ASQ Presentation January 2016

ISO 9001:2015 Presentation
QMED Corp
ISO 9001:2008
ASQ Monthly Dinner Meeting

Certified
Sections 1510, 1515

January 12, 2016
Topic: ISO 9001:2015
Revision Review
Jay Stahan
January 12, 2016
QMED Corp
ISO 9001:2008
Certified
AGENDA
• Quick Summary Review of ISO 9001 through the years
• Compare change from 2008 Revision to 2015 Revision
• Some Examples of how changes can be implemented
• Quick Review of Impact to Sector ISO QMS Standards
Jay Stahan
January 12, 2016
QMED Corp
ISO 9001:2008
Certified
Source Materials:
• READ Lots of Articles
• ATTENDED Many Webinars
Jay Stahan
January 12, 2016
ISO 9001 Through the Years

QMED Corp
ISO 9001:2008
• Foundation Mil Std 9858, BS5750
Certified
• 1987 (20 Elements; 3 Models (Design/Mfgr; Mfgr; Final Test/Insp))

• 1994 (20 Elements; Some Clarifications; ease-up Docs)
• 2000 (1 Model; Process Approach; 20 Elements Gone)
• 2008 (Minor Clarifications)
• 2015 (New focus areas eg., Risk Based Thinking and
Context of the Organization, but many facets of 2008 still
apply; 2015 “less prescriptive standard” overall)
• Compare/Contrast Evolution to Baldrige Award Criteria
Jay Stahan
January 12, 2016
What does ISO Leadership say about the 2015 Revision

QMED Corp
ISO 9001:2008
Certified
https://youtu.be/UrVIVoDq7Sg
VIDEO
Jay Stahan
January 12, 2016
Standard Clauses
ISO 9001:2008 ISO 9001:2015
QMED Corp
• 0. Introduction • 0. Introduction
• 1. Scope • 1. Scope
ISO 9001:2008
Certified
• 2. Normative Reference • 2. Normative Reference

• 3. Terms and Definitions • 3. Terms and Definitions
• 4. Quality Management Systems • 4. Context of the Organization
• 5. Management Responsibility • 5. Leadership
• 6. Resource Management • 6. Planning for the Q M S
• 7. Product Realization • 7. Support
• 8. Measurement, Analysis & • 8. Operation
Improvement • 9. Performance Evaluation
• 10. Improvement
ISO 9001:2015 format design per ISO Joint Technical Coordination Group’s
Requirements, as per ISO Guide 83. ISO 9001 and 14001 now revised.
Jay Stahan Some Rearranging, however, some NEW requirements

January 12, 2016
Terminology Changes
ISO 9001:2008 ISO 9001:2015
Products Products and Services
QMED Corp
ISO 9001:2008
Certified Exclusions Not Used (refer Clause A.5)
Management Rep Not Used
Documentation, Quality Manual, Documented Information (Q-
Procedures, Records Manual, Specific Procedures not
identified)
Work Environment Environment for the operation of
processes
Monitoring and Measuring Monitoring and measuring
Equipment resources
Purchased Product Externally provided products and
services
Supplier External Provider
(Not Used) Interested Party
Jay Stahan
January 12, 2016
Preventive Action Not Used
4. Context of the Organization – High Level – Strategic

• New Section with New Requirements
QMED Corp
ISO 9001:2008
Certified
• Organizations must determine external and internal
issues impacting its purpose and strategic direction
• Consider external context issues: legal, technological,
competitive, market, cultural, social, and economic
environments
• Consider internal context issues: values, culture,
knowledge, and performance of the organization
• Organization shall determine a) interested parties (aka
Stakeholders ?), and b) needs/expectations of the
interested parties (“Customer Req’mts” Not used)
• Must “demonstrate with evidence” all the above…
Jay Stahan
January 12, 2016
4. Context of the Organization – Interested Parties
“Interested Party” Examples of “Needs and Expectations”

QMED Corp
ISO 9001:2008
(not in standard) Examples of (not in standard)
Certified
Customers (and their Customers) Product/Service Quality; Price; On-Time

Delivery
Owners/Share Holders Sustained Profitability; ROI
Employees Safe and pleasant work environment;

Job security; Competitive compensation
External Provider ( Vendor, Personnel Continuous Operations; Sustainable
Agency, ISO Registrar) markets and business
Competitors Be more competitive/innovative; Ethical
behavior (impacts all in the industry)
Society; Regulators Ethical behavior; Compliance with
regulations
Credit to QSG 2015
Jay Stahan
January 12, 2016
5. Leadership and Commitment

