ISO 9001 Implementation Training

ISO 9001:2015 Implementation Training Program Outline

The Training Program runs for 16 weeks with two 1/2 day sessions each week. The training covers all the clauses of ISO 9001:2015 in detail so the participants will gain a thorough knowledge of the Standard and how it  they can implement the requirements in their organization.

Participants earn 2 Certificates:

  • Certified Internal Auditor
  • Certified Management System Specialist

Session Details:

Group Training Session #1 – Intro and Overview

Group Training Session #2 – Leadership

Group Training Session #3 – Risk and Opportunity Management

Group Training Session #4 – Resources: People, Infrastructure and Work Environment

Group Training Session #5 – Resources: Documented information

Group Training Session #6 – Operations: Planning, Customer Requirements, Design, Purchasing and Non-conforming Outputs

Group Training Session #7 – Performance Evaluation – Measurements

Group Training Session #8 – Performance Evaluation – Internal Audits

Group Training Session #9 – Internal Audits (continued) and Management review of Results

Group Training Session #10 – Improvement –Root Cause Analysis and Corrective Action

Group Training Session #11 – Process Analysis and Improvement

Group Training Session #12 – Developing a ‘Quality Culture’

Group Training Session #13 – Employee involvement

Group Training Session #14 – Registration and Audit Readiness

Group Training Session #15 – Final Assessment of Implementation – second Management Review

Group Training Session #16 – Preparation for Stage 1 Audit by Accredited Registrar

Total Course Calendar – 16 weeks (this can be modified to meet your requirements, but the content will still be covered). ‘Case Work’ time frames are flexible.

Module 1 – ISO 9001:2015 Introduction and Overview

  1. Course Overview – participants’ personal objectives and their respective roles
  2. Quality Managment System as a Tool for Improvement
  3. ISO 9001:2015 Overview – focus on the usefulness of ISO 9001:2015 as a business model
  4. Defining Organizational Purpose and Direction [4.1, 4.2, 4.3]
    1. Context
    2. Understanding Stakeholders
    3. Understanding Stakeholder Requirements/Expectations
    4. Defining the Scope of the Management System

Case Work

  • Define Processes – workflow overview with environmental aspects identified on the process map
  • Define Scope of the Integrated Management System (IMS)
  • Define Stakeholders and Expectations

Learning Outcomes

  • Clear Understanding of Intent and Direction of ISO 9001
  • Identifying characteristics of the organization’s context
  • Recognition of Various Stakeholders and their Distinct Requirements/Expectations
  • Defined Stakeholders, Requirements and Scope for your Organization

Module 2 – Leadership

Leadership’s Role in the QMS [5.1, 5.2]

  1. Commitment to the QMS
  2. Communication
  3. Customer Focus
  4. Defining the Quality Policy [5.2]
  5. Identifying Leadership requirements [5.1.1]
  6. Organizational structure and responsibilities [5.3]

Case Work

  • Define the Quality Policy
  • Outline Business Priorities/Goals
  • Define in terms of possible Quality Objectives
  • Consider current organizational structure
  • Review current worker participation levels

Learning Outcomes

  • Understanding of Leadership’s role in ISO 9001:2015
  • Understanding the relationship between Goals, Setting Objectives and Defining Risks
  • Defined Policy and Objectives relating to your Organizational Goals
  • Requirements related to worker participation are understood among management

Module 3 – Planning

Risk and Opportunity Management and Setting Objectives [6]

  1. Assessing current methods for identifying risks and opportunities [6.1]
  2. Setting Quality Objectives [6.2]
  3. Action plan requirements [6.2.2]
  4. Planning and managing changes to the QMS [6.3]

Case Work

  • Define Company Risks and opportunities
  • Determine applicable legal and regulatory requirements
  • Set suitable (SMART) goals
  • Create action plans to meet goals
  • Formulate an effective approach for change management

Learning Outcomes

  • Risk Assessment completed
  • Understanding the relationship between Goals, Setting Objectives and Defining Risks
  • Realizing the value of managing change as a process

Module 4 – Resources: People, Infrastructure and Work Environment

Resources

  1. Providing competent people [7.1, 7.2]
  2. Infrastructure [7.1.3]
  3. Work Environment [7.1.4]
  4. Calibration [7.1.5]
  5. Organizational knowledge [7.1.6]
  6. Awareness [7.3]
  7. Communication – internal and external [7.4]

Case Work

  • Assess current method for providing competent people
  • Determine adequacy of infrastructure
  • Review all aspects of current Work environment

Learning Outcomes

  • Understand the importance of using competent people
  • Understand the current state of the infrastructure
  • Realize the impact that the work environment has on productivity and safety.

