the objectives
Root cause: A factor that caused a nonconformance and should be permanently eliminated through process improvement
ASQ 2015
D'Angelo Advantage Consulting LLC

5. Agenda What is ISO? ISO 9001 Standards 2015 DIS Revision
Establishing the audit
Preparing the strategy
The Process approach to auditing
Exercise: Audit checklist preparation
Audit learning process
Conducting an mock audit
Exercise: Conduct YOUR audit
D'Angelo Advantage Consulting LLC

6. Understanding ISO 9001
D'Angelo Advantage Consulting LLC

7. What is ISO?
“ISO” in Greek “isos” , in English “isosceles” meaning “equal” ISO Standards: A set of standards that apply to all users equally Standard: Is a guidance document in a specific discipline/ technical area developed through expert consensus
D'Angelo Advantage Consulting LLC 7

8. ISO 9001: What is it?
ISO – International Organization for Standardization
Geneva, Switzerland
Based on ISO/IEC and ISO 9001
Worldwide Federation with 19, 500 standards in 163 countries
A panel of experts, within a technical committee
1946
ISO's first standard
In 1951, the first ISO standard (called Recommendations at this time), ISO/R 1:1951 Standard reference temperature for industrial length measurements developed by

9. ISO 9001 Standard
D'Angelo Advantage Consulting LLC

10. Structure of ISO 9001:2015 1 Scope 2 Normative references
1/3
1 Scope
2 Normative references
3 Terms and definitions
4 Context of the organization (Quality Management System)
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of QMS
4.4 Quality management system and its processes
5 Leadership (Management Responsibility)
5.1 Leadership and commitment
5.2 Quality policy
5.3 Organizational roles, responsibilities and authorities
6 Planning for the QMS (Resource Management)
6.1 Actions to address risks and opportunities
6.2 Qquality objectives and planning to achieve them
6.3 Planning of changes
Focus on that the high level structure and that the new structure should not cause an organization to renumber existing documents. However, it is realized that this might have a significant impact on software.
Common stamp format and quantity to support businesses
New stamps across the enterprise (pilot one site in 2011, complete all sites/programs in 2012)
Single source vendor contract
Approvals from applicable functions/ business units of common solutions
IT system (eSMS) for single source ordering/delivery system
Common process writings (3-BPIs, 1-PRO, sub-tier writings)
Training developed for AS9100C Auditors
QMS Teams will work with programs and sites to help them prepare
Internal Audit schedules developed 10

11. Structure of ISO 9001:2015 7 Support (Product Realization)
2/3
7 Support (Product Realization)
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
8 Operation (Measurement, Analysis and Improvement)
8.1 Operational planning and control
8.2 Determination of requirements for products and services
8.3 Design and development of products and services
8.4 Control of externally provided products and services
8.5 Production and service provision
8.6 Release of products and services
8.7 Control of non conforming process outputs, products and services
Focus on that the high level structure and that the new structure should not cause an organization to renumber existing documents. However, it is realized that this might have a significant impact on software.
Common stamp format and quantity to support businesses
New stamps across the enterprise (pilot one site in 2011, complete all sites/programs in 2012)
Single source vendor contract
Approvals from applicable functions/ business units of common solutions
IT system (eSMS) for single source ordering/delivery system
Common process writings (3-BPIs, 1-PRO, sub-tier writings)
Training developed for AS9100C Auditors
QMS Teams will work with programs and sites to help them prepare
Internal Audit schedules developed 11

12. Structure of ISO 9001:2015 9 Performance evaluation
3/3
9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.2 Internal audit
9.3 Management review
10 Improvement
10.1 General
10.2 Non-conformity and corrective action
10.3 Continual improvement
D'Angelo Advantage Consulting LLC

13. Purpose for Accreditation
ISO 9001 sets the criteria for a quality management system and is the only standard in the family that can be certified
Ensure customers get consistent, good quality products and services, which in turn brings many business benefits
D'Angelo Advantage Consulting LLC 13

14. Goals of Auditing Identify organizational problems and risks
Identify best practices and share with other groups
Reduce variation
Identify opportunities
Improve organizational performance
Increase customer satisfaction
D'Angelo Advantage Consulting LLC

15. Process of an Audit Establish the Audit Review Documents
Prepare the Strategy
Conduct the Audit
Audit Report
D'Angelo Advantage Consulting LLC

