Sticky Clauses Webinar CAC For Phila R5!10!16 17

ISO 9001:2015
The Sticky Clauses
How to get unstuck

without becoming unglued
By Charlie Cianfrani
cianfranic@aol.com
CAC © 2017 R5
All rights reserved
About Your Presenter: Charlie Cianfrani
Professional Experience
o Business advisor with over 50 years of experience as an
operations and quality executive
o Over 25 years as a participant in TC 176 and the US TAG to ISO

TC 176—the committee responsible for ISO 9001
o Direct contributor to writing ISO 9001:2008, ISO 9001:2000,

ISO 9004:2009 and ISO 9004:2018 and the latest publication of
the QMP’s
o ASQ Fellow, ASQ CQE, CRE, CQA and an Exemplar Global-

certified QMS auditor
CAC © 2017 R5
all rights reserved 2
Disclaimers
o The information provided here today is meant to give an accurate picture of the
meaning and intent of ISO 9001:2015.
o The content presented is not an “official” view of ISO/TC176 but rather based on
my 50+ years of experience in P & L and quality management assignments
domestically and internationally.
o Think carefully before making any changes to your system just to adhere to the
perceived requirements of a Standard.
o The real questions to ask are “How does the process help the organization
achieve its objectives and do the processes add value?”
CAC © 2017 R5
• ISO 9001 Has Become a Global Standard
Results from the 2015 ISO Survey
ISO 9001 Certifications by Country
CAC © 2017 R5
The evolution of ISO 9001
ISO has a requirement to review and reaffirm or update
each Standard every 5 years
• ISO 9001 was first issued in 1987
• Tweaked in 1994 (no major changes)
• Major updating in 2000
– process approach introduced
• Tweaked again in 2008
• Major updating in 2015
– Annex SL format introduced (mandated by the ISO TMB)
CAC © 2017 R5
ISO 9001:2015 journey to reality
2013 2014 2015
June 2013 CD
Committee Draft
June – October 2014 DIS
Draft International Standard
FDIS was released for translation on 10 May
2015 . FDIS ballot opened on 9 July and closed
on 9 September 2015
September 2015
International Standard published
CAC © 2017 R5
Our Goal For This Presentation
We will address eight sticky clauses in ISO 9001:2015, their requirements, and possible
approaches to address and comply with these requirements.
1. Understanding the Organization and its Context (Clause 4.1)
2. Needs and Expectations of Interested parties (Clause 4.2)
3. Leadership (Clause 5)
4. Actions to Address Risks and Opportunities (Clause 6.1 and others)
5. Knowledge, competence, and innovation (Clause 7.1.6, 7.2 and 10.1 note)
6. Understanding documented information requirements (clause 7.5)
7. Measuring customer satisfaction (Clause 9.1.2)
8. Alignment of objectives (Clauses 6.2, 7.3 and 7.4)
CAC © 2017 R5
• ISO 9001:2015 was developed to be consistent
with the Quality Management Principles (QMPs)
See ISO 9000:2015 Clause 2.3
• The QMPs are
• Customer Focus • Improvement

• Leadership • Evidence-based Decision
• Engagement of Making
People • Relationship
• Process Approach Management
CAC © 2017 R5
Think!
9
Sticky Clause #1:
Understanding the Organization and its Context (Clause 4.1)
Clause 4.1: The Requirement
1. Determine relevant external and internal issues that can impact

the strategic and tactical directions of the organization and that
directly affect the achievement of the intent of the QMS
2. Monitor and review information about the relevant external and

internal issues
Both positive and negative issues
Notes of External Issues can arise from legal, technological, competitive,

market, cultural, social, and economic environments whether
factors to international, national, regional or local
consider Internal ssues may be related to values, culture, knowledge and

performance of the organization.
CAC © 2017 R5
Why Do It?
o Ensure QMS is structured for both the needs of today and tomorrow
o Integrate QMS processes into the organization strategic and tactical activities
o Explore interactions between processes that may be related to external and

