Improving Internal Communication as required by ISO 9001 QMS

by Denise E. Robitaille 

The nuns at St. Anthony’s Catholic school used to tell a cautionary tale of a woman who’d spread a vile bit of gossip about her neighbor. Horrified by the consequences of her actions, she went to church to confess her transgression. She explained to her priest that she regretted the gossip and wished to confess, atone for her sin and make reparation. The priest granted absolution and then assigned her the following task:

“Take a pillow and climb to the top of the steeple,” he said. “When you reach the bell tower, rip open the pillow and scatter the feathers to the wind. After you’ve finished, come back to see me.” 

The contrite penitent did as she was told. When she finished, she descended and went to the priest. “Now, go and gather all the feathers,” he told her.

“But that would be impossible,” she exclaimed. “I could never find them all.” 

“That’s true,” he replied. “In the same way, it’s impossible for you to fully repair the damage that your gossip has done.”

This parable demonstrates both the intricacy of communication and the exponential consequences of losing control over this fundamental element of our shared humanity. What we say (or don’t say), the care with which we target our listener, the veracity of the content and the accountability we assume for the actions that ensue are all issues that we must control. 

The costs of inadequate communication

 
Communication is the means by which we inform one another, give instructions, exchange ideas, grant permission, conduct commerce, shout warnings and express satisfaction, etc. Implicit in any of our verbal or written interchanges is a presumption that the information is reliable both in substance and authority. We must be confident that we can trust the message and that the person who composes it is both qualified to communicate the message and in some way accountable for its content. 

Well-controlled communications are accurate, timely, complete, directed to all appropriate or required recipients, and crafted in a way that’s understood by the intended audience. 

Communications are incomplete until the recipient confirms that the messages have been received. They’re of limited value if the recipient doesn’t fully comprehend what’s being communicated, and they’re worse than useless if the information is wrong.

Within the context of ISO 9001 QMS, failing to control internal communication engenders the following risks:

• Incorrect information might be disseminated.
• Updated information might not be available in a timely manner.
• Information might be correct and timely but inaccessible.
• Interested parties might be inadvertently omitted from a distribution  list.
• Recipients might misunderstand or misinterpret what’s being communicated.

Examples of probable outcomes from these failures include:

• A customer’s concession to a deviation never gets acted upon.
• The latest revision of a specification doesn’t go to production.
• Modified quality objectives aren’t shared with employees.
• Revised safety protocols aren’t implemented.
• Material is purchased from a disqualified supplier.
• Operators miss an important training session.
• Customer complaints don’t get appropriate attention.
• New-product rollout is delayed because of multiple miscommunications.

The ultimate consequence in all instances is a breakdown of one or more processes that will adversely affect your ability to fulfill customer requirements. In some cases, poor communication guarantees you’ll ship the customer the wrong item or fail to make on-time delivery.

If you don’t control your internal communications, you don’t know where messages are going. You lose the means of knowing what actions were taken by those who received your messages. You have no way of tracing or retrieving them if the information is wrong. You don’t know if the data originated from a reliable or authorized source. And you can’t even be sure that everyone is hearing the same thing.

Failing to establish effective internal communication creates a systemic breakdown comparable to a problem with your document control process or any other feature that pervades your organization. For example, the relationship between communication and document control is that the documentation describes the requirement, and communication is the conduit for getting it to the appropriate process owner. If you have problems with document control, you could communicate the wrong specification. The input to your communication process is directly influenced by the data’s integrity; therefore, you must ensure that the content is factual.

The other aspect of communication to consider is the relationship between sender and receiver. A message’s author is responsible for ensuring that the intended audience will understand the language and format. He or she must also make the message accessible. Posting an important notice on a server that only a small population is authorized to access is nearly equivalent to not communicating at all.

Establishing appropriate channels

 
In order for an organization to control its internal communications adequately, there must be consensus as to process, protocols, authorizations and records.

How do you communicate a change to a customer order? Who has the authority to tell you to change your production schedule? Who must know about a revision to a subassembly? Who lets salespeople know if a customer’s order will be late? How does the company ensure that all affected functions sign off on the organization’s capacity to service a new contract? Whom do you tell about customer complaints? Where and when do people go for companywide notifications?

