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Implementation Training

for an Integrated System:


ISO 9001 plus ISO 45001
This Training Program runs for 16 weeks with two 1/2 day sessions each
week. The training covers all the clauses of ISO 9001 and ISO 45001 in
detail so the participants will gain a thorough knowledge of the Standards.
Participants will learn how to apply the requirements in their organization
so they can apply for ISO Certification by an Accredited Registrar.
Participants earn 2 Certificates:
 Certified Internal Auditor
 Certified Management System Specialist

Program Overview
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,
Purchasing and Non-conforming Outputs
Group Training Session #7 – Performance Evaluation – Measurements
Group Training Session #8 – Performance Evaluation – Internal Audit
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 an ‘Occupational health and safety
Culture’ and 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
 Final Evaluation of Case Work – Certification of Trainee

Total Implementation Calendar – 16 weeks (this can be modified to meet


your requirements, but the training will still be delivered to help you
implement an integrated Management System

Module 1 – ISO
9001:2015/45001:2018 –
Introduction and Overview
1. Course Overview – participants’ personal objectives and their
respective roles
2. Using a QMS/OHS Integrated Management System (IMS) as a
Tool for Organizational Improvement

3. ISO 9001:2015/45001:2018Overview – focus on the application in


your organization
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

Onsite Work:
 Define Processes – workflow overview with occupational health and
safety hazards identified on the process map
 Define Scope of the Integrated Management System (IMS)

 Define Stakeholders and Expectations

Outcomes
 Clear Understanding of Intent and Direction of ISO 9001/45001
 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 IMS [5.1, 5.2]
a. Commitment to the IMS
1. Communication

2. Customer Focus (9001 only)

3. Defining the Quality and OHS Policies [5.2]

4. Identifying different Management requirements for OHS [5.1]


5. Organizational structure [5.3]

Onsite Work
 Define Quality and OHS Policies
 Outline Business Priorities/Goals

 Define in terms of possible Quality and OHS Objectives

 Consider current organizational structure

 Review current worker participation levels

Outcomes
 Understanding of Leadership’s role in ISO 9001/45001:2018
 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 – Risk and


Opportunity Management
Risk and Opportunity Management [6.2]
a. Defining Objectives
b. Assessing current methods for identifying risks and opportunities
[6.1.1]

c. Occupational health and safety hazards (OHS) [6.1.2]

d. Determining legal and regulatory compliance requirements [6.1.3]

e. Establishing quality goals and OHS objectives [6.2]

f. Action plan requirements [6.2.2]


Onsite Work
 Define Company Risks and opportunities
 Determine applicable legal and regulatory requirements

 Set suitable (SMART) goals

 Create action plans to meet goals

Outcomes
 Risk Assessment completed
 Understanding the relationship between Goals, Setting Objectives
and Defining Risks

 Legal requirements identified and method to access them put into


place

Module 4 – Resources: People,


Infrastructure and Work
Environment
Resources
1. Providing competent people [7.1, 7.2]
2. Infrastructure [QMS 7.1.3]

3. Work Environment [QMS 7.1.4]

4. Calibration [QMS 7.1.5]

5. Awareness [7.3]

6. Communication – internal and external [7.4]


Onsite Work
 Assess current method for providing competent people
 Determine adequacy of infrastructure

 Review all hazards of current Work environment

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

Onsite Work
 Assess current method for managing documented information
 Determine adequacy of document and record control

 Review all hazards of current types of documents and demonstrate


how they would be managed

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

Module 6 – Operations:
Planning, Customer
Requirements, Design,
Purchasing and Non-
conforming outputs
1. Operational planning [8.1]
1. Managing and reducing risk [8.1.2]

2. Managing change [8.1 para 2]

2. Customer requirements and handling changes [QMS 8.2.1 – 8.2.4]

1. Determining requirements and capacity

2. Changes to orders

3. Emergency Preparedness and Response [8.2 – OHS]

4. Design and Development [8.3 – QMS only, if applicable]

5. Control of Externally Provided Products and Services [8.4 – QMS]

6. Outsourced Processes

7. Supplier/Contractor Controls

8. Purchasing Information

9. Product/Service Realization and Release [8.5, 8.6 – QMS]


10. Control of Nonconforming Outputs [8.7 – QMS]

Onsite Work
 Identify Gaps in: Operational planning, determining customer
requirements, design, purchasing and production
 Create appropriate methods to close operational gaps – review
document controls during this case work

 Review and revise ‘Occupational health and safety hazards’ [6.1.2,


8.1.2] matrix or equivalent information

Outcomes
 Clear understanding of ISO 9001:2015/45001:2018 clauses and
requirements related to ‘Operations’ including requirements related to
occupational health and safety hazards
 Recognition of the alignment between GSU Hydro’s processes and
ISO 9001:2015/45001:2018

requirements
 Identification of ISO 9001:2015/45001:2018 requirements not
currently addressed by your processes

