| | | | | throughout the organization. Training applies to all |
| The ISO 9001:2000 Standard has been revised | | | | employees directly or indirectly responsible for |
| after eight years. And the buzz is rapidly | | | | delivering a service or producing a product |
| reaching a crescendo. We continue to receive | | | | (everyone that is part of the quality chain). A |
| numerous emails and phone calls regarding the | | | | complete listing of changes can be found in Annex |
| impact of the new release. First, let me dispel | | | | B (Table B.1) of the Standard. Also, note that |
| any anxiety about the November 15, 2008 official | | | | there is better alignment with ISO 14001:2004. |
| “2008” release. There are no new | | | | |
| requirements. The changes are largely | | | | Potential Danger and Hidden Opportunities |
| interpretive, and focus on terminology | | | | |
| clarifications. The changes to the ISO 9001 | | | | The Chinese character for crisis consists of two |
| amendment, however, will have considerable | | | | parts—potential danger and hidden |
| benefit. | | | | opportunities. Clearly, the amended release does |
| | | | | not suggest a crisis, and the hidden opportunities |
| As a back drop, keep in mind that ISO 9001 is | | | | far outnumber any potential danger. So, if you |
| not just an International Standard for a Quality | | | | are anxious—don’t be. That said, perhaps |
| Management System. It is the world’s most | | | | the greatest potential danger is to dismiss this |
| recognized business management standard. And | | | | release, and to rationalize that there is no work to |
| it makes a strong business case. It focuses | | | | be done. |
| attention on leadership, business planning, | | | | |
| organizational business processes, your customers | | | | Even though there are minor changes, hidden |
| (internal and external), measurement and | | | | opportunities abound. This is the ideal time to be |
| reporting, and continual improvement. That | | | | proactive, and to reenergize your quality |
| translates to improved business results and a | | | | (business) management system. Ask yourself: Is |
| sustainable competitive advantage. | | | | your QMS integrated with your organization’s |
| | | | | vision, mission and values? Are your quality |
| Transitioning to ISO 9001:2008 | | | | objectives aligned with your organization’s |
| | | | | business objectives? Have you considered the |
| The International Organization of for | | | | needs of your customers in developing your |
| Standardization and the International Accreditation | | | | objectives? Are you using a balanced scorecard |
| Forum have agreed to a smooth transition. Both | | | | to evaluate performance (key performance |
| standards will remain current for two | | | | indicators)? |
| years—until November 15, 2010. Registration | | | | |
| of conformity to ISO 9001:2008 will be issued | | | | You could drill down further and ask: How are you |
| from November 15 on, and after a routine | | | | measuring “the voice of the customer?” |
| registrar surveillance audit, or a recertification audit | | | | Are your document and record control processes |
| against the new version. Also, as of November | | | | effective? Are your preventive and corrective |
| 15, 2009, all new registrations and recertifications | | | | action processes effective? Do you have an |
| must be to ISO 9001:2008. | | | | effective root cause analysis methodology? Do |
| | | | | you have an effective organization-wide training |
| Two years after publication of ISO 9001:2008 | | | | plan? How do you evaluate the competence of |
| (November 15, 2010), any certifications that are | | | | your employees? Are you measuring the cost |
| still to ISO 9001:2000 will no longer be valid. This | | | | of quality, and driving waste and inefficiency out |
| means that currently certified organizations in | | | | of your business? |
| “surveillance mode” in 2008-2009 have | | | | |
| until November 15, 2010 to be successfully | | | | The Path Forward |
| certified to ISO 9001:2008. We recommend a | | | | |
| proactive approach. If you can win in your | | | | This pragmatic path forward can be used as a |
| marketplace every day—why put it off? | | | | guide to craft a game plan during the transition. |
| | | | | It stresses the basic steps that your organization |
| Overview of the Changes | | | | should consider, regardless of the maturity of |
| | | | | your QMS. |
| The points of clarification focus on outsourcing, | | | | - Obtain a copy of the ISO 9001:2008 Standard. |
| documentation, management representative, | | | | Copies can be purchased from your national |
| employee competence, design verification and | | | | standards body ANSI in the United States at ( |
| validation, process monitoring, control of | | | | the International Organization for Standardization ( |
| nonconforming product and corrective and | | | | or from the American Society for Quality ( |
| preventive action. But bear in mind, no | | | | - Review Annex B, and familiarize yourself with |
| “shalls” (requirements) were added or | | | | the changes to the Standard. This Annex (Table |
| removed. | | | | B.1) identifies the text changes between the 2000 |
| | | | | and 2008 versions. It’s a must read. |
| Examples of select changes include: In an attempt | | | | - Discuss the transition requirements with your |
| to clarify the term “outsourcing,” notes | | | | registrar. Remember you have two years to |
| were added that require the organization to | | | | make the transition. We recommend transitioning |
| identify processes (and the control of these) to | | | | sooner than later. This is no time to |
| be completed by an external party. With | | | | procrastinate. |
| respect to documentation, the changes focus on | | | | - Determine whether the changes impact your |
| improving the compatibility between ISO 9001 and | | | | organization. If nothing else, it will give you and |
| ISO 14001. | | | | your management team a better understanding |
| | | | | of the nuances and underlying reasons for the |
| The only significant addition to the management | | | | change. |
| representative sub clause was to require that the | | | | - Use this opportunity to reenergize your QMS. |
| MR be a member of the organization’s | | | | Remember, “ISO” is a fundamental |
| management team. This means a contracted | | | | business model, and it is the foundation from |
| person could serve in this role as long as he or | | | | which to build a competitive, customer-centric |
| she is also considered part of management. The | | | | enterprise. |
| management representative does not have to be | | | | - Schedule a meeting with your ISO Business |
| full-time. | | | | Partner (consulting firm) to assist you with taking |
| | | | | your QMS to the next level. Along the way, you |
| With regard to competence of employees, a note | | | | should also explore ways to leverage your |
| was added to make training more pervasive | | | | certificate to accelerate growth of sales. |