ISO 9001:2015 Presentation
QMED Corp
ISO 9001:2008
Certified
ASQ Monthly Dinner Meeting
Sections 1510, 1515
January 12, 2016
Topic: ISO 9001:2015
Revision Review
Jay Stahan
January 12, 2016
ISO 9001:2015 Presentation
AGENDA
QMED Corp
ISO 9001:2008
Certified
• 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
ISO 9001:2015 Presentation
QMED Corp
ISO 9001:2008
Certified
Source Materials:
• READ Lots of Articles
• ATTENDED Many Webinars
Jay Stahan
January 12, 2016
ISO 9001:2015 Presentation
ISO 9001 Through the Years
QMED Corp
ISO 9001:2008
Certified
• Foundation Mil Std 9858, BS5750
• 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
ISO 9001:2015 Presentation
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
ISO 9001:2015 Presentation
Standard Clauses
ISO 9001:2008
• 0. Introduction
• 1. Scope
• 2. Normative Reference
• 3. Terms and Definitions
• 4. Quality Management Systems
• 5. Management Responsibility
• 6. Resource Management
• 7. Product Realization
• 8. Measurement, Analysis &
Improvement
QMED Corp
ISO 9001:2008
Certified
ISO 9001:2015
• 0. Introduction
• 1. Scope
• 2. Normative Reference
• 3. Terms and Definitions
• 4. Context of the Organization
• 5. Leadership
• 6. Planning for the Q M S
• 7. Support
• 8. Operation
• 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
January 12, 2016
Some Rearranging, however, some NEW requirements
ISO 9001:2015 Presentation
Terminology Changes
ISO 9001:2008
QMED Corp
ISO 9001:2008
Certified
Jay Stahan
January 12, 2016
ISO 9001:2015
Products
Products and Services
Exclusions
Not Used (refer Clause A.5)
Management Rep
Not Used
Documentation, Quality Manual,
Procedures, Records
Documented Information (QManual, Specific Procedures not
identified)
Work Environment
Environment for the operation of
processes
Monitoring and Measuring
Equipment
Monitoring and measuring
resources
Purchased Product
Externally provided products and
services
Supplier
External Provider
(Not Used)
Interested Party
Preventive Action
Not Used
ISO 9001:2015 Presentation
QMED Corp
ISO 9001:2008
Certified
Jay Stahan
January 12, 2016
4. Context of the Organization – High Level – Strategic
• New Section with New Requirements
• 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…
ISO 9001:2015 Presentation
4. Context of the Organization – Interested Parties
“Interested Party” Examples of
(not in standard)
QMED Corp
ISO 9001:2008
Certified
“Needs and Expectations”
Examples of (not in standard)
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
Agency, ISO Registrar)
Continuous Operations; Sustainable
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
ISO 9001:2015 Presentation
QMED Corp
ISO 9001:2008
Certified
Jay Stahan
January 12, 2016
5. Leadership and Commitment
• Greater accountability for Top Mgt. re: Q M S…
• Top Management shall demonstrate Leadership:
• 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
ISO 9001:2015 Presentation
QMED Corp
ISO 9001:2008
Certified
5. Leadership and Commitment
• Top Management shall demonstrate Leadership…
• Ensuring Q-Policy and Q-Objectives are compatible
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
ISO 9001:2015 Presentation
6. Planning the Q M S
• Quality Objectives: shall establish quality objectives
at relevant functions, levels, processes; be
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:
QMED Corp
ISO 9001:2008
Certified
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
ISO 9001:2015 Presentation
QMED Corp
ISO 9001:2008
Certified
7. Support
• Resources, People (Competence, Training),
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”
Jay Stahan
January 12, 2016
• No requirement for a Quality Manual nor any specific
Quality Procedures are identified
ISO 9001:2015 Presentation
QMED Corp
ISO 9001:2008
Certified
Jay Stahan
January 12, 2016
8. Operation
• (The current Product Realization section)
• Products and “Services”
• “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
ISO 9001:2015 Presentation
QMED Corp
ISO 9001:2008
Certified
Jay Stahan
January 12, 2016
9. Performance Evaluation
• Performance Evaluation:
• “The Organization shall determine what
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!!
