Interested Parties, what ISO 9001:2015 says
The ISO 9001:2015 edition of the standard requires organizations to identify their interested parities and determine their impact on their ability to provide products and services that meet most all applicable requirements. Most people at first read interested parties and think, “that’s just a bunch of fluff” or “we already do that.” If the latter is true if you, you’re on the right track. If you think of it as fluff, you need to understand what’s being accomplished by addressing interested parties. There are a few places in the standard that an organization must consider interested parties. Below, I will leave the relevant parts of the standard for reference.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. The organization shall monitor and review information about these external and internal issues.
NOTE 1 Issues can include positive and negative factors or conditions for consideration. 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. NOTE 3 Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization.
4.2 Understanding the needs and expectations of interested parties
Due to their effect or potential effect on the organization’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 systems b) the requirements of these interested parties that are relevant to the quality management system.
The organization shall monitor and review information about these interested parties and their relevant requirements.
4.3 Determining the scope of the quality management system
The organization shall determine the boundaries and applicability of the quality management system to establish its scope. When determining this scope, the organization shall consider:
a) the external and internal issues referred to in 4.1; b) the requirements of relevant interested parties referred to in 4.2; c) the products and services of the organization.
Clause 4.4 “Quality management system and its processes” of the standard is built upon 4.3, 4.2 and 4.1. The Quality Management system requires the identification, monitoring & measuring of relevant requirements for external & internal issues, interested parties and their impacts on products and services of the organization.So what is an Interested Party?
An interested party is any internal or external entity that can impact your organization or be often negatively impacted by your organization (potentially resulting in fines, penalties, or a negative reputation). An example of an interested party is contracted service providers. Its common for an organization to outsource some of its services, such as field install services. Here we have a few interested parties and we need to consider their requirements and needs.- Transportation company
- DOT-specifically if hazardous products are being shipped
- FCC-if the products being installed are used for communication
- The Customer and/or Customer Representative that will be assisting in the install
- Local community where the work is performed-noise or chemical releases
Interested Parties, for example
I know of one organization that spent 4+ years developing a new blasting & coatings facility. The facility had received all required air permits (interested parties to be documented there). They had received the Storm Water Discharge Permit (more interested parties). They had custom built pressure vessels to ensure proper air pressure was maintained and received the appropriate certifications (more interested parties). The dangers of a pressure vessel rupture are not to be taken lightly. They had taken time to qualify all the coatings being applied to customer specs (another interested party) and had sampled the waste and checked for dangerous levels of heavy metals on a monthly basis for a year (more interested parties). Abrasive blasting (its own set of interested parties) can be a nasty operation but they had done a superb job of keeping it clean because they knew the requirements of their interested parties (city, state and federal for environmental and health-safety aspects). Then, they received a letter from the city stating their operation was too noisy, they had received multiple complaints from the local communities. The first immediate corrective action was to close the bay doors to keep the noise in. With abrasive blasting, there is always enough dust in the air that you simply cannot run AC units. It was too hot for them to work. They had to open the doors back up and received another more serious letter from the city. Several interested parties are at play. We have City, State & Federal requirements that required operations be conducted in a closed in manner. Internal interested parties, the most important of all needs the door open for ventilation and cooling. The local community has the requirement that they live in a quiet neighborhood. The solution was a series of expensive yet highly effective noise shielding blankets that all interior surfaces were covered in. This ought to be added to an interested parties list to ensure the fix and its reasons are not forgotten in years to come.Sample of Interested Parties
Without knowing the potential positive or negative impact, “RISK & OPPORTUNITIES”, of an interested party, you’re throwing a dart at the wall hoping for the best. I prefer to track my Interested Parties at the top level at a minimum, and on a process level as applicable. I suggest using the following format.
Int/Ext |
Interested Party |
Relevant Needs |
Risk |
Mitigation of the Risk |
Int |
Production Employees |
Job & Work Safety |
Employee Illness & Injury |
Workplace safety program |
Ext |
FCC |
Required licensing |
Lose our permit to work |
FCC Certification Procedure |
Ext |
TCEQ (Texas only) / EPA |
Storm Water Discharge |
Exposing waste water to rust |
Quarterly Samples |
Ext |
Intl Transportation |
Customs |
Product arriving late |
Pre-shipment checklist |
Int |
R&D Team |
Product Knowledge |
Keeping up to date with tech |
Continue Education Program |