16. Establish the Audit Planning Phase
D'Angelo Advantage Consulting LLC
D'Angelo Advantage Consulting LLC

17. Process Approach to Auditing
D'Angelo Advantage Consulting LLC

18. Review Documentation D'Angelo Advantage Consulting LLC

19. Documentation Prior to Assessment
ISO 9001 Standard
Technical Standard
Prior Non-conformances
Safety citations
Facilities documents (procedures, policies, Quality manual) etc
D'Angelo Advantage Consulting LLC

20. Prepare the Strategy D'Angelo Advantage Consulting LLC

21. Plan for the Audit Step 1: Develop audit strategy
Research prior audits
Identify risks
Review any external audit results
Receive direction from leadership
Consider leads from accreditation agencies
Review strategy with organizational leadership
D'Angelo Advantage Consulting LLC

22. Auditing Forms D'Angelo Advantage Consulting LLC

23. Gather Forms Audit documentation form Develop an audit check list
D'Angelo Advantage Consulting LLC

24. Planning for the Audit Step 2: Form the Team
Choose team members skilled and educated in each area of discipline
Ensure auditor training is current
D'Angelo Advantage Consulting LLC

25. D'Angelo Advantage Consulting LLC

26. Planning for the Audit Step 3: Schedule the Audit
Develop a schedule to ensure are sections of the standard are covered
Discuss the schedule with the team
Share the schedule with organizational leadership
D'Angelo Advantage Consulting LLC

27. Audit Schedule
D'Angelo Advantage Consulting LLC

28. Planning for the Audit
Step 4 : Schedule the opening and closing meeting
D'Angelo Advantage Consulting LLC

29. Objectives Opening Meeting
Introduce audit team members to the auditees and
senior leadership
Review the scope, objectives and provide a short
summary of the methods and procedures to be used
during the course of the audit
Clarify the details of the audit plan
Verify time and date of any interim meetings
Verify time and date of closing meeting

30. Objectives Closing Meeting
Present leadership with a copy of the preliminary audit report
No new information is presented here
Discuss the positives aspects of the company, leadership,
staff and best practices
Present the report and discuss conclusions including
non-conformances
Discuss the follow-up, report closure process and time
frame for completion
D'Angelo Advantage Consulting LLC

31. Audit Report Cover page Introduction
Purpose and scope that was contained in either the audit plan or notification letter
Results and summary: the overall conclusions and recommendations.
Detailed results: a listing of all findings.
6. Supplemental clarifying information (Asq 2015)
D'Angelo Advantage Consulting LLC

32. Establish the Audit Roles
D'Angelo Advantage Consulting LLC
D'Angelo Advantage Consulting LLC

33. Lead Auditor Plan and schedule the audit Form the team
Provide documentation and review with the team
Assign standard segments to the team
Plan an conduct opening meeting
Assist the auditors
Review conformances
Discuss obstacles and challenges with leadership
Lead closing meeting
Provide audit report
Manage audit closure
D'Angelo Advantage Consulting LLC

34. Auditor Review the following: Prior documentation and audit reports
Non- conformances
ISO 9001 Standard
Perform the Audit
Interview staff
Ask objective questions
Review documents
Seek audit lead if necessary
Complete audit form
Review the non-conformance with management
Submit and review documentation with the Lead
Attend closing meeting
Discuss non conformance and answer any questions
D'Angelo Advantage Consulting LLC

35. Audit Preparation Exercise
Review the standard
From your audit strategy choose 4 clauses to audit your process
Generate 1 question from each clause
D'Angelo Advantage Consulting LLC

36. Audit Learning Process
D'Angelo Advantage Consulting LLC

37. Understand Management and Staff
Research Involvement:
Department and area of interest
How many employees?
How many tests?
Problem area?
Management, supervisors, leads
Employees who may be interviewed
D'Angelo Advantage Consulting LLC

38. What to Assess?
ASSESS THE SYSTEM , NOT who did it.
ASK?
What system weakness allowed this non-conformance to occur?
D'Angelo Advantage Consulting LLC

39. Steps to Assessment Converse with staff Ask open ended questions
Observe activities
Review Records ( make copies of non-conformances)
Review Documents(procedures)
(Note: This is a guide and these steps can be rearranged)
Copy and Maintain
Documented Evidence
D'Angelo Advantage Consulting LLC

