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ISO:2015 / IATF:2016 TRANSITION – ARE YOU PREPARED?

ISO:2015 / IATF:2016 Transition

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ISO 9001:2015 or IATF 16949:2016 Customizable Premium Documentation Package & Transition Guidance System

  • Over 77 Files and 300 Pages (5MB) of Updated Highly Effective Documents to the New ISO 9001:2015 and IATF 16949:2016 Standards
  • Includes the updated to new standards and customizable Forms, Formats, Procedures, Processes, Process Maps
  • Includes Initial One Hour WebEx / Phone Guidance with an ISO/IATF Specialist

WebEx and Phone Transition and Implementation Guidance Includes:

  • Quality System Transition Project Tracker
  • Whole Company Employee Quality System Accountability Process
  • Employee Actions to Procedures Synchronicity Process
  • Closed Loop Guidance, Review and Evaluation of Updated Documents
  • Pre-Certification Audit Readiness
  • Available in English, Spanish, Portuguese, Deutsch, Dutch, French, Italian, Traditional Chinese Available in 1st Quarter 2018

Sequential Process for Transformation to ISO:9001: 2015 and to IATF 16949: 2016

Contact GEC-Business Transformation Specialists to begin planning for your company’s transition to ISO 9001:2015, you should start by developing a checklist to prepare for the transition gap assessment audit. GEC-Business Transformation Specialists’ Transformation Tool Box has all the tools, documents, guidance and advice you’ll need to ensure successful transformation and transition to obtain your company’s ISO 9001:2015 certificate.

  • Purchase and Read the New Standard. Use a Cross Reference Table to Understand How the New ISO 9001:2015 Requirements Fit with Your Current ISO 9001:2008 QMS.
  • Download the GEC-Business Transformation Tool Box and contact a GEC-Business Transformation Specialist for guidance, planning, resources, tools and budget.
  • Conduct the Gap Assessment Audit
  • Develop a Transformation and Transition Team, Project Scope and Project Milestone Open Issues Tracker and Hire a GEC-Business Transformation Specialists as Your Transformation Project Lead
  • Ensure the Team Members Have Their Competency Assessed for Assurance Their Skills and Qualifications Match Their Project Tasks and Deliverable Requirements for Gap Closure
  • Develop a Firm Weekly Progress Tracking and Reporting Schedule
  • Develop and Obtain Budget Approval
  • Kick off the Project and Contact Your Registrar to Schedule Your Audit
  • Assess, Train and or Retrain the Company Personnel Utilizing GEC-Business Transformation Specialists’ Hands On Training Workshops
  • Update Your QMS Level 1,2,3,4 Documentation Using the GEC-Business Transformation Tool Box Documentation
  • Perform a Second Gap Analysis Audit and Create an Open Issues Deck for Further Closure
  • Schedule and Perform Certification Audit and Obtain Certification.

ISO:2015 / IATF:2016 Transition Deadline

ISO 9001:2008 and ISO 9001:2015 Comparison

ISO 9001:2008 STRUCTURE

  • QUALITY MANAGEMENT SYSTEM
  • MANAGEMENT RESPONSIBILITY
  • RESOURCE MANAGEMENT
  • PRODUCT REALIZATIONS
  • MEASUREMENT, ANALYSIS, AND IMPROVEMENT

ISO 9001:2015 STRUCTURE

  • CONTEXT OF THE ORGANIZATION
  • LEADERSHIP
  • PLANNING
  • SUPPORT
  • OPERATION
  • PERFORMANCE EVALUATION
  • IMPROVEMENT

ISO 9001:2008 TERMINOLOGY

  • PRODUCTS
  • EXCLUSIONS
  • MANAGEMENT REPRESENTATIVE
  • DOCUMENTATION, QUALITY MANUAL, PROCEDURES, WORK INSTRUCTIONS, RECORDS
  • MONITORING AND MEASURING EQUIPMENT
  • WORK ENVIRONMENT
  • PURCHASED PRODUCT
  • SUPPLIER
  • NONCONFORMING PRODUCT
  • CUSTOMER REQUIREMENTS

