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DNV GL ISO 9001+14001:2015 Transitie Checklist of 9

TransitiechecklistISO9001+14001:2015

Dit document geeft alleen de specifieke wijzigingen en nieuwe eisen van de ISO 9001+14001:2015 aan. In sommige gevallen is een note aangegeven om de normeis te verduidelijken, in de rechterkolom is aangegeven wat er verwacht mag worden en wat de auditor zou moeten kunnen vaststellen. Die tekst mag gedelete worden zodra er wordt ingevuld hoe de organisatie wel/niet aan de eisen voldoet. Benoem de beoordeelde documenten/registraties en geef in het kort een toelichting aan hoe deze invulling geven aan de normeis.

Minimale documentatie eisen: In dit document is aangegeven bij welke normeisen documentatie wordt vereist of dat er alleen sprake is van de verplichting dat de organisatie eea moet vaststellen.

Documentation requirements

Documentation equirements

Klant :

Project nummer :

Lead Auditor / Auditteam :

Datum uitgevoerd :

Zie Appendix 1: Documentation requirements ISO 9001:2015 (achteraan dit document)

Zie Appendix 2: Documentation requirements ISO 14001:2015 (achteraan dit document)


Veranderingen Element Items reviewed Resultaat

OK? Beoordeelde documentatie, registratie en informatie

4.1 Inzicht in de organisatie en haar context

Hoe heeft de organisatie externe en interne belangrijke punten (issues) vastgesteld die relevant zijn voor haar doel en de strategische richting ervan?

Note: - Dit kunnen positieve en negatieve

factoren zijn.- Externe factoren kunnen

voortkomen uit juridische,technologische, concurrentie-,markt-, culturele, maatschappelijkeen economischeomstandigheden, zowelinternationaal, nationaal, regionaalals lokaal.

- Interne factoren kunnen verbandhouden met waarden, cultuur,kennis en de prestaties van deorganisatie.

Specifiek voor 9001 Hoe worden deze ‘issues’ gemonitoord en beoordeeld?

Specifiek voor 14001 Welke milieueffecten kan de organisatie zelf beïnvloeden c.q. kunnen de organisatie beïnvloeden?

Ja/Nee Er is geen document vereist, maar dit zou herleidbaar moeten zijn in notulen van vergaderingen, strategie c.q. strategische analyse, SWOT analyse etc. afhankelijk van de complexiteit van de organisatie.

4.2 Inzicht in de behoeften en verwachtingen van belanghebbenden

Hoe heeft de organisatie vastgesteld:

- welke belanghebbendenrelevant zijn voor het MS

- welke eisen van dezebelanghebbenden relevant zijnvoor het MS

Specifiek voor 9001 Hoe wordt de informatie over deze belanghebbenden en hun relevante eisen gemonitoord en beoordeeld?

Specifiek voor 14001 Welke behoefte en verwachtingen betreft compliance verplichtingen?

Ja/Nee Ook hier geen documentatie vereist, maar verwacht mag worden dat de

uitkomst van de ‘stakeholderanalyse’ is

verwerkt in een tabel met verschillende belanghebbenden en overeenkomstige behoeften en verwachtingen (eisen).

4.3 Het toepassingsgebied van het kwaliteits-

Is de scope van het MS vastgelegd en zijn de producten, diensten en uitsluitingen hierin opgenomen?

Ja/Nee Dit dient gedocumenteerd te zijn.




managementsysteem vaststellen

Note: Bij het vaststellen van de scope moet de organisatie het volgende overwegen:

- de in 4.1 genoemde externe eninterne belangrijke punten (issues)

- de in 4.2 genoemde eisen vanrelevante belanghebbenden

Specifiek voor 14001 Is de scope beschikbaar voor stakeholders?

4.4 QMS en de processen ervan

Heeft de organisatie van de processen vastgesteld:

- de inputs en outputs- de bijbehorende prestatie-

indicatoren- de verantwoordelijkheden en

bevoegdheden- de risico’s en kansen (zie ook

6.1)

Note: In de norm ISO 9001:2015 staat onder 0.3.1 een schematische weergave van de elementen van een proces

Specifiek voor 14001 Deze eis is nvt voor milieu.

