LOTEC
Revised: 01/12/2015
Exploiting your transition to ISO 9001:2015
“what needs to be done – how to do it”
TEC Transnational Ltd
Dr David Scrimshire
Director
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Revised: 01/12/2015
TEC Transnational – what we do
TEC Transnational Ltd
specialise in designing and
implementing modern and
effective management
systems and in the process
train and ‘coach’ the people
who will be operating the
systems when we are no
longer around – in these
sectors
ISO9001
• Manufacturing & Design
AS9100
• Aerospace & Defence
TS16949
• Automotive & Motorsport
IRIS
• Rail
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TEC’s ISO 9001 certification and other approvals
ISO 9001 Certified
IRCA Approved Training Organization
IAQG Training Provider • we train and exam the
aerospace Certification Bodies
SC21 Strategic Partner • aerospace and defence sector
supply chain campaign
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just 15-minutes to tell you what’s new in ISO 9001:2015 – and how to do it!
Revised: 01/12/2015
The high level structure (HSL) clauses
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AS9100 – TS16959 –– IRIS Quality Management System Standards
In future all ISO management system standards will have the same format
Revised: 01/12/2015
Determining the ‘purpose’ of the organization
Mission
Values
Vision
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Leadership must determine your organization’s Purpose = Mission + Values + Vision
Revised: 01/12/2015
Internal/External Issues Purpose/Strategy
Internal/External issues –
• purpose of the
organization
Interested parties –
• requirements of these
interested parties
Products & Services –
• scope of the QMS
• QMS processes
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Once done – monitor and keep records up-to-date
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QMS processes – what you do to make money!
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… all you need to do is describe your processes and their interaction (KISS)
Stores
Fabrication Planning Production
Financial Sales
Logistics
Quality
Procurement
‘processes needed for the quality management system
and their application throughout the organization’
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Here’s an example (400-employee aerospace firm)
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New customers or
major new contracts
Enquiries, estimates
and quotations Product design &
development
SOP, contract review
& production planning
Production design &
development
Procurement &
subcontracting
Manufacture and/or
service provision
Inspection/testing,
packaging & logistics
New Part Introduction
A P Q P
production and inspection documents jigs, tools & fixtures
Customer satisfaction, feedback &
communication
Customer complaints
Scorecards & CARs
Measured performance
Quality & Delivery
New Part Introduction
(A P Q P & P P A P)
drawings, part lists and specifications plus
material/production data
Nonconformity and corrective action
Continual improvement
Support Processes Documents & Records
Leadership Management Review
Internal Audit
This ‘description’ is referred to the ‘process approach’
Revised: 01/12/2015
Operations under ‘controlled conditions’
You must implement production and service provision
under controlled conditions – use a Turtle Diagram
What (with)? Who?
Inputs Outputs
How? Monitor?
Create a Turtle Diagram for each of your processes
Use the ‘limbs’ to define the controlled conditions
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Sources of Inputs – Inputs – Activities – Outputs – Receivers of Outputs
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Here a ‘working turtle’
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I1
I2
O1
O2
I3
O3
P1
P2
P3
P4
A1
A2
A3
A4
Physical resources & Software
Machines, jigs, tools & fixtures
Work environment, TPM, PPE, etc.
Preservation of product, FOD, etc.
Planned results (Process KPIs)–
Rework (%), etc.
OTIF (%), etc.
Actual vs. Standard Times, etc.
ACTIVITIES
S
O
U
R
C
E
S
R
E
C
E
I
V
E
R
S
Planned activities –
Procedures, Work Instructions, SOPs
Nonconformities, Changes, FAIRs, etc.
Identification, traceability & inspection
Human resources –
Responsibility
Authority
Qualification/Training
Sources of Inputs – Inputs – Activities – Outputs – Receivers of Outputs
Revised: 01/12/2015
Identify and address risks (and opportunities)
4.4.1 f) – Quality management system and its processes
5.1.1 d) – Leadership and commitment
5.1.2 b) – Customer focus
6.1 – Actions to address risks and opportunities
9.1.3 e) – Analysis and evaluation
9.3.2 e) – Management review inputs
10.2.1 e) – Nonconformity and corrective action
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Okay – but how do we identify risks (opportunities)?
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Risk based thinking – typical methods
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Okay – but how do we address risks (opportunities)?
RISK
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Risk Risk mitigation approaches
Risk – an effect is a
deviation from the
expected (positive or
negative)
Risk – is about what could
happen and what the effect
of this happening might be
Risk – also considers how
likely it is (occurrence)
Accept or Exploit
Avoid
Reduce
Transfer
Watch/Monitor
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It’s simply highly focused ‘preventive action’
Revised: 01/12/2015
Do you need a Quality Manual for ISO 9001:2016?
Revision record
Purpose of the organization
(Mission – Vision – Values)
Interested parties
and their requirements
Scope of the QMS
Quality Policy
Quality Objectives
Description of the QMS
processes and their interactions
Responsibilities and Authorities (e.g. organizational chart – plus Management Representative*)
Documented Processes (maintained documented information)
Documented Procedures (maintained documented information)
QMS Process (Compliance) Matrix
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Correct! A quality manual is not mandated – but it’s a good place to put stuff
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Roadmap to ISO 9001:2015 transition
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Leadership Mission, Vision
Values Purpose Strategic direction
Business
Plan
S-W-O-T
P-E-S-T-E-L
Internal & external
issues
Products &
services Requirements
Interested
parties
PLAN DO Risk-based thinking Scope Products & Services
meet requirements
CHECK ACT Process approach Policy Support customer, statutory
and regulatory
Planning QMS requirements ISO 9001 + customer,
statutory, regulatory
Quality
objectives
QMS processes
Business processes
Maintained documented information
Retained documented information
Monitored
KPIs Operation
Internal
Audit
Nonconformity and
corrective action
Change Performance
evaluation Improvement
Revised: 01/12/2015
Thanx for listening – now it’s your turn!
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presentation
TEC Transnational Ltd
Our helpline number –
• 01926 851 403
Visit our web site –
• www.tectransntional.com
My e-mail – • [email protected]
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