ISO 9001 is often considered to be complicated and bureaucratic. Because the ISO 9001 standard was written to be applicable to any company of any industry, it its rather broad and generic, and it leaves up much to interpretation. In order to be "on the safe side", many ISO 9001 consultants have set up convoluted and bureaucratic ISO 9001 quality management systems which ultimately prove to be inefficient and create a significant burden to the business.

This need not be!

The ISO 9001 standard was designed as a tool for businesses to become more efficient, improve their processes and ultimately their quality.  We urge you to never lose sight of this basic goal, and we help you simplify the process.

ComplianceSimplified will help you keep ISO 9001 simple, efficient and beneficial to your business!

The ISO 9001 standard is intended for use in any organization which designs, develops, manufactures, installs and/or services any product or provides any form of service. ISO 9001 provides a number of requirements which an organization needs to fulfill if it is to achieve customer satisfaction through consistent products and services which meet customer expectations. While there are other standards in the ISO 9000 series of standards (see below), ISO 9001:2008 is the only one for which third-party auditors may grant certifications.

The ISO 9001:2008 standard is divided into the following five sections:

1 - Quality Management System

This ISO 9001:2008 section outlines the necessary steps to implement the ISO 9001 quality system:

1. Identify the business activities (processes) that are needed for the quality management system,

2. Determine the sequence and interaction of these processes,

3. Determine how these processes are effectively operated and controlled,

4. Ensure that all information is available to support the operation and monitoring of these processes,

5. Measure, monitor and analyze these processes, and implement action necessary to correct the processes and achieve continual improvement.

Necessary documentation includes a quality manual, quality procedures, work instructions and quality records. The quality procedures include a document control procedure that ensures that all documentation is effectively controlled. Also in this section, ISO 9001 emphasizes the need for continuous improvement.

☻Our Advice: Don't write the entire documentation from scratch! There are many pre-written documentation templates available that you can simply customize. See our section on Quality Manuals and Forms for more information.

2 - Management Responsibility

Top management’s commitment to quality is crucial to the success of the ISO 9001 quality system. This ISO 9001:2008 section requires a corporate quality policy and quality objectives, and it reinforces the involvement of top management with customer requirements.

Top management is required to clearly define responsibilities and authorities within the company, including the position of the ISO 9001 management representative.

☻Our Advice: Use a good standard form for your job descriptions – this will save you much time when creating new job descriptions, when advertising positions, when performing employee evaluations, etc. The “Forms Collection” includes a very user-friendly job description form, and the featured "Complete Package" also includes a complete job description of the ISO 9001 management representative.

3 - Resource Management

This section of ISO 9001:2008 contains requirements for a company to identify and to provide necessary resources (equipment, facilities, etc) and to address customer satisfaction. This ISO 9001:2008 section also includes requirements for employee training, as well as for the physical facilities and the work environment.

☻Our Advice: Integrate your company’s HR function well into your ISO 9001 quality system, and make them take on a leading role during the ISO 9001 implementation.

4 - Product Realization

Product Realization is defined as “that sequence of processes and sub processes required to achieve the product.” This is how a company's products (or services!) are designed, produced, tested, handled, shipped, etc. Emphasis is placed on how the company understands, communicates and actually meets their customers' requirements. This ISO 9001:2008 section also contains various requirements for the design of products and for the planning of processes, projects and services.

☻Our Advice: Most companies write work instructions and flowcharts to define and standardize their work processes. You will save yourself much time if you right away follow the ISO 9001 requirements for document control when writing these documents. 9001Simplified’s documentation templates include simple yet powerful document control procedures.

5 - Measurement, Analysis and Improvement

The last section of ISO 9001:2008 closes the loop by requiring the implementation of systems that provide feedback on all key processes, so that the company can immediately identify when not on track and implement corrective action. Measurement and monitoring activities include internal audits and the monitoring of customer satisfaction. All of these activities must be defined, planned and implemented. Measuring and monitoring allows the company to manage by fact, not by guess.

☻Our Advice: This is a very important section of the ISO 9001 standard. Depending on how it is implemented, it can add tremendous value or create a huge bureaucracy and much waste. We highly recommend placing emphasis on this crucial ISO 9001 section (as 9001Simplified's documentation templates do).

What is the difference between ISO 9000, ISO 9001, and ISO 9001:2008? And what are ISO 9002 and ISO 9003?