Ja/Nee Hier dient de organisatie documentatie bij te houden om de processen te ondersteunen en aan te tonen dat de processen beheerst verlopen.

5.1 Leiderschap en betrokkenheid

Hoe is leiderschap aantoonbaar van de directie i.r.t.:

- de effectiviteit van het MS- de strategie van de organisatie- integratie van eisen in de

processen- het betrekken van de

medewerkers om het MS teondersteunen

Specifiek voor 9001 - proces- en risicogericht denken

Specifiek voor 14001 Geen extra eisen.

Ja/Nee Dit is bvb terug te vinden in de strategie, beleid, doelstellingen, interne communicatie, (management) meetings maar ook zichtbaarheid van de directie.

5.2 Beleid Is het beleid compatibel met strategische richting en de context van de organisatie?

Specifiek voor 14001 Bevat het beleid een verbintenis tot bescherming van het milieu, waaronder

Ja/Nee Dit dient gedocumenteerd te zijn.




preventie van milieuvervuiling en andere relevante specifieke verbintenis(sen) Note: Andere specifieke verbintenissen tot bescherming van het milieu kunnen onder andere bestaan uit duurzaam gebruik van hulpbronnen, het tegengaan van en aanpassen aan klimaatverandering, en het beschermen van biodiversiteit en ecosystemen.

6.1 Acties om risico’s

en kansen op te pakken

Is er sprake van een systematische aanpak om de risico’s en kansen vast te stellen, rekening houdend met de factoren uit 4.1 en de stakeholderanalyse uit 4.2. Note: voor milieu gaat het primair om de ‘high level’ risico’s Hoe zijn acties en beheersmaatregelen voortkomend uit de risico’s en kansen geïmplementeerd in de processen zoals gedefinieerd in 4.4? Hoe wordt de effectiviteit van de acties en beheersmaatregelen geëvalueerd? Specifiek voor 14001 Is bij het vaststellen van de milieuaspecten en bijbehorende impact rekening gehouden met:

- een levenscyclusperspectief - abnormale omstandigheden - redelijkerwijs voorzienbare

noodsituaties Note: Kenmerkende fasen van de levenscyclus van een product (of dienst) zijn het winnen van grondstoffen, ontwerp, productie, transport/levering, gebruik, behandeling bij het einde van de levensduur en de definitieve verwijdering. (zie A.6.1.2 van de 14001-norm)

Ja/Nee Je mag verwachten dat er registraties worden bijgehouden, dit zijn zowel corrigerende als preventieve maatregelen.

6.2 Kwaliteitsdoelstellingen en de planning om ze te bereiken

Zijn de doelstellingen: - consistent met de strategie en

de vastgestelde factoren uit 4.1 - relevant voor het voldoen aan

eisen van producten en

Ja/Nee Doelstellingen dienen te zijn gedocumenteerd. De methode van evaluatie van doelstellingen dient te zijn vastgesteld, dit kan per doelstelling verschillen.




diensten en voor het verhogen van de klanttevredenheid

Hoe worden de resultaten geëvalueerd? Note: voor het monitoren van meetbare milieudoelstellingen dienen milieu-indicatoren te zijn opgesteld Specifiek voor 14001 Houden de doelstellingen rekening met:

- de belangrijke milieuaspecten - de bijbehorende compliance

verplichtingen - risico’s en kansen

6.3 Planning van wijzigingen

Worden wijzigingen in het QMS op geplande (systematische) wijze doorgevoerd? Wordt er rekening gehouden met:

- het doel van de wijzigingen - gevolgen (risicobenadering) - noodzakelijke middelen - verantwoordelijkheden en

bevoegdheden Specifiek voor 14001 Deze eis is nvt voor milieu.

Ja/Nee Er is geen eis van 1 methode, maar volgens de HLS (zie ook 8.1) is

‘management of change’ vereist, de

norm verwijst ook naar 4.4. v.w.b. beheersing van processen. Hier zit ook een link met 7.1.6 als het gaat om noodzakelijke kennis vaststellen, borgen en beheersen.