internal issues
o Discover, understand and plan to address threats, opportunities, and technology

shifts
CAC © 2017 R5
Examples
o Define (and in most cases document) a process or processes for considering

internal and external issues
• Who should participate
• When and how often to consider issues
• How to document results
o Method of follow-up to assess status– who and with whom
o Consider implementation of a self-assessment process (not a requirement)
o Ensure integration into the strategic and tactical plans of the organization
o Make this integral to a strategic planning process
CAC © 2017 R5
Understanding the Essence
Understanding the Organization and its Context (Clause 4.1 and 4.2)
Strategic Risk Planning
Output:
Focus Action Plans Execution
Input: Strategy & Objectives Monitoring
Itemized Mission
Threats & Learning
Risks Vision
Opportunities
External Scan
Self-Assessment
Internal Scan
CAC © 2017 R5
Understanding the Essence
Understanding the Organization and its Context (Clause 4.1 and 4.2)
Strategic Planning
Threats Ideas
Issues
External Scan Mission
Self‐Assessment Vision
Internal Scan Strategies
Risks
Principles
Innovations
Develop And Action Plans

Implement Objectives
New System Alignment
Objectives
People
System Development
Process Management Identify Key Processes
Optimization
CAC © 2017 R5
Strategic Planning
Threats Ideas
Issues
External Scan Mission
Self‐Assessment Vision
Internal Scan Strategies
Risks
Principles
Innovations
This is the essence of what is required by

ISO 9001 Clauses 4.1 and 4.2
CAC © 2017 R5
Sticky Clause #2
Needs and Expectations of Interested Parties (Clause 4.2)
1. Determine the interested parties that are relevant to the quality

management system
2. Determine the relevant requirements of these interested parties
3. Monitor and review information about these interested parties

and their relevant requirements
4. The results of the analysis of relevant interested parties should

be used in planning the QMS (see also Clause 4.3)
CAC © 2017 R5
Why Do It?
o Risk avoidance
o “Interested parties” is new language in ISO 9001:2015
o Needs of interests of parties beyond the direct customer may impact
the content of the QMS of the organization
o Ideas for new products or services that have marketplace relevance
o Consideration of relevant needs/requirements/interests of interested
parties can influence of product design, production or delivery
processes
CAC © 2017 R5
Examples
o Define and deploy processes to determine if interested parties are

impacted by the activities of the organization
o Document processes for identification of interested parties
o Establish criteria for assessing relevance
o Keep records of identification and relevance decisions
o Consider actions to lessen or eliminate the extent of any impact on
relevant interested parties
o Examples of organizations that could potentially be considered
interested parties
CAC © 2017 R5
Interested parties can impact process design
The QMS of the
Shareholders organization
Regulators The organization
Process
Providers Customer
Customer
feedback
Internal
divisions
Design
consultants
CAC © 2017 R5
Sticky Clause #3
Leadership (Clause 5)
Clause 5: The Requirement
1. Clause 5 which has 4 sub-clauses; Clause 5.1 is titled

Leadership and commitment
2. Prime leadership requirements are in 5.1.1 General
• top managers are required to demonstrate

leadership and commitment to the QMS by carrying
out specific duties
• specific activities that are required are articulated in

Clause 5.1.1
CAC © 2017 R5
What are Top Managements’ Responsibilities?
o Taking accountability for the effectiveness of the quality management

system
o Ensuring that the quality policy and quality objectives are established
for the organization and are compatible with the context and strategic
direction of the organization
o Ensuring the integration of the quality management system
requirements into the organization’s business processes
o Promoting the use of the process approach and risk-based thinking
o Ensuring that the resources needed for the quality management
system are available
CAC © 2017 R5
What are Top Managements’ Responsibilities (Continued)?
o Communicating the importance of effective quality management and

of conforming to the quality management system requirements
o Ensuring that the quality management system achieves its intended
results
o Engaging, directing and supporting persons to contribute to the
effectiveness of the quality management system
o Promoting improvement
o Supporting other relevant management roles to demonstrate their
leadership as it applies to their areas of responsibility
CAC © 2017 R5
Job 1
Communicate
Communicate
Communicate
CAC © 2017 R5
Job 2
Establish
Quality Policy
CAC © 2017 R5
Job 3
Structure objectives
that are aligned with Quality
Policy
Objective
Establish Quality
Quality Policy Objective
Quality
Objective
CAC © 2017 R5
Management Commitment
ensure that the Provide

resources needed Resources
are available Quality
Objective
Establish Quality Management