QMED Corp
• Greater accountability for Top Mgt. re: Q M S…
• Top Management shall demonstrate Leadership:
ISO 9001:2008
Certified
• Ensure integration of QMS requirements into

the organization’s business processes
• Promoting awareness of the Process
Approach
• Assuring the QMS achieves its intended
results (PDCA)
• Supporting other management roles to
demonstrate Leadership
Jay Stahan
January 12, 2016
5. Leadership and Commitment

• Top Management shall demonstrate Leadership…
QMED Corp
ISO 9001:2008
• Ensuring Q-Policy and Q-Objectives are compatible
Certified
with Strategic Direction and the Context of the
Organization
• Promote Process Approach and Risk Based Thinking
• Promoting Continual Improvement
• No more Management Rep
• From my Registrar:
“The requirement for increased Leadership
oversight for an organization’s Q M S could be the
biggest challenge.”
• How to assess Risks … more later…
Jay Stahan
January 12, 2016
6. Planning the Q M S
• Quality Objectives: shall establish quality objectives
QMED Corp
at relevant functions, levels, processes; be
ISO 9001:2008
Certified
monitored; maintain documented information
• Actions to address risks and opportunities
• Integrate/implement Actions into Q M S
• Evaluate the effectiveness of these Actions (PDCA)
• Risk Based Thinking, Risk Assessment:
Notation (from the standard): Options to address risks and
opportunities can include: avoiding risk, taking risk in order to pursue an
opportunity, eliminating the risk source, changing the likelihood or
consequences, sharing the risk, or retaining risk by informed decision.
• “Preventive Actions” has been removed
Jay Stahan
January 12, 2016
7. Support
• Resources, People (Competence, Training),
QMED Corp
ISO 9001:2008
Certified
Infrastructure, Monitoring and Measuring activities
basically unchanged
• Communication/Awareness now in this section (from
Management Responsibility Section)
• Documentation: now “Documented Information”
• Documented Information:
“The Organization shall maintain documented information to the
extent necessary to support the operation of processes and retain
documentation to the extent necessary to have confidence that the
processes are being carried out as planned”
• No requirement for a Quality Manual nor any specific

Jay Stahan
January 12, 2016
Quality Procedures are identified
8. Operation
QMED Corp
ISO 9001:2008
• (The current Product Realization section)
• Products and “Services”
Certified
• “Design” process remains, but sections on

“Verification and Validation” removed
• Section has few Impactful changes: same
overall flow remains: Customer Requirements
> Design > Externally Provided Products and
Services (Purchasing) > Production/Service
Controls > ID Traceability > Preservation >
Non-Conformances ID’d and Controlled
Jay Stahan
January 12, 2016
9. Performance Evaluation
QMED Corp
• Performance Evaluation:
• “The Organization shall determine what
ISO 9001:2008
Certified
needs to be monitored/measured”
Includes…
• Customer Satisfaction Information
• Process Performance
• External Provider Performance
• Internal Audits
• Management Review, including
checking the QMS for alignment with
the strategic direction of the
organization – this is NEW!!
Jay Stahan
January 12, 2016
10. Improvement
- Determine and Select Opportunities for Improvement…
- “Examples of Improvement can include Correction,
QMED Corp
ISO 9001:2008
Certified
Corrective Action, Continual Improvement, Breakthrough
Change, Innovation, and Re-organization.”
- “Corrective Action” is in this section
- “Retain Documented Information” as evidence results of
Corrective Action
NOTE**: Improvement can be effected

• Reactively (e.g. corrective action),
• Incrementally (e.g. continual improvement)
• Step-by-step (e.g. breakthrough)
• Creatively (e.g. innovation)
• Re-organization (e.g. transformation)
Jay Stahan
January 12, 2016
** - “bullets” for emphasis
Term: “Documented Information”
“Retaining” Doc. Info. = Records “Maintain” Doc. Info. applies to…
Quality Objectives Quality Policy

QMED Corp
ISO 9001:2008
Fitness for purpose of monitoring and measuring resources Quality Objectives
Certified
Evidence of Competence Scope of the Q M S
Conformity of Products/Services
Review of Customer Requirements
Design and Development Process
Design and Development Changes
Evaluation/Performance of External Providers
Product/Service ID and Traceability

Pre and Post Delivery Change Authorizations
Conformity with Acceptance Criteria
Authorized Release of Products/Services
Non-conformances and C/A
Internal Audits
Jay Stahan
January 12, 2016
Management Reviews
• Risk Based Thinking