7.1.6 Kennis binnen de organisatie

Hoe houdt de organisatie rekening met noodzakelijke kennis om te kunnen (blijven) voldoen:

- werking van de processen - kwaliteit van producten en

diensten - wijziging in behoeften en

trends (reageren op de factoren uit 4.1. en de behoefte en verwachtingen uit 4.2)

Note: Dit is kennis die specifiek is voor de organisatie, verkregen door ervaring en kan worden gebaseerd op: a) interne bronnen (bijv. intellectueel eigendom; aan ervaring ontleende kennis; lessen die zijn geleerd uit mislukkingen en geslaagde projecten; het opvangen en

Ja/Nee Dit is kennismanagement en gaat verder dan kennis van mensen, maar betreft ook die van (data)systemen, processen, routines, samenwerking, etc.




delen van niet-gedocumenteerde kennis en ervaring; de resultaten van verbeteringen in processen, producten en diensten); b) externe bronnen (bijv. normen;academische wereld; conferenties; hetvergaren van kennis van klanten of externeaanbieders).


7.4 Communicatie Heeft de organisatie vastgesteld welke interne en externe communicatie relevant is, inclusief: a) waarover te communiceren;b) wanneer te communiceren;c) met wie te communiceren;d) hoe te communiceren;e) wie er communiceert.

Specifiek voor 14001 Hoe voorziet interne communicatie in de mogelijkheid voor de medewerkers om bij te dragen aan continue verbetering?

Hoe wordt milieurelevante informatie extern gecommuniceerd en voorziet deze in compliance verplichtingen?

Ja/Nee Dit kan communicatie zijn naar alle stakeholders, zoals klanten en overheden.

8.1 Operationele planning en beheersing

Hoe beheerst de organisatie het doorvoeren van geplande en de consequenties van onbedoelde wijzigingen?

Wordt er rekening gehouden met de vastgestelde processen volgens 4.4, en de acties die benoemd zijn onder 6.1 om risico’s en kansen op te pakken?

Note: in dit normelement worden ook eisen gesteld over beheersing van uitbestede processen, die zijn verder onder 8.4 uitgewerkt.

Specifiek voor 14001 Hoe worden milieueisen meegewogen vanwege het levenscyclusperspectief

Ja/Nee Hier is documentatie verplicht van zowel de uitvoering als de uitkomst van processen.




bij: a) het ontwerp- en

ontwikkelproces, metoverweging van elke fase vanhun levenscyclus;

b) inkopenc) de inzet van externe

leveranciers, met inbegrip vanaannemers (ook uitbesteedwerk)

d) communicatie over mogelijkebelangrijke milieueffecten inverband met transport oflevering, gebruik, behandelingbij het einde van de levensduuren definitieve verwijdering

8.2 Voorbereid zijn en reageren op noodsituaties

Specifiek voor 14001 Hoe wordt in relatie met de vastgestelde kansen en bedreigingen uit 6.1 de noodsituaties vastgesteld?

Hoe worden relevante stakeholders voorzien van relevante informatie en training met betrekking tot het voorbereid zijn en reageren op noodsituaties.

Specifiek voor 9001 Deze eis is nvt voor kwaliteit

Ja/Nee Hier is documentatie verplicht om te kunnen aantonen dat dit volgens planning verloopt

8.4 Beheersing van extern geleverde processen, producten en diensten

Heeft de organisatie vastgesteld welke vorm van verificatie of toezicht nodig is om te zorgen dat extern geleverde (uitbestede!) processen, producten en diensten aan de eisen voldoen?

Note: onder 7.2 wordt ook de eis gesteld dat de competentie van personeel, zowel ingehuurd als van derden, wordt vastgesteld en beoordeeld. (dit wordt onder A8 in de norm toegelicht)


Ja/Nee Hier is documentatie en registratie verplicht van het toezicht, de genomen maatregelen en evaluaties.