Module 5 – Resources: Documented Information

  1. General requirements for documentation [7.5]
  2. Creating and updating [7.5.2]
  3. Control of documented information [7.5.3]
  4. Alternative forms of documented information for improved understanding and ease of maintenance
  5. Record storage including legal and customer requirements

Case Work

  • Assess current method for managing documented information
  • Determine adequacy of document and record control
  • Review all aspects of current types of documents and consider alternatives

Learning Outcomes

  • Understand the importance documented information
  • Understand the current state documents and records and their management
  • Realize the impact that efficiency of document management has on operations
  • Find ways to improve document handling to reduce time related to this activity

Module 6 – Operations: Planning, Customer Requirements, Design, Purchasing and Non-conforming outputs

  1. Operational planning [8.1]
    1. Managing risks related to customer activities
    2. Managing change [8.1 para 2]
  2. Customer requirements and handling changes [8.2.1 – 8.2.4]
    1. Determining requirements and capacity
    2. Changes to orders
  3. Control of Externally Provided Products and Services (Purchasing) [8.4]
  4. Outsourced Processes
  5. Supplier/Contractor Controls
  6. Purchasing Information
  7. Product/Service Realization and Release [8.5, 8.6]
  8. Control of Nonconforming Outputs [8.7]

Case Work

  • Identify Gaps in: Operational planning, determining customer requirements, purchasing and production
  • Create appropriate methods to close operational gaps – review document controls during this case work
  • Develop appropriate flowcharts to document work flows and identify risks

Learning Outcomes

  • Clear understanding of ISO 9001:2015clauses and requirements related to ‘Operations’
  • Recognition of the alignment between your processes and ISO 9001:2015 Requirements
  • Identification of ISO 9001:2015 requirements not currently addressed by JMS Warehousing’s processes

Module 7 – Performance Evaluation: Measurements

Performance Evaluation [9.1]

  1. Customer Satisfaction [9.1.2]
  2. Monitoring and Measurement [9.1.3]
  3. Updating of Risks/Opportunities

Case Work

  • Review Current measurement and analysis methods: Capacity, Process effectiveness, System Effectiveness, Customer Satisfaction
  • Identify opportunities for improvement of risk management and measurement methods

Learning Outcomes

  • Understanding of the requirements for measurements in QMS
  • Recognition of options relating to gathering and analyzing performance information
  • Development of tracking tools for process performance as it relates to customer satisfaction and quality of your service delivery

Module 8 – Performance Evaluation: Internal Audits [9.2]

Internal Audits [9.2]

  1. Fundamentals of auditing – planning, performing, reporting and attributes of good auditors (ISO 19011 as reference)
  2. Internal Audit Procedure – evaluation of current procedure
  3. Layered Process Auditing
  4. Auditing by Risk/Objective/Performance
  5. Interview techniques
  6. Documenting results
  7. Communicating results
  8. Logging reports and results
  9. Audit follow-up activities

Case Work

  • Assess your Internal Audit Process for conformance to the requirements of ISO 9001
  • Conduct Internal Audits of each process including an audit of QMS requirements

Learning Outcomes

  • Understanding Internal Auditing based on Risk/Objectives/Performance
  • Revision of your Internal Audit Process if required
  • Requirements for Internal Audits and the value of Internal Audits

Module 9 –Internal Auditing [9.2] and Management Review [9.3]

Internal Audits – continued (continue to apply learning) [9.2]

  1. Coaching and mentoring during continuing audit activities
  2. Coaching of ‘Management Review’ activity and training on evaluation of the effectiveness of the Management System

Case Work

  • Continue Internal Audit Process until completion
  • Conduct Internal Audits of each process including an audit of QMS requirements
  • Prepare for Management Review

