Changes and Challenges 4/14/2016 1

Changes and Challenges 4/14/2016 1

Discussion Why ISO 9001 was revised? What changed? Impact to organizations. Advance preparations. Registration. 4/14/2016 2

Key Objectives of Revisions A stable core set of requirements for next 10 years plus. Enhance an organization s ability to satisfy customers. Generic, relevant, useful for increasing user diversity. Take into account increasingly complex organizational environments. Reflect changes in quality systems, practices & technology. Facilitate integration with other management system standards- 10 sections. Maintain current focus on effective process management to produce desired outcomes/results. Incorporate risk-based thinking into management system. Use simplified language and writing styles to aid understanding and consistent interpretations of requirements. 4/14/2016 3

ISO 9001 History Major Change Minor Change Inspection Based ISO 9001:1987 ISO 9001:1994 Process Based ISO 9001:2000 ISO 9001:2008 Risk Based ISO 9001:2015? 4/14/2016 4

Status of ISO 9001:2015 Revision Standard approved September 2015. Three year transition period started Sept 2015 and concludes Sept 15, 2018. Recertification began earlier this year with most re-certifications occurring in 2017 and 2018. 4/14/2016 5

Status of Other Standards AS 9100(c):2009 - managed and revised by SAE Aerospace; expect release of revision sometime first half of 2016. ISO/TS 16949:2009 - maintained by IATF (International Automotive Task Force) and a revised ISO/TS 16949 expected to be released 2 nd or 3 rd quarter 2016. Three year implementation process begins at release date concluding Sept 2018. ISO 13485:2003 - different technical ISO committee manages this standard and it is expected to be released using ISO 9001:2008 (NOT 2015) as basis for the addition of medical device initiatives; possible release 2016 2 nd or 3 rd quarter. ISO 14001:2004 - rewritten with 10 sections and released with registration to the 2015 version by Sept 15, 2018. 4/14/2016 6

Building Blocks of ISO 9001:2015 Maintain process approach understand organization as a set of inter-related processes acting as a system. Concept implemented with 2000 revision. Manage each individual process and system as a whole PDCA. Amount of rigor, attention, discipline is governed by riskbased thinking. How each process impacts desired outcomes. 4/14/2016 7

Changes to ISO 9001 Section 4 -- Context of Organization. Risk - risk planning and effectiveness evaluation. Documentation requirements - reduction in documentation. Emphasis - Plan Do Check - Act Cycle. New language or concepts: Strategic Direction (4.1) 4/14/2016 8

Changes Between 2008 and 2015 Documentation is now flexible ISO 9001:2008 called for 6 documented procedures. New revision uses the words documented information covering both written instructions and records, maintaining documented information and retaining documented information. Number of sections do not require documented information to be in place. No requirement for a quality manual. The word risk and other key words defined in ISO 9000:2015 - a definitions standards. ISO 9001:2008 has 5 auditable sections 2015 standard has 7 auditable sections with a total of 10 sections Purchasing and outsourcing now called external provision. 4/14/2016 9

More Changes Definitions in ISO 9000: 2015 provided to define wording used with additional notes to assist in understanding the definitions as well what standard writers want organizations to focus on. Increased compatibility to ISO 14001 for smoother integration. Emphasis: - organizational context responsiveness to business environment, needs and expectations of interested parties. New concept Section 4 - risk-based thinking includes prevention New concept Section 6 - process management approach to gain more value out of QMS (output matters) - leadership engagement no management rep Top Management required to fill responsibility formerly assigned to management representative! 4/14/2016 10

2008 Content - 2015 Content ISO 9001:2008 ISO 9001:2015 1. Scope 2. Normative References 3. Terms and Definitions 4. Quality Management System 5. Management Responsibility 6. Resource Management 7. Product Realization 8. Measurement Analysis & Improvement 1. Scope 2. Normative References 3. Terms and Definitions 4. Context of Organization 5. Leadership 6. Planning 7. Support 8. Operation 9. Performance Evaluation 10. Improvement Annex A Clarification of Requirements Annex B Quality Management Principles Annex C Portfolio of Other Standards 4/14/2016 11

Remains of ISO 9001:2008 Most existing documentation from an ISO 9001:2008 QMS will address a good portion of 2015 changes. Example Recommendation: do not remove any documentation that is effectively implemented. Some language has been adjusted. Organization of sub sections has been moved around. (Next several pages list most of the sub sections from 2008 to the 2015 organization of the requirements.) 4/14/2016 12

Questions? 4/14/2016 13

New for 2015 - Three Types of Documented Information 1. Maintain documented information - must be under document control as defined in Section 7.5.1 2. Retain documented information records must be maintained as defined in Section 7.5.1 3. Documented information - organization must decide how many procedures and work instructions are needed along with appropriate records. 4/14/2016 14

