Professional Documents
Culture Documents
BY R. DAN REID
quality objectives.3
objectives.4
context.
on that later.
Finding purpose
4.1.
Defining context
In ISO 9001, context is defined as the
combination of internal and external
issues that can have an effect on an organizations (subclause 3.2.1) approach to
developing and achieving its objectives.7
ISO 9000 offers more guidance. Understanding the context of the organization
is a process. This process determines
December 2015 QP 67
STANDARDS OUTLOOK
factors which influence the organizations
purpose, objectives and sustainability. It
considers internal factors, such as values,
culture, knowledge and performance of
Mission
Strategic
direction
Interested party
expectations
(4.2)
Understanding
context (4.1)
Relevant?
(4.1, 4.2)
External issues
(Re)scope of
management
system (4.3)
Intended
outcomes
Policy
development
(5.2.1)
Quality policy
Identification
of risks
Identify risks
and
andopportunities
opportunities
(6.1)
Process
controls (8.1)
Processes (4.4)
Documented
information (7.5)
Objectives
setting and
planning (6.2)
Plans
Objectives
Documented
information (7.5)
Metrics (9.1.1)
producers to consumers.
Yes
On target?
No
Corrective
action (10.2.1)
68 QP www.qualityprogress.com
error-proofing.
design changes.
outcomes.
7.4 on communication.
costly at best.
Customer-specific requirements.
aerospace, require third-party certifica-
nizational knowledge.
Some sectors, such as automotive and
Internal issues
own work.
revision.
December 2015 QP 69
STANDARDS OUTLOOK
needs and expectations of all interested
parties and their satisfaction, by the
systematic and continual improvement of
the organizations performance.12
organization.
not met.13
Interested parties can affect the level
determining them.
conclusions.
explicit requirement. Full risk management is not required, but risks must
verification activities.
70 QP www.qualityprogress.com
REFERENCES
1. International Organization for Standardization (ISO), Final
Draft International Standard ISO 9001:2015Quality
management systemsRequirements, Subclause 4.1
Understanding the organization and its context.
2. ISO, Final Draft International Standard ISO 9000:2015
Quality management systemsFundamentals and
vocabulary, Subclause 2.3.2.2Rationale.
3. Ibid, Subclause 2.3.2.1Statement.
4. Answers.com, What is the Purpose of an Organization?
Oct. 4, 2015, http://tinyurl.com/purposeoforg.
5. Angelfire.com, The Purpose of Business Organization,
Oct. 4, 2015, http://tinyurl.com/q53hgtp.
6. ISO, Final Draft International Standard ISO 9000:2015
Quality management systemsFundamentals and
vocabulary, Subclause 3.5.11Mission.
7. Ibid, Subclause 3.2.2Context of the organization
(terms).
8. Ibid, Subclause 2.2.3Context of an organization.
9. James Manyika, Michael Chui, Jacques Bughin, Richard
Dobbs, Peter Bisson and Alex Marrs, Disruptive Technologies: Advances That Will Transform Life, Business and
the Global Economy, McKinsey & Co., Oct. 4, 2015, http://
tinyurl.com/nmbecug.
10. ISO, Final Draft International Standard ISO 9001:2015
Quality management systemsRequirements, Subclause
7.1.6Organizational knowledge.
11. Philip B. Crosby, Quality is Free: The Art of Making Quality Certain, McGraw-Hill, 1979.
12. ISO, ISO 9001:2008Quality management systemsRequirements, Subclause 0.3Relationship with ISO 9004.
13. ISO, Final Draft International Standard ISO 9000:2015
Quality management systemsFundamentals and
vocabulary, Subclause 2.2.4Interested parties.
14. ISO, Final Draft International Standard ISO 9001:2015
Quality management systemsRequirements, Subclause
8.3.2Design and development planning.
15. Ibid, Subclause 9.3.2Management review inputs.
16. Ibid, Subclause 5.2.2Communicating the quality policy.
17. ISO, Final Draft International Standard ISO 9000:2015
Quality management systemsFundamentals and
vocabulary, Subclause 2.3.7.4 Possible actions (relationship management).