Monday, October 25, 2010

ISO 9001:2008 Documents Compared Against ISO 9001:1994

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.

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.


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Sunday, October 24, 2010

Your ISO 9001 Registration Audit - My "Top 5" Tips

I can't discuss the entire technical content of an ISO registration audit in the space provided, but I can give a few pointers regarding issues I know to be significant to the audit's success. While this particular piece is geared towards an organization that is undergoing an ISO registration audit, bear in mind that these same points can apply to any type of assessment (customer, third-party, regulatory, etc.) of your organization.

As I think about it, I can actually list more than 5 points, but as this since the scope of this article is my "Top 5 Tips", we'll start with those. My Top 5 Tips are listed below, in no particular order (each item is significant):

1. Stay Current - In too many organizations, there's a natural reaction to "get busy" and play catch-up with the quality program immediately prior to the audit. Most auditors are aware that this occurs, and this fact is usually very noticeable within the program records. A good program will be current at all times, to a point where even an unannounced audit could be managed with a minimum of issues. Don't wait until the last minute to prepare.

2. Presentation is everything - When the audit day arrives, your files should be neat and orderly. In this case, this should include typed documents as opposed to handwritten documents, to the maximum extent possible (this even includes tabs on folders) - anything that could be typed should. Continuing with this line of thought, once this information is prepared, it should be assembled in a presentable format. I always provide, without exception, a reference binder or binders to the auditor at the start of the audit. Provide the auditor with will well organized material and data before they get a chance to ask.

3. Accommodate the Audit - This can be an issue, particularly if your company has experienced a growth spurt in the recent past. I can think of at least a half-dozen cases I've seen personally, where an auditor has been forced to work out in the lobby of the organization he was auditing. Even worse, I think I've actually lost count of the number of times that I've seen an auditor forced to work off a corner of someone's already occupied desk. Both of these scenarios are unacceptable - remember that an uncomfortable auditor can become an unhappy auditor, and this unhappiness may find its way into your final audit report. Also provide beverages and, as appropriate, snacks; order-in lunch if time is a constraint. Make the auditor as comfortable as possible.

4. Show Management Commitment - Everyone realizes that, in most organizations, the president or CEO doesn't participate in the day-to-day activities related to maintaining the quality program. This is acceptable, as it's generally acknowledged that they do have a business to run. Top management of the company does ultimately own this program however, and if management doesn't show interest in the registration audit process, a lack of management commitment could be perceived. I recommend the participation of at least one senior company manager or the opening meeting for the audit, and also for the review of audit results during the audit closing meeting. Management needs to participate to show their commitment to the program.

5. Don't Argue with the Auditor - As part of this audit, the auditor is required to give their professional opinion on the effectiveness of your quality program. I definitely encourage discussion with an auditor, but there comes a point where discussion becomes a heated debate, or worse, a full-blown argument. If you and the auditor can't reach agreement on an issue, you can't reach agreement on an issue; state clearly, once and one time only, that you disagree with the finding, and then move on. You will have an opportunity to dispute the issue once the final report is issued, and you should do so by providing objective evidence, references, position papers, etc. Let the auditor document his finding(s), and save your response until the final report is issued.

As for my "Top 5 Tips", this pretty much covers it. Regardless of the else, I always pay attention to each of these areas, and time and time again, they've helped to ensure a successful audit. If you're looking to get ISO certified in the future, I encourage you to consider these areas as well and I wish you the best of luck.


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Saturday, October 23, 2010

ISO 9001 Lead Auditor Training Course - FAQ

The ISO 9001:2008 Lead Auditor Training course is a intensive and formal course provided by accredited Registrars and training organizations. It teaches course participants to perform ISO 9001 quality management system audits from different perspectives and how to build an effective Quality Management System.

Who Should Take This Course?

