Event Details

40 hours
Combination lecture and classroom exercises
Available virtually in conjunction with a partner organization

Description

ISO 9001 is the international standard for a quality management system (QMS). To be certified to the ISO 9001 standard, a company must follow the requirements set forth in the ISO 9001 Standard. The standard is used by organizations to demonstrate their ability to consistently provide products and services that meet customer and regulatory requirements and to demonstrate continuous improvement.

This course is designed to help participants understand the requirements of ISO 9001:2015 in order to conduct a successful audit. Training includes hands-on workshops to prepare for real-life auditing situations, and participants will learn to manage the audit process and complete reporting.

Who Should Attend

This course is appropriate for individuals responsible for planning and scheduling an internal audit program for ISO 9001:2015 and for those who must perform audits to ISO 9001:2015, manufacturing personnel, suppliers, managers, or anyone interested in conducting first-party, second-party, or third-party audits.

Learning Objectives

Through training, participants will learn to:

Describe the ISO 9001 Quality Management System (QMS)-Requirements standard and development process
Identify ISO 9000:2015 QMS terms
Describe the intent and requirements of ISO 9001:2015
Determine the evidence needed to demonstrate conformity to ISO 9001:2015
Apply the process approach and Plan-Do-Check-Act (PDCA) methodology
Evaluate documented information required by ISO 9001:2015 and the interrelationships between the quality processes, quality planning, policy, and objectives
Apply the principles, processes, and methods of auditing
Demonstrate the activities involved in preparing for an audit
Determine an effective audit in the context of the auditee’s organizational situation
Apply effective audit skills and practice personal behaviors necessary for an effective and efficient conduct of a management system audit
Establish and plan the activities of an audit team
Manage the audit process
Prepare the audit report and perform an audit follow-up

Course Outline

Day One

Introduction to quality management systems (QMS)
ISO 9001 family of documents
Analyze ISO 9001 standard

Day Two

Apply ISO 90015 standard
Product realization process
ISO 9001:2015 auditing specifics

Day Three

Types of audits
Audit approaches
Audit objectives, scope, and criteria
Auditor competence
Auditor principles and methods
Audit program
Audit roles and responsibilities
Audit techniques
Gather information
Audit cycle

Day Four

Team leader roles and responsibilities
Conflict management
Select audit team
Prepare for an audit
Plan the audit
Conduct an audit
Opening meetings
Gather information
Closing meetings
Prepare audit report
Audit follow-up

Prerequisites

All attendees are required to have their own copy of the ISO 9001:2015 Quality Management Systems – Requirements.

Instructors

Jeremy

★★★★★ 5/5

Bob,

Thank you for all of your time and assistance with both; the Internal Audits and the Gap Analysis. I strongly feel that our QMS will have great improvements from these events.

George Belezos

Hi Bob,

Not sure if I ever told you, but the quality manual spreadsheets you provided have impressed every external auditor that’s come in.

We are grateful to you for sharing the template with us. We were certified to the 2015 version of the standard in December and the auditor said we saved him hours of auditing because we had all the information in one place.

More recently a customer asked if we might share the template with them. But I wanted to ask you if that would be alright before doing so.

Please let me know as soon as you can. Take care.

Mike Hughes

Hi Al,

I want to tell you how pleased everyone was with how far we have come. That is due in no small part to your efforts and coaching. Scott and I appreciate what you have done.

Erik Sauve

We had our ISO 9001:2015 certification audit this week and we passed with flying colors! No findings and only 3 OFI’s. We should be receiving our certificate in 4-6 weeks.

I wanted to say Thank You, to you and the QSG team for helping us with this transition. Your assistance certainly made it a much less daunting of a task for us to achieve. I’ll be sure to contact you when it’s time for our internal audit.

Thanks again for all your help!

Rick Waszkiewicz

Angelo,

It feels nice to put the successful audit behind us! We filed our corrective action report and sent it over last Friday. We should get our official re-certification in the coming days.

Al was a great resource in pulling us through this project. He fit well with the team. With Al and Don, you have some quality people working for your organization.

We’ll be getting back in touch with Al next month to begin scheduling out the training for ISO 9001:2015.

David Tucker

To Bob, Angelo, and Al,

As you have heard we successfully completed our ISO 9001, 2015 audit this past week with no findings and only 2 observations for improvements. I would like to thank you all for your efforts in helping us complete our journey. I’m confident this will make Vacuum Barrier a stronger organization going further. We will keep you in mind as additional demands surface that we may require your services again.

ISO 9001:2015 Lead Auditor, Exemplar Global Certified

Course Summary

Upcoming Events