ISO 9001: The Three Components of the Implementation Process

The three components to implementing an ISO 9001 quality management system are: 1) documentation, 2) information management, and 3) operational changes.

Documentation

On the surface it may seem like developing the ISO 9001 documentation shouldn?t be that difficult. You must have a manual that includes a policy, objectives, scope, and the interaction of the processes; and you must have written instructions for:

1. Managing the quality system documents
2. Managing the quality system records
3. Conducting internal audits
4. Controlling nonconforming product
5. Implementing corrective action
6. Implementing preventive action

The standard also hints at the need for additional instructions, e.g., referring to the work instructions, section 7.1 states ?shall determine the following, as appropriate,? but technically, aside from the manual and these six instructions, anything more is optional.

The reality, however, is that in order to get the most out of a quality management system a significant amount of additional documentation is required. A primary function of the system is to establish consistency and eliminate misunderstandings, which is best facilitated with clear and unambiguous written instructions. Policies, which are a pervasive part of any system, have absolutely no value if they're not in writing, and enforcing accountability is extremely difficult if the responsibilities are not spelled out.

The ISO 9001 system documentation is normally organized into four sections, including:

1. The Manual, which provides background information and explains how the system works;
2. The Administrative Procedures, which include the procedures and policies that define how the company complies with the requirements of the standard and how it manages the processes that are unique to its operation;
3. The Operating Instructions, which are the detailed instructions used to control manufacturing and service activities; and
4. The Reference Documentation, which are documents like industry standards, equipment maintenance manuals, corporate auditing guidelines, employee policies, etc. that define practices, procedures, or performance criteria not covered by the other documents. These can either be externally or internally generated.

No two organizations have the same goals and objectives or do things exactly the same way, which means there are always some differences between the procedures and policies of different organizations. It also means that completely documented ?off-the-shelf? systems don?t exist and some document development is inevitable. The challenge is to minimize the effort without sacrificing value.

The Manual ? The administrative procedures are usually the more difficult and time-consuming of the four sections to develop. The manual, on the other hand, is relatively straightforward and probably the easiest part to develop. The standard suggests what should be included, and an example of a ?well written? manual can provide the format for organizing the material. Most of the work is in converting the ideas of the example into documents that describe your situation. Goals and objectives have to be established, processes defined, responsibilities established, the interaction of the processes explained, and the system parameters established.

Administrative Procedures ? The secret to developing administrative procedures is 1) using a format that creates readable documents, 2) finding examples of procedures that offer solutions that apply to your needs, and 3) organizing the documentation based a process list.

The ?process approach? is the system structure recommended by the authors of the standard and the process list is the starting point of the process approach.

Think of processes as objectives, i.e., maximizing employee output, making sure new products comply with customer requirements, or making sure working conditions adequately support the production objectives. A set of procedures that constitute a means for meeting an objective is what the standard refers to as an ?activity group?. Employee vetting, performance reviews, and training procedures is an examples of an activity group that maximizes employee output. The objectives are the outputs of the ?process approach? and the procedures (the activity groups) the inputs. Example:

Input = Policies and procedures for making sure employees are motivated, informed, and capable of performing the assigned responsibilities

Output = Maximum employee output

The process list is simply a list of those objectives that best represent the needs of your organization. They can be different for every organization and are rarely in sync with the outline of the standard.

The format used for developing the procedures, to a large extent, determines whether employees will embrace the system. It can be the difference between documents that are easy to read and ones that are not. The better formats include a clear propose, policies that are relevant to the purpose, and an explanation why things are done the way they are done. A good format also leaves no doubt as to who is accountable for the actions of the procedures.

Examples of procedures from other systems provide ideas on how to develop new procedures and how to improve existing procedures. The same examples can also provide formatting ideas. Don?t fall into the trap of thinking that there must be a procedure of every requirement of the standard, or that the documentation has to follow the outline of the standard. The authors of the standard have made it clear that this is not the case. You are encouraged to use a process approach, which is inherently unique to your operation, and to include processes that are important to you but may not included in the standard.

While individual examples can be helpful, continuous system templates that lock into the outline of the standard tend to complicate the implementation process. They depersonalize the system, limit the system to the scope of the standard, and make the process of writing procedures more difficult. Also, don?t go overboard on process mapping and flowcharting. Procedures should be clear to everybody, not just the primary users. A fundamental covenant of the system is continual improvement and some of best improvement ideas come from employees with unrelated responsibilities.

