Implementing an ISO 9001 Quality Management System
Implementing a quality management such as ISO 9001:2008 requires transforming the culture. It will affect the entire company, not just the quality department. More people in the organization are affected by it than just the management representative, or the person spearheading the effort. Implementing a quality system to the point of certification and registration is a daunting task but is achievable with your current resources. Implementation times can vary but it can be accomplished. When considering implementation of a quality system such as ISO 9001:2008 you should consider "why are you doing it?" Companies pursue quality system implementation for various reasons, to become better, their customer's are requesting it, they are having quality problems or they would like the recognition of being certified. In either scenario, the circumstances are different as will be the driving force to implement the quality management system. An organization should consider the benefits of having an ISO 9001:2008 quality system and are not concerned about flying the flag. The following steps best describe the implementation process:
1. Why do you want to implement an ISO quality system? 2. Educate Top Management 3. Commitment from Top Management 4. Select a Management Representative 5. Select Implementation Team 6. Understand the current system and processes
7. Understand the Standard 8. Gap Analysis 9. Create an Implementation Plan 10. Employee Training 11. Monitor 12. Internal Auditor Training
13. Internal Audits 14. Select Registrar 15. Management Reviews 16. Continual Improvement 17. Pre-Assessment Audit 18. Registration Audit
Why implement a quality manual template such as ISO 9001:2008 To understand why you would consider implementing a quality management system, let us understand the various quality management systems. There is the ISO 9001:2008 standard along with the industry specific standards such as ISO/TS 16949 (Automotive), TL 9000 (Telecommunications) and AS9100 (Aerospace). In addition to these standards is the Malcolm Baldrige Award.
The ISO 9000 standards cover all areas of control which has a potential to impact the degree of compliance of a product or service. The standard is not a cookie cutter quality system that means you will have the same quality system as your competitor, or customer. It means you will have quality systems that meet the minimum requirements but the details of how the requirements are met can vary dramatically. There are several misconceptions surrounding the standard, one is it creates a great deal of non value added paperwork, another misconception is it does not provide any value because all I have to do is "say what I do and do what I say" and they third misconception is it restricts creativity by burdening employees with structured approaches.
Addressing the first concern of generating non value added paperwork. The belief is you must document, document, document everything you do. Actually, the standard requires one quality manual, six procedures, instructions where necessary and 26 records. This may sound like a lot but it really is not. The need for extensive documentation can be mitigated with a thorough training program that reinforces what is to be done and how it should occur. It is common for companies to utilize more documentation than the standard requires, simply because they find it valuable. When you are in an environment of continuous change and improvement, processes, duties and tasks are continually changing to keep pace with improvement. It could be extremely hard to know what the agreed upon method was without a formal documentation and change process. The end process would drift because the tasks within the process drift. It would be analogous to not having maximum speeds posted; they would be verbally communicated from area to area.
The second misconception is that the standard does not really benefit a company because it simply means you documented what you do (even if it is wrong) and you can show you do it. I recall an example when I was touring a manufacturer and I could see they were lacking in quality systems. I asked the Vice President of Quality if they considered adopting an ISO quality system. He replied, "ISO is nothing more than doing what you say you'll do. We could make cement life jackets and we could get certified. Our customers wouldn't buy cement life jackets". I listened to what he said (laughing inside) and suggested he get some training on the standard, because that is not the intent. The current standard focuses on ensuring you provide a product or service that continually meets the requirements of the customer with the aim of improving customer satisfaction. To make a long story short you could have a system that is extremely well documented and everyone follows the procedures and instructions. If this system is not producing an output that is meeting the requirements of your customer you will not get certified, end of story. Understand, the documentation portion of the standard is a tool or method, the end game is customer satisfaction and meeting you business goals.
The third misconception perceives the standard as restrictive in that it binds employees into a specific, structured way to do their job. It removes creativity and replaces it with a mundane repetitive approach. This is to some degree true and dependent upon the organization. The level of control is at the discretion of the company. My experience supports having a level of structure that is consistent with achieving the desired output of the process. For example, if the process is purchasing, the desired output is to have quality product delivered on time in the correct quantities.