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January, 2004
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January Articles
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Training
in Atlanta
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Difference between corrective action and preventive
action?
Intellectuals solve problems;
geniuses prevent
them.
Albert Einstein, physicist, Nobel laureate (1879-1955)
Click on a title to jump to the article:
1. The Continued Transition to ISO 9001:2000
2. ISO Guidance on Self-Declaration
of Conformity
3. Guidance Document N630 on Outsourced Processes
4. ISO 9001:2000 Guide for Design
and Construction
5. Survey on Most Difficult ISO 9001:2000 Clauses
6. New ISO Website for ISO 9001:2000
Interpretations
7. Class Schedule: January, 2004 - March, 2004
To see previous articles, go to Newsletter
Archives.
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Note:
Students that have attended a class in Atlanta receive a 20% discount
on future Atlanta classes.
ISO 9001:2000 Lead Auditor
March 1-5, 2004
ISO 9001:2000 Internal Auditor
January 27-29, 2004
March 23-25, 2004
Quality System Documentation
February 3-4, 2004
Implementing ISO 9001:2000
February 5-6, 2004
Understanding ISO 9001:2000 Requirements
February 2, 2004
Green Belt Certification
January 21-23, 2004
March 22-24, 2004
Black Belt Certification (3 weeks)
Group 9: 2/9-13/04; 3/15-19/04; 4/12-16/04
Group 10: 3/29-4/2/04; 5/3-7/04; 6/7-11/04
Training Classes in Other
Cities
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1.
The Continued Transition to ISO 9001:2000
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Although ISO 9001:1994 was withdrawn on December 15, 2003,
some organizations have not completed the transition to ISO 9001:2000.
Some may have let the certificates expire on purpose. However, many were
just late in making the transition. As a result, most registrars have
announced plans to issue letters of conformity or unaccredited certificates
to extend the transition period for a limited period of time.
The IAF, comprised of the larger
and better known registrars, has stated the delayed companies will not
have to undergo a full registration audit if they make the transition
in a reasonable period of time. Some registrars are saying the transitions
must complete by the next scheduled surveillance visit. A few say the
transitions must complete by April 2004. And, some have stated the maximum
validity of the letters or unaccredited certificates will be until the
end of 2004.
Of course, customers that want
their suppliers to have an ISO 9001:2000 certificate may take a dim view
of these temporary measures and impose their own deadline for ISO 9001:2000
registration.
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2.
ISO Guidance on Self-Declaration of Conformity
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If your organization doesn't need an ISO 9001 or ISO
14001 certificate to satisfy customer, regulatory, or internal requirements,
then the new ISO 17050 guidance on self-declaration may be of interest.
ISO Guide 22 was issued in 1996 to provide general criteria for a supplier's
declaration of conformity. However, it has been used primarily for self-declaration
on product standards. ISO 17050 is being drafted to replace Guide 22 and
will explicitly state self-declaration of conformity applies equally to
management systems.
An ANSI spokesman was quoted as saying self-declaration may be a viable
option for organizations that do not need third party registration. ISO
17050 will provide guidance on the way to make the self-declaration and
the documentation needed to support it. However, some customers will continue
to require suppliers to be third party registered due the assurance and
confidence provided by the independent assessment.
ISO/DIS 17050-1 Conformity assessment -- Supplier's declaration of
conformity -- Part 1: General requirements
ISO/DIS 17050-1 Conformity assessment -- Supplier's declaration of
conformity -- Part 2: Supporting documentation
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3.
Guidance Document N630 on Outsourced Processes
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In support of ISO 9001:2000 and ISO 9004:2000, ISO Technical
Committee 176/SC 2 has published the following guidance documents:
N524 – Guidance on ISO 9001:2000 clause 1.2 'Application'
N525 – Guidance on the Documentation requirements of ISO 9001:2000
N526 – Guidance on the Terminology used in ISO 9001:2000 and ISO 9004:2000
N544 – Guidance on the Process Approach to quality management systems
N630 – Guidance on 'Outsourced Processes'
Document N630 was recently published and provides guidance on the intent
of ISO 9001:2000 clause 4.1 on the control of outsourced processes. ISO
9001:2000 clause 4.1 states: “Where an organization chooses to
outsource any process that affects product conformity with requirements,
the organization shall ensure control over such processes. Control of such
outsourced processes shall be identified within the quality management system.”
N630 describes an “outsourced process” as a process that the
organization has identified as being needed for its quality management system,
but one which it has chosen to be carried out by an external party. An outsourced
process can be performed by a supplier that is totally independent from
the organization, or which is part of the same parent organization (e.g.,
a separate department or division not subject to the same quality management
system). It may be provided within the physical premises or work environment
of the organization or at an independent site.
The intent of Clause 4.1 is to emphasize that when an organization chooses
to outsource (permanently or temporarily) a process that affects product
conformity with requirements, it can not simply ignore this process or exclude
it from the quality management system. The organization has to demonstrate
it exercises sufficient control to ensure the process is performed according
to the relevant ISO 9001:2000 requirements, as well as, the requirements
of the quality management system.
The nature of this control will depend on the importance of the outsourced
process, the risk involved, and the competence of the supplier. Also, the
outsourced process will interact with other processes (either carried out
by the organization or outsourced). These interactions must be managed as
required by ISO 9001:2000 clauses 4.1.a and 4.1.b.
The acquisition of an outsourced process will normally be subject to the
requirements of both ISO 9001:2000 clause 7.4 (Purchasing) and clause 4.1
(General Requirements). In some situations, the organization might not actually
“purchase” the outsourced process. It might receive the service
from a corporate office or from another division, without a monetary transaction
taking place. Under these circumstances, however, ISO 9001:2000 Clauses
7.4 and 4.1 are still applicable.
