Certification Body Approach to ISO 9001:2015 by NQA

CERTIFICATION BODY APPROACH TO ISO 9001: 2015DR MARGARET ROONEY28 SEPTEMBER 2016

EXPERIENCE AND LESSONS LEARNTDURING 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!

HappyBirthday!!


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 [email protected]


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

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 ApproachWhen used within a quality management system, the process approach ensures:a) understanding and consistently meeting requirementsb) consideration of processes in terms of added valuec) the achievement of effective process performanced) improvement of processes based on evaluation of data and informatione) consideration of risk

RS

PROCESS AUDIT “TURTLE” TOOL

OutputsConforming product delivered to

customer schedule (8.6)

InputsCustomer 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 WhoInduction/ 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)

ProcessManufacturing 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)




















With What?





























With What?





























With What?





























With What?





























With What?










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

ISO14001:2015 – ONE YEAR ON

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

EmployeesShareholdersCustomers

Energy heavyUse of renewables.Invest in green energy

Energy efficiency measures

5% carbon reduction per year

Sourcing of raw materials

Consumption of materials

Resource depletion/ ground pollution

CustomersPressure groups

Modify design to use recycled materialsDemonstrate CSRIncrease sales

Design control and verification measures.Monitor suppliers

50% increase in recycled content in 3 years10% growth in sales in 3 years

Use of the product

Disposal of product

Ground and water pollution

EmployeesShareholdersCustomersPressure 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

LESSONS LEARNT

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

FORM TR006 – PART 2


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

ISO 45001 - DELAYED

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

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