Quality Policy Objective Review
Quality
Objective
CAC © 2017 R5
The Quality Hierarchy*
Organizational Sustainability
EFQM, World
class
Baldrige
performance
ISO 9004 Beyond minimum
requirements
ISO 9001 Prevent defects

Foundation Meet minimum requirements
* Concept developed by Joe Tsiakals
Conform to customer requirements
and used with permission
CAC © 2017 R5
Quality Objective - MD
Quality Policy • Hold quarterly meetings with key
customers
• Be the leading supplier of
hi-tech bicycles as viewed • Visit 3 customers each quarter to solicit
by our customers customer input (Quality and design)
• Be proactive in listening to
and communicating with Quality Objective - Marketing VP
customers
• Conduct market research to determine
• Achieve 99% delivery to who is perceived as the leading supplier
customer commitment date
• Ship replacement parts in Quality Objective - Design
24 hours
• Complete titanium disk brake project on
• Maintain a competent staff time and w/in budget
Quality Objective - Production

Manager
• 99.5% on time delivery to customer
CAC © 2017 R5
all rights reserved commitment date 28
Engagement of Top Management? Why? How?
• Important to know what can and should not be

delegated
• What gets measured gets done (follow the process
approach!!)
• Engagement is a critical component of sustainability
CAC © 2017 R5
Why do it?
o Facilitate top management strategic engagement with the QMS
o Ensure responsibilities, accountabilities and authorities are clear and
unambiguous
o Enhance communication with and involvement of all staff
throughout the organization
o Enhance risk assessment and exploration of opportunities
o Emphasize customer satisfaction throughout the organization
o Integrate quality management into the tactical activities of the
organization
o Ensure alignment of processes and objectives with strategic and
tactical plans
CAC © 2017 R5
Examples
o Help determine what top managers should and should not delegate and
how the delegation will work
o Practice and learn to speak in the language of management ($$$$)
o Design and deploy a Cost of Quality process
o Provide management with actionable information
CAC © 2017 R5
Sticky Clause #4
Risks and Opportunities (Clause 6.1)
1. Consider issues relevant to the organization
2. Determine the risks and opportunities that need to be
addressed in planning the QMS related to the issues that are
considered
3. Consider risks and opportunities that impact the
organization’s ability to achieve intended results, prevent or
reduce undesired effects, and achieve improvement
4. Address actions to be taken and how to integrate the actions
into the QMS
5. Determine how to evaluate effectiveness of actions taken
6. Balance actions taken to address risks and opportunities to
the potential impact of the risk on conformity of products
and services
CAC © 2017 R5
Risk and Opportunities (Clause 6.1)
o Synopsis of the intent of the requirement is:
• Consider risks and opportunities that impact the

organization’s ability to achieve intended results, prevent or
reduce undesired effects, and achieve improvement
• Address actions to be taken and how to integrate the
actions into the QMS
• Determine how to evaluate effectiveness of actions taken
• Balance actions taken to address risks and opportunities to
the potential impact of the risk on conformity of products
and services
CAC © 2017 R5
CC1
Why do it?
o Mitigate liability exposure

o Enhance sensitivity to safety
o Mitigate financial exposure related to risks
o Enhance customer satisfaction
o Meet requirements of clause 6.1.1
o Expand breadth and depth of the QMS
o Important to enhance sustainability
o Improve product development cycle times
o Prevent costly situations
CAC © 2017 R5
Slide 34
CC1 Need words around next to last bullet

