The Business Resource Centre | Course Types Understanding & Implementing

Medical Device Single Audit Program (MDSAP) Fundamentals

August 7, 2019/in Medical Devices ISO 13485:2016, MDSAP Understanding & Implementing, Understanding /by The BRC

⚙Overview

Medical Device Single Audit Program (MDSAP) Fundamentals

Course Description

The Medical Device Single Audit Program (MDSAP) is an international initiative to implement a program through which a single audit of a medical device manufacturer that will be accepted by multiple regulators to address QMS/GMP requirements. Participating regulatory authorities include Australia, Brazil, Canada, Japan and the USA.

This 1-day course is relevant for any size organization selling medical devices into the participating regions. It will help you to determine if your own Quality Management System processes are consistent with the requirements of the MDSAP audit model and assist in preparing you to host an MDSAP audit.

Who Should Take It

Individuals with responsibility for management, operation, implementation or maintenance of an ISO 13485:2016 Quality Management System.
Individuals responsible for Quality Assurance or Regulatory Affairs.
Senior Management
Quality Managers, Members of the Quality Team and/or Internal Audit Team

Learning Objectives

Understand the fundamentals, structure and scope of the MDSAP program.
- MDSAP audit processes and their interrelationships.
- MDSAP and organizational regulatory compliance.
- MDSAP reporting and nonconformity grading.
Differentiate between MDSAP audits and other types of QMS audits.
Review the different MDSAP documents.
Review the MDSAP audit sequence.
Understand the 7 MDSAP processes and what auditors will be looking for when addressing each.

Prerequisites

None. This is an introductory course. (Previous experience working within an ISO 13485 quality management system and/or a medical device quality environment is helpful, but not required.)

Click Here for the Full Course Outline

Course Details

Name: Medical Device Single Audit Program (MDSAP) Fundamentals

Duration: 1 day(s)

Sector(s): Medical Devices

Discipline(s): ISO 13485:2016, MDSAP

Type: Understanding & Implementing, Understanding

Public Course Dates

This course is available as on-site training only. Click on the On-Site Training tab for more details and to request a quote.

⌂On-Site Training

On-site group training is delivered at your place of business and can be customized to meet your specific requirements. Contact The Business Resource Centre to schedule your next on-site group training event.

Please call 1-888-535-1401 or fill out the form below to request a quote.

👥Public Training

Public training is available for this course. Locations and dates can be found using the form below. Please fill out and submit the form to register for this course.

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Online Training

Online training is available for this course. Please fill out and submit the form to register for this course.

Understanding & Implementing Integrated ISO 9001, 14001 and 45001

July 13, 2018/in Integrated Systems Integrated ISO 9001 / 14001 / 45001 Understanding & Implementing, Understanding /by The BRC

⚙Overview

Understanding & Implementing Integrated ISO 9001, 14001 & 45001

2 days of training that deliver a solid understanding of ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018 requirements, as well as practical guidance on tools and approaches to implement an Integrated Management System meeting the requirements of all 3 standards.

A combination of presentation, discussion and immersive, hands-on exercises are used to explore:

ISO 9001:2015 requirements for Quality Management Systems.
ISO 14001:2015 requirements for Environmental Management Systems.
ISO 45001:2018 requirements for Occupational Health & Safety Management Systems.

Participants will also review key concepts (risk-based thinking, documented information, leadership, life-cycle perspective, consultation and participation of workers, etc.) and understand approaches and techniques for implementing these requirements and concepts in an integrated fashion.

See below for a full list of public course dates.

Who Should Take It

Individuals with responsibility for management, operation, implementation or maintenance of an integrated ISO 9001, ISO 14001 and ISO 45001 Management System. This includes, but is not limited to:

Those responsible for transitioning their organization’s system to meet the new requirements.
Senior Management
ISO Coordinators, EHS Managers, OHS Managers, Quality Managers & Management Representatives
Members of the Quality Team, Environmental Team, Health & Safety Team, and/or Internal Audit Team
ISO 9001/14001/45001 Auditors, Quality/Environmental/Health & Safety Professionals and Consultants

Learning Objectives

Understand Annex SL – the “Structured Layer” design of the new Standard (i.e. new numbering system for clauses that will be consistent across standards).
Become familiar with the new standards’ requirements while comparing and contrasting ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018.
Recognize the main changes contained within the substance of the new standards and how they will impact your Integrated Management System.
Understand the new concepts of “Documented Information”, “Risk-Based Thinking”, “Leadership”, “Life-Cycle Perspective”, “Threats and Opportunities” and “Consultation and Participation of Workers”.
Understand the timeline for transition/implementation and how it will affect your program (documentation, training, registration, etc.).
Identify a general approach to implementing the requirements of ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018.
Learn how to use the Gap Analysis as a tool to create an action plan for implementation.
Build the confidence of QMS, EMS and OHSMS team members as you prepare your implementation project.

