1. 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

2. 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 defines competence as “demonstrated personal attributes and demonstrated ability to apply knowledge and skills” Note however that the definition in is still being debated 2 2

3. 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 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

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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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, 12 12

13. 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

14. 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

15. 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

16. 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

17. 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

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

19. The only change is to delete reference to ISO 19011.