Charlie Cianfrani, 10/14/2016
Internal Risks to Consider
o Implement internal audit and self-assessment processes
o Gather and analyze of quality cost data
o Analysis of technology trend information
o Competitive analysis
o Analyze results of customer reviews and feedback
o Assess actual vs intended internal values and culture
o Analyze operational and financial data to assess performance
o Implementing processes to consider best practices and
comparisons with industry benchmarks
o Analyze performance and interactions of processes
CAC © 2017 R5
External Risks to Consider
o Deploy processes to consider:
• The economic environment
• International trade conditions, processes and barriers.
• Competitive products and services
• Technology trends
• Regulatory changes
• Opportunities and conditions related to a wide variety of
outsourcing strategies
CAC © 2017 R5
Examples of how to do it - Tool Examples
o SWOT (strengths, weaknesses, opportunities, threats) analysis

o Process mapping and flow charting
o FMEA (failure modes and effects analysis)
CAC © 2017 R5
SWOT (strengths, weaknesses, opportunities, threats) analysis
SWOT Strength Weaknesses Opportunities Threats Process Actions
ISO
requirement
Determine external/internal
issues relevant to org purpose
Monitor info re issues
Determine interested parties
Requirements of interested
parties
Review info re interested
parties
Simple SWOT analysis format example for considering

requirements of Clauses 4 and 6
CAC © 2017 R5
Process mapping and flow charting
CAC © 2017 R5
FMEA (failure modes and effects analysis)
CAC © 2017 R5
Risk Based Thinking
o Teach Everyone
• Always consider risk
• Think about the positive aspect of risk (the risk of not taking action)
• Promote awareness and encourage personal involvement
• Reward risk input to reinforce the management desire for contribution
from ALL employees
CAC © 2017 R5
Sticky Clause #5:
Understanding Knowledge, Competence and Innovation Requirements (Clause 7.1.6, 7.2 and 10.1 Note)
Knowledge Requirements ‐ Clause 7.1.6
1. A new requirement ISO 9001
2. Somewhat vague and subject to a wide
spectrum of understanding
3. Determine the knowledge necessary for
the operation of processes
4. Maintain necessary knowledge and make it
available
5. Determine how to acquire or access the
necessary additional knowledge to address
changing needs and trends
CAC © 2017 R5
Why do it? Knowledge
o To ensure the availability of the information needed to establish,

implement, maintain and improve the quality management system
o To ensure that currently required organizational knowledge is
obtained
o To plan to acquire any necessary additional knowledge and required
updates for anticipated future needs
o To ensure QMS is effectively implemented
o To capture tacit knowledge
CAC © 2017 R5
Examples of how to do it - Knowledge
o Identify the processes of the QMS
o Consider resource requirements for processes (personnel, time,
buildings, equipment, utilities, materials, supplies, instruments,
software, transport facilities, other infrastructure)
o Deploy processes to codify, embed and communicate knowledge
required to satisfy customer requirements
o Ensure knowledge needed to meet requirements is available when
and where it is needed
o Consider short and long term resource needs; timing may be
critical
o Integrate longer-term needs into the organization’s strategic and
capital plans
CAC © 2017 R5
Sticky Clause #5:
Understanding Competence Requirements (Clause 7.2)
1. Determine the competence required for persons
doing work that affects the performance and
effectiveness of the QMS
2. Ensure that everyone has the capability to provide
product that meets customer requirements based
on appropriate education, training, or experience
3. Take actions to acquire necessary competence
4. Evaluate effectiveness of actions taken
5. Retain appropriate documented information as
evidence of competence to effective
implementation of the QMS
CAC © 2017 R5
Why do it - Competence
To Ensure That:
o People have the capability to satisfy customer requirements