Prerequisites

This is an introductory course and no prerequisites are required. For maximum benefit, some prior knowledge of ISO 9001, ISO 14001 and ISO 45001 (current or previous editions) will be an asset.

GET THE FULL COURSE OUTLINE HERE

Course Details

Name: Understanding & Implementing Integrated ISO 9001, 14001 and 45001

Price: $1050

Duration: 2 day(s)

Sector(s): Integrated Systems

Discipline(s): Integrated ISO 9001 / 14001 / 45001

Type: Understanding & Implementing, Understanding

Public Course Dates

This course is available as on-site training only. Click on the On-Site Training tab for more details and to request a quote.

⌂On-Site Training

On-site group training is delivered at your place of business and can be customized to meet your specific requirements. Contact The Business Resource Centre to schedule your next on-site group training event.

Please call 1-888-535-1401 or fill out the form below to request a quote.

👥Public Training

Public training is available for this course. Locations and dates can be found using the form below. Please fill out and submit the form to register for this course.

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Understanding & Implementing ISO 45001:2018

July 11, 2018/in Health & Safety Management ISO 45001:2018 Understanding & Implementing, Understanding /by The BRC

⚙Overview

Understanding & Implementing ISO 45001:2018

This 2-day course delivers an in-depth review of the ISO 45001:2018 requirements for occupational health and safety management systems.

Intended for members of the organization’s implementation team, this course teaches the standard’s requirements through discussion and immersive, hands-on exercises, and will review approaches and techniques for implementing these requirements within an organization.

Who Should Take It

Individuals with responsibility for management, operation, implementation or maintenance of an ISO 45001 OHSMS. This includes, but is not limited to:

Those responsible for transitioning their organization’s OHSMS to meet the new requirements.
Senior Management
ISO Coordinators, Occupational Health & Safety Managers, and Management Representatives
Members of the Occupational Health & Safety Team and/or Internal Audit Team
ISO 45001 Auditors, Occupational Health & Safety Professionals and Consultants

Learning Objectives

Understand Annex SL – the “Structured Layer” design of the new standard (i.e. new numbering system for clauses that will be consistent across standards).
Become familiar with the ISO 45001:2018 standard’s requirements (review of each section and its requirements).
Understand the timeline for transition from previous editions and how it will affect your OHSMS (documentation, training, registration, etc.).
Understand requirements around “risk and opportunities” that may affect the ability of the management system to achieve results.
Understand the “Context of the Organization” and how it is used to establish, implement and maintain an ISO 45001:2018 OHSMS.
Understand requirements related to “consultation and participation of workers”.
Identify the requirements for “Documented Information” and how this will (and will not) require changes to your existing documentation.
Understand the practical implication of the new requirements around “Leadership”.
Identify the general approach to implementing an ISO 45001:2018 OHSMS.
Learn how to use the Gap Analysis as a tool to create an action plan for implementation.

Prerequisites

None. This is an introductory course.

GET THE FULL COURSE OUTLINE HERE

Course Details

Name: Understanding & Implementing ISO 45001:2018

Price: $1050

Duration: 2 day(s)

Sector(s): Health & Safety Management

Discipline(s): ISO 45001:2018

Type: Understanding & Implementing, Understanding

Public Course Dates

This course is available as on-site training only. Click on the On-Site Training tab for more details and to request a quote.

⌂On-Site Training

On-site group training is delivered at your place of business and can be customized to meet your specific requirements. Contact The Business Resource Centre to schedule your next on-site group training event.

Please call 1-888-535-1401 or fill out the form below to request a quote.

👥Public Training

Public training is available for this course. Locations and dates can be found using the form below. Please fill out and submit the form to register for this course.

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Understanding, Implementing & Auditing ISO 17025:2017

May 17, 2018/in Testing & Calibration Laboratories ISO 17025:2017 Understanding & Implementing, Understanding, Internal Auditor /by The BRC

⚙Overview

A thorough on-site course covering your organization’s complete ISO 17025 QMS training needs…

This 3-day course provides instruction on the specific requirements of an ISO 17025:2017 quality management system, the steps to effectively implement these requirements within an organization, and the practical skills and knowledge required to conduct audits in accordance with the ISO 9000 series of standards:

ISO 19011:2011 – “Guidelines for Auditing Management Systems”, and
“Guidance on the Concept and Use of the Process Approach for Management Systems”.

