New ISO Website for ISO 9001:2000 Interpretations

ISO Technical Committee 176 has established a new website for ISO 9001:2000 interpretations at<http://www.tc176.org/Interpre.asp>. The initial set of 14 interpretations are shown below. You can submit a request for interpretation at the same site.

ISO 9001:2000 Interpretation RFI – 029
Request: ISO 9001:2000 Clause: 4.1 a)
Does the _expression “needed for the QMS” in Clause 4.1 a) require the organization to identify the QMS processes related to product realization only?
Interpretation: No
Rationale: The processes needed for the QMS include those related to product realization as well as the other processes related to the implementation of the QMS, as per the NOTE in clause 4.1.

ISO 9001:2000 Interpretation RFI – 037
Request: ISO 9001:2000 Clause: 4.2.1
Clause 4.2.1 states that the organization’s quality management system documentation shall include “a quality manual” (item b) and “documented procedures required by this International Standard” (item c). Is it in compliance with the standard to include the “documented procedures required by the standard” in the quality manual instead of having two separate sets of documents?
Background: Some advisors recommend that organizations which are implementing their quality management system develop one manual, in addition to all the six documented procedures, because of clause 4.2.1. Yet clause 4.2.2 says: “The organization shall establish and maintain a quality manual that INCLUDES:
b) documented procedures established for the quality management system or reference to them
Interpretation: Yes

ISO 9001:2000 Interpretation RFI – 030
Request: ISO 9001:2000 Clause: 4.2.3 a)
Does sub-clause 4.2.3 a) require that documents required for the QMS be reviewed as well as approved prior to issue?
Interpretation: No
Rationale: Clause 4.2.3 a) is applicable to new documents which are being developed. Some degree of checking, examination or assessment by the person or persons approving is inherent in “approval for adequacy”. There is no requirement for an additional “review” (as defined in ISO 9000:2000 clause 3.8.7).

ISO 9001:2000 Interpretation RFI – 035
Request: ISO 9001:2000 Clause: 5.4.1
Does Clause 5.4.1 of ISO 9001:2000 consider quality objectives defined by “YES/NO” criteria to be measurable?
Background: Several companies that we audit have established some (but not all) of their quality objectives based on “YES/NO” criteria. Example “Achieve product certification for “xxxxxxx” product by November 2002”; or “Develop a new product to meet the requirements of the “YYYYY” market by March 2003”. In order to provide a consistent and technically accurate audit, we would like to know if these are considered to be “measurable objectives”.
Interpretation: Yes

ISO 9001:2000 Interpretation RFI – 027
Request: ISO 9001:2000 Clause: 5.5.2
In our organization we have a management representative appointed by top management, who works for the company in a managerial capacity. He is not a permanent member of staff, but works full-time on a contract basis. Is it allowable under the standard, for such a person to act as the organization’s management representative?
Interpretation: Yes

ISO 9001:2000 Interpretation RFI – 025
Request
: ISO 9001:2000 Clause: 5.6.3 b)
Outputs from the management review shall include decisions and actions on the “improvement of product related to customer requirements”. If an improvement consists in the realization of a new product, does it respond to this specific requirement?
Background: This clause is the only place where the improvement deals with the “product”. In all other places the improvement concerns the “effectiveness of the QMS”. But it’s not clear if the sentence “improvement of product related to customer requirements intends to limit the improvement only to the products where the requirements have been already established (e.g. contractually). A clarification on this point will help users and auditors in understanding the extent of application of this requirement.
Interpretation: Yes
Rationale: The realization of a new product to improve an old one could be one of the results of the management review (Clause 5.6.3 b).

ISO 9001:2000 Interpretation RFI – 020
Request
: ISO 9001:2000 Clause: 7.2.1 
In some countries, in order to perform professional work, a law requires that a professional be a member of the appropriate Order and that the Order prescribes its own rules. Some of the rules have an impact on the product. Are these rules of the professional Order to be considered requirements related to the product?
Interpretation: Yes

ISO 9001:2000 Interpretation RFI – 031
Request
: ISO 9001:2000 Clause: 7.3.1 b)
Does Clause 7.3.1 b) allow the organization to decide on the need, appropriateness, and extent of the review, verification and validation to be carried out at each design and development stage?
Interpretation: Yes
Rationale: Review, verification, and validation at each stage of design and development shall be determined by the organization according to 7.3.1.b and shall be performed according to 7.3.4, 7.3.5, and 7.3.6.