o The capability exists to make the QMS effective
o Continual improvement of the effectiveness of the QMS processes
occurs
o Competence is maintained when transferring workers
o Competence is maintained when utilizing temporary staff
o Competence is maintained under changing conditions
o HR establishes job requirements when hiring
CAC © 2017 R5
Examples of How to Do It - Competence
o Use some form of written job requirements (i. e. job descriptions)

o Competencies required should make sense for each job type; find
the right combination of education, training, skill and experience
o Some job requirements may be only a performance standard (for
example, to produce a quantity of conforming product per day)
o Establish processes to ensure newly hired or transferred personnel
have the competence to perform assigned tasks to requirements
o Train supervision to ensure staff competence, especially in a
dynamic work environment
o Engage HR in ensuring competence of staff for assignments
CAC © 2017 R5
Sticky Clause #5:
Understanding Innovation Requirements (note to Clause 10.1)
1. No requirements in ISO 9001:2015
2. There is note 1 in Clause 10.1 listing innovation as
an example of improvement
CAC © 2017 R5
Why do it - Innovation
o Innovation is a vital component of sustainability

o Innovation is a vital component of improvement
o Competition is not static
o Customer demands are always changing
o Cost reduction is continually an issue
o Technology is continually unveiling better ways to implement
process activities
CAC © 2017 R5
How to Do It - Innovation
o Define a process
o Requires periodic attention
o Allocate resources
o The QMS should not inhibit consideration of innovative product
and process developments
o In certain customer or regulatory situations, the changes related to
innovation may not be permitted, but the process should capture
future opportunities for later action
CAC © 2017 R5
Sticky Clause #6:
Understanding Documented Information Requirements (Clause 7.5).
1. Most significant change in 2015 is in the nomenclature
2. The previous terms of “documents” and ‘records” have been
replaced with “documented information”
3. The essence of the requirements is that the QMS shall include:
‐ all documented information required by ISO 9001:2015
‐ documented information that the organization determines to
be necessary for effective operations
‐ as applicable, the availability of applicable documented
information to establish control of production and service
provision (See clause 8.5.1
4. All other requirements similar to the past editions of ISO 9001
CAC © 2017 R5
Why Address Documented Information Requirements
o To Ensure:
o Consistent performance of all activities affecting quality
o Controls are in place to issue and approve documents
o Changes in requirements are communicated to those who
must implement them
o To prevent the use of obsolete information
o To make certain that people have up-to-date instructions
and requirements
CAC © 2017 R5
Examples of How to Address Documented Information Requirements
o Define the types of documents in your system
o Determine if any change in nomenclature is required or desired
o Define the types of documentation that come from other
organizations
o Maintain a clear differentiation between documents and records
o Where the term “maintain documented information” is used, the
intent is the documented information be kept up to date
o Where the term “retain documented information” is used, the
intent is similar to the ISO 9001:2008 requirements for a record
CAC © 2017 R5
Examples of How to Address Documented Information Requirements
(Continued)
o Define the control process appropriate for each type of document

o The requirements for computer-based documentation may be
different from those for paper drawings
o Records are a special type of document and require different
controls
o See Annex A.6 Documented Information in ISO 9001:2015
o No requirement to do anything different without a good reason
CAC © 2017 R5
This Table May Help to Understand Documented Information Requirements terminology
Purpose of Documented
Old Term New Term Changes & Corrections
Information
Provide up to date
Keep up to date with
Documented procedure Maintain documented information information for process
changes
operations
No changes but
Provide objective evidence
Record Retain documented information corrections may be
of activities conducted
permitted
CAC © 2017 R5
Sticky Clause #7:
Measuring Customer Satisfaction (Clause 9.1.2)
1. Monitor information relating to customer perception as to
whether the organization has met customer needs and
expectations.
2. The methods to be used to get this information is not
specified in the standard, but methods must be
established.
CAC © 2017 R5
Why Address Measuring Customer Satisfaction
o To understand customers’ perceptions related to your products so

