For example, the ISO 9000:2005 definition states:

Corrective Action (Clause 3.6.5):
action to eliminate the cause of a detected nonconformity and its recurrence.

Preventive Action (Clause 3.6.4):
action to eliminate the cause of a potential nonconformity and its occurrence.

But does this really clear it up for anyone?

What’s the Difference between Corrective Action and Preventive Action?

Corrective action is performed on detected nonconformities.  In other words, there are real defects that exist right now and action must be taken to stop them from ever happening again in the future.  Most people get this and seem to understand the concept of real defects needing to be fixed—permanently, so they do not cause further aggravation.  But what about preventive actions?

People seem to get hung up on what a potential nonconformity is and how do you prevent it from ever occurring in the first place?  Potential defects are defects that could happen.  I think a better description would be to call these risks.  Everyone understands the concept of risk at some level.  If we keep using a dull blade on a saw, then we are taking a risk because at some point that blade is going to break.

Using a dull blade is a bad business practice, right?  So what other bad business practices are you using in your business that you should fix to prevent a bad outcome (nonconformity) from occurring?  Potential nonconformities are all around us in every business.  The question is, how do you find potential nonconformities?  The best way to find them is to look for them using common quality tools.

Top Ten Preventive Actions

1. Analyze process or product characteristics for negative trends that, if left alone, could drift into a nonconformity.  Such analysis can be documented into a control plan.
2. Install alarms to warn you when your process is drifting into a nonconformity.  Statistical process control charts provide excellent alarms.
3. Review nonconformances found in similar processes, products, or companies for ideas that could be applied to your business.  Benchmarking similar companies is great for brainstorming preventive actions.
4. Perform risk analysis to uncover latent hazards.  Failure Mode Effects Analysis (FMEA) is a great tool for process risk analysis.
5. Implement lean thinking to eliminate wastes, which are obvious signals of latent causes of future defects.
6. Establish more rigorous training programs to continuously improve your employee’s skills.  Regular training introduces new ideas into your organization that can be sources of innovation that prevent nonconformities.
7. Introduce disaster recovery, security, and contingency plans for unpredictable situations, hazards, or safety conditions.
8. Set up preventive maintenance & calibration control programs to ensure your equipment is always safe, available, and performing optimally.
9. Begin supplier surveillance audits to assist your supply chain in delivering quality product to you consistently.
10. Analyze your process capabilities to create a foundation for improvement.  Use Capability Maturity Model (CMM) or Capability Maturity Model Integration (CMMI) for inspiration.

What preventive actions do you take in your business to eliminate defects BEFORE they occur?

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.

Figure 1. PDCA Wheel

PDCA was developed by Dr. Walter Shewhart, one of the top ten quality gurus.  Dr. W. Edwards Deming preferred to call it PDSA or Plan, Do, Study, Act because he felt that “check” emphasized inspection over analysis.  Most people spend most of their time on the first two, Plan and Do, and tend to neglect the Check and Act parts.  An ISO 9001 QMS is a balanced system and to keep your ISO system working effectively you need to value each PDCA element equally and not favor one (i.e. Plan, Do) over the other (Check, Act).

We have written a lot about PDCA in the past.  Now let’s take a look at PDCA as it relates to ISO 9001 by breaking down the ISO 9001 standard into its main elements and then assigning them to each part of the PDCA process.  What you see is that each clause of the ISO 9001 standard contains a planning step, clause 7 is focused on doing, and clause 8 is focused on checking and acting.  What clause do you think people have the most trouble with?

Clause 8 is the most troublesome because it is focused on checking and acting.  People get more satisfaction in planning and doing then they do in checking and acting.  It is just human nature.  So, to master ISO 9001 you have to break the habit and budget more time for the checking and acting steps of clause 8.  Now let’s take a look at each PDCA element and see how ISO 9001 aligns with PDCA.