Operating Procedures ? The trick to developing operating procedures is in understanding the balance between training and documentation requirements, and in knowing how much information is needed. Too many companies develop too much unnecessary detail.

The standard requires employers to provide employees with the information needed to correctly perform their assigned responsibilities. Proof is either documentation showing that they have been provided the necessary instructions, or training records, which also verifies that they have been provided the necessary instructions. The value of written operating instructions is that they make it easier to hold employees accountable for their actions. From this standpoint, it is only necessary to document those aspects of an operation that are subject to misinterpretation or misunderstanding, which normally doesn?t require a great deal of detail.

Information Management

Managing information is a big part of the standard. The standard states that records shall be maintained in the case of management review meeting minutes (5.6.1); education, training, skills and experience (6.2.2); product validation and verification (7.1.d); inputs for product design and development (7.3.2); and calibration records (7.6). In addition, the standard also requires ?evidence of conformity?, which is either physical evidence or documented records, and in many cases records are preferable and sometimes the only alternative.

Records provide a means of confirming that the quality system is controlled, customer requirements are understood, audits are conducted, customers are heard, problems are found and corrected, non-conforming goods are managed, purchasing information is correct, products are traceable, and incoming goods are inspected.

The method of managing information is generally some combination of 1) a file management program, 2) database files such as Microsoft Access, or 3) hard copy files, i.e., binders, file cabinets and manila folders, all of which have advantages and disadvantages.

File Management Programs ? File management programs are typically tamper-proof and capable of handling a large volume of information. They?re designed to be paperless systems. Assignments, authorization levels, and additions and revisions to records are keyed into the program, which, under certain conditions, trigger action commands that are communicated via email. There are a few programs tailored to manage primarily ISO 9000 records, but most are universal in nature and designed to manage all types of records. The user is normally responsible for developing the forms and reports needed to manage specific types of records.

The programs are expensive; they come with annual and sometimes monthly maintenance fees; and there are usually costs associated with installation, the number of users, data migration, and training. Many have their own programming language, which makes the user dependent on people with that language skill. And some are web based, which means the program is running on someone else?s server. Generally, they are best suited for companies with a lot of people dealing with a large volume of information.

Database Files ? Database files are less expensive, more flexible, and easier to manage. You can either develop your own files or purchase files that have been programmed to deal with specific types of records.

The majority use Microsoft Access and run on a Microsoft Windows operating system. The cost is the cost of the files plus the cost of the Microsoft programs. (The 9000 Advisers offer individual Access files for all the ISO 9001 record keeping requirements.) The files are placed on a server and secured by whatever means is used to secure the server files. Changes and enhancements can be made by anyone who understands Microsoft Access. In most cases there are no user fees or reoccurring maintenance fees, and existing database files can be transferred into the files with the migration functions of the Access program.

Hard Copy Records ? Almost everyone ends up with some hard copy records: documents that can?t be scanned, documents with signatures, and documents that are available to all employees. However, building a record keeping policy completely around this approach is risky, even for small companies. It is too easy to misplace documents that move from one person to the next; and it is difficult to manage information that is located in various files, in different offices, and assigned to different people. Responsibilities change and individuals tend to change the way information is gathered and filed. Manual record keeping frequently results in unnecessary duplication, e.g., sales using a different customer list than the person keeping track of the customer complaints. It is also difficult to gather, analyze, and disseminate information. File cabinets are not as accessible as computers and don?t have the sorting, reporting, linking and analytical capabilities of database files.

Operational Changes

The final component of the implementation process is the operational changes, which are the changes needed in order to meet the procedural requirements of a system. They include both the things that are done in order to ensure that the products and services comply with the requirements specified by the customer, as well as the measure taken to in order to improve products and services and the processes used to produce the products and services.

Some of the more common ones include:

Administration ? 1) Conduct at least one management review meeting. 2) Communicate system developments to all employees. 3) Demonstrate that the key performance indicators are measured, evaluated, and communicated.

ISO Representative ? 1) Make sure that the auditors are adequately trained. 2) Develop an audit schedule and conduct audits on all of the system procedures. 3) Demonstrate that the corrective and preventive action processes are working. 4) Make system procedures and forms available to employees.

Human Resources ?1) Verify that all employees have a basic understanding of the ISO 9000 system. 2) Prove that all employees are capable of performing their respective work assignments, including the top-level executives. 2) Establish a training program for developing employee skills.

