ISO 9001:2015 IMPLEMENTATION SUPPORT SERIES 1

HOW TO DOCUMENT THE CONTEXT OF THE

ORGANISATION
The first set of auditable requirements in ISO 9001:2015 is to define the context of the
organization. How do you go about it, you will see two clear examples of
organisations that have successfully been certified to ISO 9001:2015 and how they
documented the context of their organization.
TABLE OF CONTENTS

Contents
The Need __________________________________________________________________________________________________ 1
Case Study 1- An Equipment Hire Company ___________________________________________________________ 2
Case Study 2- Motorcycling Parts and Kit Sales Company _____________________________________________ 5
Additional Context________________________________________________________________________________________ 9
Our Recommendation and a Disclaimer ______________________________________________________________ 10
Contact Information ____________________________________________________________________________________ 11
THE NEED

The Need
WHY
ISO 9001:2015 is a risk based quality management systems standards. For an
organization to understand it’s unique risks and opportunities it must first and foremost
have an introspective look at itself and gain a detailed understanding of the factors that
define its uniqueness, these factors could be both internal and external. No two
organizations can ever be the same if their context is defined in enough detail, this when
implemented correctly should be the basis of ensuring that management systems are fit
for purpose, developed and useable by the one organization alone for which it is designed.

OUR EXPERIENCE IN IMPLEMENTING THIS

This process has been quite a detailed look inside by and of our clients. We advise that to
get the best results from this activity especially for small and medium sized businesses
this activity should be carried out with senior management, perhaps to the exclusion of
other staff. Because if done right, the weakness and threats to the organization as a whole
will be identified; along , of course with its strength and weaknesses and senior
management in these settings sometime might find it uncomfortable discussing the
details in the presence of other staff, but will usually be happy to include the headline
issue in a management system document.

Many of our clients have found this an insightful exercise and in some cases revelational;
because this was the first time these range and depth of information had ever been
explored in such depth and a structured manner.

THE SWOT PERSPECTIVE

Many ‘experts’ have simply advised that a SWOT analysis addresses the requirements of
this clause 4.1 of the standard, we reckon that is a very minimalist approach. First a SWOT
analysis does not go into enough depth to give the level of self-insight the standard
intends and a SWOT does not fulfil the additional guidance provided on the clause by the
notes in the standard and the further insight in supporting documents such as ISO
9000:2015. We include a SWOT Analysis along with the additional details.

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CASE STUDY 1- AN EQUIPMENT HIRE COMPANY

Case Study 1- An Equipment Hire Company

A company that hires out equipment traditionally to the construction sector, but has more
recently diversified into providing access, heating, and cooling equipment to the food
manufacturing industry and more recently hygiene and cleaning equipment hire services
to them came up with the below definition of their context as below.

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CASE STUDY 1- AN EQUIPMENT HIRE COMPANY
PRODUCT/SERVICE OFFERING
GOVERNANCE
REGULATORY REQUIREMENTS
INDUSTRY ASSOCIATIONS (DO
YOU HOLD MEMBERSHIP/IF NOT
WHY NOT)
GEOGRAPHY OF MARKET
GEOGRAPHY OF SUPPLIERS
POLICIES, GOALS AND
STRATEGIES
ASSETS
CAPABILITIES (RESOURCES AND
KNOWLEDGE) E.G. CAPITAL,
TIME, PEOPLE, PROCESS,
SYSTEMS AND TECHNOLOGY
INFORMATION SYSTEMS,
INFORMATION FLOWS BOTH
FORMAL AND INFORMAL
ORGANISATION’S CULTURE
STANDARDS, GUIDELINES,
MODELS AND BEST PRACTICES
ADOPTED
FORM AND EXTENT OF
CONTRACTUAL RELATIONSHIPS
STRENGTHS
WEAKNESSES
OPPORTUNITIES
©2016 Charis Management Systems
Equipment Hire, Training, sales (PPE and second hand
equipment consumables. ), repairs and Maintenance
Limited Liability; 2 shareholders- Directors
Supply of Goods and Services Act- 1982
Provision and Use of Work Equipment Regulations 1998
(PUWER)
Hire Association Europe (HAE)
International Powered Access Federation (IPAF)
Prefabricated Access Suppliers' & Manufacturers'
Association Ltd
Birmingham is primary market. Heating/cooling Hire and
Training has a secondary market nationwide.
UK, Europe and Rest of the world
To be the number one supplier to the food and related
industry in the Midlands
Company Site leased facility, Company Vehicles
Over 5 year’s expertise in the hire industry. All software
purchased or leased. Website owned.
Hire Process Software- Leased
Accounting Software- Leased
Family Business; Personable, Helpful, Friendly
ISO 9001, HACCP, SAFEHIRE, Investor in people, IPAF
Rental+, PASMA accreditation.
No high level contractual relationship. Company
accountants provide a range of added financial services.
 Excellent standards of quality and equipment
 High Levels of customer satisfaction
 Strong focus on core markets
 Low Turnover of staff
 No environmental standard currently
 Website and catalogue need upgrading
 Some team leaders and salesforce need to up
competence
 Need to improve balance sheet
 HACCP standard allows us to differentiate from
market
 14001 environmental standards will bring
environmental considerations into business
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CASE STUDY 1- AN EQUIPMENT HIRE COMPANY

