ISO 9001 - Frequently Asked Questions (FAQs)

This month, I'm publishing a few more questions that we're asked on a regular basis. We hear these questions so much, that I've included them in my ever-growing my list of "Frequently Asked Questions":


Q: Is ISO 9001:2008 the right Quality Management System for my business?

A: The answer to this question may, in part, be found in the requirements of your customer(s), if such requirements have been established by contract or order. Depending on your industry, suppliers are often required to maintain a Quality Management System (QMS) compliant with ISO 9001:2008, aerospace suppliers to AS9100 rev. B, nuclear suppliers to 10 CFR 50 Appendix B, oil and gas to ISO/TS 29001:2004 (API Q1) and the list goes on and on from there...


Q: I've seen ads on the Internet for pre-written Quality Manuals and other program documentation. Is this a good approach?

A: For your system to be truly effective, it should reflect your business accurately. Instead of revising your existing processes to meet a program that you purchased on-line, my personal belief is that it's always better to develop the required documentation to reflect what you're already doing. Some adjustments to existing processes may be necessary to comply with the requirements of the applicable standard, but this way, you won't need to "start-over". While the initial time and cost of this approach may be somewhat higher, you'll save over having a program that isn't used, that you aren't happy with, or that needs to be re-written in the near future.


Q: My company isn't very large; do we need to hire a full-time Quality Manager?

A: ISO 9001:2008 requires the appointment of a Management Representative by executive management; it doesn't mention anywhere the need for a full-time Quality Manager. There's no reason that the responsibilities for your program can't be delegated between functions within your organization.


Q: If we're writing documentation to ISO 9001, how many procedures will we need to develop?

A: This is a question that will be specific to your organization. While ISO 9001 requires that an organization develops a Quality Manual and a minimum of six procedures, the exact number of procedures required should be based on the organization and the scope of the activities it performs. While procedures for document control, records, internal audits, control of nonconformances, corrective action and preventative action all are required by the ISO 9001 standard, this is only a minimum requirement. The organization should consider the other activities it performs, and determine what, if any, additional controls are needed. Such additional controls could include, but should not be limited to, procedures for training, control of measurement and test equipment, purchasing, contract review and other areas.


Q: We're looking to get ISO 9001:2008 certified; how long will this take?

A: This is one of the questions we're asked most frequently, and will really depend on the level of commitment and involvement by the client, not to mention the size and complexity of their operations. As with any other major project, the organization's executive management should establish a working group or team to lead this project, a project plan and budget, and make sure that adequate resources are available to ensure the success of this effort.


Q: We need consulting assistance to get ISO 9001 certified, but we also need to control costs. What options are available?

A: Consulting assistance can vary, ranging from the consultant acting in an advisory capacity, to providing consultative help, to collaboration. The degree of involvement will be a primary factor in determining what this consulting assistance will cost. Needless to say, the more time on-site and the more "hands-on" involvement a consultant has, the higher this cost will be. Bear in mind also, that if a consultant is left to do everything, you really haven't taken ownership of your program. The best programs are those that are "owned" by the organization, and reflect the organizations unique business needs and conditions, not simply the consultant's idea of what a good program is.


Q: If we achieve ISO certification, we will then be audited by our Registrar on a regular basis. Will this meet the requirements of ISO 9001:2008 for periodic internal audits?

A: No. The audits performed by your Registrar will be for the purposes of either initial certification, surveillance (including follow-up audits) or recertification. Registrar audits are a third-party assessment focusing on the certification status of your program. Internal audits, in contrast, are an internal assessment performed by management, for the purpose of verifying conformance with applicable requirements and for identifying improvement opportunities. While these two activities may seem vary similar at times, an internal audit is still required.

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ISO 9001 Quality Consulting

ISO 9001 Quality Consulting

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ISO 9001 - Design and Development - Design Input

Many organizations struggle with understanding design inputs as specified by the ISO 9001:2008 standard in clause 7.3.2. As part of these requirements, the organization is required to ensure that “inputs related to product requirements are identified and records maintained”.

In order to clarify what design inputs are, we must understand that design and development is a process, which therefore requires us to first define what a process is. While there are a variety of different definitions related to this subject, one of the most illustrative definitions of a process is provided by Hammer & Champy (1993)[1]:

”a collection of activities that takes one or more kinds of input and creates an output that is of value to the customer.”

Personally, I like this definition of a process, as it’s simple, relatively straightforward and it usually minimizes the amount of further explanation required. While this definition is applicable to the ISO 9001:2008 standard in its entirety, when applied specifically to design and development, we can state that our design and development process (clause 7.3) is the manner in which we transform design inputs (clause 7.3.2) into design outputs (clause 7.3.3).

