General

Eliminate the need for Introduction and Support Package documents identified in Annex A by clarifying related requirements.

General

1. Review terminology to consider potential clarification or translation issues.
2. Determine if liaison with TC176/SC1 is necessary to address the following.

4.2 documentation
6.4 work environment
7.3 review, verification, validation
7.5 product and service provision
7.5.1.f post delivery activities
7.6 calibration
7.6 monitoring and measuring device
Relationship of 8.3 nonconforming product and 8.5.2.a nonconformities
Methods used throughout the document

General

Clarify activities related to various clauses and sub-clauses of the standard that are carried out simultaneously.

General

1. Clarify whether documents (procedures, quality manual) required by the standard can be combined;
2. Clarify the different styles for identifying required documented procedures (e.g. 8.5.2 and 4.2.3).

1.1

Clarify the scope of application in relation to the intended product.

1.2

Clarify the intent of this clause in relation to when exclusions can be made in clause 7 specifically for service organizations (e.g. 7.5.5 and 7.6)

4.1

Clarify the requirement for “control required of outsourced processes.”

4.2.3.a
4.2.3.b

Clarify the meaning of “review”, including the difference between “review” and the “need for review.”

4.2.3.c
4.2.3.e
4.2.3.f
4.2.3.g

Clarify the requirement by reviewing potential conflicts with “identification,” “identified,” and “identifiable.”

4.2.4
General

Clarify the need for records by the identification of required records with the (see 4.2.4) notation and the statement in 4.2.4 that states you must have evidence of conformity to requirements.

5

Consider clarification of application of the process approach to top management activities

5.4.2

Consider the clarification of QMS planning in order to meet the Quality Objectives (5.4.1)

5.5.2

Clarify the requirement for “appoint a member of management…..”

5.6.2

Clarify that inputs to the management review are not limited to the ones listed in this clause,

6.2.1

Clarify the requirement that reads ¨personnel performing work affecting product quality.”

6.2.2c

Clarify the requirement for “the effectiveness of the actions taken.”

6.4

Clarify work environment in relation to the achievement of conformity to product requirements.

7

Clarify the relationship of clause 7 to clause 8.

7.2.1

Clarify statutory and regulatory requirements.

7.2.1.c

Clarify the requirement “requirements related to the product.”

7.2.1.d

Clarify the requirement “any additional requirements determined by the organization.”

7.2.3

Clarify the requirement for “effective arrangements” in the first sentence.

7.3

1. Clarify requirements for service oriented organizations
2. Clarify the relationship of the requirements for 7.3.4, 7.3.5, and 7.3.6.

7.4.1

Clarify the requirement for evaluation of supplier and associated records (e.g. small business).

7.5.2

Clarify the intent of the first paragraph for when this clause should be applied, including relation with special processes of ISO9001:1994.

7.5.4

1. Clarify the difference between protect and safeguard.
2. Clarify what is intellectual property.

7.5.5

Clarify application of this requirement for all product types.

7.6

1. Clarify the proper clause placemen for the first and second sentences of this clause.
2. Clarify the requirement for “when used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed.”

7.6.a

Clarify the requirement in the third paragraph that uses the word “or.”

8.2.1

1. Clarify the requirement for  customer perception in relation to monitoring versus measurement.
2. Clarify the requirement for “methods shall be determined”

8.2.2 Note

Revise from 10011 to 19011

8.2.3

1. Clarify that clause 8.2.3 focuses on processes.
2. Clarify the relationship of this clause with 8.2.4
3. Clarify the relationship between QMS processes and product (last sentence).

8.2.4

Clarify the requirement for “the release of product.”

8.3

Clarify this clause in relation to service organizations.

8.4

Review for redundancy and/or links to other clauses for possible conflicts.

8.5

1. Clarify the relationship between 8,5.1, 8.5.2, and 8.5.3
2. Clarify the differences in concepts between corrective action and preventive action

8.5.1

Clarify the requirement for product improvement in relation to continual improvement and clause 5.6.3.b.

8.5.2.f

Clarify review.

8.5.3

Clarify this clause in relation to service organizations.