Exploring ISO 9001:2015 4 Context of Organization 4.1 Context of the organization - new concept (Defining your Business Environment) 4.2 Understanding needs and expectations of interested parties new concept 4.3 Scope (4.2.2) (from ISO 9001:2008) 4.4 Process Approach (4.1) Sequence and Interactions (4.2.2) 4/14/2016 15

Exploring Context of Organization Clauses 4.1 and 4.2 could be verbal with no documentation. Only the Scope, 4.3 must be maintained along with the process definition and appropriate retained documented information. Inside of 4.1 is Strategic Direction of the organization together with internal and external issues. This could be a verbal statement - father/daughter top management of a small company. Scope of Organization is 4.3 and requires maintained documented information Clause 4.4 requires your QMS processes to be maintained as documented information and your operational processes to have retained documented information. 4/14/2016 16

Example of Context of Organization 4.1 Strategic Direction: increase business 20% over next 3 years - diversify business by reducing automotive dependence by 50% 4.2 Internal, External Issues and Interested Parties: - increase sales force, develop marketing for various industries (internal) - market conditions, regulatory issues (external) - customers, regulatory bodies (interested parties) 4/14/2016 17

More Examples 4.3 Scope: XYZ Industries is located at 1500 Slag Street in Fayette, MI. XYZ manufactures precision metal gearing and sub-assemblies for automotive and general industry. 4.4 Quality System and Its Processes: See next slide for process map 4/14/2016 18

Example Business Map System Processes: Document Control Records Control Competent Personnel C U S T O M E R Management Review Approved Suppliers Order Material Sales Order Rec d & Entered Scrap Receive & Inspect Material Check Inventory Metrics Objectives Nonconforming Material Generate Work Order Manuf. Eng. Pass? Internal Audit Preventive Action Build Order Corrective Action Design Eng. Product Objectives Test or Inspect Ship or Stock Facilities C U S T O M E R r ISO IAC 7 19

4.4 Table of Contents to QMS QAP - 1 Management QAP - 2 Document Control QAP 3 Records QAP 4 Internal Audits QAP 5 Nonconforming Material QAP 6 Corrective Action QAP 7 XXX QAP 8 XXX QAP -9 XXX 4/14/2016 20

5 Leadership - Table of Contents Management Commitment (5.1) Customer Focus (5.1.2) Quality Policy (5.2) Organization Roles, Responsibilities & Authority (5.3) 4/14/2016 21

5.3 Organization Roles A) QMS and meets requirements B) Process delivery and intended results C) Reporting performance D) Ensuring customer focus E) Maintain integrity to QMS when changing 4/14/2016 22

6 Planning and Support 6 Planning for Quality Management System 6.1 Risk and Opportunities NEW No 2008 reference 6.2 Quality Objectives & Planning for Achievement (5.4.1) 6.3 Planning for Change NEW No 2008 reference 4/14/2016 23

What is Risk Planning? Where in your existing QMS is risk to your product or business addressed? Planning for business expansion Quotation or contract review (no bid situations) Engineering or Design of Product Design or Process FMEA Error Proofing Manufacturing reviews, purchasing, on time delivery, internal scrap reduction, customer complaints and returns Customer contact and customer satisfaction surveys and reviews 4/14/2016 24

Risk Evaluation Line item in management review (9.3.2e) How effective is your risk and opportunities plan? 4/14/2016 25

Typical Quality Objectives On time delivery of product or service (OTD) Scrap Rework Inventory turns Employee attendance Quotation Capture rate Mortally rate Conception rate Waiting time at the drive up window 4/14/2016 26

Quality Objectives (6.2) 6.2.1 Shall establish Quality Objectives 6.2.2 Planning to Achieve Quality Objectives Who? What? What resources? When? How are results evaluated? Maintain documented information. 4/14/2016 27

7 Support 7.1.3 Infrastructure (6.3) 7.1.4 Environment for Operation of Processes (6.4) 7.1.5 Monitoring and Measuring (7.6) 7.1.6 Organization Knowledge (6.2) 7.2 Competence (6.2) 7.3 Awareness (6.2.2) 7.4 Communication NEW No 2008 reference 7.5 Documented Information (4.2.3 & 4.2.4) 4/14/2016 28

8 Operations 8.1 Operational Planning and Control (7.1) 8.2 Requirements for Products & Services (7.2) 8.3 Design and Development (7.3) 8.4 Control of Externally Provided Products/Services (7.4) 8.5 Production and Service Provisions ( 7.5.1, 7.5.3, 7.5.4, 7.5.5) 8.6 Release of Products and Services (8.2.4) 8.7 Control of Nonconforming Process Outputs (8.3) 4/14/2016 29