Clause 5.5.3, Internal communication, is one of the important requirements in ISO 9001. Good internal communication has always been a prerequisite for organizational efficiency--especially across departmental boundaries.

It is not necessary to write a procedure about how you control internal communications. However, it is required that communications relevant to your quality system activities are adequately controlled to facilitate the fulfillment of organizational goals. Your communications conduits must work for you. 

For the purpose of your ISO 9001 registration, it’s your registrar’s responsibility to assess the implementation of your internal communication methods as they relate to your company’s quality policy, objectives and procedures. It must be evident to the auditor that your mechanisms for communicating information are consistently applied, adequately controlled and effective.

A typical question might be, “Does the e-mail system for schedule change notifications work?” To answer that, an auditor might look upstream for issues that prompted a schedule change and then look downstream to see if they were resolved in a timely manner. 

For example, a customer might have sent an e-mail stating, “Switch purchase orders 22345 and 22361 on the schedule because we’ve had a change in projections.” Your accepted protocol is to e-mail the scheduler, flag the message as urgent and wait for a confirmation. The auditor would follow the trail from the customer request to the evidence indicating what was ultimately shipped out. If the schedule wasn’t revised soon enough to switch the orders, the customer probably didn’t get the needed parts. 

Conversely, if things happened as requested, there’s verification that the company has adequate control of this particular communication conduit. This is one of many examples of using an alternative to a documented procedure to define and control a process.

Communication as process

 
Communication is a process. In keeping with the process approach, it’s appropriate to apply the inherent concepts of input and output to this group of activities. The input is the information that creates the need for the communication. The nature of the information determines the method and flow. The output of the process is the successful transmission. The message content creates input for the next step in the series of processes. If the input (i.e., message) is, “Part X73 is going to be late; skip to the next job,” then the output (or response) might be: “OK, confirmed. Will post Job 4876 next.” The messages’ traceability ensures that requirements--even when they change frequently in a volatile market--are controlled and effectively communicated. 

When you consider internal communication as a process, you can begin to ascribe to it some of the same features you apply to other quality management system processes. Let’s look at them individually. 

Definition 

 
Consider the methods and nature of your communications. Types of communications might include:

 

• Customer concessions
• Changes to work instructions
• Revisions to customer specifications
• Rescheduling
• Project status
• Training requirements
• Objectives
• Process deviations
• Changes to supplier qualifications
• Personnel assignment
• Segregation of material

The methods you’ll use to communicate are equally diverse and might include:
Color-coding or other nonverbal status indicators

 

• Signatures
• E-mails
• Meetings
• Bulletin/white boards
• Engineering change notice forms
• Internal audits
• Lockout/tag-out protocols
• Memos
• Physical placement (e.g., finished goods on marked shelf)
• Newsletters
• Threaded discussions
• Tags

Even if you don’t have a defined procedure, you must have consensus on the communication conduits. Designers must know where on the server they can consistently find the latest updates to customer specifications. Operators must demonstrate consistent awareness that a red tag means a job has been rejected and a yellow one means it’s awaiting inspection. Employees must know that the cafeteria bulletin board is where they sign up for training sessions. Whatever communication method you use must be uniformly practiced in order to be adequate and effective.

Responsibility 

Who’s responsible for making sure information gets to the appropriate recipients? Who’s authorized to initiate certain messages, such as production schedule changes? Who must receive the information? Does the recipient have to respond? Who should archive the messages? Who handles your e-mail system? 

Resources

Does the organization provide the means for effective communication to occur? Are there bulletin boards, adequate access to computer terminals or e-mail, suggestion boxes or readily available forms? Sometimes breakdowns occur simply because the organizational culture doesn’t foster communication. People must be able to express concerns and ideas as well as information. Are supervisors intimidating or inaccessible? 

Training

Do people know how to use the e-mail system? Do they know how to use the various forms that are utilized to communicate requirements? Do they know who to ask if they don’t understand the nature of a message? Do people know the protocol or rules for contacting people at other facilities or remote locations? Does the company offer tuition assistance for “English as a second language” courses?