 Promotion opportunities in the company 50th year

anniversary
 Cleaning division, potential growth area
THREATS  Procurement companies impeding dealing directly
with customers
 Economy is still flat
 Competition trying to take our biggest customers

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CASE STUDY 2- MOTORCYCLING PARTS AND KIT SALES
COMPANY
Case Study 2- Motorcycling Parts and Kit Sales Company
This organization sells parts for motor cycles and range of rider gears and kit, more
recently they have started working on entering into the football market with such kit as
jerseys, socks and related gear. The potential exists for expanding this to other sports too.
This case study shows a combined example of a context of the organization
documentation for both ISO 9001 and ISO 14000.

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CASE STUDY 2- MOTORCYCLING PARTS AND KIT SALES
COMPANY
PRODUCT/SERVICE OFFERING :
GOVERNANCE
REGULATORY REQUIREMENTS
INDUSTRY ASSOCIATIONS (DO YOU
HOLD MEMBERSHIP/IF NOT WHY
NOT)
GEOGRAPHY OF MARKET
GEOGRAPHY OF SUPPLIERS
POLICIES, GOALS AND STRATEGIES
ASSETS
CAPABILITIES (RESOURCES AND
KNOWLEDGE) E.G. CAPITAL, TIME,
PEOPLE, PROCESS, SYSTEMS AND
TECHNOLOGY
INFORMATION SYSTEMS,
INFORMATION FLOWS BOTH
FORMAL AND INFORMAL
ORGANISATION’S CULTURE
©2016 Charis Management Systems
Storage sales and distributing of motor cycle
parts and accessories, football kits and
accessories.
Limited liability company- owned by parent
company based in mainland Europe. Consultant
/General manager- Oversees company in UK
Healthy and safety
Auto-Cycle Union (Governs everything to do with
racing) – Checks all racing helmets
CE marked products
Federation of Small Businesses
Sponsor ships
The staff and management keep a close on what is
going on in the industry.
UK and Republic of Ireland and surrounding
Islands.
Main products come from parent company.
Another product brand sold comes from
warehouse in mainland in France.
Be more profitable in the UK
Maintain and grow number one status in plastic
related products.
Increase protection for the rider.
The property (office/warehouse) is leased
Company car leased
Very good success rate in distribution- Usually next
day in the UK.
Plastics are the most prominent product sold in the
UK.
Leased software for dealers
Leased TAS (customer operations flow software)
and multi-TAS add-on
Drop-box (Media)
Young and progressive company (young people
have a big part to play). Relaxed and friendly,
everyone in an open plan office.
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CASE STUDY 2- MOTORCYCLING PARTS AND KIT SALES
COMPANY
STANDARDS, GUIDELINES, MODELS
AND BEST PRACTICES ADOPTED
FORM AND EXTENT OF
CONTRACTUAL RELATIONSHIPS
Current and future climatic and
other conditions, physical
conditions, biodiversity, rare and
endangered
species, ecosystems, resource
availability, including quantity,
quality and access, renewable and
non-renewable
Energy, and the specific
environmental sector/industry
profile.
Meteorological, geological,
hydrological and ecological
information;
Historical disaster information
related to the organization’s
location; reports on emergency
situations and incidents with
environmental consequences.
Reports from previous audits,
assessments, or reviews, such as
initial environmental reviews or life
cycle
assessments, when available;
Environmental monitoring data;
Environmental permit or licence
applications;
STRENGTHS
©2016 Charis Management Systems
ISO 9001, ISO 14001, CE marking/Type approved
products
No contractual agreements
Personal relationship with key personnel.
Located in low lying area in Bedfordshire. Not
coastal area, surrounded by both natural
vegetation and developed area. Rare and
endangered species are unlikely to be located in
office areas or through our supply chain.
Renewable sources of energy and materials are
potentially available and considered throughout
the process in product development and
distribution. Storage of environmentally friendly
options of products and shipping are opportunities
for environmental action
No tendency to flooding, sometimes during heavy
rains there is small puddles of water. Generally low
lying area, rainfall is as per the south of England
not as heavy as in the northern parts. Developed
area, limited biodiversity requiring any
preservation. Distribution activities is
subcontracted and therefore challenges such as
flooding during distribution are dealt with by
carriers company.
No history of any natural disasters or
emergencies/evacuations
Recycling, disposal of waste and spillages and
efficiencies raised in last external and being
practiced.
To be implemented as required by ISO 14001
Contract with waste carrier- XXX. Verified license
and permits
 Very good relationship with dealers
 Very reactive to the market
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CASE STUDY 2- MOTORCYCLING PARTS AND KIT SALES
COMPANY
 Very high profile with promotion
(Marketing campaigns and sponsorships)
and advertising
 Very low staff turn-over
WEAKNESSES  Staff are always running (Not enough
time)– very busy
 Stock feed is not live yet motor sports
OPPORTUNITIES  Football market
 New road products
THREATS Over legislation in the motor cycle industry
Competition (XXX, XXX, XXX, etc.)
Closure of practice areas (Environmental
Issues)
 Tear off on goggles (a product we provide
for riders) which causes litter and potential
ban on its use.
For additional details, please see company SWOT analysis