In clause 7.3.2, the ISO 9001:2008 standard identifies several types of design inputs that shall be determined by the organization, including:

• Functional and performance requirements

• Applicable statutory and regulatory requirements

• Information derived from previous designs

• Other requirements essential for design and development

In some cases, particularly where design and development activities are performed on a made-to-order basis, the initial design inputs are established as part of an order provided by an external customer, specifying their needs and expectations. This order is reviewed as part of clause 7.2.2 of the ISO 9001:2008 standard (see Customer-related processes), and upon acceptance by the organization, the information provided becomes a primary, albeit not exclusive, source of design inputs for use by the organization.

Alternatively, design and development activities may be performed to create new products or to update existing products. In such cases, these activities are not initiated by an external order, but rather by a management directive or similar order of an internal nature, in order to meet an identified market, commercial or strategic needs identified by the organization. Similar to an order received from an external customer, such internal information also serves as a primary source of design inputs.

It is important to note here, that the list of design inputs specified in 7.3.2 is not all-inclusive; in fact, the fourth type of input identified by the standard is simply indentified as “other requirements essential for design and development”. This is really a broad requirement for the organization to identify all other internal (organizational) and external (customer) inputs to ensure that all applicable needs, expectations and requirements are addressed. This could include, but would not be limited to, requirements specified by applicable codes, standards and specifications, supplier-provided information, competitive analysis, feedback from previous products, process performance data, etc., etc., etc.

Not only is the organization required to identify these inputs, it is also required to keep records relating to these inputs and to ensure that these inputs are formulated in a way that can be verified and validated. Inputs must also be reviewed by the organization prior to use, to ensure that the inputs are adequate and that there is sufficient information to carry out the assignment. Consideration must also be given to ensure that inputs are complete, unambiguous and not in conflict with each other.

*[1] Michael Hammer and James Champy (1993). Reengineering the Corporation: A Manifesto for Business Revolution, Harper Business




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ISO 9001 - Your Management Representative

As part of ISO 9001:2008, clause 5.5.2, the standard requires that Top Management appoint a member of management to serve as the Management Representative for the organization’s Quality Management System.

Expanding upon this requirement, we can consider this appointment to include the responsibility and authority to manage, monitor, evaluate and coordinate the organization’s quality management system as necessary to meet customer and other requirements and to achieve specified quality objectives. This individual would also then be responsible for communicating with Top Management, as well as the customer and other interested parties on matters pertaining to the organization’s quality management system (see ISO 9004:2000 also).

This appointment is typically documented by Top Management (e.g., President, CEO, COO, etc.) in the form of an appointment letter or other similar written statement; however direct reference within the organization’s quality manual is an equally acceptable method. In the later case, the responsibility and authority is not delegated to a particular individual, but rather to a particular position/title within the organization’s management structure, which is then assumed by an individual when they are assigned to this particular role.

Specifically, as stated within the ISO 9001 standard, the responsibilities of a Management Representative are as follows:

• Ensure that the processes needed for the organization’s QMS are established, implemented, and maintained;
• Report to top management on the performance of the QMS to Top Management and any need for improvement;
• Ensure the promotion of awareness of customer requirements throughout the organization; and
• Act as liaison with external bodies and customers on matters relating to the organization’s quality system.

While these responsibilities are defined within the standard, they are by no means all-inclusive. The actual scope of the Management Representative’s responsibility will undoubtedly vary from organization to organization, as each organization will have its own unique needs as determined by its size, the scope and the complexity of its operations, and other factors.

It’s important to note here, with regards to the responsibilities stated above, the use of the terms “ensure” and “report”, and the absence of any reference to the actual (hands-on) development, implementation and on-going maintenance of the management system itself. For these activities, it is the responsibility of the organization to define the individual who is responsible; in some organizations, it may be the Management Representative, or it may be assigned to other personnel within the organization.

While ISO 9001 does require that the Management Representative to be a member of management, no guidance is provided on the actual selection process, particularly with regards to the skills, knowledge and or abilities that are desirable. Again, this is left to Top Management of the organization, as they must ensure that the individual selected has the traits necessary to ensure that the outcomes desired by the organization are met.

The process of selecting a Management Representative should consider the responsibilities that this individual will assume and the role they will play in the actual management of the organization and its activities. For large organizations, this will require a degree of management "savvy", the ability to interact with key decision-makers as well as make key decisions, the ability to ensure conformance and to drive change. For smaller organizations, the management representative may be required to take a more hands-on approach, handling not only management issues related to the QMS, but also being directly involved in the administrative functions that make up this system and keep in it running.

An understanding of the requirements specified by the ISO 9001 standard is obviously necessary; however a deep level of subject matter expertise may only be necessary if the individual is going to actively manage the day-to-day activities and functions associated with the organization’s management system. Regardless of the capacity in which the Management Representative will function, competency is the keyword.

