6 Key Elements of the ISO 9001 Standard

Maybe you are considering becoming ISO 9001 Certified and want to know what you’re getting into.  Smart Move! Preparation is key to having the certification process go well and knowledge is power! More work at the front end of the process will eliminate hassles and headaches later on, and possibly non-certification. 

Remember, the ISO 9001:2015 certification process assures that your organization is dedicated and lives out the best quality management principles. 

Key 1: Know your numbers–10, 56, and 300.

There are 10 “clauses” or categories for the ISO 9001:2015 Standard.  Each clause has a top tier heading and corresponding number. Within each of these clauses, are 56 sub-clauses or sub-sections. For example, Clause 5 is Leadership. Clause 5, sub-clause 1 is written 5.1 Leadership and Commitment. And, those sub-clauses contain over 300 requirements!  We won’t cover the 300+ requirements now but we will give you the big picture first (then you can add details later). 

Key 2: Clauses 1-3: Scope, Normative References, and Terms and Definitions.

The first three clauses are more introductory (and still important) and do not involve actions and requirements on your part. They do, among other things though, spell out the way in which ISO views the 9001 standard and offers justification and vocabulary for subsequent clauses. For example, Clause 1 establishes the importance of meeting customer, statutory, and regulatory requirements and processes for improvement. Some of the terms you’ll want to know and use appropriately include “top management,” “process,” and “interested party.”

Key 3: Clauses 4-10 Correspond to the Plan-Do-Check-Act Cycle.

The first three clauses contain no mandatory requirements (but are still important!) but the remaining seven (7) clauses correspond to a cycle of operation that most organizations do (or should, at least) follow. This cycle is called the “Plan-Do-Check-Act” Cycle (or PDCA –I know, so many abbreviations). 

Key 4: Clause 4: Context of the Organization.

Your organization does not occur in a vacuum but rather exists in a number of environments or contexts.  Clause 4 asks you to identify elements of that context including internal and external issues that affect your quality management system (such as labor shortages, ahem), customer requirements, and the needs and expectations of “interested parties” such as suppliers, competitors, regulatory agencies, and stakeholders. Also, you must define the scope of your quality management systems (QMS) and how processes interact with each other. 

Key 5: Clauses 6-8: Planning and Support & Operation.

It’s likely that before your organization does anything, it plans for it! In Clause 6, you discuss and document how that planning is done! Good planning involves three (3) things (each of which correspond to a sub-clause). If you plan well, you’re likely a) assessing risks and opportunities –what could happen if we fail, what could happen if things go well? b) quality objectives and how you’re going to achieve them –what do you mean by “The world’s best widgets” and how are you going to ensure that you have the world’s best widgets? and c) how do you plan for changes?  

Key 6: Clauses 9-10: Performance Evaluation and Improvement.

Any time you’re trying to accomplish a goal, say running 2 miles, the feedback you receive during and after your run lets you know how you did.  You can look at your time and think “I can run faster than that!” and thus you implement training to improve the quality of your runs! The same principles operate in organizations. You need to a) know how you did (Performance Evaluation) b) think of ways to do it better (Improvement). The ISO auditors want to see documentation to show that you do both of those things and that you do them in a well thought-out, deliberate manner.  

But wait, what happened to Clause 5? 

Bonus: Clause 5: Leadership.

At the heart and center of all of the PDCA cycle is leadership, Clause 5. At all levels of the organization, especially the top level, leadership needs to demonstrate through action and documented policy their commitment to the quality management process. They need to clearly define and communicate who is responsible for what in the organization. That is, everyone should know who is in charge of various elements within the QMS. 

“Don’t wait! Get ahead of the game and start your ISO 9001 certification journey today. Knowledge is power and preparation is key to having a smooth certification process. Get familiar with the 10 clauses, 56 sub-clauses and over 300 requirements of the ISO 9001:2015 Standard.