News and Articles

Section 4.1 – Objectives: Real Value from your ISO 9000

by Colin Gray

Tucked away in section 4.1.3 Quality Policy Statement, is a requirement that management formulate objectives for quality. This is one area that is frequently overlooked when implementing ISO 9001 and just as frequently is overlooked by auditors during ISO 9000 assessments.

Generally speaking, and this case is no exception, objectives should link strategy and policy to plans and procedures. In a quality system, quality related objectives should contribute towards achievement of the stated policy.

While there is no requirement in the ISO 9000 standard to guide in the choice and formulation of objectives, Juran provides excellent information in his Quality Control Handbook. He states that objectives should be: Measurable, Optimal to the overall result (no individual objective should contribute to a bias result which subjugates the overall aim), All-inclusive (objectives should cover all activities so that all are equally high priority), Maintainable (elements can be revised without redesigning others), Economic (the value of achieving objectives must be greater than the cost of setting them). He also points out that, in order to work, objectives must be perceived as: Legitimate (undoubted official status), Understandable (language of those faced with meeting them), Applicable (fit with the conditions in which they are to be used), Worthwhile (preferably to those working towards the objective as well as the whole organization), Attainable and Equitable (the difficulty in obtaining them should relate to reward).

Companies usually run by numbers. There are numbers for sales targets, budgets for production materials, labor costs, etc. All the ISO standard is asking is for management to identify numbers which will indicate quality performance. These numbers will be different depending upon the business type, quality system structure and management focus. In fact many of them may already exist. Common numbers include turnaround time, throughput rates, scrap levels, yields, rework costs, on-time delivery rates. However each company, each management structure needs to work out its own numbers. Having picked the measures, these need to be recorded, trended over time and the formalization of plans to improve the numbers.

Formalizing the process forces management to make sure they are focusing on the right information and to ensure that the numbers are working. One client highlighted how successful their customer satisfaction was by the low frequency of customer returns and the low value of returned product. An objective viewpoint however, that of their President, was that the cost of the returned material included, shipping, restocking and loss of face with customers. His numbers indicated that there was work to be done.

Successful companies rarely happen by accident. Somebody somewhere is watching, and controlling, the numbers. This ISO requirement extends this thinking to the quality field, positively impacting quality issues, and then the business as a whole.

Exploding the Myths about ISO 9000

The process of attaining ISO 9000 is not only misunderstood but often feared. Media coverage, hearsay, and business-related horror stories have all contributed to its threatening image.

If you believe the hearsay, you may also believe that ISO 9000 is an intrusive set of unrealistic and unwelcome rules and regulations that will make doing business unbearably difficult in the short run and moderately difficult forever thereafter.

This is not the case. On the pages that follow, we at Cavendish Scott will examine and refute many of the common myths about ISO 9000. As you read on, keep two things in mind. In the first place, ISO 9000 was designed to help standardize business practices across the globe, making it possible to do business more predictably and more efficiently. Secondly, at Cavendish Scott, we’ve seen it all. With more than 400 clients on two continents, we have witnessed virtually all of the potential pitfalls — and the simple ways to avoid them.

We invite your interest and your feedback. And we hope that the information that follows will help make your road to ISO 9000 interesting, beneficial — and even enjoyable.

Document Review FDIS ISO 9001:2008 against ISO 9001:1994

By Dan Nelson

The new ISO 9000:2008 standard is complete, the deadline is set for implementation, and conversion to the new standard is causing some degree of uneasiness in many companies. The process of becoming certified in the first place was difficult enough, but to change what has already been implemented already is daunting, to say the least. In order to ease some of your doubts, we have gone through the new standard and compared it to the old version. The following is a detailed and technical evaluation of new requirements. This will allow you to understand how your system will have to change to achieve compliance in the future.

If you have any more questions, we would be happy to answer them. If you need a little more help, we can upgrade your system to meet the new requirements for a nominal, fixed fee.

