1. ISO 9001: Countdown to Presented by Ellen Diggs Ellen Diggs Consulting February 11, 2015
It’s Not Just for Manufacturing Anymore!
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2. ISO 9001 facts International standard for quality management systems
Originally published in 1987
Underwent major revision in 2000
Implemented by more than one million organizations in over 170 countries
Applies to any organization regardless of size or industry
Standards are “enablers for other major business processes” – The Boeing Company
ISO 9001 is one standard in the ISO 9000 series on quality management and quality assurance. The standards were developed to help companies effectively document the elements they need to maintain an efficient quality system. They are not specific to any one industry.
The series includes ISO 9000:2005 (definitions), ISO 9001:2008 (requirements) and ISO 9004:2009 (continuous improvement).
ISO 9001:2008 is the only standard in the ISO 9000 series to which organizations can certify.
For more introductory information, visit

3. Reasons for 2015 revision
Maintain relevance for increasing diversity of users (industry, size, customer)
Increase focus on effective process management to achieve desired results
Facilitate integration with other management system standards
Standard structure, text, definitions
Recognition of supply chain complexity
Formalize need for risk-based thinking within the context of the organization
All ISO standards are periodically updated to maintain relevance.
Regarding ISO 9001:2015, in particular, the revision will …
- Respond to the increasing diversity of users, ensuring that needs of all user groups and industry sectors are met.
- Allow for easier integration with other management system standards. The revision will use a common structure defined for management system standards such as environmental, health and safety, energy, and emergency preparedness.
For a short video discussion, play an except (0:22 to 1:49) from this ASQ TV episode on standards and auditing:

4. Major Changes Structure – 10 clauses Understand organizational context
Language – new terminology
Products and services
Risks and opportunities
Context and interested parties
Effective resource management
Systematic control of changes
Business strategy and QMS integration
Focus on process approach and effective process management
Emphasis on objectives, risks and opportunities within context
Risk and prevention in relation to context and interested parties.

5. Major Changes (continued)
Language – new terminology
Products and services
Risks and opportunities (preventive action)
Context and interested parties (customers)
Documented information (documents and records)
Relation with context and interested parties (as suitable)
External providers of goods and services (suppliers)
Effective resource management
Systematic control of changes
Deleted
Quality manual
Management representative
Verification and validation
Product realization

6. Quality Management Principles (QMPs)
Customer focused organization
Leadership
Involvement of people
Process approach
System approach
Continual improvement
Factual approach to decision-making
Mutually benefit supplier relationships
7 QMPs
Customer focus
Leadership
Engagement of people
Process approach
Improvement
Evidence based decision-making
Relationship management

7. Performance evaluation (9)
High Level Structure
Context (4)
Leadership (5)
Improvement (10)
Planning (6)
Performance evaluation (9)
Support (7)
Operations (8)

8. Comparing the two… ISO 9001: 2008 ISO/DIS 9001:2015
4. General management system
Control of Documents
Control of Records
4. Quality management system (QMS)
7.4 Documented information
4.4. Process Approach
5. Management Responsibility
Planning
Quality objectives
QMS planning
Management representative
Management review
5. Leadership
6. Planning for the QMS
9.3 Management review
6. Resource Management
6.2 Human resources
6.4 Work environment
7.1 Resources
Competence
7.1.4 Environment for the operation of processes
Planning for QMS includes identifying actions to address Risks and Opps and Change Management Planning
4.1 relevant to strategic direction
Things to consider :Changes and trends,
Relations and Perceptions of relevant IP Governance, strategic priorities, Resources
4.2 Understanding the needs - Understand and anticipate needs of and expectations of interested parties expectations affecting customer Requirements and
customer satisfaction.
Identifies relevant IP to be considered
Note on Innovation
Opportunities

