Certification Body Approach to ISO 9001:2015 by NQA

CERTIFICATION BODY
APPROACH TO
ISO 9001: 2015
DR MARGARET ROONEY
28 SEPTEMBER 2016

EXPERIENCE AND
LESSONS LEARNT
DURING THE FIRST YEAR
OF ASSESSMENTS
TO THE 2015 STANDARDS.

ISO 9001:2015 – EXPERIENCE ONE YEAR IN
ISO 9001:2015 and ISO 14001:2015 are one year old this
month!

The younger sibling, ISO 45001, is not expected until the
end of 2017.
What makes these standards siblings?
Annex SL – the common thread for these and all future
management system standards.

THE 2015
STANDARDS –
ONE YEAR ON

The certification body approach:
• 2015 is a huge learning process for us all
• A step at a time…
• Steady as she goes…

The certification body approach - internal:
• Finalised our policy in the summer of 2015
• Developed our processes
• Brief/train our assessors – we never stop improving
• Continue to brief and train our assessors – we never
stop improving
• Feedback out experience to assessors

The certification body approach - external:
• Finalised and communicated our policy
• Communicated our process
• Webinars
• Web site
• Audit booking process
• Helpline and transition@nqa.com

The certification body approach:
Range of briefing sessions for assessors and clients:
• Annex SL
• Specific changes to ISO9001:2015
• Specific changes to ISO14001:2015
• The importance of the gap analysis tool, TR006

The certification body approach to the 2015 standards:
Key changes/enhancements:
• Context
• Leadership
• Process approach
• Risk based thinking

ANNEX SL
ISO/IEC Directives, Part 1
Consolidated ISO Supplement - Procedures specific to ISO
• Annex SL (normative) Proposals for management system
standards
• Appendix 2 (normative)
High level structure, identical core text, common terms and core
definitions

ANNEX SL PURPOSE
Annex SL prescribes a high level structure with identical text headings
• Its purpose is to ensure standards can be easily integrated across an
organisations business
• There are now many standards that organisations may wish to use or be
certified to
• Annex SL allows easy integration for organisations that wish to apply
more than one standard within its business activities

ANNEX SL PURPOSE
Annex SL prescribes a high level structure with identical text headings
• It applies to all Management System Standards – full ISO standards,
Technical Specifications (TS) and Publicly Available Specifications (PAS)

ANNEX SL HIGH LEVEL STRUCTURE
1. Scope
2. Normative References
3. Terms and Definitions
4. Context of the Organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance Evaluation
10. Improvement

ANNEX SL HIGH LEVEL STRUCTURE
The ten clause numbers and titles
cannot be changed.
However, for discipline specific
text in ISO 9001, ISO 14001 or
ISO 45001, you can have:
• Additional sub clauses
• New bullets
• Discipline specific notes or
examples
• Additional enhancing text

CHANGES &
OBSERVATIONS
ONE YEAR IN

ISO 9001:2015 – THE BIG CHANGES
• Context
• Leadership
• Risks and opportunities
• Process approach

Summary
Changes
• Reduced emphasis on
documentation
• No explicit requirement for a
management representative
• No explicit reference to
preventive action
• Some new terminology
Significant changes
• Elevated focus on the process
approach
• Risk based thinking –
including opportunities
• Annex SL

A number of transition audits have taken place
Stage 1 and stage 2 audits for new ISO 9001 clients are
often based on the 2015 standard.

CONTEXT –
CERTIFICATION
BODY
APPROACH

CONTEXT
Combination of internal and external factors and conditions
that can have an effect on an organization's approach to its
products, services and investments and interested parties
In April 2016, guidance was published in InTouch, to
explain context and suggest possible ways of identifying
context and the associated interested parties

A number of organisations have used PESTEL or SWOT
tools to assist them brainstorm:
• Internal and external issues
• Risks and opportunities associated with those issues
• Interested parties

ISO 9001:2015 - STRATEGIC CONTEXT
• You will be expected to demonstrate a broader
understanding of the context in which you operate.
• QMS must be able to meet its intended outcome –
• Understanding of the organisation’s direction, culture,
resources and external influences

LEADERSHIP-
CERTIFICATION
BODY
APPROACH

LEADERSHIP
Auditors now meet with top management and discuss:
• Strategic issues
• High level risks, e.g. the risk register, if there is one
• Longer term business plans and expectations
• How the QMS should deliver these