Through a balance of formal presentations, case studies, simulation of audit activities and group activities, participants will learn the necessary elements to perform a quality audit.

Who Should Take It

Individuals with responsibility for management, operation, implementation or maintenance of an ISO 17025:2017 QMS. This includes, but is not limited to:

Those responsible for implementing (or transitioning) their organization’s QMS to meet the ISO 17025:2017 requirements.
Senior Management
ISO Coordinators, Quality Managers & Management Representatives
Members of the Quality Team and/or Internal Audit Team
ISO 17025 Auditors, Quality Professionals and Consultants

Learning Objectives

Become familiar with the standard’s requirements (review of each section and its requirements).
Understand the timeline for transition (from ISO 17025:2005) and how it will affect your quality program (documentation, training, accreditation, etc.).
Appreciate the different factors that should be considered when implementing, or working within, an ISO 17025:2017 Quality Management System.
Identify the general approach to implementing the requirements of ISO 17025:2017.
Learn how to use the Gap Analysis as a tool to create an action plan for implementation.
Appreciate the roles and responsibilities of the Auditor.
Understand the basic skills and principles of auditing.
Apply the concepts and guidelines detailed in ISO 19011:2011 when performing an audit.
Learn the different methods of gathering evidence.
Develop the communication skills, leadership skills and attitudes required to perform internal audits.

Prerequisites

None. This is an introductory course. (Previous knowledge of, or experience with, ISO 17025:2005 is beneficial but not required.)

GET THE FULL COURSE OUTLINE HERE

Course Details

Name: Understanding, Implementing & Auditing ISO 17025:2017

Duration: 3 day(s)

Sector(s): Testing & Calibration Laboratories

Discipline(s): ISO 17025:2017

Type: Understanding & Implementing, Understanding, Internal Auditor

Public Course Dates

This course is available as on-site training only. Click on the On-Site Training tab for more details and to request a quote.

⌂On-Site Training

On-site group training is delivered at your place of business and can be customized to meet your specific requirements. Contact The Business Resource Centre to schedule your next on-site group training event.

Please call 1-888-535-1401 or fill out the form below to request a quote.

👥Public Training

Public training is available for this course. Locations and dates can be found using the form below. Please fill out and submit the form to register for this course.

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Understanding & Implementing ISO 17025:2017

May 17, 2018/in Testing & Calibration Laboratories ISO 17025:2017 Understanding & Implementing, Understanding /by The BRC

⚙Overview

This introductory 2-day course provides a broad understanding of the requirements of ISO 17025:2017 – General requirements for the competence of testing and calibration laboratories. Through immersive, hands-on exercises and discussion, participants will review the standard’s requirements in detail and review approaches and techniques for implementing its requirements.

See below for a full list of public course dates.

Who Should Take It

Individuals with responsibility for management, operation, implementation or maintenance of an ISO 17025:2017 QMS. This includes, but is not limited to:

Those responsible for implementing (or transitioning) their organization’s QMS to meet the ISO 17025:2017 requirements.
Senior Management
ISO Coordinators, Quality Managers & Management Representatives
Members of the Quality Team and/or Internal Audit Team
ISO 17025 Auditors, Quality Professionals and Consultants

Learning Objectives

Become familiar with the standard’s requirements (review of each section and its requirements).
Understand the timeline for transition (from ISO 17025:2005) and how it will affect your quality program (documentation, training, accreditation, etc.).
Appreciate the different factors that should be considered when implementing, or working within, an ISO 17025:2017 Quality Management System.
Identify the general approach to implementing the requirements of ISO 17025:2017.
Learn how to use the Gap Analysis as a tool to create an action plan for implementation.
Build confidence of QMS team members as they prepare to implement, or work within, an ISO 17025:2017 quality management system.

Prerequisites

None. This is an introductory course. (Previous knowledge of, or experience with, ISO 17025:2005 is beneficial but not required.)

GET THE FULL COURSE OUTLINE HERE

Course Details

Name: Understanding & Implementing ISO 17025:2017

Price: $1050

Duration: 2 day(s)

Sector(s): Testing & Calibration Laboratories

Discipline(s): ISO 17025:2017

Type: Understanding & Implementing, Understanding

Public Course Dates

This course is available as on-site training only. Click on the On-Site Training tab for more details and to request a quote.

⌂On-Site Training

On-site group training is delivered at your place of business and can be customized to meet your specific requirements. Contact The Business Resource Centre to schedule your next on-site group training event.

