1. Quality Standards.  Documents and records are used all throughout the company.  Nobody should know more about quality, compliance and processes than the Quality Manager.  Your experience with Good Manufacturing Practices (GMP), ISO standards (i.e. ISO 9001), Sarbanes Oxley, or 21 CFR 820 within a regulated industry are important to managing and controlling documents and records.
2. Quality Project Management.  A Quality Manager is also a project manager managing corrective action, process improvement, and auditing projects.  One must have strong self-motivation, the ability to work independently, and within a team environment with strong follow up, organization and prioritization skills and excellent attention to detail helps too.  Perhaps most important of all is understanding the financial – risk-reward – trade-offs in good project management.
3. Business Process Documentation.  A Quality Manager must be able to understand, comply, and improve established company policies and procedures.  Developing standard work, policies, procedures, job aids, and business process communications are a part of the job.  A Quality Manager is also a technical writer.  Familiarity with policy and procedure writing will help you to succeed.  Technical writing conveys technical information using active voice construction, instructional design, and desktop publishing methods to transfer information into understandable and useful information.
4. Document Control.  As the Quality Manager, your Knowledge of the Quality documentation process, Document Control practices, and managing documents, records, forms, and work instructions is vital to maintaining your company’s compliance program.  A Quality Manager may be the Document Control Manager responsible for organizing documents into an easy to use and fast retrieval system.  Users need their policies and procedures to conform to requirements.  If they cannot find them, then they cannot follow them… Document control is an important priority.
5. Quality Communications.  It might go without saying but explaining business process compliance to others is what a Quality Manager has to do.  Being able to understand a variety of instructions furnished in written, oral, diagram, or schedule form helps others to follow and conform to the established best practice.  Communicating compliance and conformance is done using software such as Microsoft Word and Excel, training using PowerPoint, process mapping using Visio, Statistical Process Control (SPC) using statistics, as well as document revision control software for policies and procedures management.
6. People Management.  A Quality Manager should not be afraid of asking questions, collecting business process information, and working with others in a positive and collaborative manner.  Business processes include sensitive accounting and financial processes too.  So, you must be comfortable speaking effectively and communicating directly with all levels of personnel.
7. Quality Auditing.  A Quality Manager performs some of the quality audits.  Supply chain audits, process audits, and may even lead ISO audits an act as a Lead Auditor managing teams of auditors.  Clearly understanding the compliance requirements, collecting objective evidence, and writing up audit reports ensure the quality management system is operating effectively.
8. Problem Solving.  The Quality Manager solves problems, typically in situations where general standardization should exist, but may not be operating effectively.  Using process mapping techniques, lean, or Six Sigma process improvement methodology is essential to reducing waste and being effective in the Quality role.   A delicate balance exists between resolving problems yourself and identifying those situations that require management intervention for a solution.  Good political judgment is required where quality and compliance are concerned.
9. Team Player.  The Quality Manager is involved in teams and meetings at every level of the organization.  Management reviews, material reviews, supplier reviews, corrective action reviews, process improvement teams, audits, customer visits and strategy discussions.  A good Quality Manager is involved with many areas of the company.
10. Quality “Go To” Guy.  The Quality Manager is the person that everybody goes to to get answers about quality.  Product specifications, supplier requirements, testing, inspections, part verification, equipment calibration, corrective actions, non-conformances, workers compensation, benchmarking, voice of the customer, and on and on.  The buck stops here at Quality.

The Top Ten Quality Manager Job Description Responsibilities

1. Quality Standards.
2. Quality Project Management.
3. Business Process Documentation
4. Document Control.
5. Quality Communications.
6. People Management.
7. Quality Auditing.
8. Problem Solving.
9. Team Player.
10. Quality “Go To” Guy.

As the Quality Manager you are responsible for Quality Management System (QMS) and all of its related compliance.  You manage quality policies, procedures, processes, programs, and practices, to assure the company of continuous improvement, conformance and effectiveness.  In a smaller company you may also be the document control manager, quality auditor, and process improvement specialist.  But you are always a team player that has input on anything to do with quality.

Have you gained quality improvement expertise over the years working with many manufacturing, information technology, and service organizations?   Bizmanualz understands your ongoing challenges of building a Quality Management System, implementing Lean Thinking, or the day-to-day struggles to maintain your ISO registration.   ISO 9001 assistance is close at hand.  Bizmanualz can provide quality management support either with onsite or remote assistance.

