ISO 9001:2015

KEY CONCEPTS SERIES:

CONTEXT OF THE ORGANIZATION
AND INTERESTED PARTIES
AN IMPLEMENTATION
APPROACH

Revision 20120416 Revision 20120416

 We help build more effective and efficient business processes.
We specialize in helping complex, multi-site businesses to get the benefits
of management systems like ISO 9001, TL 9000, and ISO 27001.
www.DesaraGroup.com 631-909-3570
Copyright 2015 by The DESARA Group,
www.DesaraGroup.com 631-909-35702
Copyright 2011 by The DESARA Group, www.DesaraGroup.com (631) 909-3570
Context of the Organization
Affects Decisions on Applying Requirements
Appropriately
Documented Information (Procedures)
Documented Information (Records)
Customer Focus
Quality Objectives
Monitoring & Measuring
Competency
Organizational Knowledge
Customer Communications
Requirements of Product
Control of Externally Provided Products and Services

Copyright 2016 by The DESARA Group,

Revision 20120416 3 www.DesaraGroup.com 631-909-3570
What are the intended results of your quality management system?
Think: Quality, Cost, Speed
(Note: measurable objectives could come from some of these)

Reduce waste, Faster on-boarding Faster service / OTD Improved profits

less rework/scrap
Better product Work force Meet Regulations Easier to sell
designs flexibility

Consistent Job stability, Smooth new First to market,

customer growth, product intro, time bigger market share
experience satisfaction/morale to market
Improved incoming Clear roles, Customer loyalty Less unplanned O/T
parts, supplier communication (not shopping)
quality
Capacity utilization Employee safety Fewer failed Lower warranty
products costs
Copyright 2016 by The DESARA Group,
Revision 20120416 4 www.DesaraGroup.com (631) 909-3570
Identifying Relevant
External and Internal Issues
What is relevant?
Issues that can ____________________
the organizations ability to _________________________
Examples of relevant internal issues
Organizational performance including financial, e.g. _______________
Resource factors, e.g. _______________________________________
Human aspects, e.g. ________________________________________
Management-related, e.g. ___________________________________
Examples of relevant external issues
Economic issues, e.g. ________________________________________
Social factors, e.g. __________________________________________
Political/legal, e.g. __________________________________________
Technological, e.g. __________________________________________
Competition, e.g. __________________________________________
Copyright 2016 by The DESARA Group,
Revision 20120416 5 www.DesaraGroup.com (631) 909-3570
Capturing 4.1 and 4.2:
Some alternatives
Documented?
YES.

A short section in the Quality Manual

Maybe enough to pass but enough to be useful?
Depends on your context

A presentation
Talking points outlined, well understood and communicated effectively

Or

Copyright 2016 by The DESARA Group,

Revision 20120416 6 www.DesaraGroup.com 631-909-3570
Capturing 4.1 and 4.2:
Some alternatives, continued
Baldrige Organizational Profile Approach
Typically 5 pages
Concise but thorough statement
May address more than ISO minimum, organizations discretion
Structured, systematic approach to create and revise

Copyright 2016 by The DESARA Group,

Revision 20120416 7 www.DesaraGroup.com 631-909-3570
Benefits to using the Organizational Profile

Engages leadership in important discussion about the organizations key

characteristics
Promotes conversation about the organizations strategic situation
Provides a snapshot of the organization, how you operate, and the
challenges you face
Beyond compliance and focused upon performance excellence and
improvement
Organizations can receive expert feedback and recognition from many
state based Performance Excellence programs on completion of their
Organizational Profile

Revision 20120416 8 www.DesaraGroup.com (631) 909-3570

GETTING IT DONE:
3 METHODS FOR
DEFINING CONTEXT OF THE
ORGANIZATION
AND INTERESTED PARTIES

Copyright 2016 by The DESARA Group,

Revision 20120416 9 www.DesaraGroup.com 631-909-3570
Method 1
Straw Document
Caveat:
Leader (Quality Director, for example)
Draft a document Dont outsource!
Circulated for comments The benefit is in the
learning from doing
Refine it yourselves!
Publish with management approval

Fastest method
Least amount of discussion and learning from team
May work well for:
Mature organizations well understood by all
Small, informal organizations
Resistant teams this is at least a starting point
Copyright 2016 by The DESARA Group,
Revision 20120416 10 www.DesaraGroup.com 631-909-3570
Method 2
Input Gathering, then Straw Document
Leader facilitates input gathering (Quality Director, for example)
Written surveys ratings or short answers
Interviews team meetings or 1-1
People or groups are assigned questions to answer
Leader drafts straw document for review and approval
Potentially slowest method
Major effort on facilitator (nag)
Raises awareness and may lead to strong buy-in and discussion
May work well for:
Resistant teams where Leader is strong
Teams who work remotely or are hard to assemble
High functioning teams who take their homework seriously
Copyright 2016 by The DESARA Group,
Revision 20120416 11 www.DesaraGroup.com 631-909-3570
Method 3
Facilitated Workshop
1-2 full group sessions
Pre-work and homework: Information gathering and refinement
Facilitator guides discussion
Asks the hard questions and challenges answers
Potentially fastest method, but highest involvement and impact
Major effort to get people together
Provides education and team building
Leads to strongest buy-in and discussion
Prepares team for ongoing monitoring, review, and improvement
May work well for:
Committed teams who are open to learning and growth
Strong personalities who can benefit from outside facilitation
Busy teams who need to commit time all together to get it done
Resistant teams who need to develop buy-in through group interaction and strong
leadership

Copyright 2016 by The DESARA Group,

Revision 20120416 12 www.DesaraGroup.com 631-909-3570
Whats Next?
Step 1:
Really understand
the new standard

We offer training
in public venues
and
at your facility.

3-5 day custom

packages:
Core Team
Implementers
Top Managers

Copyright 2016 by The DESARA Group,

Revision 20120416 13 www.DesaraGroup.com 631-909-3570