QMED Corp
ISO 9001:2008
Certified
• No “Preventive Action sub-clause”. P/A is expressed
through a Risk-Based Approach to formulating Q M S
requirements
• Risk-based approach has facilitated some reduction in
prescriptive requirements and their replacement by
performance-based requirements
• There is no requirement for formal Risk Management
or a documented Risk Management Process
• Actions taken to address Risks and Opportunities
shall be proportionate to the potential impact on the
conformity of products and services
Jay Stahan
January 12, 2016

QMED Corp
ISO 9001:2008
Certified
• From my Registrar:
• Misconception: Risk assessment replaces
Preventive Action
• Truth: Risk Assessment is the initiating process
and preventive action is the result
• Root Cause of Preventive Action is Risk
Assessment
• ISO 31000 (Risk Management Principles and
Guidelines) a useful reference
• So now what ????
Jay Stahan
January 12, 2016
Risk Based Thinking

QMED Corp
ISO 9001:2008
• Remember from the Planning Section…
• Quality Objectives: shall establish quality objectives
Certified
at relevant functions, levels, processes

• Develop Actions to address Risks
• “Retain” documented information (Records)
• Plan Do Check Act (PDCA)
• “Waterfall Effect” / Cascading Objectives
Stated Assess
Objectives Risk
Company Objectives
Department Objectives
Individual Objectives
Jay Stahan
January 12, 2016
‘WaterFall”: Example of Goals/Obj. Functional Level
2016 Distribution Leadership Objectives and Goals
Objective Goals /Direct Result
Order Accuracy / VOC > 92%
QMED Corp
ISO 9001:2008
Service - Improve service metrics year over year
Certified Inventory Accuracy > 99%
CSI Distribution Events < 20% of total

Overtime Dollars
< .15% of sales
Financial - Lower labor cost year over year < 10% of total payroll
Direct Labor
< 1.30% of sales
Productivity - Increase the facility productivity rate Increase Productivity Index by 5% over 2015
Implement and sustain 5S+1 Program

Associate Development - Develop bench strength
and increase facility readiness and awareness SOP/Observation Based Certification for all
associates
Participate in Competency development
Individual Development - Focus on developing Complete and on-line learning

shared leadership skills and participate in the -share with the distribution leadership team
business outside of the day to day operations
Vendor/Customer relations
-visit a vendor or particpate in a customer audit
Risk Based Thinking: Tools…
Failure Mode and Effects Analysis (FMEA)
QMED Corp
ISO 9001:2008
Certified
RISK MATRIX
QMED Corp
ISO 9001:2008
Certified
S
E
R
I
O
U
S
N
E
S
S
Jay Stahan
January 12, 2016 PROBABILITY
Risk Based Approach: Tools…
Risk Register Ranking Matrix
Probability
QMED Corp
ISO 9001:2008 Seriousness
Certified
Jay Stahan
January 12, 2016
QMED Corp
ISO 9001:2008
Certified
Jay Stahan
January 12, 2016
If you have 3rd-party QMS software, check for updates…
Risk Modules
QMED Corp
ISO 9001:2008
Certified
Jay Stahan
January 12, 2016
Use Flowcharts for Risk Assessment
QMED Corp
ISO 9001:2008
QMed
Certified
Corp
Hi-level
Process
Flow
Chart
Assess
Risks
Jay Stahan
January 12, 2016
QMED Corp
ISO 9001:2008
Baldrige
Certified
Criteria
Enterprise
Risk Mgt.
QMS
Risk Mgt.
Jay Stahan
January 12, 2016
Other Sector ISO QMS Standards…
QMED Corp
ISO 9001:2008
Certified
ISO/TS 16949:2009 – Automotive (US, German, French,
Italian)
• Follows Section format of ISO 9001:2008 with
additions Supplemental Engineering Specs, APQP,
PPAP, MSA, Error Proofing, FMEA.
• No timeline for Revision – under study by the IATF
(Int’l Automotive Task Force)
Jay Stahan
January 12, 2016
ISO 13485:2003 – Medical Device Manufacturing
• Follows format of ISO 9001:2008 with
QMED Corp
ISO 9001:2008
Certified
Additions – Cleanliness/contamination, Batch Records,
Production Validations, Installations, Servicing,
Sterility, Implantables, less emphasis upon Continual
Improvement and Customer Satisfaction compared to
Regulatory Compliance
• Revision 2014 not approved; postponed
• Revision 2016 (3rdedition Final Draft Vote (10/15 – 12/15)).
• ISO 13485:2016 – future European regulations and
21CFR820 come into force (implications for software
controls enhanced, documentation requirements;
validations for pre-clinical and clinical evaluations;
validation of packaging and distribution requirements;
Customer communications and complaint handling)
Jay Stahan
January 12, 2016
QMED Corp
ISO 9001:2008
ISO AS9100:2009 – Aerospace