ISO 9001:2015 TERMINOLOGY

  • PRODUCTS AND SERVICES
  • APPLICATION
  • TERM NOT USED, BUT SAME RESPONSIBILITIES MUST BE ASSIGNED
  • DOCUMENTED INFORMATION
  • MONITORING AND MEASURING RESOURCES
  • ENVIRONMENT FOR THE OPERATION OF PROCESSES
  • EXTERNALLY PROVIDED PRODUCTS AND SERVICES
  • EXTERNAL PROVIDER
  • NONCONFORMING OUTPUT
  • CUSTOMER NEEDS AND EXPECTATIONS

SOME NOTABLE CHANGES

  • Exclusions are not limited Product Realization (4.3)
  • Quality policy and quality objectives must support the context and strategy of the organization (5.1.1; 5.2)
  • No longer required to assign a single “management representative” to oversee the QMS (5.1.1)
  • Personnel must be aware of implications of not conforming to the QMS requirements (7.3)
  • A documented communication plan must be maintained (7.4)
  • Contingency planning must be determined with the customer (8.2.1)
  • Control of outsourced processes now part of purchasing (8.4)
  • Actions to prevent human error must be implemented (8.5.1)
  • Post-delivery activities are now specified (8.5.5)
  • Release of products and services is detailed (8.6)

REQUIREMENTS THAT HAVE NOT CHANGED

  • Establishing the scope of the QMS (4.3)
  • Determining sequence and interactions of QMS processes (4.4)
  • Determining monitoring, measurements, and resources needed (4.4)
  • Continual improvement of QMS and its processes (4.4)
  • Top management leadership and involvement (5.1.1)
  • Quality policy and objectives (5.1.2; 5.2 ; 6.2)
  • Customer focus, customer satisfaction, and meeting statutory and regulatory requirements (5.1.2)
  • Determining and providing QMS resources including infrastructure and work environment (7.1)
  • Providing resources for monitoring and measuring (7.1.5)
  • Ensuring measurement traceability, if required (7.1.5)

About Business Transformation Specialists

Business Transformation Specialists has been providing business assessment, transformation (improvement) and sustenance services for over 30 years.

Our team of global Transformation Specialists and our extensive global network of alliance associates possess both targeted, as well as deep and wide experiences across the following industry sectors;

Aerospace, Accounting, Agriculture, Apparel, Automotive, Banking, Chemicals, Computers, Construction, Consumer Products, Consumer Services, Distribution, Electronics, Energy, Environmental, Equipment, Facilities Management, Financial Services, Food, Fulfillment, Furniture, Government, Health Care, Higher Education, Information Technology, Marine, Marketing, Medical Devices/Supplies, Metals, Military-Defense, Mining, Nuclear, Oil/Gas, Packaging, Personal Care, Pharmaceuticals, Powersports, Plastics, Retail, Safety, Software, Solar, Telecommunications, Tools & Hardware, Testing, Transportation and Waste Management, Wind and Renewable Energy.

Our dedicated team of global professionals retain a wide variety of skills, qualifications, education and especially applied experience from the following organizational levels; C-level through Director level, on through Staff level and onto the Supervisory and Skilled Trades levels.

Our Transformation Specialists are highly qualified, commanding the following core competencies; Information Technology, Software, Data Analytics, Data Security, Operational Systems, Quality Systems, Human Resources, Training Systems, Finance, Accounting, Tax, Call Center, Customer Service, Engineering, Equipment, Process Management, Program Management, Design, Lean Manufacturing & Continuous Improvement, Simple, Technical and Warranty Problem Solving, Manufacturing, Maintenance, Safety, Procurement, Production Control, Inventory and Logistics, Marketing, Sales, Intellectual Property, Legal, Regulation.

We have a global presence in Europe, North America, South America, Asia, India and Africa. Our services are delivered in diverse cultures and native languages making our transformation services measurably effective around the globe.

Our Efficient 3 Step Process

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