Category Archives: ISO 9001:2008

ISO 9001 Business Performance Shows Why You Can’t Wait

It is a known fact that failing business performance can affect your profitability and whether you will be in business tomorrow.

The mindset of Quality has proven to make internal changes that affect failing business performance. In fact, studies conducted more than eighteen years ago among companies going through Quality Systems implementation have demonstrated improvements to business performance.

Read also: Should you wait until customers ask for your ISO 9001 certification?

The 1996 survey of 1,880 companies by Irwin Publishers (see the Dun and Bradstreet summary of this earlier ISO 9000 study) showed greater internal benefits, including greater quality awareness, positive cultural change, and increased operational efficiency/production.

Now, there are many additional benefits to be derived from ISO 9001 compliance that I would like to share with you. Are better internal communications, enhanced relations with customers and suppliers, and better quality of products and services important to you?

Think of ISO 9001 as the key to unlocking business performance (read also my post on 5 Keys to Build Quality). These five principles provided a common thread in many methods of quality and business improvement:

  • A continuous improvement philosophy
  • Consistency in everything you do
  • Teamwork in the workplace
  • Measurement and analysis of business processes
  • Training and education for all

Let’s examine these Quality principles from our ISO 9001 perspective.

A continuous improvement philosophy

ISO 9001 provides a framework for continual improvement through:

  • Establishing a Quality Policy and Quality objectives to demonstrate management commitment and set the direction for the organization.
  • Conducting internal audits to check that the direction is being followed.
  • Creating and maintaining effective Corrective and Preventive Action Systems to continue on the path to improvement.
  • Conducting periodical Management Reviews to confirm the effectiveness of the system and reset the direction when necessary. 

Consistency in everything you do

ISO 9001 provides the structure necessary to maintain consistency of results by:

  • Establishing clear lines of responsibility, authority and communications.
  • Ensuring clear understanding and communication of customer requirements.
  • Requiring documentation of key processes and control of the documents used to describe these processes and control of the records generated.
  • Controlling changes, such as changes in design, in processes and in documentation.
  • By requiring controls on purchased products and services, as well as, internal processes.

Teamwork in the workplace

  • ISO 9001 requires that everyone in the organization work to satisfy customer requirements and expectations.
  • Internal communications need to be designed so that everyone understands these requirements and their role in satisfying them. 

Measurement and analysis of business processes

It has been said in many ways that you can’t control what you don’t measure. ISO provides the framework for measuring and analyzing the key processes of the business.

  • ISO 9001 requires that company wide Quality Goals are established and that these goals be drilled down to the department level so that all key process goals are measured and analyzed for effectiveness.
  • Measuring, Monitoring and Analyzing process and product and service characteristics are required
  • During the Management Review meetings the effectiveness of the Quality Management System and its components are analyzed and actions required for improvement are planned. 

Training and education for all

  • ISO 9001 requires that all employees that could affect the quality of the product or service be qualified and competent in the jobs they perform to prevent delivery of nonconforming products or services.
  • Records of training need to be maintained.

Sharing your ISO 9001 experiences can help others understand the rationale for attaining compliance and registration.

Have you experienced any incidents where ISO certification helped you to improve your business that you would not have been able to obtain without it? Please share your experiences in the comments section.

QMA specializes in leading companies in the implementation of Quality and Safety Systems, such as, ISO 9001, AS9100, ISO13485, FDA GMPs and OSHA compliance. If you have a question or would like our assistance in your ISO 9001 implementation, contact us.

ISO 9001 Implementation: Should You Wait Until Your Customer Asks?

I often hear from clients and prospects that they would consider implementing an ISO Quality System only after “my customers start asking for it.” Is this a wise strategy?

In reality, by the time customers ask for your certification, it is often too late. Let’s examine why that “waiting” strategy frequently results in huge lost opportunities.

Your customer may not have flexibility to wait for your ISO certification.

Several months are required to develop the documentation and prepare for a certification audit even when a mature quality system is already in place.Your prospect may not have the patience or the flexibility to wait for you to become certified.

For instance, a marine parts manufacturer lost several large contracts due to the lack of ISO certification. After registering to ISO 9001:2008, the company was able to bid and secure a multi-year five million dollar contract with a Middle Eastern luxury yacht manufacturer only a few weeks after passing the certification audit. The bid request specifically stated that ISO9001 registration was a pre-requisite for participation.