Implementation and verification

 
Do your employees consistently use the established methods to communicate? Are they communicating at all? 

It’s necessary to verify that the process is effective in fulfilling the requirement.

 
As described earlier, it’s possible to assess the extent to which communication methods are working by reviewing a message’s outcome and determining if it resulted in the desired action. If the document revision got to the operator, if the supervisor confirmed that the equipment maintenance schedule was updated or if the customer’s complaint was acted upon in a timely manner, then you have verification that your internal communication process is effective.

Records

 
The same rules apply to this process as to any other. Records of requisite communications provide evidence. The ability to produce an amended contract, for example, isn’t just a good QMS practice; it can also be the means of avoiding litigation. Records of communications can also help you understand problems and breakdowns. When doing a root cause analysis, it’s helpful to know when messages were sent and to whom. It might be that the revised requirements were sent but weren’t available to the person who needed them. Or there might have been a delay with a communication. If there’s a misunderstanding about the message, a record affords you the opportunity to reassess the format and improve the way you craft subsequent communications. 

Words into goals 

 
Internal communication is the link between requirements and the people who must fulfil them. Commitment to consistent and effective communication is one of the tools you use to empower individuals to fulfil organizational goals.

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STRATEGIC QUALITY PLANNING AND DEPLOYMENT:

By Joseph A. De Feo 

Strategic quality planning (SQP) is a systematic approach to defining long-term business goals, including goals to improve quality and the means (i.e., the plans) to achieve them. Many organizations have created a vision “to be the best,” toward a goal of outperforming competitors. Many of these organizations fall short in achieving this vision. Most do not align, or have difficulty aligning, their performance excellence initiatives like lean and Six Sigma to the annual business plan. This leads to lack of resources to complete projects, which in turn makes them hard to justify.

To achieve a vision it is necessary to align the annual goals to your major change initiatives or quality programs and integrate them into the strategic plan. This will ensure the new focus becomes part of the plan and sustainable.

Japanese quality leaders refer to this process as hoshin kanri or “policy deployment. Ho, shin, kan, and ri are actually four words that loosely translate to “focus, direction, alignment, and reason.”

Focus by creating goals that provide direction and alignment of the resources needed from the organization to meet those goals and the reasons for selection them. The reasons force management to understand why it is selecting these goals.

The potential benefits of strategic quality planning and deployment include:

• Clarification of goals
• Achievability of goals
• Scheduled reduction of chronic wastes and improved quality of products and services
• Better or new focus on customers

Strategic quality planning is the systematic process by which an organization defines its long-term goals with respect to quality and customers, and integrates them into a cohesive business plan. It enables an organization to execute organizational breakthroughs to achieve a competitive advantage and quality leadership.

The approach to providing organization wide financial goals has evolved into a more robust strategic plan, incorporating these goals into a hierarchy that includes the voice of the customer. A structured methodology must include a provision of rewards, universal participation, a common language, and training.

Launching a strategic plan

Creating a strategic plan requires that leaders be personally involved, eliminating the atmosphere of blame, and making decisions on the best available data. The strategic deployment process requires incorporating the customer focus. The elements needed are generally alike for all organizations. The ones in most widespread use tend to be:

• Mission
• Vision
• Values
• Policy

The mission is the reason for the organization’s existence. The vision is the desired future state of the organization. Values are what the organization stands for, and they tie into strategies, which are the means to achieve the vision. Policies represent a guide to managerial action, guiding day-to-day decision-making. And finally, the deployment plan is what turns vision into action.

Developing the plan

Strategic deployment begins with a customer-focused vision, which should define the benefits that can be expected. Good vision statements should be compelling and shared throughout the organization. But vision statements are only words—a reminder of what the organization is pursuing, which must be carried out through actions. When forming a vision, it’s important not to focus exclusively on shareholders, to properly explain the vision to everyone involved, and not to create a vision too easy or difficult to achieve.

A mission is often confused with a vision, but a mission statement should clarify an organization’s purpose. Together, a vision and mission provide an agreed-upon direction, which can be used as a basis for decision-making.