ISO 9001:2000 Interpretation RFI – 023
Request
: ISO 9001:2000 Clause: 7.5.2
Does the process of an organization, whose results can be verified by means of monitoring or measurement after their realization and prior to delivery to the customer, need to be validated in order to comply with the requirements of clause 7.5.2?
Background: The organization provides transportation of orders (goods, etc.) involving collection and dispatching services that can be monitored during their respective execution.
Interpretation: No

ISO 9001:2000 Interpretation RFI – 032
Request
: ISO 9001:2000 Clause: 7.5.2
Does Clause 7.5.2, Validation of processes for production and service provision, require the validation of the equipment, locations, and people involved?
Background: The original query implied that the question arose in relation to a hospital.
Interpretation: No
Rationale: Clause 7.5.2 does not say what shall be excluded from or included in validation of the process. It is up to the organization to determine which of the arrangements from a) to e) are applicable (refer also to 7.1).

ISO 9001:2000 Interpretation RFI – 033
Request
: ISO 9001:2000 Clause: 7.5.2
Does Clause 7.5.2, Validation of processes for production and service provision, require that any applicable statutory and regulatory requirements must be taken into account?
Background: The original query implied that the question arose in relation to a hospital.
Interpretation: Yes
Rationale: Clause 7.5.2 makes no reference to statutory and regulatory requirements. However, these statutory and regulatory requirements are general and must be taken into account wherever applicable to the intended product (see the Note in Clause 1.1).

ISO 9001:2000 Interpretation RFI – 028
Request
: ISO 9001:2000 Clause: 7.6
Is it correct that Clause 7.6 requires only the measuring and monitoring devices utilized by persons responsible for release of the product to be calibrated or verified?
Background: The Client understands that all of the workers need to have all measuring devices calibrated or verified. The contract just requires compliance with ISO 9001:2000 in this case.
Interpretation: NO
Rationale: Clause 7.6 requires calibration or verification of measuring equipment “where necessary to ensure valid results”. It could be more than measuring equipment for product release only (i.e., verification of purchased products, in process inspection, etc.) but does not necessarily mean all measuring equipment. When the organization determines the monitoring and measuring required (as defined, e.g., in clauses 4.1 a); 4.1 e); 7.1 c) and the first paragraph of 7.6), it shall decide which of them require calibration or verification of the measuring equipment because of the requirement of “valid results”.

ISO 9001:2000 Interpretation RFI – 036
Request
: ISO 9001:2000 Clause: 8.2.2 
In clause 8.2.2 it is stated that: “An audit program shall be planned, taking into consideration the status and importance of the processes and areas to be audited.” Is it a requirement of this clause that the criteria to determine the status and the importance of the processes and areas to be audited have to be documented?
Background: There is divergence with the auditor regarding a requirement for documentation of “status and importance criteria” despite the fact that evidence was provided that the planning of the audit program has taken the status and importance of the processes and areas to be audited into consideration.
Interpretation: No

ISO 9001:2000 Interpretation RFI – 018
Request
: ISO 9001:2000 Clause: 8.3 
A product is at the final stage of realization and a nonconformity is found on a product related requirement which had been specified by the customer (ISO 9001:2000 7.2.1.a). The organization believes that the best solution is to accept and deliver the product as is, i.e., with a nonconforming characteristic. The customer has not issued instructions on the reporting of nonconformities. Does Clause 8.3 require a concession by the customer for the use, release, or acceptance as is of the product?
Interpretation: Yes
Rationale: Clause 8.3 identifies three different ways to deal with nonconforming products. Clauses 8.3 a) and c) do not apply in this case. Clause 8.3 b) specifies that the use, release, or acceptance shall be authorized. In this case authorization involves a concession by the customer. Furthermore, Clause 5.2 requires that customer requirements are determined and are met.