Certified
• Follows format of ISO 9001:2008 with Additions –

• Revision due 2016 2nd quarter
• Will follow ISO 9001:2015 format
• Will consider emerging International requirements,
Product Safety, Counterfeit Parts, and Configuration
Management
Jay Stahan
January 12, 2016
QMED Corp
ISO 9001:2008
Certified ISO TL9000:2008 – Telecommunications
• Includes Release 5.5 Handbook
• Complaint Tracking and reporting via U of Texas
(Dallas)
• Published for benchmarking
• No timetable for updating to ISO:2015 format
Jay Stahan
January 12, 2016
QMED Corp
ISO 9001:2008
Certified ISO 14001:2015 – Environmental Standards
• Now released/published
• Follows format of ISO 9001:2015
Jay Stahan
January 12, 2016
SUMMARY of changes 9001:2008 > 9001:2015…
QMED Corp
ISO 9001:2008
Certified
• Top Management Involvement
• Context of the Organization
• Optional Changes to current documentation:
• Retain Q-Manual?
• Retain Management Representative?
Jay Stahan
• Revise Vocabulary?
January 12, 2016
SUMMARY of changes 9001:2008 > 9001:2015…
• My Registrar’s Summary:
QMED Corp
ISO 9001:2008
Certified
• No need to change numbering of your
documents – create a cross-reference
table
• Must incorporate Risk Analysis
• Determine Controls for External providers
• Reduced documentation requirements
• Increased focus on Leadership being
actively involved
Jay Stahan
January 12, 2016
FINAL THOUGHTS on Conversion Plan:

From my Registrar:
QMED Corp
ISO 9001:2008
•
Certified
Involve your Registrar

• Gap Analysis
• Update existing Q M S
• Develop Implementation Plan &
Timetable
• 3 years for Recertification (by Sept.
2018)
Jay Stahan
January 12, 2016
QMED Corp
ISO 9001:2008
Certified FOR ADDITONAL INFORMATION,
CHECK OUT ASQ NATIONAL’S WEBSITE
Jay Stahan
January 12, 2016

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ISO 9001:2015 Presentation

ASQ Monthly Dinner Meeting

Sections 1510, 1515

• Quick Summary Review of ISO 9001 through the years

• Compare change from 2008 Revision to 2015 Revision

• Some Examples of how changes can be implemented

• Quick Review of Impact to Sector ISO QMS Standards

ISO 9001 Through the Years

• 1987 (20 Elements; 3 Models (Design/Mfgr; Mfgr; Final Test/Insp))

What does ISO Leadership say about the 2015 Revision

• 2. Normative Reference • 2. Normative Reference

Jay Stahan Some Rearranging, however, some NEW requirements

4. Context of the Organization – High Level – Strategic

4. Context of the Organization – Interested Parties

“Interested Party” Examples of “Needs and Expectations”

Customers (and their Customers) Product/Service Quality; Price; On-Time

Employees Safe and pleasant work environment;

5. Leadership and Commitment

• Ensure integration of QMS requirements into

5. Leadership and Commitment

• “Preventive Actions” has been removed

• No requirement for a Quality Manual nor any specific

• “Design” process remains, but sections on

NOTE**: Improvement can be effected

Quality Objectives Quality Policy

Review of Customer Requirements

Design and Development Process

Design and Development Changes

Evaluation/Performance of External Providers

Product/Service ID and Traceability

• Risk Based Thinking

• Risk Based Thinking

Risk Based Thinking

at relevant functions, levels, processes

CSI Distribution Events < 20% of total

Implement and sustain 5S+1 Program

Individual Development - Focus on developing Complete and on-line learning

Risk Based Thinking: Tools…

Use Flowcharts for Risk Assessment

Other Sector ISO QMS Standards…

Other Sector ISO QMS Standards…

ISO AS9100:2009 – Aerospace

• Follows format of ISO 9001:2008 with Additions –

Other Sector ISO QMS Standards…

Other Sector ISO QMS Standards…

SUMMARY of changes 9001:2008 > 9001:2015…

FINAL THOUGHTS on Conversion Plan:

Involve your Registrar

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