Topics of Interest for Accredited
Laboratories
ISO 9001 Changes that may Impact ISO 17025
GOV 2015
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Rita D’Angelo
AFDO San Diego, March, 2015
D’Angelo Advantage Consulting
Topics of Interest for Accredited
Laboratories?
Description of Course: At this session we will discuss
proposed changes to ISO 9001 standard and illustrate how
those changes may affect your organizational processes
associated with ISO 17025
GOV 2015
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Learning Objectives
 History of Standardization
 Understand the process of ISO 9001
 Understand proposed changes within the new standard
 Understand how the changes relate to ISO 17025
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Standardization
How it all began
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History of Standardization
 Early Examples of standardization
 King Henry I - In the earliest days of recorded measurement, the
“Royal Egyptian Cubit” was decreed to be equal to the length of the
forearm from the bent elbow to the tip of the extended middle finger
Ell
 Calendar
 Motion of the sun, moon and stars to determine the time to plant harvest
-
 Modern times
 Railroad- Common railroad gauge in the U.S. at the time which measured 4 feet,
8 ½ inches, a track size that originated in England and mandated for use in the
Transcontinental Railroad in 1864 and by 1886 had become the U.S. standard
 1904-fire hose couplings to ensure uniform fire safety equipment nationwide
 Interchangeability of parts- screw which detected differences in length as small
as one millionth of an inch
 Mechanical and electrical interchangeability for electric lamps led to electric lines
and equipment.
 Metric System used worldwide (excluding the US)
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http://www.ansi.org/consumer_affairs/history_standards.aspx?menuid=5
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ISO 9001: What is it?
ISO – International Organization for Standardization
Geneva, Switzerland
 Based on ISO/IEC 17025 and ISO 9001
 Worldwide Federation with 19, 500 standards in 163
countries
A panel of experts, within a technical
committee
1946
ISO's first standard
In 1951, the first ISO standard (called Recommendations at this time), ISO/R 1:1951 Standard reference
temperature for industrial length measurements developed by
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Benefits of ISO
 Cost savings – Optimize operations- improve the bottom line
 Enhanced customer satisfaction – Improve quality, enhance
customer satisfaction and increase sales
 Access to new markets – Prevent trade barriers and open up
global markets
 Increased market share – Increase productivity and
competitive advantage
 Environmental benefits – Reduce negative impacts on the
environment
(iso.org)
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ISO Accreditation in the USA
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ISO 9001 Revision- 6 step Process
ISO 9001 is currently at the Final Draft International Stage
(FDIS), the fifth stage of a six step process
Are the
changes
really
needed?
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Working
Group of
experts
prepare
the
working
draft
Draft from
is shared
with the
members
of the
parent
committee
DIS is
circulated to
all ISO
members
who get 3
months to
vote and
comment
The FDIS is
is circulated
to all ISO
member for
a twomonth vote
(if not
previously
approved)
Final
Document
publication
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ISO 9001: DIS 2015
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Structure of ISO 9001:2015
1
2
3
4
5
6
1/3
(Prior 2008 Revision)
Scope
Normative references
Terms and definitions
Context of the organization (Quality Management System)
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of QMS
4.4 Quality management system and its processes
Leadership (Management Responsibility)
5.1 Leadership and commitment
5.2 Quality policy
5.3 Organizational roles, responsibilities and authorities
Planning for the QMS (Resource Management)
6.1 Actions to address risks and opportunities
6.2 Qquality objectives and planning to achieve them
6.3 Planning of changes
http://asq.org/standards-iso-9001-2015.html
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Structure of ISO 9001:2015
2/3
7 Support (Product Realization)
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
8 Operation (Measurement, Analysis and Improvement)
8.1 Operational planning and control
8.2 Determination of requirements for products and services
8.3 Design and development of products and services
8.4 Control of externally provided products and services
8.5 Production and service provision
8.6 Release of products and services
8.7 Control of non conforming process outputs, products
and services
http://asq.org/standards-iso-9001-2015.html
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Structure of ISO 9001:2015
9 Performance evaluation
9.1 Monitoring, measurement, analysis and
evaluation
9.2 Internal audit
9.3 Management review
10 Improvement
10.1 General
10.2 Non-conformity and corrective action
10.3 Continual improvement
http://asq.org/standards-iso-9001-2015.html
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3/3
Context of the Organization
Context:
The interrelated conditions in which something exists or
occurs
The interrelated conditions within an organization
http://www.merriam-webster.com/dictionary/context
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Why the Change?
ISO 9001
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ISO 9001 Revision
Why change to ISO 9001 Standard?