To convert the vision into an achievable plan, it must be broken into key strategies. Responsibility for them must be distributed to key executives. To determine what the strategies should be, five areas must be assessed:

• Customer loyalty and satisfaction
• Costs related to poor quality of products or processes
• Organization’s culture
• Business processes
• Competitive benchmarking

Each of these areas can form the basis for a balanced business scorecard. The key strategies can be modified to reflect long-term goals. An organization must set specific strategic goals that must be achieved for the broad strategy to be a success. Seven areas must be addressed to ensure that the proper goals are established:

• Product performance
• Competitive performance
• Business improvement
• Cost of poor quality
• Performance of business processes
• Customer satisfaction
• Customer loyalty and retention

Goals that affect product salability and revenue generation should be based primarily on meeting or exceeding marketplace quality. A widely used basis for setting goals has been historical performance.

Corporate values reflect an organization’s culture. Some organizations create value statements to further define themselves. Values are what an organization stands for, and must be supported with actions from management lest their publication create cynicism.

Policy declarations are a necessity during a period of major change. Most declare the intention to meet the needs of customers, and include language relative to competitiveness in quality. Some include specific reference to internal customers, or indicate that the improvement should extend to all phases of the business. Enforcement of new policies is a problem due to the relative newness of documented quality policies. Sometimes, an audit process is mandated to ensure the policy is carried out.

A fundamental step in establishing any strategic plan is the participation of upper management. The executives are responsible for ensuring all business units have a similar council at the subordinate levels of the organization. If a council is not in place, the organization should create one.

Once the strategic goals have been agreed upon, they must be subdivided and communicated to lower levels. Those who are assigned responsibility must determine the needed resources and communicate this to higher levels. The deployment process starts by identifying the needs of the organization.

Measuring progress

There are several reasons why an organized approach to measuring performance is necessary:

• Performance measures indicate the degree of accomplishment of objectives
• Performance measures are needed to monitor the improvement process
• Performance measures are required for periodic reviews by management

Once goals have been broken down into sub-goals, key measures need to be established. The best measures of the strategic planning process are simple, quantitative, and graphic. As goals are set and deployed, the means to achieve them must be analyzed to ensure they satisfy the objective they support. Once the system is in place, it must be reviewed periodically to ensure that goals are being met.

A formal, efficient review process will increase the probability of reaching the goals. The review process looks at gaps between what has been achieved and the target. Frequent measurements of progress displayed in graphic form help identify the gaps in need of attention. Success in closing those gaps depends on a formal feedback loop with clear responsibility and authority for acting on those differences.

Pursuing too many objectives at the same time will dilute the results. Trying to plan without adequate data can create an unachievable plan. If leaders delegate too much, there will be a lack of direction. The biggest disruption caused by strategic planning is created by imposing a structured approach on those who prefer not to have it. Resistance will be evident at the outset. Therefore, the most important prerequisite is the creation of an environment conducive to change.

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" AEROSPACE’S AS9100 QMS STANDARD " by Eugene M. Barker

Representing the first international effort to formulate a quality management system standard for the aerospace industry, the two-year-old AS9100 is beginning to show its long-term value.

The standard supplements ISO 9001 by addressing the additional expectations of the aerospace industry. Already, reports along this complicated manufacturing chain attest to among other benefits AS9100's contribution to more consistent verification methods and fewer verification audits. 

Initially released in October 1999 by the Society of Automotive Engineers in the Americas and the European Association of Aerospace Industries in Europe, and shortly thereafter by standards organizations in Japan and Asia, AS9100 was a cooperative effort of the International Aerospace Quality Group (IAQG).

As such, it combines and harmonizes requirements outlined in the SAE's AS9000 and Europe's prEN9000-1 standards.

Recently, AS9100 was revised to align with ISO 9001:2000.

Separating "whats" from "how tos"

 
AS9100 defines additional areas within an aerospace quality management system that must be addressed when implementing an ISO 9001:2000-based quality system. Typically, these requirements are included within robust aerospace quality systems. The industry experts who wrote the standard and the representatives who approved it all agree that these additions are essential to ensure product, process and service safety and quality. 