Policies, procedures, and forms documentation.  Now you can develop a simple ISO system in as little as 12 pages that requires less overhead using Lean ISO 9001:2008 conforming policies, procedures, and forms documents.  Each document is easily editable in MS-Word to customize to your situation.

Procedure management software. Once your documents are drafted you can simplify your document version control and management tasks using online software that ensures document reviews and approvals are completed prior to release.  Deliver relevant documents to every point-of-use or to your auditors via the internet.  Improved document access control, search and retrieval ensure your users have what they need.  Using an online procedure management software means no more back-up, retention, and document control findings too.

1^st and 2^nd Party audit support.  You don’t need to have a full-time internal or supplier audit staff.  Just contract experienced auditors to oversee the internal audit process, schedules, and audit plans, as needed.  You will receive timely audit reports for your supplier audits, pre-assessment audits, internal audits or full system audits.

Quality Management Support. Obtain fast answers to your quality management system questions from experienced, certified quality managers that can lead management reviews with complete records of results, follow-up on management review action items, and oversee nonconformance, corrective and preventive action processes.  Technical advise on quality policy, quality objectives, and overall QMS performance is readily available.

Continuous Improvement Support. Trained and experienced Lean / Six Sigma facilitators are available to organize, lead and document Lean / Six Sigma improvement events (like 5S, Preventive Maintenance, Set-up reduction, line balancing, etc).  Contract for a only the ISO quality, lean, and six sigma training you need.  Having problems with SPC, calibration, FMEA, control plans, customer feedback processes?  Training programs, advise, and guidance can be yours.

Using Bizmanualz provides competent and cost effective resources that reduce common audit findings and management stress related to the quality management system.  Now you can quickly resolve common audit findings related to:

• Qualified personnel and training
• Working document and record control
• Timely internal audits and management reviews
• Viable Nonconformance, Corrective and Preventive Action system

Bizmanualz maintains competent, qualified (ASQ Certified) personnel available as Lean / Six Sigma facilitators, part-time quality managers, and part-time lead auditors.  Now you have a cost effective solution using less than a full time quality staff that are available as need demands and you pay only for what you use.

Bizmanualz quality system services offer less stress for management using a working QMS to retain your ISO Certification.  Your management just reviews and approves actions on a scheduled basis.  Now that’s easy.

The Five Areas Bizmanualz can Help with Your Quality Management System

1. Policies, Procedures, and Forms Documentation Examples
2. Document Version Control and Management Software
3. 1^st and 2^nd Party Audit Support
4. Quality System Management Support
5. Continuous Improvement Support

Call us to find out how Bizmanualz can help you with your Quality Management System today.

Document Your “Plan”

The plan is really the easiest part. Start with goals that are measurable. Document your plan using objectives, policies, procedures, and forms. Assign individual responsibilities, and you’re done. When you’re building an ISO 9001 Quality Management System, this is not hard at all.  But it gets harder, and pretty quickly.

Using Your Plan is “Doing”

The “Do” in PDCA means using the policies, procedures, and forms to realize your objectives. This means collecting data, and populating your forms. You have to use your procedures and follow your policies. While this may sound easy at first, keeping it up is the hard part — you may start with good intentions (that’s the “plan” part), but as they say, “Good intentions don’t pay the bills.” Your company has to follow through on its intent, and follow-through — commitment — starts at the top. Furthermore, management commitment isn’t an isolated event — it’s part of the company philosophy.

In case you missed that, let me say it again: “doing” takes management commitment. That’s a large part of what makes PDCA so hard. As management, you get so involved in running the day-to-day aspects of the business that you forget that you started with good intentions (the plan).  It is not that the plan was ill-conceived; it’s that there’s more to it than a piece of paper. Plans need continual reevaluation — you need to constantly “check” your progress and adjust the plan accordingly.  What’s so hard about checking the plan?

“Check” Your Plan

In the “check” step of PDCA, you have to convert data into information. Charting data can make this much easier but even so, a chart is just a visualization of data.  A chart is not information without a target. In addition, you need enough data points to show trends. Furthermore, you need to understand how to separate the “vital few” data points from the “trivial many”.

Creating information from data requires what Deming called “profound knowledge” about your system.  Of course it helps to understand statistics, too.  Creating information out of data is not easy; often, it requires that you continually dissect the data and look at it from many different points of view.

