Exploiting your transition to ISO 9001:2015 “what needs to be done ...

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

Copyright TEC Transnational© 2015 Aero Engineering Show Page #1

Revised: 01/12/2015

TEC Transnational – what we do


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


Revised: 01/12/2015

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


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


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


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

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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


Once done – monitor and keep records up-to-date

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QMS processes – what you do to make money!


… 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)


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


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

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Here a ‘working turtle’


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


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

Revised: 01/12/2015

Risk based thinking – typical methods


Okay – but how do we address risks (opportunities)?

RISK

Revised: 01/12/2015

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


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


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


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!

Comments?

Questions?

More help required?

Please leave your

business card or contact

detail and we’ll e-mail

you full details of this

presentation


Our helpline number –

• 01926 851 403

Visit our web site –

• www.tectransntional.com

My e-mail – • [email protected]

Join me on LinkedIn


Exploiting your transition to ISO 9001:2015 “what needs to be done ...

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