Although the standard outlines industry "whats" for a quality management system, the "how tos" were deliberately left out and remain the system designers' responsibility. This reflects the AS9100 writing team's, and my, belief that how-to information stifles continuous improvement.
All quality systems must be designed to meet the specific needs of the users. And although AS9100 identifies areas to address within the aerospace industry, system designers are encouraged to first establish a robust quality system that's both effective and efficient. This system should be a holistic entity with practices spanning multiple functions and processes within the business.

For example, regulatory requirements are critical functions within the industry. The requirements within AS9100 are complementary to contractual and applicable law and regulations. Those implementing a quality system compliant with AS9100 must ensure that the additional requirements of their customers, regulatory agencies (such as the FAA and the JAA) and local, state and national laws are also referenced within the system's documentation.

Aerospace requirements and ISO 9001

 
Within AS9100, additions and clarifications have been made to most areas of ISO 9001:2000. Although the specific requirements of that standard don't fall within this article's scope, a discussion of the primary areas where ISO 9001 overlaps with AS9100 will benefit those implementing the aerospace standard. Some additional expectations relevant to the aerospace industry follow. Most are based upon existing best practices, which are collected and formatted in AS9100 to ensure that manufacturers meet the industry's expectations.
 

The AS9100 standard provides guidance for managing variation when a "key characteristic" is identified. Keys are features of a material, process or part in which the variation has a significant influence on product fit, performance, service life or manufacturability. AS9100 requires that an organization establish and document a configuration management process.

Planning product realization is essential for effective and efficient processes. The standard emphasizes planning for in-process verification when a product can't be verified at a later point. Tooling design must also be considered when process control methodology is used to ensure that process data will be captured.

The AS9100 standard includes extensive supplementation in design-and-development functions. This isn't surprising given the complexity of aerospace products and customers' expectations for reliable performance during a protracted period of time. The European prEN9000-1 standard provided many of these additions. Both standards cover planning for design-and-development activities and ensuring interim control points during the design process. Design outputs are supplemented to provide identification of key characteristics, and the data essential for the product that will be identified, manufactured, inspected, used and maintained is detailed.

Notes are included for both design-and-development verification and validation highlighting traditional areas of emphasis. Additionally, AS9100 provides information on areas of verification documentation and validating testing and results.

Managing suppliers throughout the aerospace supply chain remains a major challenge for the industry. The chain is very long, and within the supply base, there are sources that serve multiple industries. Because the industry is so dependent upon this supply chain, it isn't surprising that AS9100 includes a number of additional expectations for identifying and maintaining suppliers. Supplier approval is just one step in the process of managing suppliers.

Effectively communicating requirements is essential. The standard lists seven specific areas for consideration. They range from clarifying engineering requirements to managing test specimens and right of access to suppliers' facilities.

The industry typically relies upon one of three methods for product acceptance. An organization might conduct a receiving inspection, perform the inspection at the supplier's facility or formally delegate product acceptance to the supplier. Procedures for determining the method of supplier control are required, as are the processes used when employing these methods.
But no element of supplier control is more important than understanding that a supplier is responsible for managing its suppliers and sub-tier suppliers. This includes performing special processes that are frequently subcontracted to processing houses. The supplier must use customer-approved sources; however, ensuring that the processing is properly performed is the supplier's responsibility.

Product safety and quality control

Manufacturing a product as sophisticated as an airplane or space vehicle requires special attention during the production processes. It's important, for example, to ensure that the correct revision of the engineering documentation is being used and documented within the work instructions, and that work performance is recorded. This frequently requires a specific reference to the person performing the work. Controlling production processes is essential to demonstrate that operations have been correctly performed. This is especially important when conducting special processes that don't lend themselves to after-the-fact inspection techniques.
 

The industry frequently relies upon tooling and other production equipment, including computer-controlled machines, to fabricate and assemble products. This equipment often forms the basis for product acceptance. In these cases, it's essential to demonstrate the integrity of these tools and machines and to develop a process that will ensure adequate oversight of the entire process.