PLAN

Your business should have an annual planning cycle that produces business plans that contain your: vision/mission/quality policy, operational objectives, budgets, preventive maintenance/actions, document standards, milestones, and new product/market/process introductions.  These are all planning elements.  ISO 9001 calls out these planning elements in seven areas.  Maintain QMS (4.1)

• Document QMS (4.2)
• Management Responsibilities (5)
• Manage Resources (6)
• Plan Product Realization (7.1)
• Control Monitor & Measurement Equipment (7.6)
• Preventive Action (8.5.3)

Most of these obviously belong here but what about Preventive Action (8.5.3)?  It comes from clause 8 (a check act clause) and sounds like an action step.  I put it here because preventive action is a plan to eliminate a defect that has not occurred.  Since we do not know if it will ever occur (with or without the preventive action being taken) then it sounds like a well intentioned plan.  If the defect occurs then the plan failed.  If it does not occur, then is this because we took action to prevent it?  If we cannot say this with certainty, then I would call it a plan.

DO

Your do steps are more frequent, possible occurring on a monthly cycle that produces data records for measurement and analysis as a result of executing the annual plans. A lot of your doing is focused on clause 7, Product Realization. Most of your ISO records are produced in clause 7.

• Competence & Training (6.2.2)
• Design, Develop, Realize (7)
• Purchasing (7.4)
• Product & Service Provisions (7.5)

CHECK

Once you have data from your doing steps you need to analyze or study the data (remember Deming’s PDSA reminding us to Plan, Do, Study, Act).  We do not want to check to see if a step was done or check to see if data was produced.  This is nothing but inspection.  We need to analyze and understand what the data is telling us.  We do this by converting the data into information.

The ISO 9001 standard clearly defines various check processes, which are cycles of measurement and analysis to determine how well the organization is executing the annual plans.

• Management Reviews (5.6)
• Monitor & Measuring (8.2)
• Customer Satisfaction (8.2.1)
• Internal Auditing (8.2.2)
• Data Analysis (8.4)

These are not one-time events.  These check processes continuously occur, which brings to mind trend lines on charts as a way to convert data into information.

A monthly or quarterly check event is very realistic, although many companies choose an annual audit, management review or customer satisfaction survey as a sufficient check on the ISO 9001 QMS.  I guess if you have an incredibly stable business model with little to no competition and a static environment, industry or market then maybe you can get away with an annual check.  Are there any businesses like that anymore?

ACT

Actions taken — without undue delay– to close the gap, identified during measurement and analysis, between the annual plans and the data records produced during execution.   Of course there is an element of act in the management reviews because after you review the required inputs you are supposed to assign action items to individuals to take the necessary corrective actions (and maybe preventive actions).

ISO 9001 has a few clear action steps like isolating nonconforming product, taking corrective action, and maybe preventive action too.

• Nonconforming Product (8.3)
• Corrective Action (8.5.2)
• Preventive Action (8.5.3)?  ( I know some of you want this here)

ISO 9001 is not a single PDCA cycle.  It is actually a series of imbedded PDCA cycles.  Clause 7 is not just about doing.  Product realization is itself a PDCA cycle that starts with planning requirements and realization needs.  Next comes development (doing), development reviews (checking), and finally development revisions (actions).  This same PDCA cycle is occurring within training, documentation, purchasing, auditing, corrective action, etc.  The whole concept of continuous improvement relies on PDCA.

Check out Bizmanualz Internal Auditor Training programs for more information on building Lean ISO Quality systems, creating well-defined processes, or getting more value out of your quality management system.

Now, what do you think of when you hear the term “lean“? Are you thinking “no fat”, as in Jack Sprat?  Do the words “efficient”, “effective”, or “no waste” come to mind?

If we put the two terms together, we get Lean ISO 9001, which means a quality management system (QMS) with no fat…an ISO 9001 system that is efficient, effective, and reduces waste within your organization. Who wouldn’t want that?

So, tell me…why do so many organizations implement huge ISO 9001 quality management systems, with hundreds of pages of policies, procedures, and forms, seemingly limitless bureaucracies, and ?

Few organizations are satisfied with the ISO 9001 systems they’ve built for themselves, yet they typically don’t want to change them. Why? Why stick with a system that causes more pain than it removes? Why not throw the old system out if it’s that bad, and replace it with a lean ISO quality system? Think of this: a lean quality management system — one that’s a mere dozen pages or so of easy-to-follow procedures, rules, and requirements, a minimum number of uncluttered forms, and no bureaucracy, which means you spend much less time maintaining your ISO 9001 QMS in top shape.

