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Toolbox Talks - ISO 9001 Training

Train
Overview

ISO 9001:2015 Overview

  • The ISO Organisation
  • Evolution of Quality concept
  • Value for the customer
  • ISO 9001 Quality Management Systems overview
  • Benefits of having a Quality Management System and adopting ISO 9001
  • The role of Leadership
  • ISO 9001 Purpose and Structure
  • Terms and Definitions
  • Integration with ISO 45001 and ISO 14001 - Annex SL

The 7 Quality Management principles in ISO 9001

  • Understanding the 7 Quality Management principles in ISO 9001: customer focus; leadership;
    engagement of people; process approach; improvement; evidence-based decision making; relationship management.
  • Understand where you can find these principles in ISO 9001 requirement clauses

The 3 Pillars of ISO 9001 - Process Approach, Risk Based Thinking and Plan-Do-Check-Act

  • Process Approach
  • Risk Based Thinking
  • Plan-Do-Check-Act
Diving In

Process Approach

  • Definitions - Processes and procedures
  • Deliverables - Value from the client’s point of view
  • Value Stream processes and other processes
  • Process interaction - inputs and outputs
  • Measuring process performance
  • Processes vs Organisation Chart
  • Plan/Do/Check/Act
  • Required documented information

Measurement and Monitoring of the Management System Performance

  • Definitions: efficiency and effectiveness, objectives, KPI, metrics, goals
  • Actions to achieve Objectives
  • Internal and external communication about objectives
  • Different types of indicators
  • Required documented information
  • Other related ISO standards

Continual Improvement of the Management System Performance

  • Plan/Do/Check/Act
  • How is it reflected in the ISO 9001 structure?
  • Inputs for Continual Improvement
  • How it relates to the Process approach
  • How it relates to Risks and Opportunities
  • Required documented information
  • Other related ISO standards

Documented information

  • Definitions - documented information
  • Mandatory documented information
  • System Manual
  • Documented information layers, structure and supports (alternatives - + flexible vs + structured; + documents vs - documents - advantages and disadvantages)
  • Document control principles
  • Maintaining the Management System coherence and flexibility
  • Required documented information
  • Other related ISO standards

Context of the Organisation and Interested Parties

  • Definitions - internal and external context, interested parties
  • Scope and boundaries of the Management System
  • Understanding the internal and the external contexts
  • Needs and expectations of internal and external interested parties
  • Legal requirements and other requirements
  • Required documented information
  • Other related ISO standards

Business Risks and Opportunities: Actions to address Risks and Opportunities

  • Definitions -  risk and opportunity
  • Risk Based Thinking
  • "Where I am vs Where I want to go" - Risks and Opportunities
  • Identifying and evaluating risks and opportunities
  • Effectiveness of actions taken to address risks and opportunities
  • Update of identified risks and opportunities
  • Required documented information
  • Other related ISO standards

Leadership and Commitment, Organisational roles, responsibilities and authorities, Competence and Organisational Knowledge

  • Definitions
  • How does Top Management show leadership and commitment with respect to the quality management system
  • Customer focus
  • Policy
  • Organisational roles, responsibilities, and authorities
  • Competence management
  • Organisational knowledge methods
  • Required documented information
  • Other related ISO standards

Planning of Changes

  • Planning of changes - objective, actions, resources and responsibilities
  • Evaluation of impact in the Quality Management System
  • Required documented information
  • Other related ISO standards

Communication and Awareness

  • Information to be communicated
  • Awareness
  • The difference between training and awareness raising
  • How to prepare a Communication plan (internal and external)
  • Required documented information
  • Other related ISO standards

Infrastructure and environment for the operation of processes

  • Definitions
  • Identification, availability, and maintenance of the infrastructure necessary for the operation of the processes
  • Identification of the environmental conditions necessary to undertake the operations and control methods
  • Required documented information
  • Other related ISO standards

Monitoring and measuring resources

  • Definitions: calibration, verification, traceability
  • Ensuring valid and reliable results when monitoring or measuring
  • Measurement traceability requirements
  • Required documented information
  • Other related ISO standards

Operational planning and control and requirements for products and services and control of changes

  • Determining, reviewing, and changing the products and services requirements
  • Criteria for the acceptance of products and services
  • Criteria for the processes and its control
  • Planned and unintended changes
  • Release of products and services and control of non-conforming outputs
  • Post-delivery activities
  • Communication with customers
  • Required documented information
  • Other related ISO standards

Design and development of products and services

  • Definitions
  • Design and development planning
  • Design and development inputs and outputs
  • Design and development controls
  • Design and development changes
  • Required documented information
  • Other related ISO standards

Externally provided processes, products, and services - purchasing and sub-contracting