40. During the Interview Keep open conversation-2 way questions open ended
notes
Review 5-6 documents
Internal Assessments:
review documents
Collaborate with team if unclear
D'Angelo Advantage Consulting LLC

41. How to Phrase Questions
Use the following:
How, What, Where, Why, When…..
Where can we find
Could we have a look at
Can we review…..
Show me…..
What happens when…..
How have you met …..
So, can you tell me of your last management review…..
What is your role in management review…..
Walk me through…..
You seem very busy. How do you deal with…..
Can you tell me more of how that occurs…..
D'Angelo Advantage Consulting LLC

42. Difference Between Assessment & Inspection
ISO 9001 Assessment:
Assessors Look for Conformance NOT Non-Conformances
Internal and External Inspections:
Inspectors Look for Problems and Deficiencies
D'Angelo Advantage Consulting LLC

43. “Essential requirement” contain “shall” and are mandatory
ISO 9001 Terminology
“Essential requirement” contain “shall” and are mandatory
Recommendations are
“Good practice/best practice”
D'Angelo Advantage Consulting LLC

44. Non-fulfillment of any requirement to a major degree:
Non-Conformance
Non-fulfillment of any requirement to a major degree:
QM/procedures/protocols- do not address requirement
Procedures not consistently followed
Non-conformance consistently occurring, including repeat of non-conformance in the majority of requirement
Non-conformance has potential to directly impact safety*
D'Angelo Advantage Consulting LLC

45. Terminology Audit language There is no evidence…
DO NOT USE- PAST TENSE, or “Should”
Avoid providing solutions to problems this prevents an opportunity to do a root cause analysis
Never specify names of individuals responsible for the Non Conformance
Audit language
There is no evidence…
There is insufficient evidence
Current practice does not reflect
Current documentation
Not all
There is lack of evidence
Not all _____
The procedure for _____ has not been fully implemented
Not every…
Restate clause
The requirement for____ has not been fully met
As applicable
Attach – and for example……
D'Angelo Advantage Consulting LLC

46. Conduct the Audit Training
D'Angelo Advantage Consulting LLC

48. 7.2 Competence 7.2 The Organization shall:
Determine the necessary competence of persons doing the work under it control that affects its quality performance
Ensure that persons are competent on the basis of appropriate education, training and or experience
Take actions to acquire the necessary competence and evaluate the effectiveness of actions taken
Retain appropriate documented information as evidenced of competence
D'Angelo Advantage Consulting LLC

49. Scenario 1- (7.2 Competence)
Auditor/Manager Auditor: How do you provide and document continuing education for employees? Manager: Our staff are in-serviced when assigned to new area. The employee completes an evaluation before they work alone Auditor: Can I see documentation? Manager: Yes Auditor: Reviews records, policies and procedure to determine compliance
D'Angelo Advantage Consulting LLC

50. Scenario # 1
Auditor-Reviews employee training records revealing inconsistent education.
Policy/procedures stated: Evaluations required before employee can work independently
Steps:
Requirement # ( Hint: ISO 7.2 Competence)
Category (major/minor)
State Requirement:
Comments (Phrase your citation):
D'Angelo Advantage Consulting LLC

51. Scenario #1:Non-Conformance
Requirement: 7.2
Category: Major Non conformance
Requirement States:
Determine the necessary competence of persons doing the work under its control that affects its quality performance
Ensure that persons are competent on the basis of appropriate education, training and or experience
Take actions to acquire the necessary competence and evaluate the effectiveness of actions taken
Retain appropriate documented information as evidenced of competence
Comments: There is inconsistent documentation of records of education prior to performing task
D'Angelo Advantage Consulting LLC

52. Auditing Findings Form
D'Angelo Advantage Consulting LLC

53. Exercise: Conduct Your Audit
Perform the role of auditor role with your neighbor
2. From your check list interview the auditee for objective
evidence based on your audit process
3. Document any non-conformances noted
4. Present to the group:
What you’ve learned
What you would have done better
D'Angelo Advantage Consulting LLC

54. Lessons Learned
D'Angelo Advantage Consulting LLC

55. QUESTIONS?? dangeloadvantage@gmail.com Dangeloadvantage.com
D'Angelo Advantage Consulting LLC