Similarly, a Miami medical device distributor failed to qualify for bidding on several large contracts with South American hospitals due to the lack of ISO registration. After becoming certified, he was accepted as an approved vendor by many of these hospitals and was invited to participate on numerous solicitations.

Supply chain partners are required to be ISO certified.

Globally, more than one million organizations have become registered to the basic ISO 9001 international standard (http://www.iso.org). One reason for this high number is that many large companies today require their supply chains to be certified to the standard as well. The certification validates that the supplier has developed a compliant Quality System that has been recognized by an accredited and independent third party.

Dealing solely with ISO certified suppliers, the customer eliminates or reduces the need to conduct its own supplier audits. ISO registered companies, large and small, normally seek other certified companies and include the registration as an element of its vendor selection criteria.

ISO registration reduces the necessity for the customer to conduct on-site audits at the suppliers’ facilities.

As companies supply chains spread over the globe, the need to conduct supplier audits is a drain of resources for both customer and supplier. Registration to the standard provides assurance that the supplier has implemented a Quality System that will meet the customer’s primary expectations for product and service quality and on-time delivery.

Lack of certification serves as an early screening criterion on deciding what suppliers to consider.

It is very likely that some of your competitors have already registered and thereby attained a competitive edge over your organization. Of course, many customers will ask for your ISO certification. Unfortunately, others will not even ask. Like a skill that is missing from a job candidate’s resume, a lack of certification serves as an early screening criterion on deciding what suppliers to consider. The ISO certified companies will gravitate towards those suppliers that have already been registered.

An ISO certified company adds value and competitive advantage.

ISO certified companies also want suppliers that speak the same “language” and are more responsive to their Quality requirements. ISO registered suppliers understand the standard’s requirements for controlling and measuring processes and will generally be more cooperative with corrective action investigations to resolve problems promptly. To maintain registration, the ISO registered supplier must demonstrate that he has consistently met product requirements and continually improved its processes to attain full customer satisfaction.

Once registered, a company can announce its achievement to the world and use the new prestige and added value to gain competitive advantage.  Your marketing media is used to publicize the accomplishment including: web site and blogs, press releases, email signatures, email campaigns, stationery letterheads, directory listings, and so on.

The waiting strategy can result in lost business and some of these losses may never be revealed because of early disqualifications. The costs of implementation and maintaining registration are nominal compared to the potential loss of revenues and profits.

Sharing your ISO certification experiences can help others understand the sales and marketing rationale for attaining registration.

This article has covered the sales and marketing rationale for attaining registration. My next article will discuss how ISO 9001 implementation will help improve the way you do business.

Have you experienced any incidents where ISO certification helped you get business that you would not have been able to obtain without it? Please share your experiences in the comments.

QMA specializes in leading companies in the implementation of Quality systems, such as, ISO 9001:2008, AS9100, ISO13485 and FDA GMPs.

Developing Customer Focus in a Lean ISO System

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In Lean applications, it is very important to assess “value” from the customer’s vantage point. Activities that don’t add value to the product or service are by definition “waste.”

Delivering what the customer wants when he wants it is the primary thrust of Lean.  The vehicle for accomplishing this is the elimination of waste from processes.  ISO 9001:2008 emphasizes meeting customer requirements and continually improving the Quality System.

Quality objectives in the ISO Quality Management System can be derived by focusing on the customer needs and requirements and by using Lean tools in helping with the attainment of these objectives.

To maintain customer focus, you must:

  1. Research and understand your customer’s requirements–needs and expectations.
  2. Ensure that your company’s objectives are linked to these requirements.
  3. Communicate the importance of meeting these requirements to your employees.
  4. Track your performance against the Quality objectives.
  5. Use Lean and statistical tools to improve performance, eliminate waste, and reduce variation.
  6. Measure and track customer satisfaction; act on the results–complaints, as well as, compliments.
  7. Manage the details of customer relationships in a systematic manner.

Continued customer satisfaction results in improved customer loyalty leading to repeat business.  Obtaining customer loyalty should be one of your most important goals.

A Lean ISO system is one of the best means of achieving long-term customer loyalty by focusing on the customer requirements and making the customer the driving force of your organization.