Please call 1-888-535-1401 or fill out the form below to request a quote.

👥Public Training

Public training is available for this course. Locations and dates can be found using the form below. Please fill out and submit the form to register for this course.

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Understanding & Implementing AS9100 Rev. D

April 5, 2017/in Aerospace AS 9100 Understanding & Implementing, Understanding /by The BRC

⚙Overview

This 2-day course delivers a thorough understanding of the AS9100:2016 (Rev. D) requirements for aerospace quality management systems, along with a review of key concepts and techniques for implementing the requirements within an organization.

Through a combination of presentation, discussion and hands-on exercises, participants will learn to apply the key concepts and principles of the standard to the existing processes within their organization.

Who Should Take It

Individuals with responsibility for management, operation, implementation or maintenance of an AS9100:2016 (Rev. D) quality management system. This includes, but is not limited to:

Those responsible for implementing their organization’s QMS.
Senior Management
Quality Coordinators, Quality Managers & Management Representatives
Members of the Quality Team and/or Internal Audit Team
AS9100 Auditors, Quality Professionals and Consultants

Learning Objectives

Understand Annex SL – the “Structured Layer” design of the new Standard (i.e. new numbering system for clauses that will be consistent across standards).
Become familiar with the new standard’s requirements (review of each section and its requirements).
Understand key concepts and how they are applied within a QMS (Context of the Organization, Risk-Based Thinking, Leadership, Ethical Behaviour, Counterfeit Parts Production, and more).
Identify the general approach to implementing the AS9100:2016 (Rev. D) requirements.
Learn how to use the Gap Analysis as a tool to create an action plan for implementation.
Build the confidence of QMS team members as you prepare your implementation project.

Click Here for the full course outline.

Course Details

Name: Understanding & Implementing AS9100 Rev. D

Price: $1150

Duration: 2 day(s)

Sector(s): Aerospace

Discipline(s): AS 9100

Type: Understanding & Implementing, Understanding

Public Course Dates

This course is available as on-site training only. Click on the On-Site Training tab for more details and to request a quote.

⌂On-Site Training

On-site group training is delivered at your place of business and can be customized to meet your specific requirements. Contact The Business Resource Centre to schedule your next on-site group training event.

Please call 1-888-535-1401 or fill out the form below to request a quote.

👥Public Training

Public training is available for this course. Locations and dates can be found using the form below. Please fill out and submit the form to register for this course.

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Transitioning to IATF 16949:2016

March 23, 2017/in Automotive IATF 16949:2016 Understanding, Understanding & Implementing /by The BRC

⚙Overview

Course Description

This 2-day course provides in-depth review of the changes from TS 16949:2009 to ISO 9001:2015 and IATF 16949:2016. Through class discussion and hands-on exercises, participants will gain the necessary knowledge to support their organization’s transition to ISO 9001:2015 and IATF 16949:2016.

Intended for key members of the organization’s transition team with existing experience with quality management systems, this course provides critical knowledge for leadership, management and team members who need to understand the new requirements of ISO 9001:2015 and IATF 16949:2016 as they prepare to transition the organization’s QMS.

Who Should Take It

Individuals with responsibility for the implementation management, operation, or maintenance of an IATF 16949:2016 QMS. This includes, but is not limited to:

Implementation team responsible for transitioning the organization’s QMS to IATF 16949:2016.
Key functional groups involved in transitioning the organization’s QMS to IATF 16949:2016.
Senior Management
ISO Coordinators & Quality Managers
IATF 16949:2016 Auditors, Quality Specialists, and Consultants

Learning Objectives

Understand the updated Quality Management Principles and their role.
Understand how Risk-Based Thinking is used and documented within an IATF 16949:2016 QMS.
Understand the requirement changes from ISO 9001:2008 to ISO 9001:2015 within an automotive context.
Understand the requirement changes from TS 16949:2009 to IATF 16949:2016.
Understand the timeline for transition and how it will affect your quality program (documentation, training, registration, etc.).
Identify the general approach to implementing the new requirements of IATF 16949:2016.
Build the confidence of team members as you prepare your transition project.

Click Here for the full course outline.

Course Details

Name: Transitioning to IATF 16949:2016

Price: $

Duration: 2 day(s)

Sector(s): Automotive

Discipline(s): IATF 16949:2016

Type: Understanding, Understanding & Implementing

Public Course Dates

This course is available as on-site training only. Click on the On-Site Training tab for more details and to request a quote.

⌂On-Site Training

On-site group training is delivered at your place of business and can be customized to meet your specific requirements. Contact The Business Resource Centre to schedule your next on-site group training event.

