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

LOTEC

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TEC Transnational – what we do

 TEC Transnational Ltd  ISO9001
specialise in designing and • Manufacturing & Design
implementing modern and
 AS9100
effective management
• Aerospace & Defence
systems and in the process
train and ‘coach’ the people  TS16949
who will be operating the • Automotive & Motorsport
systems when we are no  IRIS
longer around – in these • Rail
sectors

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just 15-minutes to tell you what’s new in ISO 9001:2015 – and how to do it!

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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In future all ISO management system standards will have the same format

The high level structure (HSL) clauses

AS9100 – TS16959 –– IRIS

Quality Management System Standards

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Leadership must determine your organization’s Purpose = Mission + Values + Vision

Determining the ‘purpose’ of the organization

Mission
Values
Vision
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Once done – monitor and keep records up-to-date

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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‘processes needed for the quality management system

and their application throughout the organization’

QMS processes – what you do to make money!

Logistics
Sales
Financial

Quality
Procurement
Stores

Planning Fabrication Production

… all you need to do is describe your processes and their interaction (KISS)
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This ‘description’ is referred to the ‘process approach’

Here’s an example (400-employee aerospace firm)

Nonconformity Support Processes Leadership
New customers or and corrective action Management Review
major new contracts Continual improvement Documents & Records Internal Audit

Enquiries, estimates Product design & drawings, part lists and

and quotations specifications plus
development material/production data

New Part Introduction Production design & production and

inspection documents
(A P QAPP&QPPP A P) development jigs, tools & fixtures

SOP, contract review Procurement & Manufacture and/or Inspection/testing,

& production planning subcontracting service provision packaging & logistics

Customer complaints Customer satisfaction, Measured performance

feedback &
Scorecards & CARs communication Quality & Delivery

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Sources of Inputs – Inputs – Activities – Outputs – Receivers of Outputs

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

Here a ‘working turtle’

Physical resources & Software

I1 P1
Human resources – R
Machines, jigs, tools & fixtures
A1 O1
Responsibility
E
S
Work environment, TPM, PPE, etc. Authority
Preservation of product, FOD, etc. Qualification/Training
C
O P2

I2 E
I
U A2 O2 P3

V
R
E
C Planned activities – I3 A3 Planned results (Process KPIs)– R
E Procedures, Work Instructions, SOPs Rework (%), etc.
Nonconformities, Changes, FAIRs, etc. OTIF (%), etc. S
S Identification, traceability & inspection
A4 O3 P4
Actual vs. Standard Times, etc.

ACTIVITIES
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Okay – but how do we identify risks (opportunities)?

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 address risks (opportunities)?

Risk based thinking – typical methods

RISK

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It’s simply highly focused ‘preventive action’

Risk Risk mitigation approaches

Risk – an effect is a
 Accept or Exploit

deviation from the
expected (positive or  Avoid
negative)
 Risk – is about what could  Reduce
happen and what the effect
of this happening might be  Transfer
Risk – also considers how
 Watch/Monitor

likely it is (occurrence)

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Correct! A quality manual is not mandated – but it’s a good place to put stuff

Do you need a Quality Manual for ISO 9001:2016?

 Revision record  Responsibilities and Authorities
 Purpose of the organization (e.g. organizational chart – plus
Management Representative*)
(Mission – Vision – Values)
 Interested parties  Documented Processes
and their requirements (maintained documented
information)
 Scope of the QMS
 Documented Procedures
 Quality Policy (maintained documented
 Quality Objectives information)
 Description of the QMS  QMS Process (Compliance)
processes and their interactions Matrix

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Roadmap to ISO 9001:2015 transition

Mission, Vision Business
Leadership Purpose Strategic direction
Values Plan

S-W-O-T Internal & external Products & Interested

Requirements
P-E-S-T-E-L issues services parties

Products & Services

PLAN DO Risk-based thinking Scope
meet requirements

customer, statutory
CHECK ACT Process approach Policy Support
and regulatory

ISO 9001 + customer,

Planning QMS requirements
statutory, regulatory

Quality QMS processes Maintained documented information

objectives Business processes Retained documented information

Monitored Internal Nonconformity and

Operation
KPIs Audit corrective action

Performance
Change Improvement
evaluation

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Thanx for listening – now it’s your turn!

 Comments?
 Questions?
 More help required?
 Please leave your
business card or contact
detail and we’ll e-mail
you full details of this
 TEC Transnational Ltd
 Our helpline number –
• 01926 851 403
 Visit our web site –
• www.tectransntional.com
 My e-mail –
• david.scrimshire@tectransntional.com

presentation  Join me on LinkedIn

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