1. Prepared by Rand E Winters, Jr. ASR Senior Auditor October 2014
ISO 9001:2015 Revision Status
Prepared by
Rand E Winters, Jr.
ASR Senior Auditor
October 2014

2. Status of Standard Rewrite
This review based on ISO/DIS 9001 draft dated 2014; member groups now voting on draft
Contains 21 pages of requirements - compared to 9 pages for 2008 version. Draft has a lot of open space between content and will be some what shorter when finalized
Some items might change as draft is reviewed and submitted discussion points addressed.

3. Major Changes to ISO 9001
2008 version called for 6 documented procedures; This draft uses the words “documented information”(3.11) covering written instructions and records
Risk Management is added - defined in the definitions (3.09); identification of risk and risk control (6.1) are required.
No requirement for a Quality Manual
Management Representative not required
2015 draft of ISO 9001 has 7 auditable sections up from current 5 sections
69 definitions of the terminology used in 2014 draft

4. 2015 - Table of Contents 1 Scope 2 Normative References
3 Terms and Definitions
4 Context of the Organization
5 Leadership
6 Planning
7 Support
8 Operation
9 Performance Evaluation
10 Improvement

5. What Can Be Used From 2008?
Most existing QMS documentation from 2008 will address much of the 2015 requirements. Example is internal auditing
Some language has been adjusted. Procedures and records are now called “documented information”
Organization of the sub sections have been moved around
Next two pages list sub sections that are taken from the ISO 9001:2008 standard

6. 2008 Requirements Retained and Relocated
2015 Draft Section Number Segments
Determining scope of QMS including exclusions (1.2 & 4.2.2)
Leadership and commitment (5.1)
Policy (5.3)
Organization roles and responsibilities (5.5.1)
Quality objectives and planning (5.4.1)
General outsourced processes (4.1)
Infrastructure and working environment (6.3 & 6.4)
Monitoring and measuring of instruments (7.6)
Knowledge requirements
Competence (6.2.2)
Awareness (5.4.1 & & 5.3)
Communications (5.5.3)
Documented information (4.2.3 & 4.2.4)

7. 2008 Requirements Retained
2015 Draft Section Number - ID Your QMS for Retention Segments
Operational planning and control
Interaction with customers and…
Operational preparedness
Control of external processes or products
Design and development
Execution/implementation
Customer satisfaction
Internal audits
Management review
Nonconformity and corrective action

8. New Content - Further Definition
Section 4 -- Context of Organization
Risk
Documentation requirements
69 definitions; Section 3 provided to define wording used and additional notes to assist in understanding of the definition.

9. Definition of Context
Merriam-Webster definition (one of many) is….. Interrelated condition in which something exists ISO 9001:2015 draft definition is in sub clause 3.24; Context of Organization – business environment – combination of internal and external conditions that can have an effect on an organization’s approach to its products, services and interested parties.

10. Defining Context of Organization
Looking at 2015 draft some of items required to define context of organization:
4.1 Understanding External context
Understanding internal context (refer to 6.1) (two long notes provided for guidance)
6.1 Actions to address risk and opportunities
Related to product conformity and customer satisfaction

11. Context of Organization Continued
4.2 - Understanding needs and expectations of interested parties
Interested parties relevant to organization’s QMS
QMS related requirements of interested parties (2 notes provided for guidance)

12. Context of Organization Continued
4.3 Determining scope of QMS
Organization shall determine boundaries and applicability of QMS
Scope shall be documented and exclusions (2008 language) “those activities that are not applicable“ 2015 language added as “shall be determined and documented”
Scope and not applicable sections shall be available to interested parties

13. Context of Organization
4.4 QMS - organization shall……
Determine processes needed
Determine inputs and outputs of each process
Determine sequence and interaction
Determine risk
Determine criteria
Ensure availability of resources
Allocate responsibility
Monitor ,analyze and review processes
Implement action necessary to achieve planned results
Ensure revised processes continue to deliver intended outcomes