8.5.5 Nazorgactiviteiten

Heeft de organisatie vastgesteld of er sprake is van nazorg en hierbij rekening gehouden met:

a) eisen uit wet- en regelgeving;

Ja/Nee Soms zijn er geen formele verplichtingen opgenomen maar is er

toch sprake van ‘service’ waarbij aan




b) de mogelijke ongewenstegevolgen die samenhangenmet haar producten endiensten;

c) de aard, het gebruik en debeoogde levensduur van haarproducten en diensten;

d) eisen van klanten;e) feedback van klanten.

Note: Nazorgactiviteiten kunnen bestaan uit acties die voortvloeien uit garantiebepalingen, contractuele verplichtingen zoals onderhoudsdiensten, en aanvullende diensten zoals recyclen of definitieve verwijdering.


deze voorwaarden moet worden voldaan.

8.5.6 Beheersing van wijzigingen

Hoe worden wijzigingen voor productie of diensten beoordeeld en beheerst om zeker te stellen dat de organisatie aan de eisen blijft voldoen?

Note: de organisatie moet gedocumenteerde informatie bijhouden over de resultaten van de beoordeling van wijzigingen, de perso(o)n(en) die toestemming geeft/geven voor de wijziging en eventuele noodzakelijke maatregelen die voortkomen uit de beoordeling.


Ja/Nee Dit gaat alleen om wijzigingen van producten/diensten, niet zoals bij 8.1 van processen. Geplande wijzigingen kan voortkomend vanuit ontwerp of bvb Inkoop, bij ongeplande wijzigingen gaat

het erom of de organisatie deze risico’s

al in kaart had gebracht (bvb 2de leverancier, extra voorraad, extra opgeleid personeel, etc.)

9.1 Monitoren, meten, analyseren en evalueren

Heeft de organisatie t.b.v. monitoren, meten, analyseren en evalueren het volgende vastgesteld: a) watb) welke methodenc) wanneer monitoren en metend) wanneer geanalyseerd/geëvalueerd

Specifiek voor 14001 - criteria en bijbehorende

indicatoren waartegenmilieuprestaties wordengeëvalueerd

Ja/Nee Hier is documentatie en registratie verplicht van de analyse en evaluatie.




Hoe worden de analyse resultaten gebruikt om tot evaluatie te komen van:

- de doeltreffendheid vanondernomen acties voor hetoppakken van risico’s enkansen;

- de prestaties van externeaanbieders (dus ookuitbesteed werk)

Specifiek voor 14001 De organisatie moet relevante informatie over milieuprestaties zowel intern als extern communiceren, zoals geïdentificeerd in haar communicatieproces(sen) en zoals vereist volgens haar compliance verplichtingen.

9.3 Directiebeoordeling

Heeft de organisatie gebruikt gemaakt van de volgende input:

- (veranderingen in) interne enexterne factoren (4.1)

- ook terugkoppeling van anderestakeholders dan klanten (4.2)

- effectiviteit van genomenacties vanwege kansen enbedreigingen (6.1) -> dusimpliciet het functioneren vanmanagement of change (6.3)

- prestatie van leveranciers vanuitbesteed werk (8.4.1)

- geschiktheid van middelen

Specifiek voor 14001 Hier wordt meer nadruk gelegd op het behandelen van wijzigingen in:

1. externe en interne belangrijkepunten (issues) die relevantzijn voor het EMS

2. de behoeften enverwachtingen vanbelanghebbenden, metinbegrip van complianceverplichtingen

3. haar belangrijkemilieuaspecten

4. risico’s en kansen

Ja/Nee Formeel is alleen documentatie van de output van de management review verplicht, maar van de input is bij bij 9.1(3) en diverse normelementen al verplicht gesteld om dit te documenteren.

Updated October 1st 2015

Appendix 1: Documentation requirements ISO 9001:2015 In the HLS ‘Documented information’ replaces both the nouns ‘documentation’ and ‘record’ used in prior editions.