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 ADDITIONAL CONTEXT

Additional Context
In the ‘notes’ provided to clause 4.1- Understanding the organization and its context in the
standard (ISO 9001:2015); some additional guidance was provided on things to consider
in defining the context of the organization “NOTE 2 Understanding the external context
can be facilitated by considering issues arising from legal, technological, competitive,
market, cultural, social and economic environments, whether international, national,
regional or local.”. A tool that has always been used in management and marketing is a
right fit for this it is called LoNGPEST. A LoNGPEST analysis for an organization involved in
the manufacture of biological science products (peptides) used by researches and
pharmaceutical laboratory experiments

POLITICAL- ECONOMIC SOCIAL FACTORS- TECHNOLOGICA Action Required

Government type, Stage of business population growth L- research and
stability, Tax cycle, impact of rate, population development
Policy, globalization, health, education and activity, impact
Regulation, labour costs, social mobility, of emerging
deregulation likely changes in lifestyle choices and technologies,
trends, Levels of the economic attitudes towards impact of
corruption environment social cultural technology
changes transfer
LOCAL Significant grants Limited- few Devote
and funding customers in this sales/marketing
available range resources into
exploring access to
NATIONAL EU Brexit About 60% of Increased funding for the funding available
Limited funding business in UK Dementia
availability under
current economic
situation
GLOBAL Growth of Europe potential
Interests in growth area
dementia
Competition from
China
INTERNAL No issues Need to replace
lost big clients

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OUR RECOMMENDATION AND A DISCLAIMER

Our Recommendation and a Disclaimer

For our clients we always recommend and use a combinations of both the context of the
organization structure as outlined here and LoNGPEST analysis to define their context.
Between these two documents, much of the information is sufficiently captured.
Remember that there is no one way to document this requirements, there are a range of
other tools and even company own made up formats that can be acceptable as long as it
defines uniquely enough the context of your organization such that anything that could
have an impact on quality can be identified.

The content of this paper while based on real organizations has been adjusted for
confidentiality reasons while giving enough information to get the key message across.
While some information may appear generic, this is out of efforts to protect client identity.

Pictures Acknowledged- Scissor lift- Flickr Cramo Group;Motorbike- Eazigrip website

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CONTACT INFORMATION

Contact Information
Charis Management Systems
4th Floor, Media Factory (UCLAN)
Innovation & Enterprise (Northern Lights)
PrestonPR1 2HE
+44 (0)1772 896 258

Email: admin@charisventures.co.uk

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