As a final note, you may have realized that I never mentioned the position of Quality Manager (or similar title) in this article. There’s no reference or requirement in the ISO 9001 standard regarding this position. A Management Representative is a required by the ISO 9001 standard; having an individual assigned as Quality Manager is not – it is a choice made by the organization, based on resource needs and other factors, including the products and services offered and the degree of control that is required. For small organizations, there’s often little value obtained by adding additional head-count, as the duties required to maintain and administer a system can be shared amongst existing personnel. For larger organizations however, the level of activity is much greater, and often necessitate this position, or similar, to ensure compliance with specified requirements.

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Breakthrough Performance

I’m going to start this article by noting that I’ve never been a huge fan of the practice of benchmarking, particularly within one’s own industry. As a personal belief, I think that this practice establishes false performance standards that ultimately limit the performance of an organization, rather than to promote its on-going development. While some companies may initially benefit from this exercise, benchmarking places emphasis and value on another’s accomplishments rather than on promoting an internal culture where truly breakthrough performance is a regular occurrence.

In order to realize breakthrough performance, we need to re-calibrate the way we rate our performance and move away from a relative scale (ourselves vs. our competition) to an absolute scale (perfection). Average businesses are those that meet customer expectations, while better-than-average businesses make every effort possible to exceed these expectations. In contrast, businesses that are truly noteworthy have learned to shatter these expectations by performing at a level that the customer had yet to even consider. This level of performance doesn’t come from benchmarking; it doesn’t even acknowledge that the competition exists.

The competition is irrelevant. If you’re referencing your performance against that of a competitor, you may be performing better or worse or even equal to, however this also means that you’re still comparable. Assuming that you and the rest of your competition are doing things the same way, using the same performance standard, you’re not a true industry leader - you’re still just a follower, albeit you may be on the upper-to-high side of mediocrity. To coin a phrase, think “a league of their own” – not only should you be better than the competition, you shouldn’t even playing in the same ball-park. There’s a reason Hyundai’s and Ferrari’s don’t race together.

Perfection should be the goal. Industry best-practices should only serve to identify the minimum level of performance that should be tolerated; these practices shouldn’t ever be considered as a basis for goal-setting. To survive in a competitive business environment, we shouldn’t be focusing on best practices, but rather, we should be constantly looking to develop even better practices. To have the “least” amount of rework, repair or returns, or to have the “most” on-time deliveries is the point from where your continuous improvement journey truly begins, rather than being the end. The real goal is an absolute one - to never have any bad product, never have any returns and to always deliver on time. While I acknowledge that such a level of performance is nearly impossible to attain and its achievement is subject to an endless list of constraints, perfection should always be the target that we’re aiming for.

The past is history. I can't discount the importance of "lessons learned" or the value of celebrating past accomplishments, however I will say that the only time that really matters is now and tomorrow. Success doesn't consider where we started, where we’ve been or how far along we’ve come; there isn’t any award given to the organization that’s the "most improved". The most important measure of performance is not the one that's behind us, or in the case of our competition, around us - it's always the one that's in front of us. Going forward, the goal is more than merely replicating the incremental gains of the past - its about finding new ways to exponentially improve our performance.

Breakthrough performance has nothing to do with your competition. It is about where you are now, and where you are going; it is about your future state and how far (or how close) you are to a state of perfection. Just because you are as good as your competition doesn't mean that your competition is any good.

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ISO 9001 - The Adequacy of Your QMS

While I’ve briefly touched on the topic of QMS adequacy in previous discussions, I decided to commit an entire article to this subject based on its considerable importance. Many organizations experience difficulty with the concept of adequacy as it applies to their QMS; they really don’t have a full understanding of what this term relates to, or more importantly, how to assess whether or not their QMS is meeting this key requirement of the ISO 9001 standard.

Before we go any further, let’s first consider the meaning of the word “adequate”, or as used in throughout this article, “adequacy”:

Adequacy – Sufficient to satisfy a requirement or meet a need*.
*Random House Unabridged Dictionary, © Random House, Inc. 2006.

From the definition above, we learn that “adequate” relates to meeting both requirements as well as needs. If we apply this definition within the framework of an ISO 9001 based Quality Management System, we can therefore determine that a quality management system should be capable of satisfying applicable requirements including those specified by the organization, the customer, and any applicable standards and/or regulations.

In developing your QMS, and in the subsequent evaluation of its on-going performance, an adequate QMS means much more than simply addressing the clauses that make up the ISO 9001 standard. In addition to the requirements of ISO 9001, what are the governing codes, standards and/or specifications that the organization is working to? What customer specifications and other requirements does the organization need to meet? Finally, what other policies and other procedures have been established by the organization, and how does this QMS serve to ensure compliance? All of these considerations must to be taken into account when determining whether or not a Quality management System is adequate.