 Keep the standard current and relevant for the global
marketplace
 Supply chain integration
 To respond to the latest trends and be compatible with other
management systems such as ISO 14001
 Ensure the new standard reflects the needs of all interested
parties
 Identify risks from the global economy
 Final revision expected END of 2015
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Major Changes
 Greater focus on the customer
 Risk-based thinking
 Aligning QMS policy and objectives with the
strategy of an organization

Greater flexibility with documentation
ASQ, 2015
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17025
ISO 9001
Changes
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Adopt a Risk Based Approach
 ISO 9001:2015 specifically addresses risk
 The word "risk" is being incorporated into the new version
of ISO 9001

Methods for identifying, managing and mitigating risk
 Incorporating risk by the followings:




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Define the organization’s objectives
Specifying the risk categories
Identifying risks to the objectives
Developing methods for managing the risks
© 2015 D’Angelo Advantage
Consulting
Risk in ISO 9001 at a Glance
 Clause 4: The organization is required to determine the risks which can affect its
ability to meet objectives
 Clause 5: Top management are required to commit to ensuring Clause 4 is followed
 Clause 6: The organization is required to take action to identify risks and
opportunities
 Clause 8: The organization is required to implement processes to address risk
 Clause 9: The organization is required to monitor, measure, analyze and evaluate
the risks and opportunities
 Clause 10: The organization is required to improve by responding to changes in risk
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4. 1 Understanding the Organization
and its Context
 The organization shall determine external and internal
issues that are relevant to its purpose and its strategic direction
and that affect to achieve the intended result of its quality
management system:
Issues from the followings:
 Legal
 Technological
 Competitive
 Market
 Social and economic environments
Do you know your business?
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Customer Focus
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Consulting
4. 2 Understanding the Needs and
Expectations of Interested Parties
 The organization shall determine:
 The interested parties that are relevant to the QMS
 The requirements of these interested parties that are
relevant to the QMS
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Who are the interested parties and what are their
requirements relevant to your Quality Management
System?
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4.4 Quality Management System and
its Processes
The Organization shall establish, implement, maintain and
continually improve a QMS, including the processes needed
and their interactions, in accordance with the requirements
of this international standard
 Inputs, outputs and resources
 Sequence and interaction
 Effective operation
 Responsibilities and opportunities for improvement
 Risks and the opportunities and actions needed to
address them
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What is the framework for change within your
QMS?
© 2015 D’Angelo Advantage
Consulting
5.1 Leadership
5.1 Leadership and Commitment
 Top Management must demonstrate leadership and
commitment with respect to the QMS by:
 Ensuring the quality policy and objectives are are established
for the QMS and are competitive with the strategic direction
and context of the organization
 Ensure the integration of the QMS into the organizations
business practices
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5.1 Leadership
Ensure integration if the QMS requirements into the
organization business process
 Ensure the resources needed for the QMS are available
 Communicate the importance of the QMS
 Ensure the QMS achieves the intended results
 Engage, direct and support persons to contribute to the
effectiveness of the QMS
 Promote continuous improvement
 Support management
Leadership is responsible to guide the organization
and ensure intended outcomes
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5.2 Quality Policy
17025
 5.2.1 “Top management” shall establish, review an maintain a
quality policy that:
 Is appropriate to the purpose and context of the organization
 Provides a framework for setting and reviewing quality
objectives
 Communicated to staff
 Includes a commitment to satisfy applicable requirements
 Commitment to continuous improvement
MORE Detail
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What does your organizational framework look like?
How does it allow for changes in objectives?
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6. Planning for the QMS
 6.1 Actions, Risks and Opportunities
 6.1.1 When planning for the QMS the organization shall
consider the issues referred in 4.1/4.2 and determine the risks
and opportunities that need to be addressed
 Give assurance that the QMS can achieve its intended
results
 Prevent of reduce undesirable events (risk)
 Evaluate the effectiveness of these actions
 Achieve continuous improvement
What are the organizational risks?
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6.2 Quality Objectives and Planning
to Achieve Them
17025
 The organization shall establish quality objectives at relevant
functions, levels and processes and include:
 Consistency with the quality policy
 Measurable
 Applicable requirements
 Monitored
 Communicated
 Updated as appropriate
 Retain documented information on the objectives
 MORE Detail
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The Objectives
Internal and external
Factors
Strategic
Goal
Leadership Defines
Internal and external
Customers
Initiatives
Metrics
Outcome
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6.2.2 When Planning How to Achieve
Objectives
17025
Establish what, how, who, when to achieve objectives
6.3 Changes in a planned and systematic manner
 Purpose of the changes
 Responsibility and authority to make change
 Availability of resources
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Are the details to achieve objectives
planned and documented ?