9. Comparing the two…(continued)
ISO 9001: 2008
ISO/DIS 9001:2015
7. Product realization
7.1 Planning of product realization
7.2 Customer-related processes
Design and development
Purchasing
7.4.3 Verification of purchased product
7.5.2 Validation of processes
Control of monitoring and measuring equipment
8. Operations
8.1 Operational planning and control
8.2 Determine requirements for products and services
8.3 Design and development of products and services
Control of externally provided goods and services
8.4.3 Release of products and services
8.5.1 Control of product and services
7.1.5 Monitoring and measurement resources
Purchasing - Addresses all forms of external provision
• Risk based approach to determine type and extent of control

10. Comparing the two…(continued)
ISO 9001: 2008
ISO/DIS 9001:2015
Monitoring, analysis and improvement
Monitoring of process
Monitoring of product
Control of nonconforming product
8.4 Analysis of data
8.5 Improvement
8.5.2 Corrective Action
8.5.3 Preventive Action
9.1 Monitoring, measurement, analysis, and evaluation
Release of products and services
Control of nonconforming process outputs, products and services
Analysis and evaluation
Improvement
Nonconformities and corrective action
Actions to address risks and opportunities
Monitoring of process and product removed and covered by section 9.1 , Control of n/c product is now Control of nonconforming process outputs, products and services.

11. The text… Context of the organization (4) Leadership (5)
Relevant to strategic direction
Understand and anticipate customer needs and expectations
The organization shall apply a process approach
Leadership (5)
With respect to the QMS and the customer (context)
Shall be accountable for the effectiveness of the QMS
Assign responsibility and authority

12. The text….(continued) Planning (6) Support (7)
Consider context to identify risks and opportunities that need to be addressed
Identify the need and opportunity for change
Take change in a planned matter
Support (7)
Resources (infrastructure, process environment, monitoring and measurement devices, and knowledge)
Competence and awareness
Communication
Documented information

13. The text… (continued) Operations (8)
Determination of market needs and interactions with customers
Operational planning process
Control of external provision of goods and services
Development of goods and services
Production of goods and services
Release of goods and services
Nonconforming goods and services

14. The text…(continued) Performance Evaluation (9) Improvement (10)
Monitoring, measurement, analysis and evaluation
Internal audit and Management Review
Analysis of data reinforced and clarified
QMS performance indicators
Improvement (10)
Shall improve the QMS, processes, and goods and services, as appropriate, in response to:
Results of analysis of data
Changes in organizational context
Changes in identified risk and new opportunities
Shall evaluate, prioritize and determine the
improvement to be implemented

15. Where’s the risk??
Risk-based thinking…the organization is required to:
4 (Context) Determine the risks to product or service conformity and customer satisfaction
5 (Leadership) Commit to Clause 4
6 (Planning) Take action to identify risks and opportunities
8 (Operation) Implement process to address risks and opportunities
9 (Performance) Monitor, measure, analyze and evaluate risks and opportunities
10 (Improvement) Respond to changes in risk
Definition of risk – the effect of uncertainty on an expected result (in this case, product or service conformity and customer satisfaction)

16. ISO 9001:2015 timeline
June 2013: Committee Draft (CD) Mid 2014: Expected publication of Draft International Standard (DIS) Mid 2015: Expected publication of Final Draft International Standard (FDIS) End 2015: Publication of International Standard as ISO 9001:2015 
Currently, ISO 9001:2015 is in the committee draft stage.
Countries participating in the development process are forming their national positions on the committee draft, which will result in the Draft International Standard (DIS).
The DIS is expected to be released in mid 2014 and will be made available for public comment.

17. Currently certified to ISO 9001:2008?
Transition period begins when new revision is published
Expect to have three years before ISO 9001:2008 becomes out of date
Certify to ISO 9001:2015 before transition period ends (expected late 2018)

18. And members can always find more information about standards and ISO 9001 by visiting the Knowledge Center. From any page on the ASQ site, use the main menu bar to navigate to the Knowledge Center, and you’ll find a topic menu.
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