Section 4: Quality Management Systems

  • 4.1 (General requirements) requires that the organization continually improve the effectiveness of the quality management system; 4.1 b) requires that the sequence and interaction of quality management system processes be determined; e) requires that the organization measure, monitor, and analyze quality management system processes; and f) requires the organization to implement action necessary to achieve planned results and continual improvement of those processes. 4.1 also requires that the organization control and identify within the quality management system any outsourced processes that affect product quality.
  • 4.2.2 (Quality Manual) a) requires that the quality manual include not only the scope of the quality management system, but also details of and justification for any exclusions; c) requires the manual to include a description of the interaction between the processes of the quality management system.

Section 5: Management responsibility

  • 5.1 (Management Commitment) requires that the evidence provided by top management to demonstrate commitment to the quality management system includes evidence of continually improving its effectiveness; a) requires that top management communicates to the organization the importance of meeting customer as well as statutory and regulatory requirements.
  • 5.2 (Customer Focus) requires that top management ensure that customer requirements are determined and fulfilled with the aim of enhancing customer satisfaction.
  • 5.3 (Quality Policy) b) requires that the quality policy include a commitment to comply with requirements and continually improve the effectiveness of the quality management system; c) requires that the quality policy provides a framework for establishing and reviewing quality objectives.
  • 5.4.1 (Quality Objectives) requires that quality objectives br established at relevant functions and levels within the organization. (Quality objectives must include those needed to meet requirements for product.) Such objectives must be measurable and consistent with the quality policy.
  • 5.5.2 (Management Representative) c) requires that the Management Representative ensure the promotion of awareness of customer requirements throughout the organization.
  • 5.5.3 (Internal Communication) requires that top management ensures appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system.
  • 5.6.2 (Review Input) requires that management review include current performance and improvement opportunities related to: a) results of audits, b) customer feedback, c) process performance and product conformance, d) status of preventive and corrective actions, e) follow-up actions from earlier management reviews, f) changes that could affect the quality system and g) recommendations for improvement.
  • 5.6.3 (Review Output) requires that management review outputs include: a) improvement of the effectiveness of the quality management system and its processes, b) improvement of product related to customer requirements, and c) resource needs.

Section 6: Resource management

  • 6.1(Provision of Resources) requires that the organization determine and provide the resources needed to a) implement and maintain the quality management system and continually improve its effectiveness, and b) enhance customer satisfaction by meeting customer requirements.
  • 6.2.2 (Competence, Awareness and Training) c) requires that the effectiveness of any training provided is evaluated and d) requires ensurance that personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives.
  • 6.3 (Infrastructure) requires that the organization determine, provide, and maintain the infrastructure needed to achieve the conformity of product to requirements (including, for example, buildings, work space, process equipment, and supporting services).
  • 6.4 (Work Environment) requires that the organization determine and manage the work environment needed to achieve conformity of product.

Section 7: Product Realization

  • 7.2.1 (Identification of Customer Requirements) requires that the organization determine: a) requirements specified by the customer including delivery and post-delivery requirements, b) product requirements not specified by the customer but necessary for intended or specified use, c) statutory and regulatory requirements related to the product, and d) any additional requirements determined by the organization.
  • 7.2.3 (Customer Communication) requires that the organization determine and implement effective arrangements for communicating with customers in relation to a) product information, b) enquiries, contracts, or order handling, including amendments, and c) customer feedback, including complaints.
  • 7.4.1 (Purchasing Control) requires that the criteria for selection, evaluation, and re-evaluation of suppliers be established. Records of the results of evaluations and any necessary actions arising from the evaluation must be maintained.

