ISO 9001:2008 Update

The 2008 version of the ISO 9001 standard has been released. The changes from the 2000 to 2008 version are primarily clarifications to the standard. ISO 9001:2008 does not contain any new requirements. Even though the differences between the 2000 and 2008 version of the standard are relatively small, they still need to be taken into account. These important changes and clarifications have improved the standard, and they will be beneficial to your QMS.

SRI recommends our clients take the following steps:

1. Purchase a copy of the ISO 9001:2008 standard and read it thoroughly
2. Review Annex B and become familiar with the specific changes
3. Analyze whether the changes affect your organization. Attend training if needed
4. Develop an implementation plan for the changes
5. Discuss transition requirements with SRI to build into your audit timing and planning
6. Revise and improve your QMS with any needed internal audits and management reviews

In conjunction with the November 15, 2008 release of the revised Standard, the International Organization for Standardization (ISO) has set November 14, 2010, as the expiration date for all current registrations to ISO 9001:2000 (two years from the publication date of ISO 9001:2008). You may purchase a copy of the revised standard at www.ansi.org.

In order to maintain a valid ISO 9001 registration, SRI will need to conduct a registration, renewal, or surveillance audit of your quality management system under the 2008 version requirements. All registration and renewal audits after November 14, 2009 are required to be under ISO 9001:2008. Clients may also choose an ISO 9001:2008 Transition Surveillance to the new standard any time prior to the November 14, 2010 expiration date.

The most economical approach will be to review the new standard and plan a timely implementation of the changes. Your target should be a time-line that results in SRI conducting the transition audit in place of a regularly scheduled on-site audit visit in the next 18 months. Transition to the new standard at registration or renewal will not incur additional fees. SRI recommends that all upcoming registration audits be to the ISO 9001:2008 standard.

Contact SRI to plan your transition to the new standard. All of SRI's ISO 9001 qualified auditors have been trained to the new standard and are ready to help. If you need training, our training organization has courses scheduled now. The SRI team is ready to help!

SRI Quality System Registrar
300 Northpointe Circle
Suite 304
Seven Fields, PA 16046
(724) 934-9000
info@sriregistrar.com


ISO 9001:2008 Quality Management System Standard

ISO 9001:2008 is an internationally accepted set of quality management system requirements that can be applied to any service or manufacturing organization, providing proven, successful approaches to achieving customer, society, and management quality goals. ISO certification is the foundation for the development of your quality system; it enables process improvement and boosts the effectiveness and efficiency of your system.

Registration is typically a service provided by an independent third-party registrar (certification body), which is capable and qualified to assess whether an organization has successfully and effectively adopted and implemented a set of requirements. The steps to certification generally involve a quality manual review, an on-site pre-assessment or readiness review, and an on-site registration assessment, which will confirm that the documented system meets the specifications of the standard.

Hundreds of Thousands Have Chosen ISO 9001

There are over a half million organizations worldwide that have adopted and implemented ISO 9001. Organizations implementing ISO 9001 report improved profit, lower employee turnover, better than national performance average on benchmark indicators, and improved effectiveness and efficiency.

Continual Improvement: A Quality Paradigm

The desire for continued improvement in the quality systems of organizations has been well documented. Organizations must determine what is the most beneficial, proven, and cost-effective approach. Just as important is the practice of aligning quality management systems with business goals. Such goals and objectives likely include:

• Reduced variation in work practices
• Clear standardized work instructions
• Enhanced intra- and interdepartmental communications
• Practical metrics that reflect progress
• Reduced operating costs
• Error prevention
• Reduced liability exposure and cost
• Top management commitment and support

What is the Process Approach?

ISO 9001:2008 is based on the “process approach” i.e., a chain of added value activities delivering a product or service to a customer (internal or external) of the process. A process focused approach includes:

• Understanding and meeting customer requirements
• Attention to customer satisfaction
• Continual improvement
• Application of the “Plan-Do-Check-Act ” (PDCA) or equivalent cycle
• Managing interrelated processes
• Links between quality and business plans and objectives
• Defining and using process metrics

Every business operates via processes. ISO 9001:2008 can be applied to any organization’s quality management system.

Third Party Certification – Letting Everyone Know You are Committed

Achieving registration provides a tangible goal and a publicly recognized and listed attribute of your organization. In many cases, it validates your conformance to a mandated requirement. An ISO 9001 certificate has become a requirement to many large purchasers, including the military, government, auto industry, electronics industry, and aerospace organizations.

Benefits of ISO 9001 Registration

Implementing a quality management system registered to ISO 9001:2008 can lead to benefits such as:

• A demonstrated commitment to customers and stakeholders of strengthening “organizational capability”
• Improved processes that result in reduction of errors and risk of rework
• Increased customer satisfaction
• An enhanced image of the organization through proactive quality focused leadership
• A recognized responsibility for, and involvement with, quality by the entire organization
• Better defined processes and sub-processes, including their critical links
• Recognition of deterrents to an operation’s or service’s efficiency and effectiveness
• Identified opportunities for improvement
• A strengthened commitment toward the organization’s satisfaction of regulatory requirements
• Improved communications among employees

It may not be readily apparent, but quality management systems registered to ISO 9001:2008 can also be applied to address items such as: customer concerns, administration issues, equipment up/downtime, and process efficiencies.

Choosing a Registrar: Why SRI?

The auditing staff at SRI is uniquely qualified to be a value-added part of your journey to develop your quality system. The process of third party assessment helps you implement effective systems to improve overall performance.

To each audit, SRI brings industry experience, value-added contributions, and people that have a practical understanding of your organization. The result: effectiveness, efficiency, satisfaction, and a valuable relationship you can rely on to achieve your success.

SRI Brings Its Own Unique Combination of Successful Assessment Practices

• Fully accredited – SRI has conducted ISO 9001 assessments in North America, Europe, and Asia since 1990, and is one of the top five USA-based, owned, and operated registrars
• Involved - a member of TC176 team that creates and adopts new ISO standards
• Committed - SRI qualifies assessors, sponsors, speakers, and local seminars
• Electronic methodology – uses SRI’s exclusive e-VENTS online site for clients and assessors to access their schedules, audit results, reports, and status of any event
• “No surprises” - is our approach to auditing: day-ending caucuses, an open-book relationship to the registration process, optimizing communication and success
• OFI - SRI auditors provide value-added OFIs, “Opportunities For Improvement” comments based on their expertise and your business processes (never compromising other company's intellectual property or competitive advantage)
• Training - SRI has conducted public training since 1990 on documentation, interpretation, implementation, and internal auditing for all the management, quality, safety, and environmental standards to which SRI certifies

ISO 9001:2000 Training

Understand how the ISO 9001:2008 Standard relates to your organization, to all employees beginning at the very top, and to your QMS. SRI Quality System Registrar offers public training to help you and your organization understand the language of ISO 9001.

SRI trainers are experienced, practicing Lead Assessors, who have conducted hundreds of audits and who understand the standard inside and out. We have been providing this very same benefit to other organizations for nearly 14 years. We translate the standard into terms and examples with which you are familiar. Training provides the tie that binds all levels of your staff into the cohesive, effective, and efficient quality-focused organization you desire.

Please visit SRI’s training web site for additional information regarding course descriptions, schedules, locations, and training registration forms.