Purchasing ? 1) Demonstrate that all of the primary vendors are qualified and that their performance is routinely evaluated. 2) Prove that material specifications are verified before they are released to vendors.

Sales/Customer Service ? 1) Demonstrate that customer feedback is gathered and analyzed, including records of complaints. 2) Prove that processing capabilities are reviewed before orders for new products are confirmed.

Engineering ? 1) Demonstrate that the information released to production is current, accurate, and complies with customer requirements. 2) Demonstrate that product changes affecting form, fit, or function are not implemented without customer approval.

Production ? 1) Establish a calibration program that complies with the requirements of the standard. 2) Demonstrate that machinery capabilities have been validated. 3) Prove that nonconforming materials are not mixed in with satisfactory materials. 4) Prove that that shipments comply with the customer requirements. 5) Prove that incoming materials comply with purchase specifications. 6) Prove that operators are provided with the information required to produce products that conform to customer requirements. 7) Demonstrate how materials with shelf life are managed.

System documentation and information management are the paperwork part of the system. The operational changes are the action part and represent the part of the implementation process that makes the system work.

John is founder and president of http://9000advisers.com/ : a consulting firm specializing in implementing ISO quality management systems. He has over thirty years of manufacturing management experience in the metalworking industry and another six years of consulting experience implementing quality and costing systems. He has a BS in Metallurgical Engineering and an MBA.

ISO 9000 Quality Assurance

ISO 9000 is a set of standards developed by the ISO (international organization for standardization) for quality assurance systems. It was first published in 1987 and the standards were modified in 1994. ISO 9000 serves as a true base for organizations to improve their quality assurance systems.

A quality assurance system involves the organizational structure, duties, procedures, processes, and materials for applying quality management. It is designed to help businesses assure their services and products, and please customer hopes by meeting their specifications. Quality assurance covers all activities of a product?s life cycle, including planning, controlling, measuring, testing and reporting, and improving quality levels.

ISO 9000 quality assurance models view an enterprise as a network of interconnected processes. For a quality system to be ISO-compliant, the processes should address areas known in the standard and should be documented and practiced as described. Documenting a process gives an organization the opportunity to understand, control, and improve its process network.

ISO quality assurance is a management activity that contains auditing and reporting actions. These two functions assist the manager to verify the efficiency of the quality system. ISO 9000 expresses quality assurance resources in general terms that can be used by any organization irrespective of the products or services provided. However, ISO 9000 does not explain how a business should apply these quality system elements.

Most companies first attempt to get certified to one of the quality assurance system models in the ISO 9000 series. For this, the company?s quality system and actions are audited by third party auditors for conformity to the standard and for effective operation. Upon successful certification, the company obtains a certificate from a certification body represented by the auditors.

ISO 9000 provides detailed information on ISO 9000, ISO 9000 Standards, ISO 9000 Software, ISO 9000 Consulting and more. ISO 9000 is affiliated with Home Inspections.

ISO For the Small Business

ISO has been around long enough that everyone is aware of what can be gained by implementation of this system, yet many businesses are still reluctant to adopt this practice into their operations. There are several reasons for this, probably the number one being that it is deemed to be too costly and time consuming when compared to the perceived gains for smaller businesses to readily commit to this rigorous and detailed approach to improvement.

Designing and adopting this standard can appear intimidating when you look at all that is involved. As a small company you may feel that your limited staff and resources are not fully equipped to handle this myriad of documentation, standardization, auditing, and most of all, training that is required to create and maintain a successful ISO system. As daunting as the process may seem, with a little planning it can be much easier than you might think.

It is true that approaching ISO as a large organization normally will is quite overwhelming for a smaller company; however, you can approach this endeavor from at totally different perspective and still be successful. The usual route to ISO is to enroll in some form of structured process by registering in a class or seminar through a local college or private service. Since this approach typically follows a somewhat predetermined time frame, keeping pace can put a considerable burden on your limited resources.

ATTACK THE PROBLEM ON YOUR OWN TERMS

Purchase the standard and review it to get a thorough understanding of what is required. Outline where you are currently with your operational procedures. Compare where you are to where you need to be and outline the necessary actions that need to be addressed to meet the requirements of the standard. You can now develop a plan to address each the tasks that fits within your budget and progresses at a pace that does not overtax your workforce.