Section 8: Measurement, Analysis and Improvement

  • 8.1 (General) requires that the organization plan and implement the monitoring, measurement, analysis and improvement processes needed to: a) demonstrate conformity of the product, b) ensure conformity of the quality management system, and c) continually improve the effectiveness of the quality management system. This must include the determination of applicable methods, including statistical techniques, and the extent of their use.
  • 8.2.1 (Customer Satisfaction) requires that, as one of the measurements of the performance of the quality management system, the organization must monitor information relating to customer perception as to whether the organization has fulfilled customer requirements. The methods for obtaining and using this information must be determined.
  • 8.2.3 (Monitoring and Measurement of Process) requires that the organization apply suitable methods for monitoring, and where applicable, measuring of the quality management system processes. These methods must demonstrate the ability of the process to achieve planned results. When planned results are not achieved, correction and corrective action must be taken, as appropriate, to ensure conformity of the product.
  • 8.4 (Analysis of Data) requires the organization to determine, collect, and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement can be made. This must include data generated as a result of monitoring and measurement and other relevant sources. This analysis of data must provide information relating to: a) customer satisfaction, b) conformance to product requirements, c) characteristics and trends of processes and products including preventive action, and d) suppliers.
  • 8.5.1 (Continual Improvement) requires that the organization must continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions, and management review.

Auditing Calibration: What you need to know! (Presentation)

Auditing Calibration: What you need to know

This presentation covers all the key issues about calibration and how to audit a calibration function

It includes:

  • Information about traceability to NIST,
  • The difference between a manufacture”s cert and calibration cert,
  • Calibration records,
  • Frequency of calibration and
  • FAQs about calibration.  (attached)

Emily has a strong background in Metrology and ISO audits. She has specific experience with temperature, pressure, dimensional, humidity and torque calibrations, and has been trained by NIST and NCSL.

Emily currently works for Cavendish Scott, Inc. as a Lead Auditor and manages the Outsourced Internal Audit program. She is also a certified ISO 9001:2008 IRCA Lead Auditor Training classes.

Emily Myers Meet the Speaker Sep-2009

Calibration FAQs 100109

Five Easy Pieces: The Basic Steps to ISO 9000

In the Jack Nicholson film “Five Easy Pieces,” there’s a memorable scene that takes place in a diner. He orders toast, and the waitress answers that they don’t serve toast. His reply: “You make toasted sandwiches, don’t you? Bring me a toasted chicken sandwich. Hold the mayo, hold the tomatoes. And hold the chicken.”

That anecdote says something about keeping it simple and about the human tendency to complicate matters. Likewise, ISO 9000 can be easy, or it can be complicated. Following is a “Five Easy Pieces” approach to understanding and simplifying the process of certification.

Piece One: What are you hungry for?

“Where are you?” and “Where do you want to be?” Realistic answers to those two simple questions will help put you on the right track to successful certification.

First, make a personal visit to every department, and examine the individual operations to determine exactly what each one does. Double-check the standard itself to make sure you are not missing any facet of the business.

As you do this, arrange to get copies of all existing documentation. That means everything, from every department: policies, written procedures, work orders -everything. Categorize these documents by department or function, and index them so that you can find what you need when you need it.

Now that you have the documentation in hand, identify what’s missing. What still needs to be written? What must be rewritten to ensure a consistent style? What must be changed completely in order to comply with the standard?

After it’s clear what remains to be done, you can take the first steps toward ISO 9000. One good way to move the project forward is to have a goal – an actual date by which you hope to be certified – and make a plan for reaching that goal. Set the date, and commit to it. Without an EDC (Estimated Date of Celebration), the project lacks the urgency and importance required to generate support from all levels of staff and management.

Piece Two: Hold the Mayo

The best way to handle this piece of the project is to ignore the standard (initially, anyway) and write documentation that describes the business fully and intelligibly. As for structure, the most logical one is based on company departments, but some multi-department functions or company-wide functions may have to be covered under general procedures.

For each department, write only about the management processes. The procedures should describe what happens and how it happens – not the particular products or services produced by the department or the company.

Your main concern at this stage is the documentation that describes your business – not compliance per se. As you complete the documentation, consider whether you’ve explicitly covered everything in the standard and whether it might be advisable to make minor changes in emphasis.

