Agenda Why this group exists Who is behind it State of the ISO 9000 Certification Industry and lessons learned from the Transition “New” ISO Documents Official ISO/TC-176 interpretations Not so official guidance documents The ELSMAR Forum Free for all

Why this group exists? To spread knowledge on Management System Standards, in So Cal. Remember, So-Cal is a POWERHOUSE. We are the strongest economic area of the 5th largest Economy in the World.

Who is behind it? Me and You

The current state of affairs Generally speaking the ISO 9000 Certification Sector is still strong Reduced rate of new Registrations High % of organizations MADE the transition; ≥ 90% Market is very fragmented and diverse for both Consulting and Certification Accreditation Bodies also under pressure and promise tougher policing

Lessons from the transition Most misunderstood and ineffectively implemented sections are: 4.1 Outsourced processes 5.4.1 Quality objectives for all relevant functions and levels 8.2.3 Monitoring and measurement of processes

“New” ISO Documents

Official ISO TC 176 interpretations

Official ISO TC 176 interpretations

RFI’s

RFI’s

RFI’s

RFI’s

RFI’s

RFI’s

RFI’s

RFI’s

RFI’s

RFI’s

RFI’s

RFI’s

RFI’s

RFI’s

Not so official Guidance

Not so official Guidance The need for a 2-stage approach to auditing Measuring QMS effectiveness and improvements Identification of processes Understanding the process approach Determination of the “where appropriate” Auditing the “where appropriate” requirements Demonstrating conformity to the standard Linking an audit of a particular task, activity or process to the overall system      

Not so official Guidance Auditing continual improvement Auditing a QMS which has minimum documentation How to audit top management processes The role and value of the audit checklist  Scope of ISO 9001:2000, Scope of Quality Management System and Defining Scope of Certification Value-added auditing Auditing competence and the effectiveness of actions taken

The need for a 2-stage approach to auditing Activities performed at a preliminary 1st stage audit include: Identification of the key risks of the business and related statutory, regulatory aspects and compliance An assessment of whether the auditee's defined processes are adequate to meet its objectives and customer requirements Conducting a Documentation Review Drafting the future certification documentation, including the Scope statement Planning the certification (stage 2) audit, including the requirements for audit team selection

The need for a 2-stage approach to auditing Obtaining evidence that internal audits and management reviews are being planned, or performed, effectively Checking that the QMS is implemented and ready for the stage 2 audit, including appropriate level of documents and supporting records. If the system is lacking in any way, the auditor should note this in the audit report, so that the organisation has an opportunity to rectify deficiencies prior to its certification (2nd stage) audit. Agreeing a date for the stage 2 audit

Value Added Audits A “value-added third-party audit” should be useful: to the certified organization by providing information to top management regarding the organization’s ability to meet strategic objectives by identifying problems which, if resolved, will enhance the organization’s performance. by identifying improvement opportunities and possible areas of risk to the organization’s customers by enhancing the organization’s ability to provide conforming product to the certification body, by improving the credibility of the third party certification process.

Value Added Audits Understand the auditee’s expectations/corporate culture Any specific concerns to be addressed (output from previous audits)? Risk analysis of industry sector / specific to organization. Pre-evaluation of statutory/regulatory requirements Appropriate audit team selection to achieve audit objectives Adequate time allocation

Value Added Audits

Use of checklists Conclusion There are advantages and disadvantages in using audit checklists. It depends on many factors, including customer needs, time and cost restraints, auditor experience and sector scheme requirements. Auditors should assess the value of the checklist as an aid in audit process and consider its use as a functional tool.

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