“Act” On Your Results

So, let’s say you started with a good plan, you were able to collect some meaningful data, and you turned it into useful information. If you’ve accomplished this, the “Act” phase should be easy, right? Possibly, if you have a stable environment.

Today’s business world is an increasingly unstable environment — old and new forces are continually changing the dynamic.  There’s local and global competition, widespread and affordable technology, weather and climate, cultures, beliefs — a host of forces acting on your business. Deciding what to do to compensate for or leverage external forces has always been difficult; it’s just becoming more so. But if you do a good job at the first three phases, the “Act” phase becomes a lot easier.  You just need to make better information out of your data.

PDCA

So there you have it.  Plan, Do, Check, and Act — PDCA, for short. It’s one of the cornerstones of the quality world, of the ISO 9001 standard. If executed correctly, it can help you get control over a seemingly chaotic world.  Yes, it is hard to do PDCA right…but what’s worth doing well that isn’t difficult, too?

If it were that easy, everyone would be doing it…don’t you think?

St. Louis, MO – June 18, 2009 – Bizmanualz, Inc., a business publications, training, and consulting company based in St. Louis, MO, today announced the release of the updated ISO 9001 Policies and Procedures Manual. The company has greatly improved its product by modeling its policies and procedures on the Deming (“Plan-Do-Check-Act”) Cycle.

“The updated manual reflects our lean philosophy in multiple ways,” said Christopher Anderson, Managing Director of Bizmanualz. “For example, rather than borrow the text of the standard verbatim in the quality manual, we stripped it to the bare essentials. Putting in a lot of verbiage not required by the standard can make your Quality Manual less user-friendly, less useful, and less likely to be improved.”

The updated ISO 9001 Policies, Procedures & Forms Manual conforms to the ISO 9001:2008 standard, which was updated for the first time in eight years and released in November, 2008. ISO 9001 requirements for procedures and records are clearly identified throughout the updated manual. Recently ISO 9001 certified by using lean principles, the company has used a similar approach in the update process.

“We carried procedures over (from the old to the new ISO 9001 QMS manual) that most organizations consider critical,” said Steve Flick, Bizmanualz Product Director. “Similarly, we removed procedures that customers didn’t consider a high priority, or had little-to-nothing to do with 9001 requirements, or didn’t amount to more than simple work instructions.”

Twenty-three QMS procedures are included in the updated ISO 9001 manual. A forms list at the end of each procedure points out if the filled out form is a “required record” and which ISO 9001 clause requires that record. Bizmanualz redesigned its ISO 9001 QMS manual to help companies easily establish an effective quality management system, as well as to simplify the certification journey for organizations wishing to comply with ISO 9001:2008.

Bizmanualz also offers manuals for Accounting, Finance, Computers & Networks, Sales & Marketing, Human Resources, ISO 22000, Disaster Recovery, and Security. All of Bizmanualz® Policies & Procedures manuals are available via instant download or in hard copy form, with easily editable MS-Word documents included on CD.

Each manual provides prewritten policies, procedures, and forms that enable executives to create and maintain internal controls and implement best practices for all departments in their business.

Bizmanualz® ISO 9001 QMS Policies, Procedures, and Forms: How to Quickly Create an ISO 9001 Quality Management System with easily editable Policies, Procedures, and Forms. (400 pp/trade binder/$495.00) is a Knowledge Management title from Bizmanualz, Inc. It is available through the company’s website, www.bizmanualz.com, or by calling the publisher at 800-466-9953 (outside the USA, call 314-863-5079), faxing your request to 314-863-6571, or by e-mailing sales@bizmanualz.com.

St. Louis, MO (April 24, 2009) - Bizmanualz, Inc., a business strategy consulting and quality publishing company based in Clayton, Missouri, today announced the successful certification to ISO 9001:2008 for the design, development, realization, and delivery of its policy and procedure publications, training courses, and consulting services.  The certification demonstrates the Bizmanualz commitment to continually improve its ability to assist business owners achieve the growth they envision. 

“We developed a Lean visual management approach to implementing our Quality Management System (QMS) to dispel the notion that an ISO system requires a lot of paperwork,” explained Chris Anderson, Bizmanualz, Inc., Managing Director. “Now we can show clients the benefits of a working ISO-compliant quality system using Lean visual techniques to streamline the operations, focus employees on the objectives, and reduce wasted efforts.”