Learning Outcomes

  • Understand Internal Auditing based on Risk/Objectives/Performance
  • Be prepared to perform Management Review for the Integrated System
  • Completed Internal Audits and Management Review [9.2 & 9.3]

Module 10 – Improvement [10] – Root Cause Analysis and Corrective Actions

Opportunities for Improvement [10]

  1. Customer Satisfaction [QMS 9.1.2, 8.2.1]
  2. Monitoring and Measurement [9.1]
  3. Audits – Internal [9.2] and External (Registrar, customers, regulatory bodies such as the Ministry of Transport if required)
  4. Management Review [9.3]

Case Work

  • Review Current methods for identifying opportunities for improvement
  • Identify opportunities for improvement of risk management
  • Development of tracking tools for process performance as it relates to Quality

Learning Outcomes

  • Understanding of the requirements for improvement to the effectiveness of the management system
  • Understanding of the requirements for monitoring and measurement of QMS factors
  • Recognition of options relating to gathering and analyzing performance information

Module 11 –Process Analysis and Improvement

Identify projects for Improvement Activities

  1. Based on performance evaluation [9.1]
  2. Structured plan (template) for managing an improvement activity
  3. Resources
  4. Personnel
  5. Time line
  6. Success measures

Case Work

  • Identify an area of weakness that could benefit from an improvement project
  • Create the action plan [Use 6.2.2 as a guide]
  • Prepare to implement the action plan

Learning Outcomes

  • Understand the value of ‘Improvement’
  • Be able to plan an improvement project

Module 12 – Developing a Quality Culture

Determine the characteristics of an ‘Quality Culture’

  1. Assess current awareness/commitment
  2. Review Context [4]
  3. Does the QMS support an ‘Quality Culture’?
  4. Success measures as a result of a ‘Quality Culture’

Case Work

  • Assess the commitment to the environment
  • Determine whether the current QMS supports and environmental, safety and quality culture
  • Prepare make recommendations to strengthen the culture to create more focus on your customer satisfaction impact, both positive and negative
  • Determine whether focus on the QMS would have any impact on customer satisfaction

Learning Outcomes

  • Understand the meaning of and existence of a ‘Quality Culture’
  • Be able to plan a culture awareness campaign with the intention of strengthening the Quality Culture at JMS Warehousing

Module 13 – Employee Involvement

Employee Engagement [5.1.1 h)

  1. Assess current awareness/commitment of Management with regards to employee engagement
  2. Has an acceptable level of ‘Awareness’ [7.3] been achieved?
  3. Is an acceptable form of ‘Communication’ [7.4] taking place?

Case Work

  • Establish a method to measure the level of Awareness and Communication
  • Create the action plan to improve the levels above [Use 6.2.2 as a guide]
  • Prepare to implement the action plan

Learning Outcomes

  • Understand how to measure ‘Awareness’ and ‘Communication’
  • Make the link between ‘Competence, Awareness and Communication
  • Understand how these 3 requirements apply to ‘persons working under the control of the organization’

Module 14 –Registration and Audit Readiness

Preparation Requirements for Registrar visit for Stage 1 Audit

  1. Review of registrar requirements for your organization
  2. Coordination and planning for your external audit

Case Work

  • Prepare all participants for the audit

Learning Outcomes

  • Be able to prepare everyone for the Stage 1 Audit

Module 15 – Final Assessment of Implementation – second Management Review

Complete projects suggested as outputs from the first Management Review [9.3.3]

  1. Structured plan for managing an improvement activity
  2. Resources
  3. Personnel
  4. Time-line
  5. Success measures

Case Work

  • Review commitments made in the first Management Review
  • Identify any further action required
  • Prepare to implement the action plan

Learning Outcomes

  • Understand the cycle of ‘Management Review’ and follow-up
  • Communicate findings from Management Review to appropriate Interested Parties
  • Carry out necessary adjustments and follow-up

Module 16 – Preparation for Stage 1 Audit by Accredited Registrar

Identify requirements for Registrar visit for Stage 1 Audit

  1. Review of registrar requirements for your organization
  2. Coordination and planning for your external audit

Case Work

  • Prepare all participants for the audit

Learning Outcomes

  • Be able to assess how well everyone is prepared for the Stage 1 Audit and close any gaps