From the text it is normally evident when “documented information” relates to “records” as evidence of performed activity/process and when “documents information” relates to how to perform an activity/ process. Normally the standard refers to “shall maintain documented information” when the meaning is how to perform an activity/process and “shall retain documented information” when the meaning is to keep evidence of performed activity/process.

These are the minimum documentation requirements. Organizations themselves can decide that they need additional documented information.

Clause Documentation requirement 4.3

(Scope) The scope of the organization’s quality management system shall be available and be maintained as documented information. The scope shall state the types of products and services covered, and provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system.

4.4 (Quality

management system and its

processes)

4.4.2 To the extent necessary, the organization shall: a) maintain documented information to support the operation of its processes;b) retain documented information to have confidence that the processes are beingcarried out as planned.

5.2.2 (Communicating

the quality policy)

5.2.2 The quality policy shall:

a) be available as documented information;b) be communicated, understood and applied within the organization;c) be available to interested parties, as appropriate;

6.2 (Quality

objectives and planning to

achieve them)

The organization shall maintain documented information on the quality objectives.

7.1.5.1 (Monitoring and

measuring resources –

General)

The organization shall retain appropriate documented information as evidence of fitness for purpose of monitoring and measuring devices.

7.1.5.2 (Measurement traceability)

When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be:

a) calibrated or verified, or both, at specified intervals, or prior to use, againstmeasurement standards traceable to international or national measurementstandards; when no such standards exist, the basis used for calibration or verificationshall be retained as documented information;

7.2 (Competence) The organization shall:

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d) retain appropriate documented information as evidence of competence.

7.5.1 (Documented information -

General)

The organization’s quality management system shall include:

a) documented information required by this International Standard;

b) documented information determined by the organization as being necessaryfor the effectiveness of the quality management system.

NOTE The extent of documented information for a quality management system can differ from one organization to another due to:

- the size of organization and its type of activities, processes, products andservices;

- the complexity of processes and their interactions;- the competence of persons.

8.1 (Operational planning and

control) e) determining, maintaining and retaining documented information to the extent

necessary

1) to have confidence that the processes have been carried out as planned;2) to demonstrate conformity of products and services to their requirements.

8.2.3 (Review of

requirements for products and

services)

8.2.3.2 The organization shall retain documented information, as applicable:

a) on the results of the review;

b) on any new requirements for the products and services.

8.3.2 (Design and development

planning)

In determining the stages and controls for design and development, the organization shall consider:

j) the documented information needed to demonstrate that design anddevelopment requirements have been met.


inputs)

The organization shall retain documented information on design and development inputs.


control)

The organization shall apply controls to the design and development process to ensure that:

f) documented information of these activities is retained


output)

The organization shall retain documented information on the design and development outputs.


The organization shall retain documented information on: a) design and development changes;

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changes) b) the results of reviews;c) the authorization of the changes;d) the actions taken to prevent adverse impacts.

8.4 (Control of external provided

products and services -

8.4.1 General)

The organization shall retain documented information of the results of these activities and any necessary actions arising from the evaluations.

8.5.1 (Control of

production and service

provision)

Controlled conditions shall include, as applicable:

a) the availability of documented information that defines:

1) the characteristics of the products to be produced, the services to beprovided, or the activities to be performed;

2) the results to be achieved;

8.5.2 (Identification

and traceability) The organization shall control the unique identification of the outputs when traceability is a requirement, and shall retain the documented information necessary to enable traceability.

8.5.3 (Property

belonging to customers or

external providers)

When the property of a customer or external provider is lost, damaged or otherwise found to be unsuitable for use, the organization shall report this to the customer or external provider and retain documented information on what has occurred.

8.5.6 (Control of changes)

The organization shall retain documented information describing the results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review.

8.6 (Release of goods and services)

The organization shall retain documented information on the release of products and services. The documented information shall include:

a) evidence of conformity with the acceptance criteria;

b) traceability to the person(s) authorizing the release.

8.7.2 (Control of

nonconforming outputs)

The organization shall retain documented information that: a) describes the nonconformity;b) describes the actions taken;c) describes any concessions obtained;d) identifies the authority deciding the action in respect of the nonconformity.