that you can take action to improve the QMS of the organization
to improve that perception
o To understand actions needed to retain customers
o To understand actions needed to expand business
o To understand actions needed to grow markets
o Typically customer satisfaction is a stated objective of many
organizations, but not supported by processes to ensure it is
achieved
CAC © 2017 R5
Examples of How to Address Measuring Customer Satisfaction
o Decide what information you will monitor
o Determine how to get that information
o Determine how to analyze information (see examples of sources of
customer satisfaction information in next slide)
o Consider that to demonstrate conformity in regulated markets, it
may be sufficient to monitor customer reports of product
deficiencies
o Consider using focus groups and surveys of product users
o Go beyond the requirements in Clause 9.1.2 to deploy aggressive
processes to gather and USE customer satisfaction information to
enhance sustainability
o Consider ALL sources of customer satisfaction data
CAC © 2017 R5
Examples of How to Address Measuring Customer Satisfaction
o If you manufacture products for other companies, consider face-
to-face interviews with the individuals who make key buying
decisions in customer organizations
o Consider that the products you produce may have associated
services that are important to the customers
o Keep the process dynamic and flexible; the results of monitoring
may indicate a need to gather more information through
measuring
o Include methods to understand what is important to the
customers, including price and delivery performance, when
deciding what to monitor and measure
o Consider using QFD and voice of the customer techniques
CAC © 2017 R5
Sources of Customer Satisfaction Data
Surveys
Active Focus groups
Site visits
Interviews
Complaints
Methods of
Gathering Receptive Warranty costs
Allowances
Letters
Articles
Indirect
Trade Shows
Repeat business
CAC © 2017 R5
Trade
Key Shows R&D
Measures
Sales Surveys
Calls Articles
Credits &
Returns Complaints Customer
Ratings
Often our customer data is like an incomplete puzzle
CAC © 2017 R5
Key
Measures Trade
Shows R&D
Sales Surveys Articles

Calls
Credits & Customer
Complaints
Returns Ratings
Get the pieces to fit together
CAC © 2017 R5
Possible Sources of Data
CAC © 2017 R5
Sticky Clause #8:
Alignment of Objectives (Clauses 6.2, 7.3 and 7.4)
1. Establish quality objectives at relevant functions, levels and processes needed for the
quality management system
2. Quality objectives shall:
• be consistent with the quality policy;
• be measurable;
• take into account applicable requirements;
• be relevant to conformity of products and services and to enhancement of
customer satisfaction;
• be monitored;
• be communicated;
• be updated as appropriate.
3. Plan achievement of objectives. Determine:
• what will be done;
• what resources will be required;
• who will be responsible;
• when it will be completed;
• how the results will be evaluated.
CAC © 2017 R5
Why Align Objectives
o To Ensure:
• Achievement of operational and financial objectives
• Commonality of understanding of vision and mission and how they will
be realized
• Requirements are met
• Resources are allocated
• Staff works with commonality of purpose
• Communication of objectives and feedback of performance status
CAC © 2017 R5
Managing to Achieve Results
ensure that the Provide

resources needed Resources
are available Quality
Objective
Establish Quality Management

Quality Policy Objective Review
Quality
Objective
CAC © 2017 R5
Any final comments or questions
CAC © 2017 R5
Thank You!
CAC JW © 2016 all rights reserved

Books by Cianfrani and West
Jack and Charlie are Co-authors of several books published by the American Society for
Quality (ASQ) Quality Press including:
 ISO 9001:2015 Explained (Fourth Edition)

