ISO 9001 Consultants | Cheshire | North Wales | Manchester

4. Context of the organisation

4.1 Understanding the organisation and its context


Determine internal and external issues that are relevant to your purpose and strategic direction.


Explain what the purpose of your organisation is.


Because of your focus on continual improvement, aim to understand and recognise issues that affect your organisation for the following topics.


These are the external issues (topics) that you should consider and write down


  • Legal
  • Technological
  • Competitive
  • Market
  • Cultural
  • Social and economic


And, the internal issues (topics) you should consider and write down


  • Values
  • Culture
  • Knowledge
  • Performance



Your ability to achieve your intended purpose will be based on taking appropriate actions on occasion such as


  • Identifying improvement and potential non-compliance and their causes.


  • Evaluating the need for action to prevent reoccurrence of non conformities.


  • Determining and implementing improvement actions.


  • If necessary, recording results of action taken.


  • Review of actions and results.




4.2 Understanding the needs and expectations of interested parties


A) Relevant to Quality Management Systems. The interested parties relevant to quality  management systems are as follows


Your employees and others working on behalf of your organisation in a similar capacity including contractors, consultants, temporary staff, student placements etc.


Staff are broadly informed of your main quality requirements through training and awareness and are specifically informed of any quality issues that are directly relevant to their activities through the associated quality awareness activities, terms and conditions of employment, training, management briefings and procedures.


Also, there are third parties such as business partners, external auditors and industry regulators. These will refer to your operations to understand your overall quality position and, where appropriate, to evaluate or direct the operation of specific quality controls to meet contractual obligations.



B) Interested parties more accurately defined as (examples)



  • Bank
  • Shareholders
  • Employees
  • Local government
  • Government programmes
  • Clients - name a few
  • External providers
  • Educational establishments
  • Certification and accreditation bodies
  • Health and Safety Executive
  • Environment Agency
  • Grant Awarding Bodies
  • Industry bodies



C) The requirements of these parties are for you to be


  • Socially and economically responsible to the local and international environment
  • Legally aware and responsible
  • Due diligence to health and safety
  • Timely and suitably economical delivery
  • Utilising sustainable resource where appropriate
  • Long term development of staff



4.3 Determining the scope of the quality management system


We also take into consideration the following with regards to your scope


  • External and internal issues as identified by clause 4.1


  • All relevant interested parties as identified by clause 4.2.


  • All the requirements of ISO 9001:2015 and justification for exclusion where appropriate.


  • Your products and / or services.




4.4 Quality management system and its processes


4.4.1 Establish, implement, maintain and continually improve your QMS, your policies and  procedures within the context of your overall activities and the processes that you operate.


Take into consideration the requirements of ISO 9001 when completing your improvement process.


Determine the processes needed for your QMS by


  • Determining the inputs and outputs required for the success of your business.


  • Determine the sequence and interaction of these processes.


  • Determine and apply the criteria and methods needed to ensure effective operation of your processes.


  • Determine availability and requirement of resource for your processes to work properly.


  • Assign delegated people to manage your processes.


  • Address the risks and opportunities at clause 6.1.


  • Evaluate your processes and implement any changes necessary, to ensure these processes achieve intended results.


  • Improve the processes and your QMS.



4.4.2 Due to the above, maintain and retain documented information to support

your organisation. This shall help you to establish further confidence in your processes

and support the viability of your organisation.


I hope this helps.


SteveB