IWA 4: ISO 9001 Applied to Local Governments

The International Workshop Agreement (IWA) system allows guidelines to be issued for compliance with ISO standards for specific sectors. These guidelines are not new requirements, nor do they change the requirements of the standard; the intention is not to be used for compliance or certification, but serve as guidelines for better application of the standard.

The document IWA 4, revised in 2009, is an International set of guidelines created by approval of the ISO Technical Management Board and under the leadership of the Mexican Government Directory of General Norms of the Secretary of the Economy. The objective was to provide “Guidelines to facilitate the application of ISO 9001:2008 to Local Governments.”

This document provides alignment for the application of ISO 9001:2008 to local governments and provides timely examples to facilitate interpretation. In addition, Attachment A provides a process map as a guide for the organization of local government initiatives.

The IWA 4 Attachment B contains an integrated tool for the self-assessment of parameter metrics for the minimum elements that a local government must have in order to comply, or exceed the directives.

The structure of IWA 4 is based on ISO 9001:2008 with the addition of the two attachments as follows:

  1. Objective and scope
  2. Normative references
  3. Terms and definitions
  4. Quality Management System
  5. Management Responsibility
  6. Resource Management
  7. Product Realization
  8. Measurement Analysis and Improvement

Attachment A – Process Map

Attachment B – Assessment for Reliable Governments

The IWA-4:2009 document can be purchased from the ISO website.

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Adapted from FIDEGOC (Fundacion Internacional para el Desarrollo de Gobiernos Confiables: International Foundation for the Development of Reliable Goverments).

6 Myths to Dispel Before a Lean ISO Implementation

People not familiar with the ISO 9001 standard may think of it as being bureaucratic with lots of extra paperwork.  In reality, this is far from the truth.

The ISO 9001:2008 standard requires that you establish controls for your business, that you monitor customer satisfaction and that you continually improve your processes.  These basic elements are essential for any organization to succeed.

The ISO standard does not specify “how” these elements are to be implemented, thereby giving each organization the flexibility of complying while conducting its business in an effective manner. Using Lean concepts in the implementation of ISO 9001 enables the organization to gain all the benefits of the structure of this system without creating a bureaucratic burden.  Following are some of the popular myths regarding ISO requirements that often prevent a Lean implementation.

1)     Myth. The Quality Manual needs to be very detailed in describing the quality system.

Truth. The manual should briefly state the key processes and their interactions.  It needs to make reference to the procedures and flow diagrams that describe the processes in more detail. The manual does not contain any proprietary information and does not have a minimum length.

2)    Myth. Several “controlled” hard copies of the Manual are needed.

Truth. The entire document and records control system can be in electronic format.  Although many organizations prefer having a certain number of “controlled” hard copies, the standard does not require it. The key here is control; making sure that only the latest valid information (procedures, forms, etc.) are used.  Having several sets of “controlled” copies makes it more difficult to maintain the documentation.  Maintaining one controlled “hard copy” set may be a good idea as a quick reference.

3)    Myth. Employees must have easy access to a “hard copy” of the procedures and “work instructions” that apply to them.

Truth. Again, these procedures and work instructions can be available in a controlled electronic format. Documentation must be readily available and securely stored and a method needs to be developed for revision and approval.

4)    Myth. A procedure is needed for everything.

Truth.  ISO requires only six procedures which can be condensed to five: document control, records control, non-conforming product handling, internal auditing, preventive and corrective actions. Other procedures should be developed when they add value to an internal customer or external customer viewpoint or improves communications between the functions that will use it.

5)    Myth. ISO prevents Lean implementation because all changes need to be documented and approved.

Truth.  The ISO standard expects Continual Improvement to take place and Lean provides a set of concepts and tools to reduce waste and thereby improve processes.  Lean improvements should be documented once the new procedure is confirmed to result in improved results.  

6)    Myth. All procedures and work instructions need to be written in a consistent format.

Truth.  ISO documentation can take many forms including written procedures, pictures, drawings, flow charts, and screen shots.  Procedures need not be wordy or complex.  The key is that the information be understood and accessible by the people using it.

Will people with different language and cultural backgrounds be able to understand the procedure or work instruction without much need for interpretation? Dispelling these myths will allow for the implementation of a highly effective Lean Quality Management System using the ISO 9001 structure.

