ISO 9001 CLAUSES EXPLAINED – 5.2 Policy (Quality Policy)

Creating a quality policy is a fundamental step in establishing a robust Quality Management System (QMS). In Episode 181 of the #QualityMatters podcast, we delve into the essential elements of crafting a quality policy that aligns with your organization’s goals and regulatory requirements. Here’s a step-by-step guide based on our discussion, complete with practical examples

ISO 9001 8.4 Control of externally provided processes, products and services

Understanding ISO 9001: Clause 8.4 – Control of Externally Provided Processes, Products, and Services When establishing or revising a management system under ISO 9001, Clause 8.4 – which focuses on the control of externally provided processes, products, and services – is crucial. Typically, these external entities are referred to interchangeably as vendors, suppliers, or external

WORK LIFE BALANCE and the 95%/5% balance

Work life balance has always been a personal struggle for me.  Before I started my own business, I worked out a deal with my previous company.  I was a salaried employee, but often worked well over 50 hours a week.  They agreed to pay me overtime pay for more than 50 hours a week.  This

WHAT IS THE PURPOSE OF A QUALITY MANAGEMENT SYSTEM?

Before we dive into the purpose of a Quality Management System, we should probably define what a QMS is.  In defining what a QMS is, we will likely touch on the purpose of a Quality Management System. When quality management folks talk about a Quality Management System (and Lord bless you if you get them

ISO 9001 Clauses Explained – 8.7 Control of Nonconforming Outputs

In this post “ISO 9001 Clauses Explained” we dive into Control of Nonconforming Outputs. CONTROL OF NONCONFORMING OUTPUTS (Consider reading HOW TO STANDARDIZE THE FUNDAMENTAL QMS TOOLS FOR OPERATIONAL EXCELLENCE) Control of nonconforming outputs can be viewed in several different lights. For instance, if we’re looking strictly at the quality of our products or services,

ISO 9001 CLAUSES EXPLAINED – 5.2 Policy & 6.2 Quality objectives and planning to achieve them

In this post “ISO 9001 Clauses Explained” we dive into Quality Policy & Objectives. POLICIES & OBJECTIVES The management system policy is effectively the mission statement of the company, if it were written by a lawyer. By that, I mean the mission statement ought to convey the purpose of this management system clearly. It ought

ISO 9001 CLAUSES EXPLAINED – 4.2 Understanding the needs and expectations of interested parties

In this post “ISO 9001 Clauses Explained” we dive into Interested Parties. 4.2 Understanding the needs and expectations of interested parties Interested Parties is a relatively new term to our management systems, but again a very old concept that we’re all familiar with. An interested party is oftentimes a useful catch all term when there’s

ISO 9001 Clauses Explained – 7.5 Documented Information

7.5 Documented Information | CONTROL OF DOCUMENTED INFORMATION In this post “ISO 9001 Clauses Explained” we dive into Documented information, arguably at the core of any effective management system. Documented information includes not only our documents, but also our records. There are many types of documents and many types of records, but with a simple

How to Standardize the fundamental QMS tools for operational excellence (NCR/CARs)

The Value of well-defined NCR and CAR Introduction to NCR’s “Nonconformance Reports” & CAR’s “Corrective Action Reports” When it comes to operational excellence, fundamentals of QMS “Quality Management System” are critical. I would argue that nonconformities and corrective actions are the foundations of an effective quality management system (QMS). They represent the “boots on the