November 2015 ISO9001-2015 TOPS & APICS Presentation

34 Pages·2015·1.26 MB·English

by  Tom Shelley

What’s it all About?
www.sustainingedge.com
Delivering Manufacturing and Service Organizations
Solutions for Improved Business Performance
Background and Satisfied Clients
Walter Tighe
President/Owner of Sustaining Edge Solutions, Inc.
Management Consulting & Training Firm

Founded 2002 in Arizona
28 years quality assurance management experience
MBA, CQM, SSBB, RAB/QSA QMS Auditor
Dennis Stambaugh
Senior Management Consultant
30 years organizational effectiveness experience
National Baldrige Examiner and Regional Judge
MHA, FACHE
Donavan Hardenbrook
President/Owner of Leap Innovation, LLC.
30 years’ experience in engineering, manufacturing, quality,
marketing and product development

Tucson [phone]
Phoenix [phone]
Email: [email protected]
Website: www.sustainingedge.com
What We Deliver - Our Services

Business Performance Improvement Systems
ISO 9001: 2015 Management System
AS 9100/10/20 Aviation, Space and Defense Management System

ISO 13485 Medical Devices Management System
ISO 14001 Environmental Management System
ISO 27001 Information Security Management System
ISO/TS 16949 Automotive Management System
National Aerospace and Defense Accreditation – NADCAP
Lean Manufacturing, Kaizen Events and Six Sigma
Value Stream Mapping, 5S and Performance Measurement
Systems & Processes Lead to Success
Training: Onsite, E-Learning and Classroom
Baldrige Performance Excellence Assessments
Market Research
Business Development
Project Management and Social Media
Agenda
• Why the Change?

• ISO 9001:2015 Standard Changes

• Annex SL
• Terms and Definitions
• Context of the Organization
• Documented Information
• Risk-Based Thinking and Requirements
• Auditing Risk
• Leadership
• Business and Quality Importance
ISO 9001 Journey
• International standard for a Quality Management System (QMS)

• Originally published in 1987 – Inspection Based

• Underwent major revision in Year 2000. 2008 revision included
no new requirements - Process Based
• ISO 9001:2015 – Risk Based Approach
• Applies to any organization regardless of size or industry
• Implemented by more than 1.3 million organizations in over 170
countries
ISO 9001:2015 Timeline
ISO TC/176: Technical Committee oversight leading revision

June 2013: Committee Draft (CD)
May 2014: Publication of Draft International Standard (DIS)
July 2015: Expected publication of Final Draft International Standard
(FDIS)
Sept 23, 2015: Publication of Standard as ISO 9001:2015
Sept 2018: All 2008 standard certifications will be under the new
standard. All initial certifications from March 2017 will be under the
new standard.
Why the Change?
• Increased organizational complexity

• Technical advances in business

• Growth of global business and services
• Multiple standards held in many organizations
• Fifteen years since the ISO 9001 standard has changed!
Impact of Change: over 1 million globally certified companies, OEMs, customers,
supply chain, certification bodies, third party auditors, end users, consultants and
regulatory agencies.
ISO 9001:2015 Main Changes
• The adoption of the high level structure

• Risk-based thinking to improve process approach application

• Fewer prescribed requirements
• Less emphasis on documents
• Improved applicability for services
• Requirement to define the QMS boundaries
• Increased leadership requirements
Annex SL - The New ISO 9001Structure
There is now 10 Sections (instead of 8 )
in the Standard. The requirements Clause Description
themselves are set out in Clauses 4 - 10
1 Scope

2 Normative references
3 Terms and Definitions
4 Context of the organization – New Clause
5 Leadership
6 Planning for the quality management system
7 Support
8 Operation
9 Performance evaluation
10 Improvement
High Level Structure – Annex SL
• The new standard adopts the high-level structure and terminology of
Annex SL (used for the development of all new ISO standards)

• High level structure, identical core text and common terms, including
core definitions for use in all Management System Standards
• Enhance the consistency and alignment of different management
system standards
• Organizations that implement a single system addressing multiple
standards (e.g. QMS, EMS, ISMS) will see the most potential benefit

There is no requirement for the structure of an organization's quality

management system documentation to mirror the Standard