Lean ISO and the Eighth Waste

The elimination of waste is the main focus of Lean Manufacturing.  In recent years, many organizations have incorporated the concept of the “eighth waste” in their implementation of Lean Manufacturing.  Many early sources spoke about the Seven Wastes that are found in most processes:

  • Overproducing
  • Transporting
  • Waiting
  • Inappropriate processing
  • Building unnecessary inventories
  • Conducting unnecessary movements
  • Defects and errors

Lean practitioners have come to recognize that elimination of these seven wastes is highly dependent on getting people involved in the Improvement process.  This failure to fully utilize the workforce talents and fully engage employees is now considered the most significant waste of all and is referred to as the eighth waste.

These wastes are symptoms of the underlying root cause for the real problems. For instance, excess inventories may be an indication of unbalanced workloads, machine breakdowns, misunderstood customer requirements, and unreliable suppliers.

Being on the lookout for the evidence of waste provides a starting point for the investigation of the root causes and for finding solutions to the problems.  Employees are not only closer to the symptoms, but also closer to the root causes of the problems.

In a previous article, I explained the compatibility of ISO 9001:2008 and Lean Manufacturing.  ISO 9001:2008 specifies that the organization must disseminate its’ Quality Policy and Objectives so that all employees understand them and how their jobs contribute to them. It also specifies that the organization must be engaged in the continual improvement of its Quality Management System.

The eighth waste can be described as “underutilized minds.”  Although ISO has some built-in requirements for improvement such as internal audits, corrective and prevention action systems, it does not prescribe how employees, in general, should be involved in the continual improvement of the organization.

To address the eighth waste, organizations desiring to institute a Lean ISO system need to:

  • Train employees early in the process on the Quality Policy and Objectives  so that they begin to understand their roles in the process.
  • Engage employees in the documentation process including involvement in writing the initial drafts of procedures or work instructions.
  • Select and train employees as Internal Auditors so that they learn about other areas within the company when participating in audits.
  • Involve employees in Internal Audits as both Auditors and Auditees.
  • Engage employees in workspace organization and standardization (5S) and in improvement events such as Value Stream Mapping and Kaizen activities.
  • Train employees in root cause analysis and basic problem solving techniques so that they can assist in maintaining the Corrective and Preventive Action Systems (CAPA).
  • Develop workplace organization score cards and train your Internal Auditors in their use.

These actions will significantly reduce the eighth waste in the organization by engaging the workforce in the Continual Improvement process.

Lean and ISO Working Together

Some people think that compliance with ISO 9001:2008 inhibits innovation and Lean transformational change. This is very far from the truth. I previously wrote about how compatible and complementary both methods are when implemented in the same timeframe. I will explain in more detail below.

ISO requires the organization to be engaged in Continual Improvement.  Lean provides one vehicle for a company to be focused on the customer, while constantly working at making the organization’s processes more effective.

ISO 9001 is designed in a Plan-Do-Check-Act (PDCA) format for Continual Improvement.  In implementing ISO, we plan for the development (Plan), we implement it (Do), we audit against the standard (Check) and we take corrective action when necessary and continue the cycle by identifying and pursuing opportunities for improvement (Act).

During the Planning stage, we can use the Lean principles to assure that the documentation is “value-added”, that they are truly needed, that procedures are written in a simple concise manner and that work instructions are made as visual as possible and easily understood by the user.  Procedures and work instructions should encourage their use and facilitate training and cross-training.

The key for the ISO implementation is to get a “snap-shot” of the Current State and to document it.  Value Stream Mapping, a Lean method, is useful in identifying process steps  and opportunities for improvement in the Current State and to document the possible improvements in a Future State Map.  A Continual Improvement Plan could then be developed to identify actions, responsibilities, and target dates for the improvements.

Significant improvements will be documented as “Preventive Actions” for follow-up in the ISO system.  Any improvement that reduces lead-time or increases product/service Quality is a valid candidate as a Preventive Action as it will prevent customer dissatisfaction.

In Lean, Rapid Improvement Events (Kaizen) address solutions to the opportunities identified in the Continual Improvement Plan. Once such solutions are identified, tested and implemented (again, P-D-C-A), the new process needs to be documented in the ISO system.

