Is ISO 9001: 2000 Worth It?
A discussion on whether or not your shop should pursue the following registrations: ISO9001: 2000, ISO/TS 16949, AS 9100, ISO 13485, ISO 17025.
MMT Columns
During the past eight years of helping a large number of tool and die companies implement quality management systems to meet ISO 9001 and other standards, the following question has been asked: “Why should I do this?” While there are great answers to this question, this article explains what these companies themselves are saying after they have achieved and held registration over several years.
ISO Benefits to the Mold Manufacturer
Moldmaker benefits of a well implemented ISO 9001-based system include:
- Many times it is a requirement just to bid on new jobs or to get a foot in the door with a new customer. Basically it is a ticket to get into the bid process for many companies. They are looking for a minimum level of recognized quality management systems by their suppliers.
- New employees are trained more quickly when processes and procedures are documented correctly. This also helps with delegating work and ensuring consistency between builders and jobs. While you do not want to stifle creativity and make the builders always work the same way, you want to ensure that important aspects of the job and product are consistent—such as meeting customer specific requirements for components, performing a certification layout, etc.
- While mapping out the processes and workflow for ISO 9001 implementation, many moldmakers have discovered wasted steps that have lead to streamlined processes.
- Most moldmakers rely heavily on a job folder and use this to document many of the items required by ISO 9001 and other standards. This documentation is extremely valuable when engineering changes occur; repairs or changes need to be made after delivery and use; and, when disputes with the customer arise.
- For companies that have used ISO 9001 as a quality and management improvement tool, the key performance measures they put in place and monitor drives improvement and growth. This may be growth in sales or in specific areas of expertise that yield higher margins.
- When a company is registered to ISO 9001 or another standard, discussions with new potential customers quickly move past quality to the more differentiating topics of service and delivery. This is due to the customer’s confidence in, at least, a minimum level of quality based on the management system registration to the international standard.
Another way to think about the benefits is this: your best tool and die person or project manager does not need much documentation for a project; they inherently know what to do and how to react to the issues that arise. The system documentation is really for:
- The newer, less experienced, less qualified people.
- Ensuring that jobs are consistently completed to increase efficiency—especially when completing after-the-fact engineering changes, project and workload shifting, handling project and customer issues, etc.
- Documenting the way that you handle your projects and conduct your business. This creates value in your business and allows you to handle all changes (staff, workload, work mix, etc.) more effectively.
- Increasing quality. The quality mana-gement system is the tool that is used to focus on areas of the companies work that struggle. The processes in an ISO 9001 system can be used to drive improvements where they are most needed.
ISO Challenges
While most mold shops (and other companies) see most or all of the aforementioned benefits, many also see challenges in maintaining a registered and effective ISO 9001-based quality management system. This is normal and typically happens during ongoing organizational changes and periods with very high workload.
The following are some of the struggles and challenges encountered by companies when implementing on ISO. The mold shops sharing their feedback here have between five and 75 people.
When a company has 20 people, they do not have the volume to support a full-time quality manager that spends a significant amount of time on the ISO-based quality management system as well as other quality-related tasks.
In addition, many times they do not have staff that has significant experience creating and managing a formal quality management system. This can result in staff only focusing on the quality management system before audits and not really using it as a tool to operate the business and ongoing work.
A good analogy is that the company ends up with a show car that it brought out and polished before registrar audits; however, this car has no engine and does not take the company where it wants to go. This implementation of a quality management system costs a company considerable money, but does not drive improvement in efficiency or quality. In other words; there is no payback.
Implementation Pitfalls
More specific pitfalls of implementation include the following:
• Too much documentation.
If the system is not carefully established and implemented, many companies write too many procedures and create a nightmare to manage. This occurs during implementation due to a lack of expertise with creating documentation and a fear of nonconformance during a registrar audit. After registration, documentation is oftentimes increased by the addition of procedures and work instructions due to process changes and surveillance audit nonconformance. In most cases, slight modification to current documents is a more effective response. One good approach to documentation is: “If in doubt, leave it out.”
• The company became too busy and put the system on the shelf.