Documentation gives you a unique opportunity to take a good look at what is being done and what improvements might be made. It’s a rare chance to modify procedures in a seamless fashion, which, according to many who have achieved certification, often results in unexpected improvements in business operations. Do be careful, however, about making major management shifts at this point. Changes like these can confuse the issue and undermine your staff’s commitment to ISO 9000 in general.

Piece Three: Briefings du Jour

Which brings us to a critical issue: awareness. What you don’t want is to have your staff inadvertently and possibly unconsciously sabotaging your certification efforts. You can avoid that possibility by making sure everyone – and we mean everyone – is aware of what is happening at each stage.

Many companies schedule employee meetings to explain what certification is and what it will mean to them. It’s an excellent time to dispel any hearsay rumors, and insecurities that might surface. If you schedule these briefings in a pleasant setting (say, over complimentary coffee and doughnuts first thing in the morning), you’ll find the staff more willing to listen, understand, and support your efforts over the months to come.

You might also consider using posters, flyers, bulletin board reminders, and your company Newsletter to conduct an ongoing public relations campaign to keep the subject fresh in the minds of employees and to maintain positive momentum.

In addition to employee awareness training, there’s also a need for formal training of internal auditors. Often, the most cost-effective and non-disruptive approach is to send one person to an external training program and then have that person train your internal auditors. Just like Pieces One and Two, auditing is yet another opportunity to fine-tune your operations and you should be sure your internal auditors keep that possibility in mind.

Piece Four: Send it Back?

ISO 9000 will help you in many ways: by allowing you to meet customer requests for certified suppliers, to do business internationally, and to maintain a competitive edge. You may find that its greatest benefit, however, is in the way it helps you streamline company operations. To do that, it must produce procedures that work – for every department.

To make sure it does, let the people who will use the documentation evaluate it. Ask them for feedback and expect several revisions. Act as the devil’s advocate. Look for problems, and then look for efficient ways to improve the systems.

Now it’s time to send in the internal auditors – and to give them plenty of support, especially at the beginning. Suggest that they question everything. It’s likely that they’ll suggest further changes to the documentation, which is an extremely healthy process. You can also ask others (your customers, for example) to audit you. You’ll find it helpful, since they have a different agenda and fresh point of view.

After you’ve had at least two internal audits, you should schedule a dummy assessment. Use someone with plenty of experience, such as a consultant, a customer or associate who has already been through the process.

Have them verify that the documentation accurately represents your company and truly covers the ISO 9000 standard. Is it really on the mark – that is, not overly detailed, but comprehensive enough to cover all of the business in light of the standard’s requirements?

Double-check the standard section by section and note, in writing, precisely where in the documentation you’ll find each section addressed. Notes from this exercise will not only help guide the assessor on Assessment Day but also help justify your own interpretation of the standard.

Piece Five: Dinner is Served

You will no doubt choose your Registrar carefully and can therefore expect an experienced professional who will let you know how you’re doing along the way, with no last minute surprises.

Keep in mind that you may disagree with a judgment over minor non-compliance. If you do, you are free to say so. Your only real cause for concern would be a matter of major non-compliance, in which case you may be able to point out that the alleged non-compliance is merely the result of a misunderstanding. Whenever possible, negotiate majors down to minors.

Compliments to the Chef

Now it’s time to honor your employees, who deserve the credit for your earning a distinction that belongs to only a few thousand companies in the United States: certification to ISO 9000. So schedule the party, bring on the champagne – and hold the chicken.

More Questions?

If you’ve any questions about the right approach to implementing ISO 9000 or want some advice about your own program, feel free to call us at 303-480-0111, or fax your questions to us at Denver 303-481-9000 or Boston 781-431-7681.

Alternatively, click on this link to email us your questions: ISO 9000 Expert We’ll be pleased to help you determine the truth about ISO 9000 and, at your request, to provide a free evaluation visit to establish exactly where you stand on the path to ISO 9000.