Lean uses the concept of “standard work”, a method that identifies the sequence of activities, the use of the resources needed, and the time planned to keep up with customer demand.  Standard work provides an excellent vehicle for identifying the “inputs” and “outputs” for each process as required by ISO standards.

Sustainability of Lean methods, such as the 5s workplace organization, requires following up and auditing to assure that the organization does not return to the “old ways”.  The ISO systems for conducting Internal Audits and taking Corrective and Preventive Actions provide methods for sustaining the Lean improvements made, provided these processes are standardized and documented.  Checklists can be written to include these improved processes so that they can be audited and monitored.

It all fits together.  There is no need to be concerned with a “chicken/egg” argument, as to which should be done first. Just plan what you want to do, then do it, check it and act on it! You will always want to make it better, and should.

Developing Quality Policy and Objectives

Some people get stuck soon after starting an ISO 9001:2008 implementation with developing a Quality Policy and, soon after, in developing Quality Objectives.  Once you know what is expected, the process of developing them is very simple.

You could think of a Quality Policy as a company’s mission statement from the customer’s point of view. The policy should mention that your company is dedicated to meeting customer requirements and exercising continual improvement of the Quality Management System (QMS).  The policy informs everyone inside and outside the organization of the company’s Quality perspective, taking the customer’s requirements as primary consideration.

The Quality Policy needs to be appropriate to the business of the company. It should be stated in simple terms that everyone in the organization can relate to and make it their own.  This also means that the policy needs to reflect the overall values of the company and be consistent with other company public statements.

The policy should be developed early in the process of building the QMS.  It then becomes the guiding light for the QMS. Top management needs to be closely involved in its development and needs to disseminate it throughout the organization.  Ideally, top management should involve the management team and get consensus on its final form.

If the Quality Policy is a true reflection of the organization, the Quality Objectives will be easy to develop. The Quality Objectives are measurable and achievable statements that support the policy.

What measures do you need to assure that you are meeting customer requirements?  This will vary from company to company and even will vary for different type of customers within the company.  For instance, if you are encountering customer complaints, customer returns, high internal reject rates, poor supplier quality, or late deliveries, these are all good areas to target.  You need to first establish your metrics and develop a baseline, so that you can determine what level of improvement is attainable. The metrics and targets become your Quality Objectives –usually three or four.

In many cases, the company is already using these metrics to measure its business, but has not established clear measurable improvement goals. The performance against the objectives should be tracked frequently and reviewed formally at Management Review meetings. The suitability of the objectives, the policy and the effectiveness of the QMS, in general, should be reviewed at these meetings as well.

The Quality Policy and Objectives are the keystone of the QMS in guiding the organization in complying with customer requirements and the need for Continual Improvement.

Making ISO 9001 Part of Your Culture

Why make ISO 9001 part of your organization’s culture?

I have seen many companies registered to ISO 9001:2008 failing to take full advantage of the structure that this standard provides.  These organizations only see the marketing benefits of the certification while missing the opportunity to improve the quality of their products and services by testing their systems against their customer requirements.

ISO 9001 is a basic business process system that provides a solid structure for future improvements. In fact, this standard expects a continual improvement approach to quality and expects that organization fully understand and meet the customer requirements.

ISO provides an excellent roadmap for developing a culture that supports positive change. To maximize the benefits of ISO implementation, the ISO requirements need to become seamless with the workings of the organization.

Internal Audits need to be scheduled and conducted during the course of the year, not just before the external auditor is due to visit.  This helps to recognize and correct any nonconformity before any adverse consequences occur.

ISO requires that the organization establish systems for controlling documents, records, nonconforming products and changes in design.  These requirements are so basic that it is hard to imagine a company operating successfully without them.

Another ISO requirement, a robust Corrective and Preventive Action System is an invaluable tool for improvement. ISO expects that with every problem or potential problem, the organization will drill down to its root cause and develop a solution based on this investigation.  ISO’s emphasis on continual improvement is totally compatible and complementary to other systems and methods of business improvement and provides a platform for future evolution of the business in its journey towards excellence.

These very basic requirements need to be made part of your organization, not because they are ISO requirements, but because to succeed you need to make these part of your culture, that is, part of the way you do business.