There are two situations that frequently must be considered when deciding
the appropriate level of control of an outsourced process:
1. When an organization has the competence and ability to carry out a process,
but chooses to outsource that process (for commercial or other reasons),
the process control criteria should already have been defined and can be
transposed into requirements for the supplier, if necessary.
2. When the organization does not have the competence to carry out the process
itself, and chooses to outsource it, the organization has to ensure the
controls proposed by the supplier of the outsourced process are adequate.
In some cases, it may be necessary to involve external specialists in making
this evaluation.
It may be convenient, or even necessary, to define some or all of the methods
to be used for control of the outsourced processes in a contract between
the organization and the supplier. Care should be taken, however, not to
inhibit the supplier from proposing innovations to the outsourced process.
In some situations, it might not be possible to verify the output from the
outsourced process by subsequent monitoring or measurement. In these cases,
the organization needs to ensure that the control over the outsourced process
includes process validation in accordance with ISO 9001:2000 clause 7.5.2.
Guidance document N630 and the rest of the ISO 9000 Introduction and Support
Package can be downloaded from <http://isotc176sc2.elysium-ltd.net>.
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4.
ISO 9001:2000 Guide for Design and Construction
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The "ISO 9001:2000 Interpretive
Guide for the Design and Construction Project Team" was written by the
ASQ Design and Construction Division. Effectively implementing a quality
management system to conform to ISO 9001:2000 can be challenge, especially
for organizations that are not in the manufacturing sector. This Interpretive
Guide was written to assist project management teams (owners, designers,
and constructors) in understanding the ISO 9001:2000 requirements and
developing the appropriate policies and procedures.
The Interpretive Guide updates for ISO 9001:2000 the guide that the Division
originally published in 1997. In this revision, the design and construction
community is provided advice and specific examples on establishing
and maintaining a quality management system throughout the project process.
Teamwork between the owner, the designer, and the constructor is clearly
laid out in the Guide. All practitioners in the design and construction
business can use this guide to improve both internal, as well as, external
processes.
The Interpretative Guide is available from ASQ as a downloadable e-Book
in Adobe Acrobat PDF format. You can order it at:
<http://e-standards.asq.org/perl/catalog.cgi?item=E1204>
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5.
Survey on Most Difficult ISO 9001:2000 Clauses
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A report on the user experience with ISO 9001:2000 is
available at: <http://standardsgroup.asq.org/news/psi/IMS06-2002E-Implementing_ISO_9001-BD.pdf>.
The 227 survey responses included a ranking of the most difficult ISO 9001:2000
clauses for which to develop a process, document, and/or implement:
Most Difficult ISO 9001:2000 Clauses
1. Customer satisfaction (8.2.1)
2. Competence, awareness, and training (6.2.2)
3. Analysis of data (8.4)
4. Preventive action (8.4)
5. Quality objectives (5.4.1)
6. Continual improvement (8.5.1)
7. Design and development planning (7.3.1)
These seven clauses were in my own list of the 12 Toughest ISO 9001:2000
Requirements. See the earlier newsletter articles on the Dirty Dozen.
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6.
New ISO Website for ISO 9001:2000 Interpretations
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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.
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7.
Class Schedule for January, 2004 - March, 2004
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To enroll in these public classes, go to Class
Schedule at our web site, or call us at 800-404-7585. The classes
taught by Larry Whittington are shown in gold.
ISO 9001:2000 Lead Auditor (RAB Accredited) - BSI
Management Systems
Initial course version developed by Larry
Whittington
| January |
February |
March |
| 05-09 Houston, TX |
02-06 Dallas, TX |
01-05 Atlanta,
GA |
| 12-16 San Diego, CA |
02-06 Detroit, MI |
01-05 Memphis, TN |
| - - |
09-13 San Diego, CA |
08-12 Orange County,
CA |
| - - |
23-27 Reston, VA |
15-19 Charlotte, NC |
| - - |
- - |
22-26 Kansas City, MO |
| - - |
- - |
29-02 San Jose, CA |
ISO 9001:2000 Internal Auditor (RAB Accredited) - BSI
Management Systems
| January |
February |
March |
| 14-16 Houston, TX |
18-20 Reston, VA |
22-24 Charlotte, NC |
| 27-29 Altanta,
GA |
- - |
23-25 Atlanta,
GA |
Implementing ISO 9001:2000 - Course
developed by Larry Whittington
| January |
February |
March |
| 12-13 Houston, TX |
05-06 Atlanta,
GA |
08-09 Orange County, CA |
| - - |
19-20 Reston, VA |
- - |
Understanding ISO 9001:2000
| January |
March |
May |
| 23 Orlando, FL |
12 Kansas City, MO |
18 San Diego, CA |
Understanding ISO 9001:2000 Requirements (Atlanta
Only - $295) - Course developed by Larry Whittington
| February |
May |
| 02 Atlanta, GA |
10 Atlanta, GA |
Quality System Documentation (ISO 9001:2000) -
Course developed by Larry Whittington
| January |
February |
March |
| 22-23 Detroit, MI |
03-04 Atlanta,
GA |
16-17 Detroit, MI |
| - - |
23-24 Reston, VA |
- - |
The above public courses can be offered on-site at your
facility. In addition, we offer these on-site courses:
- Understanding ISO/TS 16949:2002 Requirements (1 day)
- Course developed by Larry Whittington
- Internal Quality Auditing (2 Days) - Course developed
by Larry Whittington (based on ISO 19011)
To arrange an economical on-site
class, please call us at 800-404-7585.
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