ISO 9001 System Launch and Confirmation
As you are launching and implementing your ISO 9001 management system, it might be a good idea to review, confirm, and if needed, update some key activities and artifacts that were created along the way. Take some time to consider the full extent of the management system that has now been implemented along with the results of your internal audit and management review as you complete this exercise. Once your reviews and updates are complete, but sure to update any needed documentation. [Read more…]
Identification, Traceability, and Preservation
As we dig into the detailed ISO 9001 production control clauses and requirements, some organizations, especially the service-oriented ones, might find that some of these requirements don’t apply to their specific operations. Be careful though, as some of these requirements, while they may not appear to apply on the surface, actually can be applied to your business, and taking an exemption to a clause that is truly applicable can cause problems during your ISO 9001 certification audit.
Let’s take a look at how ISO 9001 wants you to manage (control, label, track, etc.) your raw material, in-process (WIP), and finished goods. [Read more…]
ISO 9001 Culture
Over the years I’ve had the opportunity and privilege to work with and experience dozens of different organizations across many different industries, many of which had or were working on some type of formal management system. When it comes to quality management systems, I’ve seen what works and what doesn’t work and the one common denominator that often seems to determine the difference is the organizational culture. Establishing and maintaining the right ISO 9001 culture within your organization can shift your company from one of mediocrity to one of organizational excellence. [Read more…]
ISO 9001 QUALITY POLICY AND SYSTEM SCOPE
Two key elements of the ISO 9001 standard are the management system scope and the quality policy. Each of these must be defined and established by every ISO certified organization, usually by the executive leadership team. The QMS scope defines the boundaries for the management system while the policy communicates the mission or vision for the organization. The first of our three March ISO 9001 DIY series articles explores these two ISO 9001 system elements and provides some tools for getting the job done. [Read more…]
RETURN ON INVESTMENT FOR ISO 9001 CERTIFICATION
If you are going to invest all the needed time, effort, money, and resources into the development, implementation, and certification of an ISO 9001 management system, then there better be some type of payoff in the end. This is often in the form of new market opportunities, customers, or revenue streams. However, many organizations fail to realize and recognize the internal benefits and value of ISO 9001. [Read more…]
Leadership in ISO 9001
The ISO standard Leadership section (Clause 5.0) is all about the specific ISO 9001 leadership principles and requirements that your organization’s top management or leadership must fulfill. Some of the requirements spell out very tangible tasks and activities while others are a little more intangible. These include:
- General Leadership and Commitment,
- Customer Focus,
- Establishing and Communicating the Quality Policy,
- Organizational Roles, Responsibilities, and Authorities.
While some of the Leadership requirements are satisfied through other ISO 9001 requirements and processes, top management must still be knowledgeable about these requirements and the actions they must take to satisfy them. Every member of the leadership team should be able to intimately discuss each clause and demonstrate how they influence, impact, and satisfy each requirement and the associated management system processes and results. [Read more…]
Who (or What) is ISO
ISO 9001 is a global management system standard which provides a framework of requirements and processes which ensure that products and services consistently meet customer requirements and expectations. ISO 9001 benefits to just about any organization are numerous and can impact the organization through every function and department. The ISO 9001 standard requires organizations to determine its operating and support processes, constantly measure performance against established criteria, and identify and act on opportunities to improve products, services, and organizational performance. Let’s take a closer look at what ISO is and ISO 9001 benefits. [Read more…]
EBS Article Series – A DIY Approach to ISO 9001 Certification
For most organizations, achieving ISO 9001 certification can be a rather daunting undertaking. For many smaller companies that don’t have the resources to retain a full-service ISO consultant and who attempt ISO 9001 certification on a do-it-yourself basis, the work can be overwhelming.
Without an internal or external resource who is knowledgeable and experienced with ISO 9001, most organizations struggle to properly interpret the ISO 9001 standard and implement processes that satisfy the standard requirements. With that said, it is still possible to complete your certification as a do-it-yourselfer, but the company also needs to find a source of expertise to guide the project.