Presented to <name> By <name> <date> This is a train-the-trainer program developed by Randy Dougherty, one of the co-conveners of WG 21, which was reviewed and includes input by other members of WG21. This presentation addresses the changes related to competence Another presentation addresses the changes related to the audit process This presentation does not address all of requirements in ISO/IEC 17021; just the changes. What is shown in yellow is existing wording from ISO/IEC 17021:2006, with what is shown in white as new wording. 1

ability to apply knowledge and skills to achieve intended results 3 Terms and definitions 3.7 competence ability to apply knowledge and skills to achieve intended results What is different? We eliminated the word ‘demonstrated’. Why? Including the word ‘demonstrated’ turns the statement into a qualification rather than a statement of an inherent characteristic. Logic is from a comment by Sweden that we considered persuasive. Later sections of the standard, requirements sections not the principles or definitions, require that competence be demonstrated. So the concept of demonstrating competence is not lost. ISO 9000:2005 defines competence as the “demonstrated ability to apply knowledge and skills” ISO 19011 defines competence as “demonstrated personal attributes and demonstrated ability to apply knowledge and skills” Note however that the definition in 19011 is still being debated 2 2

3 Terms and definitions 3.10 technical area area characterized by commonalities of processes relevant to a specific type of management system When we wrote ISO/IEC 17021:20XX we intentionally avoided the term ‘scope’ to prevent any misunderstanding with the 39 IAF scopes. The word we agreed upon was ‘technical area’ and as used in 7.1 for competence, a CB “shall determine the competence required for each technical area (as relevant for the specific certification scheme), and for each function in the certification activity”. However, in CBs applying 17021 and ABs assessing CBs this is a point of contention…what is meant by technical area. In writing part 2 we included some notes in section 7 trying to explain how the phrase is used relative to QMS, EMS etc. But later on we decided to try to define it. While there were some comments on the DIS challenging the definition, there were no suggested interventions for improving it. So it stays as is. But I think when read in context, as in some of the notes added to 7.1.2, I think the concept is understandable. 3 3

When we revised the definition of competence, we had to edit this principle which had included the definition from ISO 9000:2000. 4 4

7.1.2 Determination of competence criteria CB shall have a documented process for determining competence criteria Competence criteria shall be determined for Each type of management system standard Each technical area For each function in the certification process This is the first new requirement added to section 7. This is a requirement to determine competence criteria for each function in the certification process. So it is not just for auditors. 5 5

7.1.2 Determination of competence criteria Output shall be documented criteria of required knowledge and skills to achieve intended results Normative annex A specifies types of knowledge a skills a CB shall define for specific functions The output of the process is competence criteria, for auditors but also for other personnel functions involved in certification processes. 6 6

Reviewing audit reports and making certification decisions Certification functions knowledge and skills Conducting the application review to determine audit team competence required, to select the audit team members, and to determine the audit time Reviewing audit reports and making certification decisions Auditors Leading the audit team Knowledge of business management practices X Knowledge of audit principles, practices and techniques X+ Knowledge of specific management system standards/normative documents Knowledge of certification body’s processes Knowledge of client business sector This view shows part of the Normative Annex A. X means the certification body shall define the criteria and depth of knowledge and skills. X+ indicates a need for deeper knowledge and skills. Competence criteria also means determining what is considered to be passing or failing, or said another way, what is satisfactory competence and what is not. However, such a determination is related to the evaluation methods. So the CB will have determine how is will evaluate competence along with the process of determining competence criteria. 7 7

7.1.2 Determination of competence criteria Note elaborates on ‘technical area’ as applied to a QMS Related to processes needed to fulfill customer expectations and regulatory requirements for an organization’s products and services Note the focus on the processes for making the products or delivering the services provided by the organization. 8 8

7.1.2 Determination of competence criteria Note elaborates on ‘technical area’ as applied to an EMS Related to categories of activities, products and services related to environmental aspects affecting air, water, land, natural resources, flora, fauna and humans Note the focus on environmental aspects that result from the processes for making the products or delivering the services provided by the organization. 9 9

7.1.2 Determination of competence criteria Note elaborates on ‘technical area’ as applied to an SCMS Related to processes in the context of security risks of supplies such as transportation, storage and information Note that this is not related to the organization’s products or services. 10 10

7.1.2 Determination of competence criteria Note elaborates on ‘technical area’ as applied to an ISMS Related to categories of information security technologies and practices and selection of adequate security controls that protect information Note that this is not related to the organization’s products or services. 11 11

7.1.3 Evaluation processes CB shall have documented processes for initial competence evaluation and on-going monitoring of competence and performance All personnel-audits and certification Applying the determined competence criteria This is the second new requirement added to section 7, and requires the CB to evaluate its personnel applying the criteria that is the output of the first new requirement, 7.1.2. 12 12

7.1.3 Evaluation processes CB shall demonstrate that its evaluation methods are effective Output shall be to identify personnel who have demonstrated the level of competence required Note: informative Annex B for possible evaluation methods Informative Annex C provides an example of a process flow for determining and maintaining competence using the methods in Annex B An earlier draft required the CB to validate the effectiveness of its evaluation processes. The final wording softens this a bit, but still requires a CB to demonstrate that its evaluation processes are effective. 13 13

Informative Annex B—Possible Evaluation Methods Review of records Feedback Interviews Observations Examinations The informative annex is just that, informative not normative. So a CB may or may not use any of the methods in Annex B. The annex also provides useful information on the strengths and weaknesses of each of the methods. 14 14

7.2.4 CB shall have defined processes for selecting, training, and authorizing auditors and experts initial competence evaluation shall include observing an on-site audit—by a competent evaluator Deleted “applicable personal attributes” Added a note referring to Annex D for desired personal behaviors instead of required personal attributes Changed to eliminate personnel attributes as a requirement consistent with the revised definition of competence Annex D is an informative annex M y personal belief, which is shared by some members of WG21, that CBs will not ignore personal attributes or desired personal behaviors and that these will still remain the major reason for an auditor being fired, as this is a business imperative for any CB 15 15

Informative Annex D—Desired personal behaviors Ethical Open-minded Diplomatic Collaborative Observant Perceptive Versatile These desired personal behaviors will look familiar to most CBs as most of these are what was in ISO 19011:2002 as personal attributes. 16 16

Informative Annex D—Desired personal behaviors Tenacious Decisive Self-reliant Professional Morally courageous Organized WG 21 did identify a few new desired personal behaviors, such as professional, morally courageous, and organized. 17 17

This is one example of where WG21 deleted a reference to ISO 19011 without adding newrequirements. 18 18

The only change is to delete reference to ISO 19011.