Aircraft are designed to perform for 50 years or more, and properly maintaining the aircraft is essential for continued safe operation. Thus, servicing requirements are an important part of the total quality system. These include maintenance and repair manuals as well as the actual servicing work. Again, record-keeping is important in documenting the work performed, the equipment used and the people doing the work.

Some products require traceability of part or all of their components. This requirement may be imposed by contract, regulatory agency or internal need. In any case, AS9100 provides the essentials of an effective traceability program.

Using measuring devices of known accuracy and this may include computer-assisted measuring and test equipment is essential in the verification process. Maintaining a calibration history of this equipment and documented proof that it's reviewed and verified periodically underlies the entire metrology system. 

Diagnosing the quality management system's health and using this information to guide improvement activity is important for efficiency and effectiveness. Internal audits performed by competent personnel are a vital input into this health measurement system. AS9100 provides some additional expectations regarding internal quality audits.

Detailed first-article inspections are frequently performed to demonstrate product conformance to engineering requirements. Documenting the actual inspection and test results is an established method of demonstrating initial item acceptance. The standard provides general direction in this regard and suggests that AS/EN/JISQ9102 be consulted for further guidance. Another international aerospace standard, called AS9102 and developed by the IAQG, outlines a methodology for performing and documenting first-article inspections.

When things don't go as planned, AS9100 gives directions for controlling and disposing nonconforming material. This includes specific requirements for contacting the customer for authorization when using or repairing a product that doesn't conform to engineering requirements.
 

Verifying compliance to AS9100

 
More than 60 percent of IAQG members have implemented the AS9100 standard internally and are flowing it down to their suppliers. Most members will require suppliers to comply to the updated version of AS9100 (which is aligned to ISO 9001:2000 and supercedes older ISO 9000 standards) beginning in December 2003. This is consistent with the transition from the old ISO 9001 standard to the new version.

Organizations within the industry differ in their compliance to AS9100 verification requirements. Some use their own external auditors to verify suppliers' quality management systems. Others share the results of their quality system audits with suppliers in the industry. Most provide suppliers with copies of external audits. Most permit suppliers to share the audit results with other customers, too.

Increasingly, the industry is using the results of third-party registrars as a means of demonstrating a quality management system's compliance to AS9100. The Americas Aerospace Quality Group, working with the Registrar Accreditation Board, has established a process and requirements for auditors performing audits to AS9100 and registrars granting supplemental registrations. The process includes additional training and practical experience and ensures that auditors are competent and that registrars are experienced in the industry. The AAQG has created a Registrar Management Committee to oversee this important function. Its methodology is defined in SAE AIR5359. Europe and Asia are developing equivalent methods.

The Federal Aviation Administration has determined that AS9100 is "a comprehensive quality standard containing the basic quality control/assurance elements required by the current Code of Federal Regulations (CFR), Title 14, Part 21." Both the U.S. Department of Defense and NASA have reviewed the standard and have published guidance material on using the standard for contractual requirements.

As AS9100 becomes established within the industry, the standard's benefits become apparent. Two obvious ones are a reduction in multiple expectations and a consistency in verification methodology. Both prime manufacturers and their suppliers are pleased with the results. Suppliers report a reduction in verification audits and an increased consistency in expectations. As a direct result, suppliers' customers are seeing a reduction in oversight costs and an improvement in supplier performance.

Additional information on the philosophy behind the specific additions within AS9100 are available in the AS9100 technical requirements chapter found in The ISO 9000:2000 Handbook published by ASQ Quality Press in 2002.
 

About the author
Eugene M. Barker is a technical fellow at The Boeing Co. responsible for quality industry association interfaces. He led the industry writing team that drafted SAE AS9000 and chaired both Working Group 11 of ISO TC20 and the International Aerospace Quality Group that developed AS/EN9100. Barker is also a fellow of the American Society for Quality, a member of the Registrar Accreditation Board board of directors and a founding member of the IAQG.