9.1 (Monitoring,

measurement, analysis and evaluation -

9.1.1 General)

The organization shall retain appropriate documented information as evidence of the results.

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9.2 (Internal Audit) 9.2.2 The organization shall:

f) retain documented information as evidence of the implementation of the auditprogramme and the audit results.

9.3.3 (Management

review) The organization shall retain documented information as evidence of the results of management reviews.

10.2 (Nonconformity and corrective

action)

10.2.2 The organization shall retain documented information as evidence of:

a) the nature of the nonconformities and any subsequent actions taken;

b) the results of any corrective action.

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Furthermore, the new standard in several places uses the wording “shall determine”. What does this mean? Annex A.3 of ISO 14001:2015 explains “The change from “identify” to “determine” is intended to harmonize wih the standardized management system terminology. The word “determine” implies a discovery process that results in knowledge.”

There is no explicit “documentation” requirement, but where “determine” is used the organization should at least be able to demonstrate and give confidence of completeness and control of such activities/processes.

4.1 (Understanding the organization and its context)

The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.

4.2 (Understanding the needs and expectations of

interested parties)

Due to their impact or potential impact on the organisation’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine:

a) the interested parties that are relevant to the quality management system;

b) the requirements of these interested parties that are relevant to the qualitymanagement system.

4.3 (Scope) The organization shall determine the boundaries and applicability of the quality

management system to establish its scope.

4.4 (Quality

management system and its

processes)

The organization shall determine the processes needed for the quality management system and their application throughout the organization and shall:

a) determine the inputs required and the outputs expected from theseprocesses;

b) determine the sequence and interaction of these processes;

c) determine and apply the criteriaand methods (including monitoring,measurements and related performance indicators) needed to ensure theeffective operation and control of these processes;

d) determine the resources needed and ensure their availability;

e) assign the responsibilities and authorities for these processes;

f) address the risks and opportunities as determined in accordance with therequirements of 6.1;

g) evaluate these processes and any needed to ensure that these processesachieve their intended results;

h) improve the processes and the quality management system.

6.1 (Actions to address risks and

6.1.1 When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to:

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opportunities) a) give assurance that the quality management system can achieve its intended

result(s);b) enhance desirable effects;c) prevent, or reduce, undesired effects;d) achieve improvement.

6.2 (Quality objectives and planning to achieve them)

6.2.2 When planning how to achieve its quality objectives, the organization shall determine:

a) what will be done,

b) what resources will be required,

c) who will be responsible,

d) when it will be completed, and

e) how the results will be evaluated.

7.1 (Resources -

7.1.1 General) The organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system.

7.1.2 (People) The organization shall determine and provide the persons necessary for the effective

implementation of its quality management system and for the operation and control of its processes.

7.1.3 (Infrastructure) The organization shall determine, provide and maintain the infrastructure necessary

for the operation of its processes to achieve conformity of products and services.

7.1.4 (Environment for the operation of

processes)

The organization shall determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services.

7.1.5 (Monitoring and

measuring resources)

The organization shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements.

The organization shall determine if the validity of previous measurement results have been adversely affected when measuring equipment is found to be unfit for its intended purpose and shall take appropriate action as necessary.

7.1.6 (Organisational

knowledge) The organization shall determine the knowledge necessary for the operation of its processes and to chief conformity of products and services.

When addressing changing needs and trends, the organization shall consider its current knowledge and determine how to acquire or access any necessary additional knowledge and required updates.

7.2 (Competence) The organization shall:

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a) determine the necessary competence of person(s) doing work under itscontrol that affects the performance and effectiveness of the qualitymanagement system;

7.4 (Communication)

The organization shall determine the internal and external communications relevant to the quality management system including:

a) on what it will communicate,

b) when to communicate,

c) with whom to communicate,

d) how to communicate

e) who communicates.


inputs)

The organization shall determine requirements essential for the specific type of products and services being designed and developed. The organization shall consider:

a) functional and performance requirements;

b) information derived from previous similar design and development activities;

c) statutory and regulatory requirements;

d) standards or codes of practice that the organization has committed toimplement;

e) potential consequences of failure due to the nature of the products andservices.

