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.

What is ISO 9000

ISO 9000 is a set of international standards that ensure product and service quality. In 1987, International Organization for Standardization (ISO) created the ISO 9000 standards providing guidelines to implement and operate quality management systems.

The ISO revised the standards in 1994, and again reorganized the standards and published an updated version in December 2000. The revised version includes three quality standards, namely, ISO 9000:2000, ISO 9001:2000, and ISO 9004:2000. The first one presents requirements, while the last two present guidelines.

ISO 9000 standards help businesses create in-house quality systems and monitor their existing quality systems. To develop quality systems, businesses should first identify areas in which quality control is required. Next step is to recognize what changes are to be made. After that, they should implement the standards by updating and managing their new quality processes.

ISO 9000 certification provides several benefits that can influence almost all activities of a company. The advantages range from increased stature to bottom-line operational saving. Of the numerous benefits include increased marketability, reduced operational expenses, better management control, improved internal communication, reduction of product-liability risks, and improved customer service.

For quality management, ISO 9000 standards require a total of twenty elements (sections.) They include management responsibility, quality management system, order entry, design control, document and data control, purchasing, control of customer supplied products, product identification and tractability, and process control.

ISO 9000 standards are generic as they can apply to any business, service or product, regardless of the industry. Businesses that employ these standards include manufacturing, processing, servicing, printing, forestry, electronics, steel, computing, legal services, financial services, accounting, trucking, and banking.

ISO 9000 is of great importance owing to its worldwide orientation. It has become the logical selection of all organizations that do business internationally, and for customers who want an international standard of quality. At present, national standards bodies from more than 120 nations support ISO 9000 quality standards.

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.

Is ISO 9001 Registration For My Organization?

Firstly you should decide your own reasoning behind considering ISO 9001 2000 registration for your organization.

Is the number of registrations in your market sector increasing?

Are your competitors seeking registration?

Are your customers asking about registration?

Are registrations increasing in your industry?

Are your customers asking you to become registered?

Have your group HQ asked you to gain registration?

Do you want to reap the financial benefits of registration?

Have the number of customer or consumer complaints increased?

Do preventable errors keep occur again and again in your business?

It is not possible to state exactly what benefits will your organization will gain by having a formal quality system, primarily because each organization is different. However, I think it is fair to say that most organisations will benefit from having a formalized Quality Management system where:

Work proceeds in an orderly and predictable way.

The same old preventable errors stop occurring.

Customer and consumer complaints fall dramatically.

Your Management System improves.

Internal communication within your organization improves.

Returned product from customers reduces week on week.

The quality of your product and or service improves.

The level of customer and employee satisfaction improves.

Your organization produces quality data to improve your business.

By now you should have a reasonable idea of whether or not ISO 9001 2000 registration is right for your organization and whether or not you will gain financially from adopting the ISO 9001 2000 standard as a method of running your business effectively and efficiently.

If you are now seriously considering seeking registration to the ISO 9001 2000 standard you must begin to understand what the standard requires of an organization. There are many books and resources available which discuss implementing the ISO 9001 2000 Quality Management Standard into an organization, including the documentation and resources to be found on this web site.

You may like to begin your ISO 9001 2000 education by reading the various articles and resources to be found on this web site. I would thoroughly recommend reading the Questions and Answers (Q&A) section of this web site as it will answer many of the initial questions that you might have about the ISO 9001 2000 registration process.

To begin to understand the requirements of the ISO 9001 2000 standard we recommend that you read Preparing For ISO 9001 2000 Registration. Alternatively you could take a training course which will teach you about the ISO 9001 2000 Quality Management Standard and the registration process.

To determine the amount of input required by your organization to comply with the requirements of the ISO 9001 2000 standard will require that you assess your existing management system. You could to fetch in a consultant at this stage because a consultant will be able to identify exactly what your organization needs to do in order to achieve the requirements of the ISO 9001 2000 Quality Management Standard.

Many organizations opt to carry out a gap analysis audit by themselves. However, this is such an important part of the ISO 9001 2000 registration process it is worth seeking professional help from a consultant. Many organizations who opt to jump straight into the gap analysis audit process themselves can often waste time, money and resources by not fully understanding the intent of the ISO 9001 2000 standard. Whereas seeking professional advice from a consultant will set your organization on the right path with clear instructions on who, what, where, why, when and how things should be done.

If on the other hand your organization already has a very good understanding of the ISO 9001 2000 Quality Management Standard and you have:

A documented Quality policy.

Been setting and using documented Quality objectives.

Documented Top management reviews of your Quality Management System.

Documented top level Quality Management System Manual.

Documented effective and efficient process procedures and or work instructions.

Documented employee skills and training records which are regularly reviewed.

Documented ISO 9001 2000 compliant Quality Management System Audits.

Documented an effective and compliant Customer complaint process.

Documented an effective corrective & preventive action process.

If you are doing all the above then you may be well on your way toward gaining ISO 9001 2000 registration. However, if your Quality Management System is incomplete or immature it will require much more effort to become compliant. You can continue to adjust your system, carry out internal quality audits to check for compliance, train employees etc. Until you reach a position where you feel you have done as much as you are able to do yourself. Once you have reached this stage you may be concerned that you have missed something important. It seems rather silly to embark on a full registration audit at great cost to your organization when you can hire a consultant to carry out a gap analysis audit for a relatively small sum of money to ensure that your quality management system is compliant with the requirements of ISO 9001 2000. If you fail the certification body initial assessment audit the cost of a full re-audit by a registration body can be prohibitively expensive.

A pre-assessment or gap analysis audit is survey carried out by a professional who compares what processes your organization has in place compared to those required by the ISO 9001 2000 Quality Management Standard. The consultant will report any deficiencies in your organizations processes, it is then up to you to decide if you want to tackle these deficiencies by yourself or to engage the professional services of consultant.

Driso provide ISO 9001 2000 consultancy, auditing, software, and training Services. They also supply Easy ISO 9001 2000® software for initially setting up an ISO 9001 2000 compliant Quality Management System or improving upon an existing one. To contact Driso Consultancy Services visit the web site below and see what they can do for you and your business.http://www.driso.co.uk