LEADERSHIP
• Strategic issues – high level documents and messages
• High level risks, e.g. the risk register, if there is one
• Longer term business plans and expectations – internal
communications
• How the QMS should deliver these

ISO 9001:2015 - STRATEGIC LEADERSHIP
• Senior managers will need to promote & be accountable
for the QMS.
• QMS should be integrated with other business processes
• Decisions are made with consideration for the QMS at all
levels

INTERVIEWING TOP MANAGEMENT
Risks to the business and how these are managed
Business
Legal
Technological
Social
Economical
Business
Political
Environmental

What about…….
• Values
• Culture
• Knowledge
• Performance

• Commitment to effective implementation
• Internal communication processes
• Performance review process
• Understanding the customer requirements

The assessor may be a customer and ask about things like;
• Delivery
• Returns
• Rework
• Complaints
• Efficiency

RISK AND
PROCESS-
CERTIFICATION
BODY
APPROACH

RISK REFERENCES PREVADE ISO 9001:2015

RISK, CONTROL AND OBJECTIVES
• ensure all equipment is correctly calibrated –
• risk - workmanship
• controlled by internal audit
• ensure rule books, work instructions on site are at correct issue –
• risk - workmanship and personal safety
• Controlled by internal audit and site safety tours
• all staff to be correctly trained and certified: no staff to be
unavailable because of late certification
• risk - workmanship, safety and business risk
• controlled by daily monitoring of the database

RISK BASED THINKING - EXAMPLE
John Smith demonstrated the cutting of 32 m of AMC-50FY. The cable
was delivered as a 500 m drum.
John and two other colleagues have received specialist training, in
Holland, in the use of the cutting machine.
A previous contractor damaged a significant amount of cable, so the
company took the decision to have proper training to reduce damage
risk.
There has been no cable damage as a consequence.

THE PROCESS BASED APPROACH
Auditors now discuss processes and process effectiveness
• How do you know your process is effective?
• What measures do you need to judge efficiency and
effectiveness?
• What are the potential weak points in your process,
(risk), and how do you address these?

THE PROCESS BASED APPROACH
• What are the challenges you face in delivering an
effective solution?
• What might go wrong and how does your approach, (or
procedure) address this?

WHAT IS THE PROCESS APPROACH? – ISO 9001:2015
0.3 Process Approach
When used within a quality management system, the process approach ensures:
a) understanding and consistently meeting requirements
b) consideration of processes in terms of added value
c) the achievement of effective process performance
d) improvement of processes based on evaluation of data and information
e) consideration of risk

PROCESS AUDIT “TURTLE” TOOL
Outputs
Conforming product delivered to
customer schedule (8.6)
Inputs
Customer schedule (8.2.1)
Raw materials (8.4.1)
How?
Control plans (8.5.1)
Work instructions (8.5.1)
Preventive maintenance (7.1.3)
SPC (9.1.3)
Nonconforming product procedure (8.7)
Dispatch process (8.6)
Contingency plan (8.5.6/6.1)
Document control/ records (7.5.3)
Change control (8.5.6)
What Results?
Analysis of data (9.1.3)
Customer satisfaction (9.1.2)
Other Organisational objectives (6.2)
Maintenance objectives (8.5)
Cost of poor quality (9.1.3)
Process capability (9.1)
Management review (9.3)
Continual improvement results (10.3)
Audit records (9.2)
With Who
Induction/ training records (7.2)
Agency/ Contract labour (7.3/8.4)
Job responsibilities/ authorities (5.3)
Training effectiveness (7.2)
SPC awareness (7.2)
Personnel safety (7.1.4)
Awareness of policy/ objectives (5.2.2)
With What?
Plant and machinery (7.1.3)
Measuring equipment (7.1.5)
Tooling (7.1.3)
Maintenance (7.1.3)
Packaging/labelling (8.5.4)
Cleanliness of premises (7.1.4)
Customer property (8.5.3)
Transportation (7.1.3)
Process
Manufacturing Process (8.5)
(Support Processes)
IT (7.1.3)
Human resource (7.1.2)
Logistics (7.1.3)
Sales (7.4)
Preventive maintenance (7.1.3)
Identify risks (6.1)

PROCESS
Questioning a process
• Who is the process owner
• Who is the customer of the process and what are their expectations
• What are the KPI’s / objectives / targets
• Are these appropriate to the risks
• Ask about the risks that were identified earlier
• What are the measurements / performance indicators
• What are the results
• What are they doing to improve
• What are the inputs
• What are the required outputs
• How do they know it is working well
• Record inputs to various process categories
• Is information correct and up to date
• Effectiveness and Efficiency

