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 or 32 weeks with one 1/2 day session per 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
- Course Overview – participants’ personal objectives and their respective roles
- Quality Managment System as a Tool for Improvement
- ISO 9001:2015 Overview – focus on the usefulness of ISO 9001:2015 as a business model
- Defining Organizational Purpose and Direction [4.1, 4.2, 4.3]
- Context
- Understanding Stakeholders
- Understanding Stakeholder Requirements/Expectations
- 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]
- Commitment to the QMS
- Communication
- Customer Focus
- Defining the Quality Policy [5.2]
- Identifying Leadership requirements [5.1.1]
- 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]
- Assessing current methods for identifying risks and opportunities [6.1]
- Setting Quality Objectives [6.2]
- Action plan requirements [6.2.2]
- 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
- Providing competent people [7.1, 7.2]
- Infrastructure [7.1.3]
- Work Environment [7.1.4]
- Calibration [7.1.5]
- Organizational knowledge [7.1.6]
- Awareness [7.3]
- 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
- General requirements for documentation [7.5]
- Creating and updating [7.5.2]
- Control of documented information [7.5.3]
- Alternative forms of documented information for improved understanding and ease of maintenance
- 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
- Operational planning [8.1]
- Managing risks related to customer activities
- Managing change [8.1 para 2]
- Customer requirements and handling changes [8.2.1 – 8.2.4]
- Determining requirements and capacity
- Changes to orders
- Control of Externally Provided Products and Services (Purchasing) [8.4]
- Outsourced Processes
- Supplier/Contractor Controls
- Purchasing Information
- Product/Service Realization and Release [8.5, 8.6]
- 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]
- Customer Satisfaction [9.1.2]
- Monitoring and Measurement [9.1.3]
- 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]
- Fundamentals of auditing – planning, performing, reporting and attributes of good auditors (ISO 19011 as reference)
- Internal Audit Procedure – evaluation of current procedure
- Layered Process Auditing
- Auditing by Risk/Objective/Performance
- Interview techniques
- Documenting results
- Communicating results
- Logging reports and results
- 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]
- Coaching and mentoring during continuing audit activities
- 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]
- Customer Satisfaction [QMS 9.1.2, 8.2.1]
- Monitoring and Measurement [9.1]
- Audits – Internal [9.2] and External (Registrar, customers, regulatory bodies such as the Ministry of Transport if required)
- 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
- Based on performance evaluation [9.1]
- Structured plan (template) for managing an improvement activity
- Resources
- Personnel
- Time line
- 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’
- Assess current awareness/commitment
- Review Context [4]
- Does the QMS support an ‘Quality Culture’?
- 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)
- Assess current awareness/commitment of Management with regards to employee engagement
- Has an acceptable level of ‘Awareness’ [7.3] been achieved?
- 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
- Review of registrar requirements for your organization
- 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]
- Structured plan for managing an improvement activity
- Resources
- Personnel
- Time-line
- 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
- Review of registrar requirements for your organization
- 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