Please call 1-888-535-1401 or fill out the form below to request a quote.

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Understanding & Implementing ISO 13485:2016

July 5, 2016/in Medical Devices ISO 13485:2016 Understanding & Implementing /by The BRC

⚙Overview

This introductory 2 day course provides a broad understanding of the requirements of ISO 13485:2016 – Medical devices – Quality management systems – Requirements for regulatory purposes. Through immersive, hands-on exercises and discussion, participants will review the standard’s requirements in detail and review approaches and techniques for implementing its requirements.

Who Should Take It

Individuals with responsibility for management, operation, implementation or maintenance of an ISO 13485:2016 QMS. This includes, but is not limited to:

Those responsible for implementing (or transitioning) their organization’s QMS to meet the ISO 13485:2016 requirements.
Senior Management
ISO Coordinators, Quality Managers & Management Representatives
Members of the Quality Team and/or Internal Audit Team
ISO 13485 Auditors, Quality Professionals and Consultants

Learning Objectives

Become familiar with the standard’s requirements (review of each section and its requirements).
Understand the timeline for transition (from ISO 13485:2003) and how it will affect your quality program (documentation, training, registration, etc.).
Appreciate the different factors that should be considered when implementing, or working within, an ISO 13485:2016 Quality Management System.
Identify the general approach to implementing the requirements of ISO 13485:2016.
Learn how to use the Gap Analysis as a tool to create an action plan for implementation.
Build the confidence of QMS team members as you prepare your implementation project.

Click here for a full course outline.

Course Details

Name: Understanding & Implementing ISO 13485:2016

Price: $1050

Duration: 2 day(s)

Sector(s): Medical Devices

Discipline(s): ISO 13485:2016

Type: Understanding & Implementing

Public Course Dates

This course is available as on-site training only. Click on the On-Site Training tab for more details and to request a quote.

⌂On-Site Training

On-site group training is delivered at your place of business and can be customized to meet your specific requirements. Contact The Business Resource Centre to schedule your next on-site group training event.

Please call 1-888-535-1401 or fill out the form below to request a quote.

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Understanding & Implementing ISO 9001:2015 & ISO 14001:2015

January 4, 2016/in Integrated Systems Integrated ISO 9001 / 14001 / 45001 Understanding & Implementing /by The BRC

⚙Overview

2 days of training that deliver a solid understanding of the ISO 9001:2015 and ISO 14001:2015 requirements and practical guidance on tools and approaches to update your Integrated Management System.

Day 1 – Understanding Requirements – Learn the new standards through immersive, hands-on exercises and discussion.

Day 2 – Implementation of Changes – Review approaches and techniques for implementing the key changes (risk-based thinking, documented information, leadership, life-cycle perspective, etc.).

Click Here for Full Course Outline

Course Details

Name: Understanding & Implementing ISO 9001:2015 & ISO 14001:2015

Price: $

Duration: 2 day(s)

Sector(s): Integrated Systems

Discipline(s): Integrated ISO 9001 / 14001 / 45001

Type: Understanding & Implementing

Public Course Dates

This course is available as on-site training only. Click on the On-Site Training tab for more details and to request a quote.

⌂On-Site Training

On-site group training is delivered at your place of business and can be customized to meet your specific requirements. Contact The Business Resource Centre to schedule your next on-site group training event.

Please call 1-888-535-1401 or fill out the form below to request a quote.

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Understanding & Implementing CSA Z1000-14

December 30, 2015/in Health & Safety Management CSA Z1000-14 Understanding & Implementing /by The BRC

⚙Overview

Provides a detailed overview of the requirements of CSA Z1000-14, Canada’s National Standard for occupational health and safety management. Attendees will develop a solid understanding of how to create an effective policy for health and safety in their organization.

Full Course Outline

Course Details

Name: Understanding & Implementing CSA Z1000-14

Price: $995

Duration: 2 day(s)

Sector(s): Health & Safety Management

Discipline(s): CSA Z1000-14

Type: Understanding & Implementing

Public Course Dates

This course is available as on-site training only. Click on the On-Site Training tab for more details and to request a quote.

⌂On-Site Training

On-site group training is delivered at your place of business and can be customized to meet your specific requirements. Contact The Business Resource Centre to schedule your next on-site group training event.

Please call 1-888-535-1401 or fill out the form below to request a quote.

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Medical Device Single Audit Program (MDSAP) Fundamentals

Course Description

Who Should Take It

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Understanding & Implementing Integrated ISO 9001, 14001 & 45001

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Understanding & Implementing ISO 45001:2018

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