Audit Trail Index for ISO 9001:2000

 

When developing an audit plan, you may need to look beyond the primary clause for a subject to fully evaluate it. For example, to assess compliance with the requirement for “quality objectives”, you would first look at clause 5.4.1:

 

5.4.1  Planning – Quality Objectives

 

Top management must ensure that quality objectives, including those needed to meet requirements, are established at relevant functions and levels within the organization. The quality objectives must be measurable and consistent with the quality policy.

 

However, there are eight more clauses with requirements for “quality objectives” in the ISO 9001:2000 standard, as shown below:

 

4.2.1 (a) Documentation Requirements – General
The QMS documentation must include documented statements of quality policy and quality objectives.

 

5.1 (c)  Management Commitment
Top management must ensure that quality objectives are established.

 

5.3 (c) Quality Policy
Top management must ensure the quality policy provides a framework for establishing and reviewing quality objectives.

 

5.4.2 (a) Planning – QMS Planning
Top management must ensure the planning of the QMS is carried out in order to meet requirements given in 4.1, as well as, the quality objectives.

 

5.6.1  Management Review – General
Top management must assess the need for changes to quality objectives.

 

6.2.2 (d) Human Resources – Competence, Awareness, and Training
The organization must ensure that its personnel are aware of how they contribute to the achievement of the quality objectives.

 

7.1 (a) Planning of Product Realization
The organization must determine, as appropriate, the quality objectives and requirements for the product.

 

8.5.1 Improvement – Continual Improvement
The organization must continually improve the effectiveness of the QMS through the use of the quality policy, quality objectives, …

 

Clause Index
To help you identify possible audit trails, and to see the linkages, we created a clause index for some key topics in the standard:

 

Approve or Approval: 4.2.3 (a), 4.2.3 (b), 7.3.3, 7.3.7, 7.4.2 (a), 7.5.2 (a), 7.5.2 (b), 8.2.4
Communication: 5.5.1, 5.5.3, 6.3 (d), 7.2.3, 7.3.1, 7.4.2
Corrective Action: 5.6.2 (d), 8.2.3, 8.5.1, 8.5.2
Criteria: 4.1 (c), 7.1 (c), 7.3.3 (c), 7.4.1, 7.5.2 (a), 8.2.2, 8.2.4
Customer Satisfaction: 5.2, 6.1 (b), 8.2.1, 8.4 (a)
Delivery: 7.2.1 (a), 7.3.6, 7.5.1 (f), 7.5.5, 8.2.4, 8.3
Document(s), Documented, or Documentation: 4.1, 4.2.1, 4.2.1 (a,c,d), 4.2.2 (b), 4.2.3, 4.2.3 (a-g), 4.2.4, 7.1 (b), 7.2.2, 8.3, 8.5.2, 8.5.3

 

Evidence: 4.2.4, 5.1, 7.1 (d), 7.6, 8.2.4
Improve or Improvement: 4.1, 4.1 (f), 5.3 (b), 5.5.2 (b), 5.6.1, 5.6.2 (g), 5.6.3 (a,b), 6.1 (a), 8.1, 8.1 (c), 8.4, 8.5.1
Inspection: 7.1, 7.4.3
Preventive Action: 8.4 (c), 8.5.1, 8.5.3
Procedure(s): 4.2.1 (c), 4.2.2 (b), 4.2.3, 4.2.4, 7.4.2 (a), 7.5.2 (c), 8.2.2, 8.3, 8.5.2, 8.5.3
Process(es): 4.1 (a-f), 4.2.1 (d), 4.2.2 (c), 5.5.2 (a), 5.5.3, 5.6.2 (c), 5.6.3 (a), 6.3 (b), 7.1 (b,d), 7.4.2 (a), 7.5.2, 7.5.2 (a), 7.5.5, 7.6, 8.1, 8.2.2, 8.2.3, 8.2.4, 8.4 (c)

 

Record or Records: 4.2.1 (e), 4.2.3, 4.2.4, 5.6.1, 6.2.2 (e), 7.1 (d), 7.2.2, 7.2.3, 7.3.4, 7.3.5, 7.3.6, 7.3.7, 7.4.1, 7.5.2 (d), 7.5.3, 7.5.4, 7.6, 7.6 (a), 8.2.2, 8.2.4, 8.3, 8.5.2 (e), 8.5.3 (d)

 

Release: 7.3.3, 7.4.3, 7.5.1 (f), 8.2.4, 8.3 (b)
Resource(s): 4.1 (d), 5.1 (e), 5.6.3 (c), 6.1, 7.1 (b)
Responsible or Responsibilities: 5.5.1, 5.5.2, 7.3.1 (c), 8.2.2, 8.3
Review, Reviews, or Reviewing: 4.2.3 (b), 5.1 (b), 5.3 (c,e), 5.6.1, 5.6.2, 5.6.2 (e), 5.6.3, 7.2.2, 7.3.1 (b), 7.3.2, 7.3.4, 7.3.7, 7.5.2 (a), 8.5.1, 8.5.2 (a,f), 8.5.3 (e)

 

Verify or Verification: 7.1 (c), 7.1 (c), 7.3.1 (c), 7.3.3, 7.3.5, 7.4.3, 7.6, 7.6 (a), 8.2.2, 8.2.4, 8.3
Quality Policy: 4.2.1, 5.1 (b), 5.3, 5.4.1, 5.6.1, 8.5.1

 

This index does not include any references contained in notes or clause titles.