Bizmanualz ISO 9001:2008 Registration

Bizmanualz received its ISO 9001:2008 certification on April 10,2009, from Platinum Registration.  Auditor Colin Gray noted particular areas of excellence, including Bizmanualz customer feedback, corrective action, and internal communication methods, which involve morning staff meetings around the company’s “scoreboard” — a bulletin board listing the company’s main processes, projects, action items, and metrics.  Mr. Gray also praised the Bizmanualz Internal Audit process, saying in his report that the company’s internal audits are “thorough, effective, and meaningful.”

Kaizens/Corrective Actions are posted on the Bizmanualz "Kaizen Wall"

With the new lean implementation, Dan Davison, Vice President of Sales and Marketing has noticed a difference, saying, “clients are seeing tighter project definition, project management, status reports, and budget forecasts by job for the coming weeks. Tracking tasks posted on the wall increase our communication’s effectiveness.”

ISO 9001:2008 is an internationally recognized QMS standard, which ISO Secretary General Rob Steele said has “an estimated one million users worldwide.”  Certification is obtained through independent registrars that audit every aspect of a company’s QMS.  Lean is a quality system approach that seeks improvement through the elimination of waste, a focus on the customer, and systems of visual management.

Bizmanualz has been at the forefront of deploying business best practices since 1995, delivering Policies and Procedures publications, Lean ISO Quality Management Systems, and strategic marketing implementation services to help business owners achieve growth and expansion.

Bizmanualz Policies and Procedures publications are available through Amazon.com, calling Bizmanualz at 800-466-9953 (outside the USA, 314-863-5079), faxing your request to 314-863-6571, e-mailing sales@Bizmanualz.com, or by logging onto store.bizmanualz.com.  Bizmanualz® is a registered trademark of Bizmanualz, Inc.

Matching Abilities to Demand

What is the biggest difference between Company A and Company B?  While their offerings are somewhat different, they are actually very similar in many respects.  Both work in the technology field, and both deal with customized services.  Both have a strong web presence.  Both are fairly small companies with the desire to grow.  Both see their customers as large organizations, and both strongly believe there is great potential in their business.  The biggest difference is the level of success.

Both companies also started off in much the same way.  Someone had a vision of how to do something that seemed like a really good idea.  They felt they had an innovative approach that should be in demand.

So why the big difference?  Both companies talked to potential customers and heard what the prospective clients had to say.  The biggest difference is that one company actually listened. 

You Can’t Force Customers to Buy What They Don’t Want

Company A had a concept that they felt would differentiate them from competitors.  And they frequently managed to find their way into the conference rooms of potential customers because their service concept addressed an area where many companies struggled – and felt pain.  The problem was that Company A’s focus during these meetings – the thing that they felt differentiated them from competitors (and that they wanted customers to pay for) – was not really the thing that potential clients were interested in. 

Most potential clients were interested in quickly and temporarily increasing their expertise bandwidth in a particular area when needed.  And while this technology expertise was included in the service, Company A also wanted to include other facets of service that most clients believed did not provide enough value and many thought was also too risky.

Yet, the selling proposition never changed.  Company A intuitively felt the additional dimensions of service were valuable to customers, but the customers just didn’t recognize it.  The communication was simply too one way.  They continued to use the same message and tried to convince customers of its value – usually to no avail.  They never really listened to what the customer wanted.

Sometimes Listening Means Changing

Company B also got their foot in the door of some big-time potential accounts to propose their idea.  But Company B actually listened to what the prospects had to say.  They realized that the service they had to offer was flexible enough to meet the customer needs.  It wasn’t set in stone that they had to do things a certain way.  Company B was more interested in pleasing the customer than selling something that they thought was a great idea, even if the customer didn’t want it. 

Company B also listened to the language that potential clients used to talk about their problems, and then employed that language to talk about the benefits and value their service could provide.  Company B didn’t have expensive market research to guide them.  All they had was the information a few key potential clients were willing to provide during their discussions.  But they effectively employed this information to alter their service and then they used it to talk about their service.

As the selling proposition shifted to incorporate the voice of the customer, potential clients quickly recognized the value of the service that Company B offered.  They could get exactly what they wanted and needed from Company B, and they were willing to pay for it.  More and more frequently, when Company B got their foot in the door, they ended up settling in for a nice long stay.

Provide Value to Your Customers

At Bizmanualz we like to help companies succeed.  Whether it is helping management align vision and mission along with objectives throughout the organization, improving processes and compliance, or making sure your sales and marketing efforts include hearing the voice of the customer, we want to help. 