Assessing a QMS for adequacy however, relative to the above considerations, can be problematic for many organizations. With insulated management and silo-like structures, these organizations lack a comprehensive understanding of what requirements they’re actually working to. Such requirements may be known to pockets within the organization, but often they are not known across the organization, so there is little or no global understanding or awareness.

While a single organization, which produces a single product, in accordance with a single set of requirements is most likely a simple case requiring a simple solution, the complexity of many organization's operations makes their identification of these requirements and needs considerably more difficult. Multiple sites, multiple products, multiple standards, multiple sets of customer specifications, etc. all factor into the adequacy of the QMS. Without a good understanding of your entire business, and the corresponding requirements and needs that apply, it is nearly impossible to make a valid assessment of the adequacy of the QMS.

Just because an organization that has a documented system that addresses the requirements of this ISO 9001 standard, this only contributes to its adequacy; it doesn’t totally satisfy this requirement. In order to be totally compliant with ISO 9001, you QMS must not only address each applicable requirement of the standard, but also be in compliance with any additional requirements that may apply to your organization and its products. This means that a typical ISO system audit, in-and-of itself, has limitations as far as this determination is concerned. Product and process data can be used to supplement any conclusion, but as these are typically reactive measures (based on identified nonconformances), they only address issues when noted, rather than evaluating all areas of concern.

So exactly how do you find out what all of these requirements are? - Better start asking, researching and learning. If this is a new QMS or one that's under development, it's always better to find out at the beginning

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Fourteen Points of Total Quality Education

Libyan Labiosa and Philip Cassone from the International Center for Accelerative Learning (ICAL) provided us with the following guest feature, which is an adaptation of Deming's "14 Points for Management" to corporate training and educational processes; the result - Total Quality Education.- M. Randig

Dr. W. Edwards Deming’s principles support the global success of Toyota, Proctor & Gamble, Ritz Carlton, Harley-Davidson, and many other leading organizations. His teachings are essential for the effective application of Six Sigma, Lean Manufacturing, Loyalty / Net Promoter and other quality improvement, customer retention and business growth methods.

Deming’s 14 Total Quality Education points were created for the White House Task Force for Education in 2000 and presented to a congressional committee by Libyan Labiosa in conjunction with her position on the board of the National Learning Foundation within the United States Department of Education.

The 14 TQE points are as meaningful today as they were a decade ago. For education to be meaningful in a rapidly changing world, it must adapt. We are in a globalized society and the worldwide education system must adapt to fit the times ahead. To date the results have not been encouraging.

There is an international test from the Organization of Economic Cooperation and Development (OECD) that measures average mathematics literacy, reading literacy, science literacy, and problem-solving scores of 15-year-olds from over 50 industrialized countries. The highest possible score is 1000.

Currently the highest scoring nation in the world is Finland with a average score of 550 and the USA is in 29th place with an average score of 483.

In the USA, Massachusetts is the highest scoring of all 50 states with only 44% of its students at performing grade level in 4th and 8th grade. Washington DC is dead last with less than 10% of its students performing at grade level.

It is clear that Deming’s 14 points of Total Quality Education bear taking another look at in a time where the best scoring nation in the world is only at 55% and the best scoring state in the USA is at 44%. As Deming so eloquently puts it in his quote at the end of this article, we have no less than our survival at getting our educational systems right.

Fourteen Points of Total Quality Education
(Adapted from Deming’s Total Quality Management principles)

1. Create constancy of purpose toward improvement of education and learning with the aim to prepare learners to be productive in a changing world.
2. Adopt a new philosophy. We are in a new information age. Western educators must awaken to the challenge, must learn new responsibilities, and take on leadership for change.
3. Cease dependence on testing to achieve quality. Eliminate the need for testing as the only way of measuring quality. Ensure that quality is always present in the classroom.
4. End the practice of awarding students on the basis of grades. Instead minimize competition with others. Move toward a goal of learning as a long-term reward in itself.
5. Improve constantly and forever the system of education and learning to improve quality and student productivity.
6. Institute interactive and creative teaching and learning.
7. Institute leadership. The aim of leadership should be to help people do a better job. Leadership of educators is in need of overhaul, as well as leadership of students.
8. Drive out fear so that everyone may work effectively for themselves and their community.
9. Break down barriers between administrators, teachers, parents and students. People in education must work as a team to foresee problems in the educational process.
10. Always expect the best from students.
11. Eliminate minimum requirements for achievement. Each student assumes a proactive role in his/her education.
12. Remove barriers that rob the students of their right to pride in achievement. The responsibility of educators must be changed from sheer information giving to ensuring knowledge through use of global teaching strategies.
13. Institute a vigorous program of education and self-improvement.
14. Put everyone in the system to work to accomplish the transformation.
    
    “No one has to change. Survival is optional.” Dr. W. Edwards Deming
    

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