ISO 14001:2015 - EXPERIENCE ONE YEAR IN
• As with ISO 9001:2015 published on 15th September 2015
• Follows the Annex SL Model
• Will continue to be used until 2025 and possibly beyond.
• 5 Main Changes:
• Strategic Leadership
• Strategic Context
• Interested Party Analysis and Communication
• Risks and Opportunities
• Lifecycle Perspective

ISO 14001:2015 - RISKS AND OPPORTUNITIES
• There are three principle sources of risk and opportunity:
• Environmental aspects
• Compliance obligations
• Other issues and requirements
• Requirement to assess these sources for risks and
opportunities that need to be addressed.
• Maximise the opportunities & minimise/mitigate the risks
• This will ensure the success of the EMS and
benefit the organisation as a whole

ISO 14001:2015 - LIFECYCLE PERSPECTIVE
• Determine environmental aspects at each stage of the
lifecycle of product or service:
• Acquisition of raw materials
• Design
• Production
• Transportation/delivery
• Use and end of life/disposal
• Not just those relating to onsite activities
• Information about potential significant
environmental impacts can be provided

ISO 14001:2015 – OBJECTIVES EXAMPLE
Activity Aspect Impact Interested
parties
Risk/opp -
ortunity
Control Objective
Production
of the final
product
Use of
energy
Global
warming
Employees
Shareholders
Customers
Energy heavy
Use of renewables.
Invest in green
energy
Energy
efficiency
measures
5% carbon
reduction per
year
Sourcing
of raw
materials
Consumpti
on of
materials
Resource
depletion/
ground
pollution
Customers
Pressure groups
Modify design to
use recycled
materials
Demonstrate CSR
Increase sales
Design
control and
verification
measures.
Monitor
suppliers
50% increase
in recycled
content in 3
years
10% growth in
sales in 3
years
Use of the
product
Disposal of
product
Ground and
water
pollution
Employees
Shareholders
Customers
Pressure groups
Take back for re-
use/re-working.
Sales promotion
Programme
to offer take
back of
product to re-
use materials
Increase sales
and take back
by 10% per
year

ISO 9001:2015 & ISO 14001:2015 – LESSONS LEARNT
• So what have we learned in the last 12 months?
• The most successful transitions have been undertaken by those
companies with an advanced, mature EMS and QMS
• Planning this change for some time – use of ‘FDIS’
• Dialogue with their assessor
• Use of gap analysis tool
• Although new standard allows for radical changes to style of
documented system – most have adapted existing system
• ‘Buy in’ and demonstrable leadership at a senior level
(Managing Director or equivalent)

ISO 9001:2015 & ISO 14001:2015 - PITFALLS
• So what are the pitfalls?
• Assuming the new standard only requires a minor ‘tweak’ to the
existing EMS / QMS
• Failure to go ‘back to basics’ and properly understand the context of
the organisation
• Still thinking that the EMS is JUST about their own environmental
impact and failure to look at how the environment affects them
• Top management not being involved – “we pay you to do that!”
• Not allowing sufficient time.

To ensure a smooth transition, clients must complete a
transition gap analysis checklist
• Ensures all changes have been considered and addressed
• Ensures a smoother transition audit on the day
• Fulfils internal audit requirements
Many transition clients have benefitted from this

ISO 9001:2015 – TOP TAKE AWAYS
• We are all still learning – Assessors too!
• It may take several years for the full benefits of the
Annex SL, context and risk to enable your QMS to fully
integrate with and support the business.
• Don’t delay with your implementation

ISO45001:2017(?)
– STATUS OF THE
YOUNGER
SIBLING

NQA’S ADVICE
STARTING FROM SCRATCH
• Implement OHSAS 18001 as a
stepping stone
• Read the standard
• Identify sources of legal
compliance info
• Review hazard and risk
assessment
• Gap analysis – to identify
improvement points
MIGRATING FROM OHSAS 18001
• Maintain OHSAS 18001 until FDIS
of ISO 45001
• Read the standard (from ISO)
• Gap analysis – to identify
improvement points
• Mapping exercise for management
system migration
NB: Be prepared, but remember, migration of certification is not
possible until the ISO is published in 2017.

Thank you for listening
Keep In Touch
• www.nqa.com
• 0800 052 2424
• nqaukwebinar@nqa.com
• NQA Certification Ltd

Certification Body Approach to ISO 9001:2015 by NQA

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