We frequently talk about hearing the voice of the customer, but if you are convinced you know more than the customers do about their business, then perhaps you aren’t really listening.  Make sure you actually hear the voice of the customer and not just voices in your head.

Get a Handle on Your ISO 9001 Required Records

Clause 7 “Product Realization” (recall that we can substitute “service” anywhere the word “product” occurs) covers the spectrum from product development (literally from the moment an order is taken or a product conceived) until the product is shipped to the customer.

Besides understanding and complying with the “shall statements” in Clause 7 (as we discussed for Clause 5 and Clause 6), a key element to complying with ISO 9001 Clause 7 is getting a handle on the required records.  A lion’s share of the ISO 9001 required records (14 of 21) come from Clause 7.  These include

• Clause 7.1 Planning of Product Realization – 1 record
• Clause 7.2 Customer Related Processes – 1 record
• Clause 7.3 Design and Development – 5 records
• Clause 7.4 Purchasing – 1 record
• Clause 7.5 Production and Service Provision – 3 records
• Clause 7.6 Control of Monitoring and Measuring Equipment – 3 records

Some organizations seem to struggle with all the required realization records.  For example, I recently worked with a company that took great effort and pride in their meticulous record keeping.  The problem was, however, that they did not understand how the records they kept met the record requirements of the ISO 9001 QMS.

As you create a QMS to comply with Clause 7, there are two things to always keep in mind:

1)  What do I need to do to comply with the requirements?
2)  How can keeping these records help my organization?

In order to comply, particularly in terms of records, an organization has to reflect on the specific requirements listed, as well as on how this record fits in with the unique ways each organization fulfills product realization.  Ensuring you comply with the spirit and letter of the ISO 9001 Standard will require taking some time to understand the requirements and to reflect on your realization processes.

Understand Specific ISO 9001 Requirements for Records

As we know, the ISO 9001 QMS requirements are not very detailed or specific when it comes to record keeping.  It is this generic approach that gives ISO 9001 the flexibility to be applied to disparate organizations.  So each organization can define exactly what form the records will take, and what kind of information will be collected.

But there are some specifics associated with each record that one must be aware of in order to comply with ISO 9001 requirements.  For example, Clause 7.3.4 states specifically that the design and development review records shall contain the results of the reviews and any necessary actions.  So, early in the effort to create records to comply with Clause 7, an organization must have a clear picture of what records are needed and what specifically must be included in the record.

Using ISO 9001 Records for Continual Improvement

While compliance is important, the whole goal of implementing ISO 9001 is to improve as an organization.  So how you use the records to help the organization improve is equally important.  The point of keeping records is not because ISO says we need to, or even because auditors want to see them (though it does, and they will…).   In several places of the ISO 9001 QMS requirements (i.e. Clause 4.1e) the standard requires organizations to monitor, measure, and analyze processes.  Records play an important role in that they are used to capture data and information about processes that are used for monitoring, measuring, and analyzing.

This is what record keeping is really about.  Using them to understand your processes and learn ways to improve.  Are we capturing the customer requirements properly and avoiding rework, scrap, and other waste?  Are design reviews generating actions that improve the product and meet requirements?  Are design projects on schedule and budget or do they consistently suffer from scope creep or delays?  Are process objectives being met?

Employ the ISO 9001 Process Approach

One useful way to get a handle on realization records is to consider product realization as a set of processes, and then identify where, as part of the process, a record is generated and what record requirement is fulfilled.  Ideally, realization processes, like all processes, should have key objectives established that measure effectiveness.  The goal should be to collect information in the records that relates to process effectiveness.

Your ISO records should tell you a lot about how effective your processes are operating.  If they don’t, then perhaps you are meeting bare minimum ISO requirements by generating the record, but you’re not meeting the spirit of the ISO standard by using the QMS for continual improvement.  And the continual improvement philosophy applies to the records themselves.  If you find that you are not getting useful information from your records, then change what you are doing.

Try to Simplify ISO Compliance

With so many required records from Clause 7, it also important to look for ways to streamline and simplify the record keeping.  Do you need 14 different forms?  For example, perhaps a general form can be used for all the design and development records.  For the calibrations records, it may be easier to track the calibration of monitoring and measuring equipment electronically in a database or spreadsheet instead of on paper.

As always, the best approach is to start simple and build on it as you identify needs and areas for improvement.  It is easier to build on a basic, simple system than it is to strip unnecessary elements from an overly complex system.