Make a commitment to methodically work toward implementation on your own. You can enroll in the accreditation programs or work through your underwriter down the road, after you have implemented all or most of the system. This approach leaves room to adapt and to achieve your goal while still remaining capable of handling your day to day manufacturing issues. The downside is that you must remain committed. It is easy to get sidetracked or buried in your daily problem solving and let your completion of ISO to go by the wayside.

BREAK THE PROCESS DOWN

Like any other large and seemingly involved problem, break it down into smaller more manageable tasks. Choose a familiar task to work on that fits into your current experience and capability. Break it down further by limiting the chosen task to a specific area of your organization. Pick one shift, one department, perhaps one work cell that you are comfortable with.

By limiting your area of implementation you increase your odds for success for several reasons. First, you will only be affecting a small portion of your facility which means expense and disruptions will be minimized. If you make mistakes their impact will not be as detrimental. You will be able to visualize not only what needs to be done, but how well you are progressing. You will be able to debug your system on the fly without having to remove the controls, etc. to keep your normal production on schedule.

Secondly, you will be able to determine exactly what is required to implement the change. Do you have the necessary data on hand? What supporting processes or documentation will be required? Is your staff capable of handling all the duties? Will additional investigation, personnel or training be required? You will be able to spread out the expenses over a longer period and allow the necessary time to train your staff.

Furthermore, as you finish a task you will gain a clearer understanding of what will be required to implement this same task into other areas. This will allow you to budget your costs and time much more accurately in the future. As you complete the required documentation and procedures you will have valuable templates that can be easily adjusted for use in other areas or for different processes.

And lastly, once your system has been debugged and implemented in one area it will be much easier to implement it in another. The entire process will also be more readily accepted by your workforce as you progress because having taken the time to get it right the first time, you will have made it easier to understand and comply in the rest of your operation.

LEARN AS YOU GO

As you progress through the standard and the different areas of your organization you be gaining the experience and confidence needed to be successful. Your technical writing skills will improve. Your team building skills will improve. Your mentoring abilities will improve. Your staff will have a deeper and broader understanding of your processes and capabilities down to the fine details. All these will improve your operations and your bottom line. Before you know it, you will be running a much more efficient, capable and reliable business.

As your processes improve so will your competitiveness in the market and you can take advantage of your new found experience to streamline your operations. You will be able to sell, estimate, produce and deliver to more accurate numbers. You will be capable of predicting trouble, discovering problems, solving issues and adapting to your needs more quickly than you could before. When the time comes to increase personnel you will have a clearer picture of the skills the potential employees need to bring with them to your company.

GET ONLY THE HELP YOU REALLY NEED

As an issue comes to light you can’t readily handle, do the research or hire the help you need at that time. Attend the seminars, take the classes or hire a consultant to provide the needed help or direction. Another great source of help in this area is your insurance provider or the underwriter you propose to use when the time comes for certification. You can greatly reduce your training costs by getting the assistance as it is actually needed. Rather than pay for a broad range of advice and direction, some of which you will undoubtedly already possess, get the specific help you actually need and only as the need arises.

DECIDE IF CERTIFICATION IS RIGHT FOR YOU

As you progress through the implementation of the ISO system your understanding of what is required to achieve success will grow. Those tasks which at first seemed complicated and beyond comprehension will become clearer and attainable and suddenly you will be at a point where the system is in place and working. Now is the time to determine if you want to take that last step and actually become ISO certified.

Becoming certified offers some advantages. Certification is a way to celebrate your new found success. The inherent requirements of certification lend themselves to keeping the system in place and functioning properly. It also tells your current and prospective customers, as well as your competition, that you are a world class organization. Certification opens the door to markets that were previously closed to you. Still, certification may not be for everyone. If your products or market access are not limited by being ISO then you may decide to delay or put off certification altogether.

Whether you opt for that piece of paper or not, you will still be able to reap the benefits the ISO system provides. By taking the time to implement the ISO system on your own terms you can significantly reduce the costs of doing so and outperform that section of your competition that found ISO unnecessary or too costly. At the end of the day, the fact is, you will have made enormous strides in your organizations potential, and even though it may have taken you a bit longer, it is still better late than never.

Mr. Cavalluzzi is the founder and owner of CONSOLUTE, LLC. His extensive background in engineering dates back to 1978 an includes the robotics, automotive, aerospace, metals and plastics industries.

Visit us at Consolute, LLC

What is ISO 9000?