  • Definitions
  • Responsibilities
  • Type and extent of control
  • Requirements for the processes, products, and services to be provided
  • Control and monitoring of the external providers’ performance
  • Required documented information
  • Other related ISO standards

Identification and Traceability, Property belonging to customers or external providers and preservation

  • Traceability requirements
  • Identification of conformity status of products and services
  • Communication with external providers and customers
  • Required documented information
  • Other related ISO standards

Customer satisfaction

  • Monitoring customer perceptions
  • Improving customer satisfaction
  • Required documented information
  • Other related ISO standards

Internal Audit

  • Required documented information
  • Audit Programme and the risk-based approach
  • Audit Plan
  • Audit results and continual improvement
  • Criteria for selection of auditors
  • Other related ISO standards

Management Review

  • Purpose of the management review
  • Frequency
  • Mandatory inputs and outputs
  • Required documented information
  • Other related ISO standards

Non-conformity and corrective action

  • Definitions: non-conformity, correction, and corrective action
  • Steps involved in the treatment of non-conformities
  • Required documented information
  • Other related ISO standards
Implementation Tools

Process Approach

  • Case Study:
  • Identifying the processes involved and producing a process interaction map and matrix
  • Process Map representation: SIPOC, Turtle, Swimming lanes
  • Mapping workshop
  • Processes vs organisation chart matrix

Measurement and Monitoring of the Management System Performance

  • Performance management
  • Aligning teams - objectives and action deployment
  • Case Study: Deployment matrix

Continual Improvement of the Management System Performance

  • Management Toolbox Talks
  • How to lead meetings around objectives and performance
  • Continual improvement tools

Documented information

  • Examples, advantages and disadvantages of different documental structures
  • How to build control matrixes

Context of the Organization and Interested Parties

  • Case Study
  • PESTEL analysis
  • SWOT analysis

Business Risks and Opportunities

  • Case Study
  • Risks and Opportunities prioritization methods

Leadership and Commitment, Organisational roles, responsibilities and authorities, Competence and Organisational Knowledge

  • How to determine the necessary competence
  • How to describe roles, responsibilities, and authorities
  • How to build competence matrixes
  • How to evaluate the effectiveness of training
  • How to retain critical organisational knowledge

Planning of Changes

  • Case study

Communication and Awareness

  • Communication as a strategic enabler

Infrastructure and environment for the operation of processes

  • TPM
  • Predictive, preventive, and corrective maintenance of equipment’s
  • How to prepare and implement a maintenance plan
  • Examples of KPI

Monitoring and measuring resources

  • How to prepare a measurement equipment log
  • How to define the requirements to  specify a calibration
  • How to evaluate adequacy of measurement equipment
  • How to determine calibration intervals

Operational planning and control and requirements for products and services and control of changes

  • Case study
  • How to control the process in order to control the product or service
  • How to build a Control Plan

Design and development of products and services

  • Case study for a service development project (e.g.  website )
  • Case study for a product design and development project

Externally provided processes, products, and services - purchasing and sub-contracting

  • Case study
  • Clinical assessment, selection and continual evaluation of external providers

Identification and Traceability, Property belonging to customers or external providers and preservation

  • Methods of traceability in sensitive industries: automotive, aerospace, cosmetic, food, etc.

Customer satisfaction

  • Validation of customer satisfaction questionnaires and surveys

Internal Audit

  • Go to Internal Audits Training

Management Review

  • Preparing and Conducting management review meetings

Non-conformity and corrective action

  • Problem solving basic tools
  • Problem description 2H4W
  • Root cause analysis techniques: 5W and fishbone
choose a standard

What Standard are you looking to obtain:

ISO 9001 – Quality Management System Standard
ISO 14001 – Environmental Management System Standard
ISO 27001 – Information Security Management System Standard
ISO 20001 - Information Technology Service Management Part 1
ISO27701:2019 – Privacy Management System Standard
ISO 30071-1 - Digital Accessibility Standard
ISO 37001 – Anti-Bribery Management System Standard
ISO 45001 – Health and Safety Management Standard
ISO 50001 – Energy Management System Standard
ISO 14064:1 - Quantification And Reporting Of Greenhouse Gas Emissions And Removals
ISO 14067 - Carbon Calculator
PAS 2060 - Carbon Neutrality
ISO 17024 - Conformity Assessment of the Certification of Persons
ISO 17025 – The competence of testing and calibration laboratories
ISO 20121 – Event Sustainability Management System Standard
ISO 37301:2021 – Legal Compliance Management System 
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If you would like to know more about ISO Standards, Certification and the value of a good management system you can add to your business we would love to hear from you: Kent: 01892 800476 | London: 02037 458 476 | info@avisoconsultancy.co.uk

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