Using and Auditing ISO 9001 QMS

Now we have covered all the clauses of the ISO 9001 QMS that have requirements.  If you build your ISO compliant QMS in phases over a period of time it becomes less daunting.  Obviously, we could not cover all the elements of compliance, but hopefully we have delineated a path to compliance in manageable steps.

If you recall, earlier we only created drafts of some system procedures.  As you use and review your system, you should get the procedures in finalized forms and release them into document control.  To verify and improve the QMS you should regularly audit it (including records, documents, and improvement activity).  But the most important thing you can do with you ISO 9001 QMS is use it.  Communicate the QMS to the staff; involve them with reviewing procedures, keeping records, and conducting process reviews.  Develop an internal auditing staff who understands the requirements and the organizational goals in employing ISO 9901.

Once you feel comfortable that your ISO Quality Management System is operating and functional, you are ready to contact an ISO 9001 Registrar and set up an audit for certification.  If you need help building your ISO 9001 QMS, we have products and consulting services that can help.  We also offer public and on-site ISO 9001 Internal Auditing classes that can help get the most out of your continual improvement efforts.

Management Commitment is Vital to ISO 9001 Success

Now we are starting phase three: implementing the requirements of Clause 5 – Management Responsibility and Clause 6 – Resource Management. While there are a number of required documents we created to meet requirements from Clauses 4 and 8, Clauses 5 and 6 are long on stated requirements (“Top Management shall … ,” “The organization shall … “), but they have few required documents and records.

In Clause 5, the responsibilities of meeting the requirements of the ISO 9001 QMS are put squarely on the shoulders of top management. Those who are familiar with how organizations tend to function know that the success or failure of any organizational endeavor depends on the commitment of top management. If top management does not see it as important or a priority, then it becomes starved for resources and eventually dies. Whatever top management focuses on, however, becomes a priority for the whole organization. This is certainly true for implementing, maintaining, and improving the ISO QMS.

There are specific requirements relating to Management Review in Clause 5, including a management review meeting record. Otherwise, there are no specific requirements to create particular records showing management’s commitment and responsibility. The requirement is a general one of providing evidence of commitment.

ISO 9001 Is Generic Application Depends on the Organization

It is this type of general requirement that many organizations struggle with. In contrast with specific requirements that are straightforward (for example, an Internal Audit procedure that includes responsibilities and requirements for planning and conducting internal audits, establishing records and reporting results), these more general “shall statements” require organizations to come up with their own method of compliance.

One way to deal with these less specific requirements is to convert “shall statements” into questions. For example, top management has to answer the question, “How do we ensure appropriate communication processes are established and that communication takes place regarding the effectiveness of the QMS?” The formal language in the standard seems intimidating and adds to the difficulty. Appropriate communication processes? But most organizations have communication processes; it is just a matter of recognizing them and being aware that those activities meet a requirement of the ISO 9001 standard. For example, perhaps you have monthly department head meetings, and departments have weekly staff meetings. Perhaps you have an on-line or printed quality newsletter. These are all communication processes.

Focus on ISO Compliance Not Unnecessary ISO Documentation

So in a sense, phase three is about reviewing and considering requirements in Clause 5 and Clause 6, and then recognizing how your organization meets them. You don’t have to have procedures or even records in order to comply, unless you feel they are important for the needs of your organization. Obviously, as you work through this, when you recognize a weakness or an area of non-compliance it is time to implement new or altered methods. But as in our communication example, frequently organizations are doing things that comply with the requirements. It is just a matter of being cognizant of them, plus knowing what evidence exists that verifies your compliance.

Clause 6, Resource Management, requires a similar approach. Phrase the “shall statements” as questions and then give reflective responses. For Clause 5 and 6 you may want to capture these responses in notes for your own purposes or for training, but there is no requirement to do so. In terms of compliance, just be sure you can answer the question appropriately when the internal or external auditor asks, and that others give answers that are consistent with your compliance methods. Be aware, however, that after you give an auditor the answer, he or she will then seek objective evidence that you do, indeed, do things that way (such as meeting agendas, minutes, or collaboration from the earlier communication example).

Training Records Are Required in ISO 9001

Let’s emphasize, however, the training record requirement for Clause 6 of the ISO 9001 QMS Requirements. Many auditors agree that this is a common area of weakness among ISO 9001 certified organizations. So one focus for phase three of ISO 9001 QMS implementation should be creating a training record system where education, training, skills, and experience are captured. In larger organizations this probably has to be handled at the department level, but there should still be consistency throughout the organization. This will require a systematic approach that is communicated through training, examples, etc., to department leaders.