Module 7 – Performance
Evaluation: Measurements
Performance Evaluation [9.1]
a. Customer Satisfaction [QMS 9.1.2]
b. Monitoring and Measurement [QMS 9.1.3, OHS 9.1.1]

c. Evaluation of Compliance [OHS 9.1.2]

d. Updating of Risks/Opportunities

Onsite Work
 Review Current measurement and analysis methods
 Determine (or arrange to have determined) degree of Legal
compliance

 Identify opportunities for improvement of risk management

Outcomes
 Understanding of the requirements for measurements in QMS
 Understanding of the legal requirements required for a safe work
environment

 Recognition of options relating to gathering and analyzing


performance information

 Development of tracking tools for process performance as it relates


to Quality and OHS

Module 8 – Performance
Evaluation: Internal Audits [9.2]
Internal Audits [9.2]
a. Fundamentals of auditing – planning, performing, reporting and
attributes of good auditors (ISO 19011 as reference)
b. Internal Audit Procedure – evaluation of current procedure

c. Auditing by Process and Auditing by Objectives

d. Auditing by Risk/Objective/Performance

e. Interview techniques

f. Documenting results

g. Communicating results

h. Logging reports and results


i. Audit follow-up activities

Onsite Work
 Assess your knowledge of the Internal Audit Process for
conformance to the requirements of ISO 9001/45001
 Conduct Internal Audits of each process including an audit of OHS
requirements – this will be an ongoing exercise

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

Onsite Work
 Continue Internal Audit Process until completion
 Conduct Internal Audits of each process including an audit of OHS
requirements

 Prepare for Management Review to include requirements for both


OHS and QMS

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]
a. Customer Satisfaction [QMS 9.1.2, 8.2.1], Occupational health and
safety performance [OHS 9.3.d)]
b. Monitoring and Measurement [9.1]

c. Evaluation of Compliance [OHS 9.1.2]

d. Audits – Internal [9.2] and External (Registrar, customers, regulatory


bodies)

e. Management Review [9.3]

Onsite 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 and OHS if needed

Outcomes
 Understanding of the requirements for improvement to the
effectiveness of the management system
 Understanding of the requirements for monitoring and
measurement of QMS and OHS factors

 Recognition of options relating to gathering and analyzing


performance information

Module 11 –Process Analysis


and Improvement
Identify projects for Improvement Activities
a. Based on performance evaluation [9.1]
b. Structured plan (template) for managing an improvement activity

c. Resources

d. Personnel

e. Time line

f. Success measures

Onsite 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

Outcomes
 Understand the value of ‘Improvement’
 Be able to plan an improvement project
Module 12 – Developing an
Occupational Health and Safety
Culture
Determine the characteristics of an ‘Occupational health and safety
Culture’
a. Assess current awareness/commitment
b. Review Context [4, Annex A.4.1]

c. Does the OHS MS support an ‘Occupational health and safety


Culture’? [Annex A.4.4]

d. Does Leadership encourage an ‘Occupational health and safety


Culture’? [Annex A.5.1]

e. Is the OHS Policy conducive to an ‘Occupational health and safety


Culture’? [Annex A.5.2]

f. Success measures [A.9.1]

Onsite Work
 Assess the commitment to the environment
 Determine whether the current IMS supports and occupational
health and safety, safety and quality culture

 Prepare make recommendations to strengthen the culture to create


more focus on your occupational health and safety impact, both positive
and negative (OHS)

 Determine whether focus on the environment would have any


impact on customer focus
Outcomes
 Understand the meaning of and existence of ‘Culture’
 Be able to plan a culture awareness campaign with the intention of
strengthening the Quality and Safety cultures in your organization

Module 13 – Employee
Involvement
Employee Engagement [QMS 5.1.1 h), OHS 5.1 g)]
a. Assess current awareness/commitment of Management with
regards to employee engagement
b. Has an acceptable level of ‘Awareness’ [7.3] been achieved?

c. Is an acceptable form of ‘Communication’ [7.4] taking place?

Onsite 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

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

Onsite Work
 Prepare all participants for the Stage 1 audit

Outcomes
 Everyone is ready for the Stage 1 Audit

Module 15 – Final Assessment


of Implementation – second
Management Review
Complete projects suggested as outputs from the first Management
Review [QMS 9.3.3, OHS 9.3]
a. Structured plan for managing an improvement activity
b. Resources

c. Personnel

d. Time line
e. Success measures

Onsite Work
 Review commitments made in the first Management Review
 Identify any further action required

 Prepare to implement the action plan

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

Onsite Work
 Final preparation of all participants for the Stage 1 audit

Learning Outcomes
 Be able to assess how well everyone is prepared for the Stage 1
Audit and close any gaps
Any modifications to the IMS that are required for the Stage 2 audit will be
addressed. Any issues arising from the Stage 2 Audit will be addressed
together as well.
The outcome for this project is to gain the knowledge to achieve
Certification of your Integrated Management System.

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