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ISO 9004:2009 Is Out and It Sure Looks Different

by Denise Robitaille

The new revision to ISO 9004 came off the press in the last quarter of 2009. It is significantly different from its predecessor. ISO 9004:2009 embodies the quality management principle relating to continual improvement. The technical experts made bold strides in their quest to address market needs by producing a standard that would help organizations maintain and improve their quality management systems over time. While that was the stated intent with the 2000 version, the fact is that the majority of users considered it a road map for implementing ISO 9001.

Individuals who were familiar with the 2000 version will have several questions. The first is: “Where’s 9001?” In ISO 9004:2000 the entire text of ISO 9001:2000 was embedded into the standard. The clauses, by and large, mirrored ISO 9001 and the structure was identical. Those who utilized ISO 9004 as a how-to guide for ISO 9001 had no trouble finding the relevant clauses. The only problem with that approach is that ISO 9004 was not intended to be a handbook on how to implement ISO 9001. It was intended, as the title plainly indicated, to provide “Guidelines for performance improvements.”

“Performance improvements” sounds like a great idea. Until you ask yourself the next question: “Why?” What is the value in improving performance? Within the answer lies the crux and purpose of both ISO 9001 and ISO 9004. That answer is found in ISO 9004’s new title—“Managing for the sustained success of an organization—A quality management approach.”

It’s not good enough to achieve ISO 9001, proudly displaying the coveted certificate on the wall. To conform to the requirements of ISO 9001, it’s important to maintain the quality management system that has been established. It’s important to consistently fulfil requirements found in multiple sub-clauses relating to establishing objectives (5.4.1), monitoring and measuring product and processes (8.4), reviewing changes that could affect the quality management system (5.6.3), and striving for continual improvement (8.5.1).

So ISO 9004:2009 is about what you do after you’ve established and implemented your quality management system to keep it going and to make sure both you and your customers continue to derive benefit from your organization. They get a reliable supplier and you get to stay in business. It also addresses one of the basic truisms of our universe: things change. Hence, the new ISO 9004, and particularly the annexes, is heavily weighted toward monitoring and periodically assessing so that you can respond to change.

The new version of ISO 9004 was structured to facilitate this quest. The sub-clauses flow from the organization’s environment, to strategic planning, through resource management to managing processes, to monitoring and analyzing, and ending up with improvement, innovation, and learning.

Think of it like this: “This is who we are. This is the big plan for the organization. This is what we have to work with. This is how we do things. This is how we figure out what’s working and what isn’t. And these are the things that will allow us to still be around tomorrow—this is how we plan for our future.” Any of these can, and probably, will change over time. How your organization handles those changes will determine your “… sustained success.”

Under the first sub-clause we look at who we are. We also look at stakeholders, or as the standard refers to them, “interested parties.” This concept is situated early on in the standard because interested parties are directly relevant to our organization now and in the future. You could say they are an element of our identity. Interested parties can be customers, stockholders, employees, suppliers, and society at large, just to name a few. Changes with any of these interested parties affect our organization.

The next sub-clause talks about strategy and policy. I think this is a great step forward. It illustrates the very tight bond that should exist between the real business of the business and the quality management system. For too long top management in many organizations has considered the quality management system, and its requirements for management review and management involvement, as an odious infringement on their sanctum sanctorum. Time is overdue to recognize that a good quality management system is in harmony with strategic goals and planning.

Consideration of resources is another key factor that often changes over time. Monitoring what resources currently exist and which will be impacted by changes such as turnover of personnel, slower cash flow, cost of fossil fuel, and scarcity of raw materials, sequels directly into the next section dealing with managing processes. It’s impossible for processes to remain consistent when support such as resources and infrastructure are changing.

You’ll note throughout the emphasis on monitoring. This is carried through to annexes that give you tips on how to assess your organization. Doing it once gives you a starting point. But the assessments, just like any other effective monitoring tool, needs to be utilized cyclically to achieve any real benefit. The annexes are a useful guide; but you can also devise your own methodology to assess your organization. Whatever method you use, make sure that your assessment reflects inter-dependencies and interrelations between various factors. The results should help you identify what needs to be enhanced, what needs to be discarded, and what needs to be improved.

Use ISO 9001 to build a great quality management system. Use ISO 9004 to maintain it and to help it to become even greater.

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