So there is no simple advice or direct methods for complying with the requirements found in Clause 5 and Clause 6. Phase three is as much about understanding and awareness as it is about creating new processes and documentation. Each and every organization has to decide how they currently fulfill them or how they will fulfill them. It is this flexibility, however, that makes ISO 9001 flexible enough to be applied to any type of organization.

Our next and final piece in the series will cover phase 4, implementing ISO 9001 Clause 7 – Product Realization, also known as design, development and fulfillment. Here the ISO 9001 Requirements are heavy on records that many organizations have difficulty with in terms of compliance. We will discuss ways to simplify and streamline Clause 7 compliance.

At Bizmanualz, we have helped a number of small and medium sized businesses move from having no real QMS to becoming ISO 9001 certified.   It is a process that usually takes about six months, but it can be done in three to four months for very small companies.  A project typically includes establishing all the required elements of the ISO Quality Management System and assisting them in getting it off ground functionally.

One way to establish priorities and milestones is to use the organization of the ISO 9001:2008 QMS Requirements itself as a pro-forma project plan.  The project we describe in this series is heavily influenced by the layout of the requirements.

The ultimate goal, however, of an ISO QMS is continual improvement.  So, to gain the benefits of improvement, an organization has to be committed to maintaining and modifying the system over time to best suit its needs.  Creating the ISO QMS is just the beginning.

Create an ISO Implementation Plan

Since the best approach is to treat your ISO implementation as a project, you should start with a project plan that estimates the resources needed (people, materials, expertise) and the project timeline from beginning until the certification audit.   If you have experience and knowledge of the ISO 9001 requirements, you might begin with a gap assessment, which provides input into the project plan.  A gap assessment is just as the name describes – comparing current systems and documentation to what is needed for a system that is ISO 9001 compliant.  If you don’t feel comfortable with the ISO 9001:2008 Standard, then perhaps the first step is ISO training for you and members of the project team or ISO Steering Committee.

The ISO Steering Committee includes key members from the quality department along with representatives from other departments like Sales & Marketing, Design & Development, Human Resources, Production, and Accounting.  The Steering Committee members provide valuable input to the ISO QMS development project about systems and processes, they divide up tasks and actions items, and assist in distributing important information throughout the organization.  But remember, involving a committee can also take more time as you wait for meetings in order to make decisions and follow-up on actions.  So be sure to build such delays into your project plan.

Start with Clause Four in the ISO 9001 Standard

The QMS really starts where the ISO 9001 General Requirements begin – in Clause 4, and that is where the efforts of phase one are focused.  It is well established that ISO 9001 is a process-based standard, and the General Requirements listed in 4.1 establish this clearly:

1. Determine the processes of the QMS
2. The sequence and interaction of the processes
3. The criteria and methods to ensure process are effective
4. Ensure availability of resources and information to operate and monitor the processes
5. Monitor and measure and analyze the processes
6. Continually improve the processes

The first two items are the focus while setting up your ISO QMS.  The remaining four become central as you maintain the ISO QMS and use it to improve the organization.

Define Your ISO Processes

Therefore, step one in creating the ISO QMS is to understand and define the processes of the QMS.  Understanding your processes is key to a functional QMS.  There is a scope question each organization has to answer (which will also eventually be included in the Quality Manual).  Exactly what processes will be part of the ISO QMS?    The ISO QMS could encompass the entire organization, a particular facility, or perhaps just a single product line.

Figure 1: Typical Organization Processes

One way to get started defining processes is to consider the over-arching, top level processes that convert supplies and resources (i.e. materials, knowledge, and capital equipment) into customer deliverables.  Figure 1 shows the top level processes of a typical organization.  If necessary, once top level processes are defined, you can identify key sub-processes that make up the top level process.  Notice that Figure 1 also displays the interaction of the top level processes.

Be sure to identify the process owners who have ultimate responsibility.

Creating the First Level of ISO 9001 Documents such as the Quality Manual

Once the QMS processes are defined, you are ready to start the next step in phase 1: creating the first level of documentation.  The first document tier in the QMS consists of the Quality Manual, the Quality Policy, and the Quality Objectives.