- Those that want to pursue a career as a professional third party auditor, conducting certification audits for Registrars or Certification Bodies.
- Consultants that want to hone their knowledge and improve the quality of their services
- Quality Management and Auditing personnel of larger organizations that perform internal and supplier audits.
- Other professionals in related fields wishing to diversify their credentials.

What You Should Find Out Before Taking This Course?

- Check whether the course is accredited by RAB/QSA, UKAS or similarly recognized accreditation body.
- Check whether the course provider is accredited by these same bodies.
- Find out the location, schedule and cost of the course
- Ask if they provide any special discounts for - groups, handicaps, on-site, or other. If the course is provided by your registrar, you may be able to negotiate a better price.
- Check if they have any special arrangements for travel and accommodations.
- Ask for a course syllabus or outline.
- Check whether you are expected to reside at the venue where the course is held if you are from out of town.
- Ask about their cancellation policy and course attendance requirements

What Background Should You Have To Take This Course?

- You should have a good understanding of the ISO 9001:2008 standard, even though it is covered in-depth in the course.
- You should have some prior exposure to auditing.
- You should have some experience in a managerial or supervisory role in an organization
- You should have at least a high school certificate and preferably a degree.

What Is The Typical Course Structure And Format?

- The ISO 9000 Lead Auditor training has 40 hours of in-class time spread over 5 days. This is not counting time you spend after class reviewing each days material.
- Roughly half that time is devoted to theory covering the ISO 9001 standard and auditing concepts, principles and practice as per the ISO 19011:2002 Auditing Guidelines for quality and environmental management systems.
- The remaining time is directed towards in-class case studies, audit role-playing, team exercises, practice exams and open discussions.
- The course typically ends with a two hour written exam covering a variety of questions from multiple choice, true/false, short and long essay and case situations.

How Will Course Participants Be Evaluated?

Most course providers will use some combination of the following evaluation techniques:

- Daily and continual assessment of student participation, interaction, leadership and time-management skills.
- Daily exercises and quizzes - audit role playing; interviewing; situation handling; etc.
- Presentation exercises - oral and written
- Opening and Closing meeting role play exercises
- Case study Audit Report
- Written examination

What Can One Expect To Learn From The ISO 9001:2008 Lead Auditor Training Course?

- Understand the concepts, principles, terminology and benefits of a Quality Management System based on ISO 9001:2008 Standard.
- Understand the requirements of the ISO 9001:2008 Standard and how to implement and audit a Quality Management System.
- Understand the purpose, content, and interrelationships of related standards such as ISO 9000, ISO 9001, ISO 9004, and ISO 19011.
- Learn the knowledge and skills required to manage and conduct internal, second-party (Supplier/Vendor) and third-party Quality Management System audits.
- Be able to facilitate and manage quality audits performed by Accredited Certification Bodies or Registrars.

Does Taking And Passing This Course Make Me An ISO 9001:2008 Lead Auditor?

Taking and passing this course (both exam and other evaluation requirements) is just the first step. Other requirements to become a formally recognized Lead Auditor includes applying to an Auditor Certification Body like RAB/QSA or IRCA for Lead Auditor certification and meeting their specific requirements for:

- Education - minimum requirement is a high school certificate. The higher your education, the less will be required of you for the other requirements
- Work experience - four or more years of work experience.
- Quality experience - at least two years of your work experience should be quality related.
- Auditing experience - perform sufficient first, second or third part audits to meet their requirements.
- Managing audits - Manage (lead) sufficient number of the above audits to meet their requirements.
- Maintenance of proficiency - Once you satisfy the above requirements and submit your application and appropriate fees, you will then get your formal card as a Lead Auditor. After that you must continue to "professionally develop" yourself to some combination of the above requirements, again based on the requirements established by body that certified you (RAB/QSA or IRCA).


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Tuesday, October 19, 2010

how to answer iso 9001 audit questions

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Monday, October 18, 2010

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Sunday, October 17, 2010

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Saturday, October 16, 2010

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Friday, October 15, 2010

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