ISO 9001 The Basics Explained: Clause 4.2 Understanding the Needs and Expectations of Interested Parties

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All organisations need to ensure they satisfy the groups or individuals that are significantly linked to the business. In order to do this, obviously you must identify those needs and who those parties are. This is what clause 4.2 refers to, those parties who have an interest in your organisation’s activities

Obviously you will never be able to list every single group or individual that come into contact with your business, however the standard only requires you to determine those that are relevant to your QMS and your requirements.

What are ‘Interested Parties’?

Relevant interested parties are different for every single business. They also impact different businesses in different ways when focusing on the organisation’s ability to consistently supply products and services that meet customer and applicable statutory and regulatory requirements.

For example, customers have a level of expectations for quality and personal satisfaction with the product or service they receive, some organisations will have service level agreements (SLA’s) that obligate the organisation to fulfill certain requirements, Legal requirements may be applicable to the organisation and evidence of compliance may be necessary, environmental concerns may affect an organisation when manufacturing products with high pollution issues. These are all relevant groups and individuals that are not only affected by the organisations activities but also require certain commitments from the organisation to meet that will relate to the QMS.

Where changes happen to those needs and expectations, such as a legal standard is revised, or an SLA is updated, you will need to adapt your QMS approach, and likely, the Scope of the QMS. This will affect how you manage the new needs and expectations, ensuring you remain compliant to your obligations and perhaps even the frequency of reviews.

The interested parties consist of external and internal groups or individuals. First consider, who are the interested parties externally and then who are those parties internally?

Once you have listed those interested parties, you will be able to identify their needs, expectations (sort by biggest impact), objectives (sort by priority), risks, actions and status, responsibility, action taken and date actioned.

Who are the External Interested Parties?

The external interested parties raise issues you must consider that can influence the outputs of your QMS.

PESTLE analysis is a useful framework when analysing the key factors (Political, Economic, Sociological, Technological, Legal and Environmental). For example: 

  • Political issues could be Government policies, Government term and change, Inter-country relationships/attitudes etc.
  • Economic issues could be specific industry factors, Market trends, Customers, International trade, Job growth/unemployment, Exchange rates etc.
  • Sociological issues could be Consumer attitudes and opinions, Media views, Law changes & social factors, Brand, Consumer buying patterns, Buying access and trends, etc.
  • Technological issues could be Information and communications, Consumer buying mechanisms/technology, Technology legislation, Innovation potential, Technology access, licensing, Intellectual property issues, etc.
  • Legal issues could be Current legislation home market, Future legislation, European/international legislation, Regulatory bodies and processes, Environmental regulations, Employment law, Consumer protection, etc.
  • Environmental issues could be Ecological, Environmental issues, International, National, Local, Environmental regulations, Customer values, Market values, Stakeholder/ investor values, attitudes, etc.

Who are the Internal Interested Parties?

Who are the interested parties internally? This may be individual staff members, specific groups of people within your organisation, your stakeholders, your sub-contractors etc.

The internal interested parties also raise issues you must consider. For example:

  • Structure of the organisation
  • Stability of work force
  • External providers competence and availability
  • Values promised to employees
  • Strategies
  • Knowledge
  • Roles within the organisation
  • Allowances for staff with special circumstances

Upon review of this exercise, perhaps during the management reviews, top management must revisit the interested parties:

  1. Specific needs
  2. Specific expectations
  3. Objectives

Top management must identify any current, and any new, risks, actions taken and yet to take, date actioned or deadlines set and finally assign responsibility.

Document Requirements

The standard requires this activity to be conducted but does not require it to be documented.



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