8.4 Control of externally provided

processes, products and

services - 8.4.1 General)

The organization shall determine the controls to be applied to externally provided processes, products and services when:

a) products and services from external providers are intended for incorporationinto the organization’s own products and services;

b) products and services are provided directly to the customer(s) by externalproviders on behalf of the organization;

c) a process, or part of a process, is provided by an external provider as aresult of a decision by the organization.

The organization shall determine and apply criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers, based on their ability to provide processes or products and services in accordance with requirements.

8.4.2 (Type and extent

of control) The organization shall:

a) determine the verification, or other activities, necessary to ensure that theexternally provided processes, products and services meet requirements.

9.1 (Monitoring,

measurement, The organization shall determine:

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analysis and evaluation -

9.1.1 General)

a) what needs to be monitored and measured;

b) the methods for monitoring, measurement, analysis and evaluation neededto ensure valid results;

c) when the monitoring and measuring shall be performed;

d) when the results from monitoring and measurement shall be analysed andevaluated.

9.1.2 (Customer satisfaction)

The organization shall monitor customers’ perceptions of the degree to which their needs and expectations have been fulfilled. The organization shall determine the methods for obtaining, monitoring and reviewing this information.

10 (Improvement - 10.1 General)

The organization shall determine and select opportunities for improvement and implement necessary actions to meet customer requirements and enhance customer satisfaction.


Appendix 2: Documentation requirements ISO 14001:2015

In the HLS ‘Documented information’ replaces both the nouns ‘documentation’ and ‘record’ used in prior editions.

From the text it is normally evident when “documented information” relates to “records” as evidence of performed activity/process and when “documented information” relates to how to perform an activity/ process. Normally the standard refers to “shall maintain documented information” when the meaning is how to perform an activity/process and “shall retain documented information” when the meaning is to keep evidence of performed activity/process.

These are the minimum documentation requirements. Organizations themselves can decide that they need additional documented information.

Clause Documentation requirement4.3

(Scope) The scope shall be maintained as documented information and be available to interested parties.

5.2 (Policy)

The environmental policy shall be maintained as documented information.

6.1.1 (General)

The organization shall maintain documented information of its: - risks and opportunities that need to be addressed;- process(es) needed in 6.1.1 to 6.1.4, to the extent necessary to have

confidence they are carried out as planned.

6.1.2 (Environmental

aspects)

The organization shall maintain documented information of its: - environmental aspects and associated environmental impacts;- criteria used to determine its significant environmental aspects;- significant environmental aspects

6.1.3 (Compliance obligations)

The organization shall maintain documented information of its compliance obligations.


objectives)

The organization shall retain documented information on the environmental objectives.

7.2 (Competence)

The organization shall retain appropriate documented information as evidence of competence.

7.4.1 (Communication –

General)

The organization shall retain documented information as evidence of its communications, as appropriate.

7.5.1 (Documented information –

General)

The organization’s environmental management system shall include: a) documented information required by this International Standard;b) documented information determined by the organization as being

necessary for the effectiveness of the environmental management system.

NOTE The extent of documented information for an environmental management system can differ from one organization to another due to:

- the size of organization and its type of activities, processes, products andservices;

- the need to demonstrate fulfilment of its comlaince obligations- the complexity of processes and their interactions;- the competence of persons.

8.1 (Operational

The organization shall maintain documented information to the extent necessary to have confidence that the processes have been carried out as planned.

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planning and control)

8.2 (Emergency

preparedness and response)

The organization shall maintain documented information to the extent necessary to have confidence that the process(es) is (are) carried out as planned.

9.1.1 (Monitoring,

measurement, analysis and evaluation –

General)

The organization shall retain appropriate documented information as evidence of the monitoring, measurement, analysis and evaluation results.

9.1.2 (Evaluation of compliance)

The organization shall retain documented information as evidence of the compliance evaluation result(s).