The quick answer is “none”. These terms are all used to describe the ISO 9001 standard. Prior to December 2000, there used to be an ISO 9001, an ISO 9002 and an ISO 9003 standard; without focusing on the technical differences between them, people would just simply refer to each as ISO 9000. In December 2000, the International Organization for Standardization (ISO) merged ISO 9001, ISO 9002, and ISO 9003 into a revised ISO 9001 standard. In order to distinguish between the previous ISO 9001 version, the revised standard was then often referred to as ISO 9000:2000 or ISO 9001:2000 (":2000" indicates the year of the revision).  The current revision of ISO 9001 is ISO 9001:2008; it was published in November 2008 as successor to ISO 9001:2000.

For all practical purposes, ISO 9000 and ISO 9001 mean the same.

☻Our Advice: More detailed information can be found on www.iso.ch and these Frequently Asked Questions.

What is ISO 9001 Certification?

ISO 9001 certification is also known as ISO 9001 registration, ISO 9001:2008 certification (if one specifically refers to the latest version of the ISO 9001 standard), or ISO 9001:2008 registration. All of these refer to an independent certification body attesting that your company’s ISO 9001 quality management system meets all requirements of the ISO 9001:2008 standard.

The Benefits of ISO 9001

The benefits of a certified ISO 9001 quality management system are:

1. Improvement: ISO 9001 is an excellent tool to develop a strong foundation of good quality processes and quality systems. Processes and systems are essential for the performance and expansion of any company. Quality improvements come along with this. Remember, ISO 9001 was developed as a real tool to improve companies.
   

2. Marketing: ISO 9001 certification can effectively be used in marketing as it is globally recognized as indicator for high quality; it sends a message to your customers that you take quality seriously, that you are proactive and that you put your customers’ satisfaction first.
   

3. Customer Requirements: if your company provides products or services to other companies, some of those customers may require ISO 9001 certification in order to do business with you.

☻Our Advice: If you are close to ISO 9001 certification, you may want to review this Marketing Guide for ideas and tips.

Revision of ISO 9001

Like all of the more than 17,000 standards published by the International Organization for Standardization (ISO), ISO 9001 is periodically (approximately every 6-8 years) reviewed to ensure that it continues to be state of the art. Based on the review, a decision is taken to keep as-is, withdraw or revise the standard. After its major year 2000 revision (ISO 9001:2000), the latest revision of ISO 9001 was published on November 14, 2008; the latest revision is called ISO 9001:2008.


Changes in ISO 9001:2008

The changes in ISO 9001:2008 are relatively minor.  ISO 9001:2008 does not contain any new requirements nor does it contain changes to any of the existing requirements in ISO 9001:2000; also, it does not change the intent of ISO 9001:2000. Further, the structure and outline of ISO 9001:2008 is identical to that of ISO 9001:2000.

However, ISO 9001:2008 introduces clarifications to the existing requirements of ISO 9001:2000 based on eight years of experience of implementing the standard world-wide with about one million certificates issued in 170 countries to date. It also introduces changes to the wording intended to improve consistency with ISO 14001:2004

The International Organization for Standardization (ISO) explains one of the reasons for the limited changes in the 2008 version as follows: “A key factor in the development of ISO 9001:2008 was to limit the impact of changes on users.”

According to ISO, the benefits of the changes to the wording in ISO 9001:2008 are as follows:
• Easier to use
• Clearer language
• Easier to translate into other languages
• Better compatibility with the environmental management standard ISO 14001:2004
 

Documentation is a big part of ISO 9001. Necessary documentation includes a quality manual, quality procedures, quality policy, quality objectives, quality records, a process flowchart, work instructions and forms.  See our section on Quality Manuals & Forms for more information.

When is the Best Time to start the ISO 9001 Implementation?

Ideally you should begin your ISO 9001 implementation when you first start up your company. If you are in the position of starting up a new company, you should be setting up your business processes according to ISO 9001 requirements and start to implement ISO 9001 before hiring your employees. This is the most efficient approach as your company not only immediately reaps the benefits of ISO 9001 but you also don’t have to overcome resistance to change when adjusting work processes later to meet the requirements of the ISO 9001 standard.

However, most companies have been long established before they start their ISO 9001 implementation. Since a complete ISO 9001 quality system brings many benefits to a company, it’s always better to start the ISO 9001 implementation sooner rather than later.

How do I start the ISO 9001 implementation?

As a first step, you should make yourself familiar with the ISO 9001:2008 quality standard and its requirements. You can find some important information on ISO 9001:2008 and links to organizations selling the standard at www.iso.ch.

Once somewhat familiar with ISO 9001, you may want to read an overview of the five steps to ISO 9001 certification . The easiest and best way for small to midsize companies is to use a do-it-yourself implementation package that includes all documentation templates, forms, checklists, implementation tools and a detailed project guide. We recommend the "Complete Package".

How long does it take to implement ISO 9001?