By having already clearly defined the QMS processes, creating a draft of the Quality Manual becomes easier because you have already determined much of the key content.  Remember, the description and interaction of the processes in the Quality Manual does not have to be large amounts of text.  Diagrams, process maps, and flow charts all describe processes just as well, if not better, than verbal descriptions.  Also, be sure to list all exclusions your organization has to the ISO QMS.

Completing Phase One with Quality Policy, Quality Objectives, and Document Control

At this point you have completed two crucial steps on your way to ISO compliance – defined processes and a draft of the Quality Manual. The next step is write drafts of the quality policy and quality objectives.  Remember, the quality objectives should be measurable and align/fulfill the quality policy.

The last step for phase one of your ISO QMS project is to create the document/record control system that will be used for the QMS documents.  How are they reviewed and released, updated, stored, and retrieved?  These questions should be addressed in ways that meet the requirements for document and record control established in Clauses 4.2.3 and 4.2.4.  This also includes writing the drafts of the required Document Control and Record Control procedures that will define your system of documents and records.

Now, at the end of phase one, you have fulfilled most of the requirements established in Clause 4 of the ISO 9001 Requirements, and you have also created the framework for meeting the additional requirements in other clauses of the ISO 9001 Standard.  While you may only have drafts of the quality manual and document and record control procedures, having a good draft in place represents a majority of the effort.  Hopefully you will only need to make minor additions and revisions to them as you continue on your ISO QMS project path.

In the next article, we will discuss phase 2 of your ISO QMS implementation project – putting in place the continual improvement processes described in Clause 8.

St. Louis, MO – February 27, 2009 – Bizmanualz, Inc., a business publications, training and consulting company based in St. Louis, MO, today announced the launch of a completely redesigned version of its ISO 9001 QMS Internal Auditor Training course.  This ISO training course demonstrates requisite auditing skills to beginning auditors, and is also valuable to experienced auditors and quality managers looking for a refresher course or the opportunity to discuss innovative approaches.

The redesigned two-day ISO auditor class focuses on helping participants understand the criteria, the skills, and the activities required to be an effective internal auditor as part of an ISO 9001 Quality Management System.  The class is offered regularly at the Bizmanualz Learning Center in St. Louis. It can also be conducted privately on-site for organizations that would like to hold group internal auditor or quality auditor training sessions in-house.

“We had been using the previous design for several years now, and we have continually improved and updated it,” said Don Reed, Technical Writing Director at Bizmanualz and the primary designer/instructor for the class. “We have learned so much, however, through our experience teaching the course and through carefully listening to student feedback, that we felt it was time to start from scratch and use everything we have learned to completely rework the course.” 

The ISO 9001 Internal Auditing course is currently the most popular training class offered by Bizmanualz.  The totally redesigned Internal Auditor class was conducted for the first time on February 9 & 10 at the Bizmanualz to a great success. The participants responded very positively to the new approach and the reworked materials.

“The newly redesigned ISO 9001 Internal Audit Class focuses on giving the participants exactly what they want and need from an ISO 9001 Internal Auditor class: an interactive, seminar-style discussion along with real world examples and exercises,”  said Chris Anderson, Managing Director of Bizmanualz. “For example, we no longer use PowerPoint because we just don’t feel it creates the interactive environment that participants expect and deserve.”

Mr. Reed agrees. “Professionals prefer to learn in smaller classes with an atmosphere that encourages discussions and questions; where participants share their experiences and challenges. This produces a better learning experience for everyone.”

In this auditor training course, students will learn the basics of an ISO Quality Management System, as well as how it can drive organizational improvement.  Students will become familiar with using the ISO 9001 Standard as criteria for auditing, the importance of an audit program, along with basic auditing principles.  Most importantly, however, students will learn the step by step methods of conducting an audit, and participate in an audit of a QMS process. ISO 19011 – Guidelines for Quality and Environmental Auditing is used for fundamental guidance on auditing principles and methods. Plus, all participants receive a free copy of the ISO 9001:2008 Quality Management System Requirements.

Bizmanualz schedules the Internal Auditor Training Course at least once every  three months.  Please visit the Bizmanualz website at Bizmanualz.com to register for the class or to see a detailed course description and a upcoming training schedule

Bizmanualz also offers strategic process improvement services for growing businesses as well as a range of quality training classes. In addition, standard operating procedures manuals from Bizmanualz have helped thousands of companies develop policies and procedures to standardize their core business processes and implement best practices.