9.2.2 (Internal audit programme)

The organization shall retain documented information as evidence of the implementation of the audit programme and the audit results.

9.3 (Management

review)

The organization shall retain documented information as evidence of the results of management reviews.

10.1 (Non-conformity and corrective

action)

The organization shall retain documented information as evidence of: the nature of the nonconformities and any subsequent actions taken; the results of any corrective action.

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Furthermore, the new standard in several places uses the wording “shall determine”. What does this mean? Annex A.3 of ISO 14001:2015 explains “The change from “identify” to “determine” is intended to harmonize wih the standardized management system terminology. The word “determine” implies a discovery process that results in knowledge.”

There is no explicit “documentation” requirement, but where “determine” is used the organization should at least be able to demonstrate and give confidence of completeness and control of such activities/processes.

Clause ISO 14001 requirement

4.1 (Organisational

context)

The organization shall determine external and internal issues that are relevant to its purpose and that affect its ability to achieve the intended outcome(s) of its environmental management system. Such issues shall include environmental conditions being affected by or capable of affecting the organization.

4.2 (Interested parties)

The organization shall determine: the interested parties that are relevant to the environmental management

system; the relevant needs and expectations (i.e. requirements) of these interested

parties; which of these needs and expectations become its compliance obligations.

4.3 (Scope)

The organization shall determine the boundaries and applicability of the environmental management system to establish its scope.

6.1 (Actions to address risks and

opportunities) 6.1.1 (General)

When planning for the environmental management system, the organization shall consider:

a) the issues referred to in 4.1;b) the requirements referred to in 4.2;c) the scope of its environmental management system;

and determine the risks and opportunities, related to its environmental aspects (see 6.1.2), compliance obligations (see 6.1.3)and other issues and requirements, identified in 4.1 and 4.2,that need to be addressed to: — give assurance that the environmental management system can achieve its intended outcomes; — prevent, or reduce, undesired effects, including the potential for external environmental conditions to affect the organization; — achieve continual improvement.

Within the scope of the environmental management system, the organization shall determine potential emergency situations, including those that can have an environmental impact.


aspects)

Within the defined scope of the environmental management system, the organization shall determine the environmental aspects of its activities, products and services that it can control and those that it can influence, and their associated environmental impacts, considering a life cycle perspective.

The organization shall determine those aspects that have or can have a significant environmental impact, i.e. significant environmental aspects, by using established criteria.

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6.1.3 (Compliance obligations)

The organization shall: a) determine and have access to the compliance obligations related to its

environmental aspects;b) determine how these compliance obligations apply to the organization.

6.2.2 (Planning actions

to achieve environmental

objectives)

When planning how to achieve its environmental objectives, the organization shall determine:

what will be done; what resources will be required; who will be responsible; when it will be completed; how the results will be evaluated, including indicators for monitoring

progress toward achievement of its measurable environmental objectives

7.1 (Resources)

The organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the environmental management system.

7.2 (Competence)

The organization shall: - determine the necessary competence of person(s) doing work under its

control that affects its environmental performance and its ability to fulfil itscompliance obligations.

- determine training needs associated with its environmental aspects and itsenvironmental management system;

8.1 (Operational planning and

control)

Consistent with a life cycle perspective, the organization shall: b) determine environmental requirement(s) for the procurement of products

and services, as appropriate;

9.1.1 (Monitoring,

measurement, analysis and evaluation –

General)

The organization shall determine: a) what needs to be monitored and measuredb) the methods for monitoring, measurement, analysis and evaluation, as

applicable, to ensure valid results;c) the criteria against which the organization will evaluate its environmental

performance, and appropriate indicators;d) when the monitoring and measuring shall be performed;e) when the results from monitoring and measurement shall be analysed and

evaluated.

9.1.2 (Evaluation of compliance)

The organization shall: a) determine the frequency that compliance will be evaluated;

10 (Improvement)

10.1 (General)

The organization shall determine opportunities for improvement (see 9.1, 9.2 and 9.3) and implement necessary actions to achieve the intended outcomes of its environmental management system.

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