Interested Parties
- How does ISO 9001:2015 define interested parties?
- How should companies identify and prioritize relevant interested parties and their requirements?
- What do companies need to know about interested parties for an audit?
What is an Interested Party?
An interested party, also called a “stakeholder,” is a party that can impact, be impacted by, or believe itself to be impacted by an organization. Some examples include competitors, unions, customers, special interest groups, and society as a whole. ISO 9001 clause 4.2 directs organizations to not only figure out who these interested parties are and what they expect from the organization but also to track the needs of interested parties as they evolve to promote continual improvement.
Be aware that ISO 9001 specifies some interested party requirements outside of clause 4.2. These requirements are:
- Clause 5.2.2.c, which directs organizations to make their quality policy available to interested parties.
- Clause 8.3.2.i houses a mandate to take into account the amount of design and development (DD) control that interested parties expect.
- Clause 9.3.2.c1 requires organizations to conduct regular management reviews to acknowledge and examine interested parties’ comments and criticism.
“Relevant interested parties” and “requirements” are ambiguous terms. Identifying them may seem like daunting task, especially in light of their critical importance in the development of a successful ISO 9001-compliant QMS. Fortunately, there are a number of straightforward strategies for identifying relevant interested parties their requirements.
How to Identify and Prioritize Relevant Parties and Their Requirements
Don’t let ISO 9001’s abstract language discourage you or complicate the development of your QMS. As with the rest of the ISO 9001 standard, clause 9.2 leaves plenty of room for interpretation, but it lays out its requirements in plain english. A close, careful reading of clause 4 as a whole will help prevent undue confusion.
First, note that Clause 4.1 precedes the interested party clause and requires issues relevant to the organization’s QMS and its Strategic Direction to be identified. Relevant issues are conditions that impact an organization and its goals. Consider meeting the requirements of clause 4.1 a prerequisite to addressing interested parties. Relevant issues are what motivate a party’s interest in an organization, so you need to know what they are before you can identify interested parties and their needs.
The interested parties clause itself boils down to three requirements:
1. Figure out who holds a stake in the organization and determine the relevance of each stakeholder to the success of the organization and its QMS. “Interested parties” is too broad a term to be a practical starting point for the brainstorming process, so break it down into smaller categories such as employees, business partners, lawmakers, suppliers, etc.
When the list of relevant parties is complete, determine the relevance of each to the organization and its QMS. Relevance varies from one interested party to the next, so rate the priority of each and design the QMS to devote resources according to satisfying each party in proportion to the party’s potential to impact the organization. (example?)
2. Ascertain the relevant requirements that each party expects the organization to satisfy. Industry standards, contracts, employee policies, and other relevant records can reveal the needs of interested parties. Participate in industry groups and associations as an additional strategy for keeping the “pulse” of interested parties within the context of your organization. Remember that employees and personnel are interested parties themselves and are therefore potentially valuable information sources.
3. Keep track of any information related to interested parties and their requirements over time. Just as your organization evolves, so to do its stakeholders. Organizations must continually ascertain the expectations and relevance of interested parties to successfully satisfy their needs.
Interested Parties and the Audit Process
Clause 4.2’s abstract nature can mystify organizations attempting to prepare for an audit. What does an auditor need to see to determine that an organization is compliant with clause 4.2?
The simple answer is evidence. Though not required by ISO 9001, you should maintain detailed documentation of your organization’s procedures for determining interested parties and their needs as evidence that your organization takes active measures to ensure compliance.
Auditors will check lists of interested parties and requirements for completeness, because organizations can’t satisfy the requirements of parties they haven’t identified. Therefore, auditors expect organizations to define interested parties specifically enough that each group with a unique set of requirements is considered an individual party. Again, thorough documentation of such a carefully considered interested party discovery process demonstrates unequivocally that your organization is meeting its obligations related to clause 9.2 of the standard.
To decide how relevant an interested party is, you need to determine how much the party can potentially impact your organization. This “relevance level” is largely a function of the party’s
Ability to influence or affect the organization, its revenues, operations, or QMS.Level of interest in the organization
- Ability to influence or affect the organization, its revenues, operations, or QMS
- Level of interest in the organization
Expect auditors to check that the QMS devotes resources to each interested party in proportion to its relevance. A great strategy for planning QMS resource allocation is to assign each party numerical “influence” and “interest level” ratings between 1-10 and multiply the two to get a “percentage” rating of a party’s overall importance.
Documenting the specific clauses that an interested party might affect will provide additional evidence of affecting compliance.
In general, the best way to prepare for an audit is to comprehend how your organization, quality management system, and interested parties relate to one another well enough to be able to explain how these relationships factored into the design and planning of your quality management system.