14. Risk Management Where is risk addressed?
3.09 Risk - effect of uncertainty on expected results (definition)
4.1 Organization shall take account these issues for determining risk (2 long notes)
4.4 QMS - determine risk if unintended output produced
5.1 Leadership - ensuring risks that could affect meeting product requirements … managed
6.1 Actions to address risk and opportunities

15. Risk Continued
6.3 Planning and Controlling changes a) identification of risk and control measures associated with product
8.4 Control of External processes or products - evaluation based on risks and risk control
Design and Development, define c) risk
Implement c) risk control measures
8.6 Execution/Implementation h) implementation of risk controls
9.3 Management Review input b) determined risks

16. Four Phases of Risk Risk Management Approach (ISO 14971 Flow Diagram)
Risk Analysis Risk Evaluation
INTENDED USE Identification
HAZARD identification
RISK estimation RISK ASSESSMENT
RISK acceptability decisions
Risk Control
OPTION analysis
Implementation of measures
RESIDUAL RISK evaluation
Overall RISK acceptance
Post Production
Information
Post-production experience
Review of RISK MANAGEMENT
experience- customer use
Take appropriate actions 16

17. Risk Risk is documented in most sections of new draft
Risk is very detailed in this standard as compared to ISO 13485, medical devices or AS 9100, aerospace.
Four phases of risk on the previous slide can be used to address risk in an organized method that will meet requirements in the revised standard.
Risk in this standard is addressed as risk to your business, the product that the organization is manufacturing or distributing, and customer satisfaction.

18. Documentation Requirements
Definition of documented information (3.11)…..
Information required to be controlled and maintained by an organization and medium on which it is contained.
Note 1 - documented information can be in any format and media from any source
Note 2 - documented information can refer to
management system, including related processes;
Information created in order for organization to
operate
Evidence of results achieved (records)

19. Examples of Documentation
Process flow charts both hard copy and electronic
Work instructions both hard copy and electronic
Forms - both hard copy and electronic
Procedures, work instructions, charts
Records - hard copy, electronic, chart recorders, etc.

20. Specific Documents Needing Controls
Scope and “requirements that can not be applied” shall be documented ( )
Quality Policy (5.2)
Quality Objectives (6.2.1)
Documented information of calibration and verification ( 7.1.5)
Competence - retain appropriate information (7.2)
Documentation of internal and external sources determined to be necessary by organization for planning and operation of QMS (7.5.3)
Keep documented information to the extent necessary to have confidence processes have been carried out as planned (8.1)

21. Specific Documents Needing Controls
Documented information describing results of reviews (contract review) ( )
Changed product requirements (8.2.3)
Documented information that design and development processes and products meet requirements (8.3.2)
D&D outputs (8.3.5)
D&D changes (8.3.6)
External processes or products (suppliers) - documented information regarding evaluation and any necessary actions (8.4.1)
Production or services - define, controlled conditions, and results (8.5.1)

22. Specific Documents Needing Controls
Monitoring and measurement of product - documented information include person authorizing release ( )
Nonconformity and corrective action - documented evidence of:…..(8.7)
Monitoring, measurement, analysis and evaluation -documented information as evidence of results (9.1.1)
Internal audits - documented information as evidence of audit program and audit results (9.2)
Management review - documented information regarding results (9.3)
Corrective action and non conforming material - information regarding action taken (10.2.2)

23. Annex A – 2015 Draft
Clarification of New Structure Terminology & Concepts - Maintain documented information (procedures/work instructions) - Retain documented information (records)

24. Balance of 2014 – What To Do?
Still too early in process of revising ISO 9001 for organizations to make changes to an existing ISO 9001 system; Last quarter of 2015 is a more logical start date Some items in Draft Standard may change or disappear from future drafts or the final version. An existing registered system might be OK as written. Compare draft requirements to your QMS and determine how many items might be new and require some work.

25. Address Risk Now
Most organizations have informal to formal risk programs; start to formalize a risk program
Think about documenting how your organization today handles risk to the business
Think about using some language that is typical in a risk process such as risk determination, risk control, risk mitigation, acceptable level of risk

26. Updates
ASR will update this ISO 9001:2015 presentation when a new draft or official release is distributed
If you have questions now, please contact your ASR sales representative.
Thank you.