What do we REALLY have to do for ISO 9001:2015 transition? Part 2 of 5: Interested Parties

Your CB might start your ISO 9001:2015 transition audit by talking to your leadership team to make sure the major changes to the standard are in place. The first major change, “Context of the Organization”, was covered in the first article in this 5-part series. Now let’s look at “interested parties”, the second major change.

ISO 9001 clause 4.2 requires you to understand the “needs and expectations of interested parties.” What does that mean? 

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 system;

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.
— ISO 9001:2015 Clause 4.2

Let’s start with the key word “relevant”:

Q. What makes someone relevant?
A.  Their ability to help or hurt you in your attempt to meet requirements for quality. 

Examples: How could this group help or hurt you?

Customers: Clear requirements; actionable feedback; collaborative planning and problem solving

Suppliers: Meet your needs for materials and services on time, on quality, at fair prices; collaborative planning and problem solving

Employees (all levels): Meet QMS requirements; low turnover; build skills and knowledge; continual improvement

Owners, Investors: Investment to enable QMS effectiveness

Unions: Contracts or labor actions that limit flexibility; strong skills and knowledge; low turnover

Partners: Major role in customers’ perception of your quality and service

Competitors: Their large increase or decrease in quality, cost, or speed influences market expectations for your company

Regulators: Impose requirements and penalties for failure to meet them

Q. Which requirements are relevant to your QMS?
A. Requirements from any of your “interested parties” about things like:

·      Quality - fitness for use and meeting specifications for products and services;

·      Cost  - to your business or others; or

·      Speed – delivering on time, responding to requests without undue delay, and adapting to changes quickly. These might include jointly committing to business processes with partners, suppliers, or customers.

·      Business requirements – not necessarily required by customers but set up by the business itself for profits, branding, or other purposes. These could be things like your commitment to ISO 9001 certification, 6 Sigma, 5S, and so on.

·      Legal requirements and regulations including those related to products, delivery, processes, packaging, and so on.

It would be easy to assume that this new requirement is not actually new.  Requirements have always had to be defined under ISO 9001, for example during the design, sales, and purchasing processes.  

The change is that businesses now need to show that needs and expectations from the broader range of stakeholders are systematically determined, monitored, reviewed, and updated as needed.

Well-managed companies have probably already taken into account the expectations from the full range of interested parties. Now, all companies who want to be certified need to. Also, it is not enough for top management to consider this information informally; ISO 9001 expects systematic methods for identifying who puts requirements on the business, what those requirements are, and whether they change.

So what do you really have to do to show that you meet this requirement?

At a minimum, an organization should set up a systematic way for creating, monitoring, and reviewing a high level statement or table of interested parties along with their needs and expectations. A “systematic way” usually means a method that has a person (or position) in charge of setting it up and executing it on a planned basis in a consistent way. The owner should keep records of what is done so that changes can be traced across time.

The list above could be a thought-starter, but you should definitely make it specific to your company. For example, add more details including references to specifications, contracts, business decisions, and so on, or at least give links or descriptions of where such information can be found.   Show that you a way to trace any given interested party to its requirements. 

While Clause 4.2 might look like a paperwork drill to write down information that is well known where it needs to be known throughout the organization, experience shows that the process of defining and presenting the information can be eye-opening across function who do not work closely together. 

An auditor might “pass” you on a bare bones approach to meet this requirement. Still, quickly throwing something together to show your CB will shortchange your company from the intended benefit of the clause. You’ll see as you go through later clauses in ISO 9001:2015 that your successful implementation relies on understanding the needs and expectations of your interested parties.

For more a deeper look at Context of the Organization…

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