Articles

Spring Cleaning with ISO 9001:2008

By Tim Woodcome

With the ISO 9001: 2008 revision out on the streets and working its way into QMS's over the past few months many organizations have found the review of their QMS valuable, not only in light of the updates, but as a chance to do a little 'spring cleaning' throughout their system.

Several NQA tools were released late last year for an organization's use when preparing for the implementation of the new standard. In particular, the NQA Change Checklist is useful in identifying the deltas from the 2000 to 2008 revisions of the standard, along with interpretation commentary from NQA. Additionally, the NQA Transition Tracker highlights the items the NQA auditors will be looking to review during implementation audits.

Both of these tools form part of the overall 'formula' for a successful implementation. In short, NQA recommends organizations do the following to prepare for their upcoming ISO 9001: 2008 implementation audit:

• Get a copy of the new ISO 9001: 2008 standard. It is available in hardcopy or electronic versions from either ASQ (www.asq.org) or the International Organization of Standardization (www.iso.org).
• Review the standard for its changes. Utilize the NQA tools or the Annex B of the standard itself to help identify areas of change.
• Update areas of the organization's QMS as needed. This will be the output of the above process, and largely dependent upon the organization's initial interpretations and implementation strategies.
• Document the review and analysis made, including any changes. This will create records of your QMS evolution and also facilitate the implementation audits.

Simply (if not poetically) put, you can remember this process as G.R.U.D.…Get, Review, Update, Document.

In a nutshell, that is all the NQA auditors will be looking for. Their implementation audit will drill down into whatever areas are appropriate, but the implementation begins with the organization's own review and analysis.

A few helpful hints can also be provided for organizations through this transition time:

• Do get a copy of the standard… even though the changes are not earth-shattering, there are changes you need to be aware of, and more so, 4.2.3 of the standard requires that certified organizations control documents of external origin determined by the organization to be necessary for the QMS, and ensure that relevant versions of applicable documents are available. Certainly the current ISO standard to which you wish to be certified to would qualify as such a document.
• Give the review the new standard the appropriate time and attention. The most direct manner would be via Management Review: 5.6.2 (f) requires organizations to review with top management any changes that could affect the quality management system. We can't think of many better examples of a change that could affect the QMS...
• It would be acceptable to hold a 'special' Management Review meeting to focus on the review of the ISO 9001:2008 changes if your regularly scheduled meeting recently occurred, or there was not time in the regular agenda to cover this topic.
• When reviewing and analyzing the changes, record those actions as part of your process (be in via Management Review, Internal Audits, or otherwise). Additionally utilize action items to track any follow-up needs.
• Some organizations may find several areas they may need to update, some organizations may find few or none at all; it will be very much an individual analysis on a case-by-case basis.
• Use this review as an opportunity to get re-acquainted with your QMS. Certainly in respect to the areas of change, but even beyond that scope… Are there processes that have changed recently? Responsibilities that have been re-defined? Areas that might be leaned down? Is it effective in facilitating delivery of a good product and service?
• One obvious change that may be needed is an administrative one: does your QMS reference ISO 9001:2000 throughout? At a minimum those references will need to be updated. You may consider updating simply to "ISO 9001" or indicating that current version of the standard is thereby implied.
• Do not necessarily feel the need to re-train or re-audit your entire QMS based on the ISO 9001:2008 revision. These decisions again will be unique to each organization based on the changes they find necessary to make. All future ISO training and internal audits should be conducted to the new standard on an on-going basis.
• And lastly, communicate with NQA throughout the process. NQA CSR's and Auditors have all been trained on the ISO 9001:2008 implementation process. Your auditor will be planning to audit to the new standard with his/her next visit most likely. Be sure to communicate with them about the audit plan and your 2008-readiness prior to their arrival on-site.

NQA's goal is to assist all clients through this transition process. Transition of certificates will be made as part of an organization's regularly scheduled next audit. No additional time will be required, but the auditor will include some portion of their audit time to review the changes analyzed and/or made by the organization. This review will be in addition to other time spent on the regularly scheduled audit plan.

We are expecting that most clients will be able to implement the ISO 9001:2008 standard in the year 2009. As of March 2009, only a few months after its release, NQA has already issued nearly 200 certificates to the new ISO 9001:2008 standard in North America alone.

One last note should be made in regard to other QMS standards which use ISO 9001 as a base-line. Many of these are also going through a transition process in 2009. Each NQA Business Unit will be communicating on the specifics in the coming months, but here's a quick preview of the timelines we are presently hearing:

• AS 9100 Rev C Standard released; Audits to commence Q1 2010
• ISO 13485 No changes to the standard pending
• TL 9000 R5.0 Standard in Q4 2009; Audits in Q1 2010
• TS 16949: 2009 Standard in Q3 2009; Audits in Q3 2009