ISO 9001:2015 Presentation
QMED Corp
ISO 9001:2008
Certified
10. Improvement
- Determine and Select Opportunities for Improvement…
- “Examples of Improvement can include Correction,
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
ISO 9001:2015 Presentation
Term: “Documented Information”
“Retaining” Doc. Info. = Records
QMED Corp
ISO 9001:2008
Certified
“Maintain” Doc. Info. applies to…
Quality Objectives
Quality Policy
Fitness for purpose of monitoring and measuring resources
Quality Objectives
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
ISO 9001:2015 Presentation
QMED Corp
ISO 9001:2008
Certified
• Risk Based Thinking
• 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
ISO 9001:2015 Presentation
QMED Corp
ISO 9001:2008
Certified
• Risk Based Thinking
• 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
ISO 9001:2015 Presentation
QMED Corp
ISO 9001:2008
Certified
Risk Based Thinking
• Remember from the Planning Section…
• Quality Objectives: shall establish quality objectives
at relevant functions, levels, processes
• Develop Actions to address Risks
• “Retain” documented information (Records)
• Plan Do Check Act (PDCA)
• “Waterfall Effect” / Cascading Objectives
Stated
Objectives
Jay Stahan
January 12, 2016
Company Objectives
Department Objectives
Individual Objectives
Assess
Risk
ISO 9001:2015 Presentation
‘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
Certified
Service - Improve service metrics year over year
Inventory Accuracy > 99%
Financial - Lower labor cost year over year
CSI Distribution Events < 20% of total
Overtime Dollars
< .15% of sales
< 10% of total payroll
Productivity - Increase the facility productivity rate
Direct Labor
< 1.30% of sales
Increase Productivity Index by 5% over 2015
Implement and sustain 5S+1 Program
Associate Development - Develop bench strength
and increase facility readiness and awareness
Individual Development - Focus on developing
shared leadership skills and participate in the
business outside of the day to day operations
SOP/Observation Based Certification for all
associates
Participate in Competency development
Complete and on-line learning
-share with the distribution leadership team
Vendor/Customer relations
-visit a vendor or particpate in a customer audit
ISO 9001:2015 Presentation
Risk Based Thinking: Tools…
Failure Mode and Effects Analysis (FMEA)
QMED Corp
ISO 9001:2008
Certified
ISO 9001:2015 Presentation
Risk Based Thinking: Tools…
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
ISO 9001:2015 Presentation
Risk Based Approach: Tools…
Risk Register Ranking Matrix
Probability
QMED Corp
ISO 9001:2008
Certified
Jay Stahan
January 12, 2016
Seriousness
ISO 9001:2015 Presentation
Risk Based Thinking: Tools…
QMED Corp
ISO 9001:2008
Certified
Jay Stahan
January 12, 2016
ISO 9001:2015 Presentation
If you have 3rd-party QMS software, check for updates…
Risk Modules
QMED Corp
ISO 9001:2008
Certified
Jay Stahan
January 12, 2016
ISO 9001:2015 Presentation
Use Flowcharts for Risk Assessment
QMED Corp
ISO 9001:2008
Certified
QMed
Corp
Hi-level
Process
Flow
Chart
Assess
Risks
Jay Stahan
January 12, 2016
ISO 9001:2015 Presentation
QMED Corp
ISO 9001:2008
Certified
Baldrige
Criteria
Enterprise
Risk Mgt.
QMS
Risk Mgt.
Jay Stahan
January 12, 2016
ISO 9001:2015 Presentation
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 9001:2015 Presentation
Other Sector ISO QMS Standards…
ISO 13485:2003 – Medical Device Manufacturing
• Follows format of ISO 9001:2008 with
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)
QMED Corp
ISO 9001:2008
Certified
Jay Stahan
January 12, 2016
ISO 9001:2015 Presentation
Other Sector ISO QMS Standards…
QMED Corp
ISO 9001:2008
Certified
ISO AS9100:2009 – Aerospace
• 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
ISO 9001:2015 Presentation
Other Sector ISO QMS Standards…
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
ISO 9001:2015 Presentation
Other Sector ISO QMS Standards…
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
ISO 9001:2015 Presentation
SUMMARY of changes 9001:2008 > 9001:2015…
QMED Corp
ISO 9001:2008
Certified
• Top Management Involvement
• Context of the Organization
• Risk Based Thinking
• Optional Changes to current documentation:
• Retain Q-Manual?
• Retain Management Representative?
• Revise Vocabulary?
Jay Stahan
January 12, 2016
ISO 9001:2015 Presentation
SUMMARY of changes 9001:2008 > 9001:2015…
QMED Corp
ISO 9001:2008
Certified
Jay Stahan
January 12, 2016
• My Registrar’s Summary:
• 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
ISO 9001:2015 Presentation
FINAL THOUGHTS on Conversion Plan:
From my Registrar:
QMED Corp
ISO 9001:2008
Certified
Jay Stahan
January 12, 2016
•
•
•
•
Involve your Registrar
Gap Analysis
Update existing Q M S
Develop Implementation Plan &
Timetable
• 3 years for Recertification (by Sept.
2018)
ISO 9001:2015 Presentation
QMED Corp
ISO 9001:2008
Certified
Jay Stahan
January 12, 2016
FOR ADDITONAL INFORMATION,
CHECK OUT ASQ NATIONAL’S WEBSITE