9 Performance Evaluation 9.1 Monitoring, Measurement Analysis & Evaluation (4.2, 8.2.3, 8.4) 9.1.2 Customer Satisfaction (8.2.1) 9.1.3 Analysis & Evaluation (8.4) 9.2 Internal Audits (8.2.2) 9.3 Management Review (5.6) 4/14/2016 30

10 Improvement 10.1 General (8.5.1) 10.2 Nonconformity & Corrective Action (8.3, 8.5.2) 10.3 Continual Improvement (8.5.1) 4/14/2016 31

Questions? 4/14/2016 32

Internal and External Auditing Many sub sections do not require documentation. Auditors will be required to document interviews provided by responsible individuals. Example is 4.1 &4.2 - Strategic direction and internal and external issues. Auditor will need to document who they spoke with and any type of evidence presented to demonstrate these issues are effectively implemented. In most cases they may have to interview a 2 nd or 3rd person to verify implementation. 4/14/2016 33

Auditing Example - No Documentation 9.1.3 Analysis and Evaluation Organization shall analyze and evaluate appropriate data Results shall be used to evaluate conformity of products and services Degree of customer satisfaction Performance and effectiveness of QMS If planning has been implemented Effectiveness of actions taken for risk Performance of external providers Needs for improvement to QMS 4/14/2016 34

Questions? 4/14/2016 35

Implementation Help Your third party registrar Annex A - ISO 9001:2015 Seminars and consultants 4/14/2016 36

Annex A - ISO 9001:2015 Provides clarification of requirements. This is informational section rather than requirements. A.1 Structure and terminology A.2 Products and services A.3 Understanding needs of and expectations of interested parties A.4 Risk based thinking A.5 Applicability A.6 Documented information A.7 Organizational knowledge A.8 Control of externally provided resources, products and services 4/14/2016 37

Example of Resource Material asrworldwide.com Click search button and type in ISO 9001:2015 and following articles appear: - Clause by clause comparison (2008 vs 2015) - Readiness review checklist - Risk-based thinking - Context of organization - Determining adequate documentation - Audit tips 4/14/2016 38

Thoughts on Registration 4/14/2016 39

Documented Information May Be Issue How many procedures or work instructions does an organization need? ISO 9001:2015 Section 4.4.2 QMS & Processes: Organization shall maintain documented information to the extent necessary to support the operations of processes and retain documented information to the extent necessary to have confidence that the processes are being carried out as planned. 4/14/2016 40

Who Decides Adequate Documentation? Your organization. Your third party registration auditor. Your registrar. Accreditation bodies Example ANAB 4/14/2016 41

Risk Effectiveness Who decides if risk is adequately documented? & effective? Your organization. Your third party registration auditor Accreditation body Example - ANAB. 4/14/2016 42

A Challenge - Defend Your QMS 2015 vague language will prompt organizations to be fully prepared to defend their firm s interpretation of the QMS to customers or third-parties. Each organization is expert of their QMS Some organizations may have lots of maintained documentation, others might have reduced the amount of documentation. Which is correct path? This is going to be issue for registrars and may increase use of appeal process during first half of transition process. 4/14/2016 43

Defending Your QMS Determine Your Approach Document Your Approach Provide Document of Your Approach to Auditors Retain Documented Evidence to Demonstrate Effectiveness 4/14/2016 44

Appeal Process An appeal process with your registrar is available for every non-conformance that an organization feels is incorrect during an audit. 1. If organization determines a finding is not appropriate, prior to closing meeting, engage in a business-like discussion with the auditor outlining why you feel situation is effectively implemented and a non-conformance should not be written. 2. If organization believes they should go further, they need to contact their registrar. They should file a documented appeal using the registrar s appeal form. Organization may include a copy of NC, any procedures or work instructions that are applicable, and any records/metrics that might demonstrate effective implementation. 3. Organization will follow-up with registrar or several discussions held to come to a decision as to the appeal. Organization can ask for and obtain written response from registrar regarding their decision and why. 4/14/2016 45

Approach to Registration Do not be one of the first to register to new standard nor be one of the last organizations to register. 2015 is released and registrars will be approved to audit this standard in the early stages of 2016. It is expected registrars will develop guidelines to help their clients implement the new revisions such as number of procedures required and how risk is measured or managed? Expect guidelines to be adjusted based on the first 10 or 20 audits with results shared with client organizations and the registrar s auditors. This information will be helpful to an organization s implementation process and finally to the 2015 transition audit. 4/14/2016 46

Thank You If you have any further questions feel free to email me randwinters9@gmail.com 4/14/2016 47