Easily Create a Lean ISO Quality System

It might be easier than you think to create a lean ISO quality system: mix one part ISO with two parts lean and you get a great quality system. Really, ISO is pretty straightforward once you introduce lean thinking into your organization.  Add lean kaizen improvement events for your corrective and preventive actions, lean standard work to create lean procedures, lean value stream mapping to define your processes, a lean dashboard to track your quality objectives, and a lean quality policy focused on your customer.

Starting with lean makes a ISO 9001 quality system implementation simple — certainly, much easier than trying to introduce a Six Sigma (DMAIC) process into your organization. Once you get lean, you’ll get ISO 9001 as well. Both are aimed at producing the same result — more satisfied customers.

To sum it up, don’t get started on the wrong foot by trying to design and implement a quality management system without Lean. Think of “a QMS without Lean” as something like “building an airplane from scratch”. It could be done, buy why would you?  Start with lean thinking and make getting your ISO 9001 registration a piece of cake.  Lean ISO quality is the way to go.

* * * * * * *

Need help “leaning out” your ISO 9001 Quality Management System?  Contact Bizmanualz to learn how you, too, can have a Lean ISO Quality system of your very own.

We regularly send out e-mails, to continually keep our name in front of potential (and existing) customers. Some of us even have LinkedIn^TM and Facebook^TM pages (Figures 2, 3) where we invite not just commentary, but participation and engagement.

We have a plan for strategically managing our web presence. In that plan, we:

1. Establish SMART objectives;
2. Develop and implement the various aspects of our web presence (web pages, newsletters, social media, etc.);
3. Monitor, measure, and analyze to see if we’re meeting planned objectives;
4. Make changes to the plan, as needed, and implement them; and
5. Continue to monitor, analyze, change, ad infinitum.

Why does that 5-step plan look familiar? It’s the “Plan-Do-Check-Act” (PDCA) cycle! It’s how companies ensure product quality, continual improvement, and customers who are more than satisfied — they’re actually advocates!

Figure 1

Ask yourself, “Are we doing that?” Do we have a plan, or did we just throw something out there so we could say, “We have a web presence”?

Figure 2

Without a clear, comprehensive plan, your web presence can do you more harm than good. If you’re lucky, prospects and customers contact you about broken links, inconsistencies, and the occasional link to a product you discontinued months or years ago. In reality, most of your target market just “walks away” and never comes back.

Figure 3

The best advice I can give you is to establish a process of developing, implementing, and maintaining your company’s web presence before you build a single page online or send out a single e-mail. To do that, you need to understand:

• What your company stands for (its vision and mission);
• What you want to accomplish in the short and long term (i.e., what objectives you have for your web presence, specifically, and how – and if – those objectives tie into your company’s overall objectives);
• How extensive your web presence could (or should) be; and
• Why it’s important to establish a system of internal controls early and not let your efforts, accidentally or otherwise, go off target.

If you haven’t had a program for managing your web presence up to now — not a problem! There’s no reason to believe that because you’ve been working without one, you can’t implement one at any time. It may seem difficult at first, but the reward is unquestionably well worth the effort.

Take a few steps back and reevaluate your situation from a user’s perspective. If you have a particularly trustworthy customer, one you can count on to give you an unvarnished (but not a brutal) opinion, ask for their input. Find out whether they’re getting what they want from your web page and your social media. Find out if their objectives align with yours, and vice versa.

Refresh – reinvigorate – your web presence a little bit at a time. You don’t need to get everything done in a day or even a month or two. Work on the “low-hanging fruit” first, then move on to areas where your weaknesses aren’t so problematic.

And remember — stick with the plan! Keep reminding yourself — you only get one chance to make a first impression!

* * * * * * *

If you see an inconsistency or error on another company’s web site, do you say anything or do you let it go? Does it make a difference if they’re a vendor/customer of yours or not?

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.