ISO 9000 refers to a group of international standards developed by professionals from around the world. These standards allow companies to create in-house quality standard systems and to monitor their existing quality systems. The standards were developed and are maintained by the International Organization for Standardization and are implemented in over 90 countries worldwide. The standards set within ISO 9000 are considered to be generic because they can apply to any business, product or service regardless of the industry.

The International Organization for Standardization first developed standards for quality control in 1987 and has updated it twice since then. According to the organization, the standards were developed to enhance the growing global marketplace. With a set of standards that has met widespread acceptance, and people of all nations can recognize and understand their value.

ISO 9000 has quickly become the leading set of standards for companies throughout the globe. Quality management saves time, money and ensures customers are satisfied. Because many managers ask the question, “What is ISO 9000?” many resources for information have become available.

“9000” refers to five standards that are not specific to any particular company or industry. These standards do not reflect the quality of goods or service, but rather refer to the manner in which a company ensures its quality level. Registration and certification as compliant with ISO 9000 means that the company adheres to the rigorous set of standards as determined by an independent auditor. Employee relations, record keeping, product testing, and response to issues are among a few of the areas that are covered in ISO certification.

Whether large or small, ISO 9000 standards have been widely accepted in nearly every developed country. Having a set of quality standards has shaped the new millennium’s global marketplace and provides for enhanced customer service and employee relations. A company that has undergone ISO 9000 certification basically guarantees that they are true to their word. This gives customers and clients a sense of satisfaction and peace of mind.

ISO 9000 Info provides detailed information about ISO 9000 standards, software, consulting, help, and solutions. ISO 9000 Info is affiliated with Business Plans by Growthink.

Quality Standards with ISO 9001

Standardizing Quality Systems

The ISO, or International Organization for Standardization, was established in 1947 to develop international standards for everything from electronics to management systems. Having over 13,000 standards currently in place, ISO has created the auditing and certification process known as ISO 9001. This began the drive toward quality standards.

Improving Customer Satisfaction

Companies choose to implement ISO 9001 and get certified because many customers and industries require it. By keeping customers happy, they can increase sales and profitability for their business. And if an area of the company’s program appears to be too bureaucratic and non-value-adding, then it might also be an area for continuous improvement efforts.

Enhancing Company Performance

Both customers and industries alike use ISO certification as a way to evaluate and audit their suppliers and products. Through an independent verification process, customers can gain assurance of their suppliers’ products. And as a supplier becomes certified, the testing requirement is waved, which saves the company both time and money.

Developing Best Practices

Employed as a “Best Practices” model, ISO 9001 utilizes the philosophy of the “Plan-Do-Check-Act” continuous improvement cycle to achieve requirements. This process approach centers around eight quality management principles used by management as a guide toward improving performance and identifying the main elements needed in a good quality system:

1. Customer Focus

2. Leadership

3. Involvement of People

4. Process Approach

5. Systems Approach to Management

6. Continuous improvement

7. Factual Approach to Decision-Making

8. Mutually Beneficial Supplier Relationship

Building Stable Processes

ISO 9001 policies, procedures and forms can provide employers, managers and employees with a systematic and consistent approach to implementing policies, plans, procedures and work routines. Instead of building their own policies and procedures from scratch, some companies prefer to hire professional writers that have already prepared a set of written policies and procedures to help on the way to certification.

Auditing a Company System

In the certification process, an independent registrar will perform an on-site audit of a company’s operations to verify that it complies with the ISO standard. If the business complies, then that company will be registered as ISO 9001 compliant.

Meeting Company and Customer Needs

On the way to certification, a business can meet its ISO needs by:

• Using well-defined processes and procedures to build stable processes

• Training in the audit and certification process

• Continuously improving with ISO 9001 standards

Noticing the Difference

With complete procedures manuals for ISO 9001 Quality Management System, required HR procedures, and an ISO training class, a template like an ISO 9001 Quality Manager Procedures Manual Series can help a business on its way to ISO 9001 certification. Sometimes the effort can be very great, but companies typically notice a remarkable difference in efficiency and effectiveness after the first year.

Chris Anderson has over 18 years of management experience working with business process design, software and systems engineering, consulting with companies large and small. He is also co-author of policies and procedures manual products, producing the layout, process design and implementation of the information to increase performance. He is currently the Managing Director of Bizmanualz, Inc.

Visit: http://www.bizmanualz.com