All companies go through peaks and valleys of workloads. It is okay to postpone audits and some system-related tasks; however, a company must return to a systemic focus and complete responsibilities and quality system tasks. When a company is extremely busy is when the system is most needed.
• Purchased a software package or a set of procedures.
Companies buy software, pre-written procedures and computer systems that are supposed to make it easier. The process itself is not complicated to start with and the software typically does not fit very well. If you start with paper and simple spreadsheets, you will find what you really need. Then if you want to consider software, you will know the features and structure you really want.
These common challenges faced by companies maintaining and improving their ISO 9001-based quality systems are not difficult to overcome, but do require focus and attention. They do not require large continuing investments in time or money if a company just consistently invests small amounts of resources and continues with a focus on quality when managing their jobs and business.
ISO Goals
So, if you want to implement an ISO 9001-based quality system or improve your present system, the following are some goals on which you should focus.
A good ISO 9001 based management system should take only a handful of hours per week to manage and use. This amount of time also should come back in the form of less rework, less searching for customer and job information, and better business performance. However, if the system is over documented or ineffective, a company will spend more time on the documented system without the increased payback.
Ask your present customers and research what certifications your potential new customers are requiring of their suppliers. Many smaller companies are pursuing additional certifications as a way to diversify and attract new customers. Here are some of the most common certifications typically required in addition to or based on ISO 9001:
- AS9100 for aerospace suppliers (machining, etc.)
- ISO 13485 for medical device suppliers
- ISO 17025 laboratory accreditation to perform measurements on product that are accepted by the customer
- ISO/TS 16949 for automotive parts manufacturers
When implementing and improving your management system or responding to nonconformance from your registrar you should:
- Only document what is required and/or necessary for business. Remember that this is your quality (business) management system. While you may need to have a few documents or process steps to satisfy a customer or the standard, the vast majority are there to assist you in being more efficient and effective with higher levels of quality. Your quality management system should be a tool to help you keep your business moving, not act as an anchor weighing it down.
- Keep it simple. Use the software and systems you have now. Only purchase new software when there is a direct business need. Checklists, Excel spreadsheets, and templates are tools to use. They ensure you address and cover everything you have determined is important and are much more likely to be useful then a book of procedures.
- Choose the correct metrics for your processes. You may focus on improving some of the items you measure and you may just watch others that monitor if the processes are working correctly. If things go bad, these will highlight the things that have changed. You do not want to choose metrics to please the auditor or to meet an ISO 9001 requirement.
- Use internal audits to drive improvement in the company. You are required to complete internal audits for ISO 9001, but they can have a positive impact on your company in many different ways including streamlining processes, improving customer satisfaction, and increasing the bottom line.
- If your current system is not adding any value to your company, change it. This takes time, but will benefit your company in the longer term. You also can schedule and plan your time over a few months—keeping the weekly resources needed to a minimum. It may not be a rush project, it just needs consistent focus to make necessary improvements. Working to meet new requirements is a good time to address these issues.
Many companies that have been assisted with ISO implementation have experienced the following:
- Companies with good ISO 9001-based quality systems can much more easily address the sector specific requirements in the standards listed above and achieve registration. This leads to new work as well as new work being obtained with the agreement that the company will achieve certification within a specified timeframe.
- Companies that have an ineffective management system, too much documentation or have not kept up with the maintenance of the system can use this new push to revamp their documentation and remove the items that are unnecessary, redundant or ineffective.
- Companies that use an ISO 9001-based quality system as a tool to drive quality, improvements and efficiencies
in their organizations typically have higher customer satisfaction, are more innovative and have higher profit margins over the long term. This is not solely due to ISO 9001, but from an overall focus on understanding how and why things are done internally and looking for improvements.
Summary
With the struggles in different sectors of manufacturing in the U.S. today—including the automotive supply chain—more companies that are traditionally automotive mold shops are looking to expand and diversify in different areas.
This is an important time to take a close look at your customer base and look for ways to expand and diversify as well as looking for internal improvements in quality, service and efficiency. A well implemented quality management system can be an important tool.