It depends on you and your company. The very fastest ISO 9001 implementation takes 2-3 months because most ISO 9001 registrars require at least 2 months of ISO 9001 track record before the ISO 9001 certification audit. More realistically: if you have a relatively small company (say, less than 20 employees), if your employees are motivated and if they don’t oppose change, if you have the backing of all senior executives, if you and other managers are ready to put some significant time and efforts into this endeavor, and if you use a really good ISO 9001 quality manual template (a sample ISO 9001 quality manual that you can modify to make it your own ISO 9001 quality manual), then you may be able to get certified in as short as 3-4 months; templates for ISO 9001 forms are an additional time-saver. Some companies are significantly slower, with 6-12 months not being unusual. However, companies that write their ISO 9001 quality manual and their ISO 9001 quality procedures from scratch, rather than base them on a proven sample ISO 9001 quality manual, often take up to 2 years or longer.

Should we use an ISO 9001 consultant?

We found that ISO 9001 consultants can be of great help, and they can also cause great damage, depending on the ISO 9001 consultant and depending on how you use them.

Good ISO 9001 consultants can add value as trainers. It may be beneficial if an expert in ISO 9001 matters is used to train the ISO 9001 management representative, or to “sell” the benefits of ISO 9001 to top management. However, since most ISO 9001 consultants try to sell their consulting services, pure ISO 9001 trainers are usually a much better choice. We have heard of countless cases in which ISO 9001 consultants purposely made the ISO 9001 requirements appear overly complicated and restrictive only in order to justify the high price of their ISO 9001 consulting services.

The most common problems that we have encountered are inefficient and bureaucratic ISO 9001 quality management systems. These are typically the result of an ISO 9001 consultant writing and implementing an overly complicated and convoluted ISO 9001 quality manual and quality procedures.

If outside help is desired, we recommend using a professional ISO 9001 trainer (either in-house or in a public class) to teach the ISO 9001 management representative and executive management. An excellent (and less expensive) alternative to a professional instructor are web-based ISO 9001 training programs and video presentations. We further recommend developing the ISO 9001 quality management system in-house because the result is usually more suitable for the individual company. A great help and time-saver is the use of templates for quality manuals, procedures and forms.

☻Our Advice: Consider taking an interactive e-learning course by 9001Courses. Excellent documentation templates and guides are available at 9001Simplified.

Cost of an ISO 9001 Quality System

While operating a good ISO 9001 quality management system results in significant cost savings (even after paying the periodic audit fees of about $1,000 - $2,000 per auditor day), the initial ISO 9001 implementation can be expensive. Large companies often spend in excess of hundred thousand dollars, while small companies could get by with a thousand dollars. We found that small to medium size companies can achieve significant savings by implementing the ISO 9001 quality management system internally in-house using a good implementation package like the "Complete Package".

It is important to recognize that an ISO 9001 quality management system is alive and constantly evolving. ISO 9001 includes “continuous improvement” as one of its requirements, and “continuous improvement” not only refers to a company’s products and services but to the ISO 9001 quality management system itself.

Achieving Continuous Improvement

The ISO 9001 standard incorporates several processes that help a company continuously improve:

• Goals and Metrics: setting goals on various levels and using metrics to gage performance.

• Customer Feedback: measuring what customers think about the company and its products or services.

• Internal Audits: periodical evaluating if the company still meets all ISO 9001 requirements.

• Corrective Action: systematical identification of underlying causes of existing problems and then correcting these causes.

• Preventive Action: systematical search for potential problems and correcting their underlying causes before the problems can occur.

• Management Review: management’s periodical review of key business indicators and planning of improvement initiatives.

☻Our Advice: We recommend keeping all employees involved in the ISO 9001 quality system. A great idea is to periodically send tips to all employees. Check out this useful collection of Tips on ISO 9001 Compliance.

Revising the ISO 9001 Quality Manual

Revising the ISO 9001 quality procedures and the ISO 9001 quality manual should be a normal part of the ever-improving ISO 9001 quality management system. These revisions can reach from small corrections to a total makeover of the entire ISO 9001 documentation. If you find your company’s ISO 9001 quality management system to be bureaucratic and cumbersome, if you find your employees completely negative about ISO 9001, and if you end up extensively preparing for each audit, then your ISO 9001 system has plenty of opportunities for improvement and you should consider a complete makeover.

☻Our Advice: For an easy way of upgrading your ISO 9001 documentation to an excellent one, use the “Streamlining Manual”. You can simply edit it following the included customization instructions.

It is not uncommon to find employees with negative opinions on ISO 9001. Most of them complain about excessive bureaucracy, much paperwork and extra work before audits. At the same time, they feel that there are no benefits to ISO 9001.