 Cracking the case of ISO 9001:2015 for Manufacturing (Second Edition)
 Cracking the case of ISO 9001:2015 for Service(Second Edition)
 ISO 9001:2008 Explained & Expanded
 Unlocking the Power of your Quality Management System - Keys to
Performance Excellence
 How to Audit the Process-Based QMS (Second Edition)
 Also see our many articles in Quality Progress on all aspects of
 ISO 9001
CAC © 2017 R5
CAC © 2017 R5
Context
of the
Organization
Quality Management System
C Improvement C
U R S
U
E Leadership, Planning, Support, & A
S Q
U Resource Management
T
I
S
T I
R
S
F
T
E Performance A
O m
E evaluation
C
T
O
M N
T
I
O
M
S N
E Operational planning and control E
(Product and/or service realization)
R R
CAC © 2017 R5
Get Real About What Leaders Need To Do
Measuring
Quality
Objective Customer
Monitoring satisfaction Analyzing
Establish Quality data
Quality Policy Objective
Improving
Quality
Objective
Communicate! Management
Quality Review
Management
System Improvement
CAC © 2017 R5 Processes


Sticky Clauses Webinar CAC For Phila R5!10!16 17

Hochgeladen von

Dokumentinformationen

Originaltitel

Copyright

Verfügbare Formate

Dieses Dokument teilen

Dokument teilen oder einbetten

Freigabeoptionen

Stufen Sie dieses Dokument als nützlich ein?

Sind diese Inhalte unangemessen?

Copyright:

Verfügbare Formate

Sticky Clauses Webinar CAC For Phila R5!10!16 17

Hochgeladen von

Copyright:

Verfügbare Formate

ISO 9001:2015

The Sticky Clauses

How to get unstuck

o Over 25 years as a participant in TC 176 and the US TAG to ISO

o Direct contributor to writing ISO 9001:2008, ISO 9001:2000,

o ASQ Fellow, ASQ CQE, CRE, CQA and an Exemplar Global-

2013 2014 2015

1. Understanding the Organization and its Context (Clause 4.1)

2. Needs and Expectations of Interested parties (Clause 4.2)

4. Actions to Address Risks and Opportunities (Clause 6.1 and others)

6. Understanding documented information requirements (clause 7.5)

7. Measuring customer satisfaction (Clause 9.1.2)

8. Alignment of objectives (Clauses 6.2, 7.3 and 7.4)

• Customer Focus • Improvement

Clause 4.1: The Requirement

1. Determine relevant external and internal issues that can impact

2. Monitor and review information about the relevant external and

Both positive and negative issues

Notes of External Issues can arise from legal, technological, competitive,

consider Internal ssues may be related to values, culture, knowledge and

o Explore interactions between processes that may be related to external and

o Discover, understand and plan to address threats, opportunities, and technology

o Define (and in most cases document) a process or processes for considering

o Method of follow-up to assess status– who and with whom

o Consider implementation of a self-assessment process (not a requirement)

o Make this integral to a strategic planning process

Strategic Risk Planning

Develop And Action Plans

This is the essence of what is required by

Clause 4.2: The Requirement

1. Determine the interested parties that are relevant to the quality

2. Determine the relevant requirements of these interested parties

3. Monitor and review information about these interested parties

4. The results of the analysis of relevant interested parties should

o Define and deploy processes to determine if interested parties are

Clause 5: The Requirement

1. Clause 5 which has 4 sub-clauses; Clause 5.1 is titled

2. Prime leadership requirements are in 5.1.1 General

• top managers are required to demonstrate

• specific activities that are required are articulated in

o Taking accountability for the effectiveness of the quality management

o Communicating the importance of effective quality management and

ensure that the Provide

Establish Quality Management

ISO 9001 Prevent defects

Quality Objective - Production

• Important to know what can and should not be

Clause 6.1: The Requirement

o Synopsis of the intent of the requirement is:

• Consider risks and opportunities that impact the

o Mitigate liability exposure

CC1 Need words around next to last bullet

o SWOT (strengths, weaknesses, opportunities, threats) analysis

SWOT Strength Weaknesses Opportunities Threats Process Actions

Monitor info re issues

Determine interested parties

Simple SWOT analysis format example for considering

o To ensure the availability of the information needed to establish,

o People have the capability to satisfy customer requirements

o Use some form of written job requirements (i. e. job descriptions)

o Innovation is a vital component of sustainability

o Define the control process appropriate for each type of document

o To understand customers’ perceptions related to your products so