changes under iso 9001:2015 and how they will impact auditors and quality professionals richard...
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CHANGES UNDER ISO 9001:2015 AND HOW
THEY WILL IM
PACT AUDITORS AND QUALITY
PROFESSIONALS
Richard Green, Head of Technical Services,
IRCA
‘Spare me the jargon’
Richard Green, Head of Technical Services
EQMS User Group 2015
Leadership
Context
The Norwegian Blue
Annex SL
How far is London Waterloo?
Risk
Auditor - > Assessor
Opportunities
Documented information
Don’t panic Mr Mainwaring!
The Jargon Wall
Leadership
Context
The Norwegian Blue
Annex SL
How far is London Waterloo?
Risk
Auditor - > Assessor
Opportunities
Documented information
Don’t panic Mr Mainwaring!
The Jargon Wall
Annex SL
‘The most important management system event since the launch of ISO 9001 itself’ (IRCA)
Annex SL = ‘The management system writers’ standard’
ISO problem –> ISO solution
It is called Annex SL because it comes after Annex SK and before Annex SM (in ISO Directives Part 1)
Annex SL• High Level Structure• Identical Core Text• Common Terms and
Core Definitions
Clause 1 - ScopeClause 2 - Normative referencesClause 3 - Terms and definitionsClause 4 - Context of the organizationClause 5 - LeadershipClause 6 - PlanningClause 7 - SupportClause 8 - OperationClause 9 - Performance evaluationClause 10 - Improvement
Organization Interested PartyRequirement Management systemTop management EffectivenessPolicy ObjectiveRisk CompetenceProcess PerformanceOutsource MonitoringMeasurement AuditConformity NonconformityCorrective action Continual improvementDocumented Information
5. Leadership
5.1 Leadership and commitmentTop management shall demonstrate leadership and commitment with respect to the XXX management system by:- ensuring that the XXX policy and XXX objectives are established and are compatible with the strategic direction of the organization- ensuring the integration of the XXX management system requirements into the organization’s business processes;- ensuring that the resources needed for the XXX management system are available
Annex SL‘The adoption of Annex SL is the beginning of the end of the conflicts, duplication, confusion and misunderstanding arising from different management system standards’
Mike James, LRQA.
Leadership
Context
The Norwegian Blue
Annex SL
How far is London Waterloo?
Risk
Auditor - > Assessor
Opportunities
Documented information
Don’t panic Mr Mainwaring!
The Jargon Wall
How far is London Waterloo?
1.9 miles
113 miles
The length of a journey depends not just on the destination but also, crucially, the start point.
Leadership
Context
The Norwegian Blue
Annex SL
How far is London Waterloo?
Risk
Auditor - > Assessor
Opportunities
Documented information
Don’t panic Mr Mainwaring!
The Jargon Wall
Leadership‘management commitment’ replaced by ‘Leadership and commitment’
3.05 - ‘top management’ – the person or group of people who directs or controls and organization at the highest level’.
Top Managers -> There’s now stuff you cannot delegate but HAVE to do yourselves.
ENSURING vs ENGAGING/ PROMOTING/ SUPPORTING
Beware, the audit team cometh……
Leadership
Context
The Norwegian Blue
Annex SL
How far is London Waterloo?
Risk
Auditor - > Assessor
Opportunities
Documented information
Don’t panic Mr Mainwaring!
The Jargon Wall
The Norwegian Blue
has ceased to be’‘This is a dead parrot. It ‘The management representative
Leadership
Context
The Norwegian Blue
Annex SL
How far is London Waterloo?
Risk
Auditor - > Assessor
Opportunities
Documented information
Don’t panic Mr Mainwaring!
The Jargon Wall
Context of the organisationDetermination of Scope of the XXX Management System (i.e. its’ boundaries and applicability)
Determine those internal and external issue with the potential to affect the XXX management systems’ ability to achieve it’s intended results
Determine the requirements of relevant interested parties (stakeholders) that are relevant to the XXX management system
Determination of XXX policy and XXX objectives
Determination of risk and opportunities as part of Planning
Determination of processes necessary for considering and controlling ‘organisational knowledge’
CONTEXT OF THE ORGANIZATION
Context of the organisation‘The good news is that if your organisation was still in business when you left this morning the chances are it’s already got a
pretty good understanding of what its’ Context is’.
Unlike this lot!
Leadership
Context
The Norwegian Blue
Annex SL
How far is London Waterloo?
Risk
Auditor - > Assessor
Opportunities
Documented information
Don’t panic Mr Mainwaring!
The Jargon Wall
Risk3.09 - risk‘effect of uncertainty’
Note 1 to entry: An ‘effect’ is a deviation from the expected — positive or negative.
Technical Committee 176 - ‘Holy wars’
Risk1. Determine the risks and opportunities that need to be addressed to:
• give assurance that the XXX management system can achieve its intended outcome(s);
• prevent, or reduce, undesired effects;• achieve continual improvement.
Annex SL does not prescribe or mandate a risk management methodology
2. The organization shall plan:• actions to address these risks and opportunities;• how to integrate and implement the actions into its XXX management
system processes and evaluate the effectiveness of these actions.
Leadership
Context
The Norwegian Blue
Annex SL
How far is London Waterloo?
Risk
Auditor - > Assessor
Opportunities
Documented information
Don’t panic Mr Mainwaring!
The Jargon Wall
Documented Information
Typical pre Annex SL documentation ‘pyramid’
More freedom to decide what information you want to hold and how you want to hold it.
Standards now refer to ‘retaining’ or ‘maintaining’ specific ‘documented information’.
You don’t have to throw out your XXX manual and XXX procedures if you don’t want to. If they work for you – keep them!
Policy
XXX Manual
XXX Procedures
Records and FormsDocumented Information
Post Annex SL
Documented information is media agnostic.
Leadership
Context
The Norwegian Blue
Annex SL
How far is London Waterloo?
Risk
Auditor - > Assessor
Opportunities
Documented information
Don’t panic Mr Mainwaring!
The Jargon Wall
Auditor -> Assessor
The way audits are planned, conducted and reported will need to change.
Auditors will increasingly need to use their judgement = less black and white, more grey
Auditors will need to upskill – increasing not just their knowledge of the new requirements but also their interpersonal skills, technical skills and sector awareness
Leadership
Context
The Norwegian Blue
Annex SL
How far is London Waterloo?
Risk
Auditor - > Assessor
Opportunities
Documented information
Don’t panic Mr Mainwaring!
The Jargon Wall
Opportunities
For organisations – cost and efficiency savings if operating more than one management system.
For quality managers – a greater duplication of requirements = less work to manage systems. More people helping you – no longer the ‘lone champion’
For auditors - should eventually make life easier for auditors = common requirements (but will bring other challenges)
Leadership
Context
The Norwegian Blue
Annex SL
How far is London Waterloo?
Risk
Auditor - > Assessor
Opportunities
Documented information
Don’t panic Mr Mainwaring!
The Jargon Wall
‘Don’t panic Mr. Mainwaring’ISO 9001:2015 - September - 3 year transitionISO 14001:2015 - October - 3 year transition
• Increase awareness in your organisation• Speak to your certification body• Develop a transition plan• Upskill where necessary• Realise the opportunities
We can help so stay in touch!