These problems are not the fault of ISO 9001 – these problems result from the way the ISO 9001 quality management system was implemented!

Typical Problem #1: Management Attitude and Purpose

Previously in this article, we talked about the benefits of ISO 9001: internal improvements, marketing and customer requirements. If management desires to implement ISO 9001 solely for marketing reasons or due to customer requirements, the resulting ISO 9001 quality management system often lacks the all-important internal improvement component. It is possible to pretend (even to an experienced auditor) to have an effective ISO 9001 quality management system in place that is designed to improve the company, but the costs due to bureaucracy and inefficiency could be huge.

Typical Problem #2: Implementation by Consultants

Frequently management decides to hire ISO 9001 consultants that are tasked with the implementation of ISO 9001. These ISO 9001 consultants promise to write a quality manual, quality procedures and other documents; in many cases, they also provide implementation training. Typical problems with this approach are:

• The ISO 9001 consultant is unfamiliar with the business, the company and its culture. The resulting ISO 9001 quality management system does not fit the company.

• The ISO 9001 consultant tries to justify his high fees by setting up an overly complicated and convoluted ISO 9001 quality management system.

• The ISO 9001 consultant does not adjust to the particular company and sets up a standard ISO 9001 quality system. These “standard” systems are often geared towards large corporations, and they are often far too bureaucratic and labor intensive for small and medium size companies.

• The ISO 9001 consultant is not flexible. Instead of creatively molding the ISO 9001 quality managment system to fit the realities of the company, the ISO 9001 consultant tries to mold the entire company to fit his one-size-fits-all ISO 9001 quality procedures.

Typical Problem #3: ISO 9001 Management Representative Without Power

Executive management of some companies erroneously consider ISO 9001 a documentation task rather than an improved and systematic management style. As a consequence of this misconception they appoint an ISO 9001 management representative without the power to make real changes. In these situations, it is very common to find an increasingly disenchanted ISO 9001 management representative who is desperately trying to improve the company while top management pays mere lip service to ISO 9001.

Typical Problem #4: Insufficient Resources

Unless a company’s management processes and performance is well above average, the implementation of ISO 9001 usually requires significant resources: the ISO 9001 management representative needs to be trained and guided; top management needs to learn about the concept of ISO 9001 and its benefits; a quality manual, quality procedures and other ISO 9001 documentation need to be written; work processes throughout the company need to be analyzed and streamlined; employees need to be trained, etc. It is crucial to the success of the ISO 9001 implementation that management allocates enough time, as well as financial resources (for example, for documentation templates, for employee training, for auditor training).

Typical Problem #5: Lack of Improvement

It is a common misconception that an ISO 9001 quality management system needs to be implemented, certified and that’s it. In reality, the ISO 9001 quality management system must constantly evolve as the company changes, as the market conditions change, as products change, as technologies improve and as the competition moves forward.

Typical Problem #6: Making it Complicated

ISO 9001 does not need to be complicated! In fact, the easier to follow and understand the ISO 9001 documentation, the better the ISO 9001 quality management system! There are countless causes for overly complicated and overly bureaucratic ISO 9001 quality management systems, including the problems mentioned above, including inflexible auditors, including bad documentation templates, and including bad training.

☻Our Advice: It is interesting to note that the described problems are a direct consequence of management action and management attitude, rather than the often blamed employee resistance to ISO 9001. Ensuring that top management buys into the benefits of ISO 9001 and that top management remains actively involved in ISO 9001 is crucial important to the success of ISO 9001. An executive overview by a competent trainer or through a web-based training program (for example, from 9001Courses) prior to the start of the ISO 9001 implementation is highly recommended.

☻Our Advice: Implementing ISO 9001 by a company insider as opposed to an external consultant is in most cases not only cheaper but it also results in a more efficient ISO 9001 quality management system. We recommend appointing a manager as the ISO 9001 management representative who has sufficient authority to make internal changes. The ISO 9001 management representative should then undergo training in the ISO 9001:2008 standard, then give this individual the resources to acquire an implementation package to set up ISO 9001 based on templates (be careful, many packages on the market are hard to read and unnecessarily complicated; however, a refreshing exception is the “Complete Package”), and ensure that all functions in the company allocate enough time to work with the ISO 9001 management representative.

☻Our Advice: Choose your ISO 9001 registrar carefully! We recommend that you compare different ISO 9001 registrars and pay particular attention towards auditor background (for example, some may consider former military auditors to be rigid and inflexible in their interpretation of the standard) and towards attitude towards sharing ideas (in order to ensure objectivity, auditors are not allowed to consult; however, some registrars permit their auditors to share their experiences). A complete ISO 9001 registrar evaluation guide and form is included in the Forms Collection.

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