ISO 9001.

Advancing in matters of continuing global competitiveness and reducing risks, the series of the International Standard ISO 9000 propitiates the fundamentals to progress and become better, better, better. ISO 9001 2008 does not carry any significant change.

Continual improvement is not optional, it is a condition of survival. The specific ISO 9001 Quality Management System Specifications... assist organizations in identifying and managing improvements. ISO 9001:2008 assists in developing, implementing and maintaining systematical methods for acting effectively through tackling problems and improving its products and services, and thus a vehicle for improving competitiveness and reducing risks. 

Leadership is an effective starting point by defining mission (policy), strategy, and key indicators. These are then carried throughout the organization, communicating with everyone on the issues that matter most to sucees through tackling strategic approaches for deploying of metric-indicators through process focus reviewing organizational performance, effective problem solving, internal assessment-auditing, and thus progressing through organizational cultural.

ISO 9001 is more of a challenge to third party assessments than previous versions of the standard. Why is this...? Procedures requiring documentation are less than previous versions; the process approach is not at an easy grasp with many years of element-by-element scholl of auditing, and adding to the challenge a high level of competence for conducting adding-value-assessments.

Latest Issues and developments of interest

• Organizations are OK, the challenge is within the 3rd Party Registrars - Talking with key players within the US TAG 176, Jack West and Jim Bigelow, themselves expressed that the standard will be more difficult for 3rd parties to audit. take 6.5 Work Environment: The organization shall identify and manage the human and physical factors of the work environment needed to achieve conformity of product. So if a company needs a "clean room", it is to be stated some where (documented). A 3rd Party auditor must have some knowledge about the industry to ascertain this aspect.
   
• Since the year 2000 version the term "clearly" is out, while seen in the 2008 version but however it should have never been in the Standard ISO 9001? "and was 7.2.2 Review of customer requirements... to ensure that: (a) customer requirements are clearly defined for product and/or service;" ... and "7.4.2 Purchasing information - Purchasing documents shall contain information clearly describing the product and/or service ordered, including where appropriate: ...".:...". Our collaborative effort has paid in eliminating this subjective term and which has in the 1994 version rise to a level of discomfort between 3rd Party and organizations. This issue is being brought to TC 176 by our Global associates and the change has taken its course.
   
• Clauses of Section 6 (6.1 through 6.4) and 7.1 could bring a handful of reviews for transition/advancement to some organizations.

TC 176 and Accreditation Bodies have concerns relevant to ISO 9001; (1) Are registrars and auditors competitively qualified to assess against the requirements of ISO 9001, and (2) that attention is given to the scope of the Registration issued.

BULLTEK's ISO Kaizen-Blitz^© initiative (mutually inclusive or exclusive to the international management systems serve as guideline).