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7.0 Support
17025
 7.1 The organization shall determine and provide the
resources needed for the establishment implementation,
maintenance, and continual improvement of the QMS
How is the continuous improvement program
implemented? Who is responsible?
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7.2 Competence
17025
7.2 The Organization shall:
 Determine the necessary competence of persons doing the
work under it control that affects its quality performance
 Ensure that persons are competent on the basis of appropriate
education, training and or experience
 Take actions to acquire the necessary competence and
evaluate the effectiveness of actions taken
 Retain appropriate documented information as evidenced
of competence
Is there a process in place to take action for employees
who require retraining or reassignment to ensure
competency?
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7.3 Awareness
Persons doing the work under the organization's control shall be
aware of the following:
 Quality policy
 Their contribution to the effectiveness of the QMS,
including the benefits if improved quality performance
 Implications if not conforming with the QMS requirements
7.4 Communication
 The organization shall determine the internal and external
communications relevant to the QMS including:
 What will be communicated
 When to communicate
 Whom to communicate
 How to communicate
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7.5 Documented Information
17025
 The organizations QMS shall include:
Documented information required by this standard
Documented information determined by the organization
as being necessary for the effectiveness of the QMS
May differ from one organization to another due to:
 The size of the organization
 The complexity of the processes and their interactions
 The competence of employees
Are all processes are documented?
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8.1 Operation
Operation Planning and Control
The organization shall plan, implement and control the processes
as outlined in 4.4, needed to meet requirements and to implement
actions determined in 6.1 by:
 Establishing criteria for the processes
 Implement control of the processes in accordance with the
criteria
 Retaining documented information to the extent necessary to
have confidence that the process have been carried out as
planned
 The organization shall control planned changes and review
the consequences of unintended changes
 Endure outsource processes are controlled
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9.0 Performance Evaluation
9.1 Monitoring, measurement, analysis and evaluation
The organization shall determine:
 What needs to be monitored and measured
 The methods for monitoring measurement, analysis and
evaluation, to ensure valid results
 When monitoring and measuring shall be performed
 When the results from monitoring and measurement shall
be analyzed and evaluated
 Maintain documented information
 Evaluated the quality performance and effectiveness of the
QMS
What are your methods for monitoring effectiveness?
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9.2 Internal Audit
17025
Organization shall conduct internal audits at planned intervals to
provide information on whether the QMS conforms to:
1. Its own requirements
2. ISO Standard
9.2.2 Plan, establish, implement, and maintain an audit program
including
"frequency, methods, responsibilities, planning requirements
and reporting."
 Importance of the process related risks
 Results of previous audits
 MORE detail
ISO Audits Scheduled Audits
Are the quality objectives being met?
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9.3 Management Review
1702
5
 9.3.1 Top management shall review the organizations QMS at
planned intervals to ensure its continuing suitability, adequacy
and effectiveness
The management review shall be planned and carried out
taking into consideration:
 Status of actions from previous management reviews
 Changes in external and internal issues that are relevant
to the QMS
 Non-conformities/corrective actions
 Monitor and measurement results
 Audit results
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10.2 Conformity and Corrective Action
When a conformity occurs the organization shall react to the
non-conformity:
1702
5
 Take action, control and correct it
 Deal with the consequences
 Evaluate the need for action and eliminate the nonconformance so it does not occur again
 Review and determine the cause
 Determine if similar NC exists
 Implement any action needed
 Review the effectiveness of any corrective action
 Make changes to the QMS
 Corrective actions shall be appropriate to the effects of
the NC
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10.3 Continual Improvement
1702
5
 The organization shall continually improve the
suitability, adequacy and effectiveness of the QMS:
 Results of data collection
 Changes in the context of the organization
 Changes in identified risk
 New opportunities
What is the process for continuous improvement of the
QMS?
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Next Steps
1. Document applicable changes of ISO 9001 that have the
potential to effect your organization
2. Review the organizational QMS for necessary updates
3. Stay informed on the upcoming changes to the standard
4. 3 year grace period to comply with changes
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QUESTIONS??
dangeloadvantage@gmail.com
Dangeloadvantage.com
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References
1. Sandford Liebesman, ISO 9001:2015 specifically addresses risk. Is your
organization ready?
2. http://www.qualitydigest.com/inside/quality-insider-article/iso-90012015preparing-change.html
3. http://asq.org/standards-iso-9001-2015.html
4. http://www.ansi.org/consumer_affairs/history_standards.aspx?menuid=5
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