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IAF/ILAC Template for comments – Certification of Multiple Sites Date: 2007-05-17 Document: IAF-GM-07-012 (NCD Z:200X)
1 2 (3) 4 5 (6) (7)
MB1 Part, Clause No./
Subclause No./
Annex/Figure/Table(e.g. 3.1, Table 2)
Paragraph/List item/
Note(e.g. Note 2)
Type of
com-ment2
Comment (justification for change) by the MB Proposed change by the MB Convener observationson each comment submitted
CAI No comment.
CNAS No comment
EMA No comment
INMETRO No comment
JAS-ANZ No comment.
MAURITAS No comment
OLAS OLAS has no particular comment to propose on this document.
SANAS No comment.
Standards Malaysia
No comment
COFRAC Whole document
ed This document is an “IAF normative and informative criteria…” I remember we had a rather long discussion in the IAF TC in march 2007 on the way to designate this kind of document, and “guidance” had not been selected to be appropriate; then it is preferable not to refer to “guidance” in the document
Replace “guidance” by “document” wherever it appears
Agreed. "guidance" replaced with "document" or "criteria" as appropriate
FINAS All ge Certification of multiple sites especially the sampling procedure is one of the most misused guides by the CBs. Also the clients expect sampling to be used in any situation where the company has activities on more than one site. The restriction for use of sampling, although in a way stated in 3.1.6, should be further clarified.
To collect all the conditions for multi site procedure and where sampling can be applied, which are now separated in the document, into one paragraph and maybe partly reformulate to make the conditions more clear.
Nice idea. However, this is a minimum change document and resources are not currently available to carry out the proposed exercise.
1 MB = Member Body (enter the IAF Member acronym, e.g. RvA)2 Type of comment: ge = general te = technical ed = editorial NB Columns 1, 2, 4, 5 are compulsory.
Page 1 of 27IAF electronic balloting commenting template/version 2002-10
IAF/ILAC Template for comments – Certification of Multiple Sites Date: 2007-05-17 Document: IAF-GM-07-012 (NCD Z:200X)
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MB1 Part, Clause No./
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Note(e.g. Note 2)
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Comment (justification for change) by the MB Proposed change by the MB Convener observationson each comment submitted
IQNet All All te Document lacks clarity and distinction between requirements for multi-site certification [irrespective of whether sampling is employed] and requirements for auditing by sampling.
This recommended text may be included for definitions of multi-sites and certification documents
.
The proposal mixes definitions and requirements. Standards writing protocol prevents meeting this proposal although I have sympathy with it. That is why the definitions and explanatory requirements have been separated.
ANAB Page 2 ge Paragraphs edited to reflect the recent understanding that ‘certified once-accepted everywhere’ applies only where there is an MLA for the framework standard and the specific conformity assessment standard or scheme.
Accreditation reduces risk for business and its customers by assuring them that accredited bodies are competent to carry out the work they undertake within their scope of accreditation. Accreditation bodies which are members of the International Accreditation Forum, Inc. (IAF) are required to comply with appropriate international standards and to require the bodies they accredit to comply with appropriate international standards and IAF Guidance normative criteria to for the consistent application of those standards.
Accreditations granted by Accreditation body members of the IAF Multilateral Recognition Arrangement (MLA) , based on have regular surveillance to assure the equivalence of their accreditation programs. , allows companies and persons with an accredited conformity assessment certificate in one part of the world to have that certificate recognized everywhere else in the world.
Incorporated
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Page 2 of 27IAF electronic balloting commenting template/version 2002-10
IAF/ILAC Template for comments – Certification of Multiple Sites Date: 2007-05-17 Document: IAF-GM-07-012 (NCD Z:200X)
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MB1 Part, Clause No./
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Therefore certificates in the field of management systems, products, services, persons or other similar programs of conformity assessment issued by bodies accredited by members of the IAF MLA are relied upon in international trade.
An organization or person with a certificate of conformity to a specific standard or scheme that is accredited by an IAF MLA signatory accreditation body for that standard or scheme can be recognized everywhere else in the world thereby facilitating international trade.
SCC Page 2 ge The three paragraphs on accreditation should be harmonized for all documents. These three paragraphs are different from the once reproduced in the IAF Normative Criteria for Advanced Surveillance and Recertification Procedures
Harmonize Agreed. Propose this task fall to IAF TC convenor to ensure harmonization
ANAB Page 4 First sentence after the Title
ed For consistent wording with the normative criteria for transfers
This document provides normative criteria for the consistent application of…
Agreed
JAB Page 4 Title in the text (P.4)
te Should be consistent with the title on the cover page IAF Normative and Informative Criteria for the Certification of Multiple Sites Based on Sampling
Reference to "informative" deleted – although clearly the document is both normative AND informative
JAB Page 4 1st paragraph in the text
te Although ISO/IEC 17021 is applicable to all types of management systems, this document is not the case, which should be clarified.
This document provides criteria on Clause 9.1.5. of ISO/IEC 17021:2006 and covers criteria on certification of multiple sites
Disagree. The intention is to widen the use of this document, although there are several standards for which the
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Page 3 of 27IAF electronic balloting commenting template/version 2002-10
IAF/ILAC Template for comments – Certification of Multiple Sites Date: 2007-05-17 Document: IAF-GM-07-012 (NCD Z:200X)
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MB1 Part, Clause No./
Subclause No./
Annex/Figure/Table(e.g. 3.1, Table 2)
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Note(e.g. Note 2)
Type of
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Comment (justification for change) by the MB Proposed change by the MB Convener observationson each comment submitted
(p.4) previously provided in IAF GD2: 2005, Annex 3 and IAF GD6:2006, clause G.5.3.5 – G.5.3.6. This means that this document is intended for only Quality Management System (QMS) and Environmental Managements System (EMS), in which IAF members have had experience of accredited certification of multiple sites based on sampling. For other management systems, relevant standards may provide specific requirements for multiple sites (e.g. ISO/IEC 27006 for ISMS, ISO 22003 for FSMS).
sampling technique cannot be applied. It is based on GD2 and GD6 – but several management system standards can follow the same principles.
HKAS Title Page4 ed The title on page 4 is :
“IAF Normative and Informative Criteria for the Certification of Multiple Sites Based on Sampling”
It cannot be normative and informative.
Delete “and Informative” from the title. Agreed
KAB Title ed Need to unify title
IAF Normative Criteria for ~
IAF Normative and Informative Criteria for~
IAF Normative Criteria for the certification of Multiple Sites Based on Sampling
Agreed. Reference to "informative" deleted – although clearly the document is both normative AND informative
SWEDAC Title ED Not correct references: G.5.3.5- G5.3.6 G5.3.6- G5.3.13 Agreed, but G.5.3.5 included as it defines "site"
UKAS 0 0.1Line 4
te Insert “across all the sites listed” after relevant standard
Agreed
DAR/ TGA 0 0.2 ge This Guidance document distinguishes between “procedures” and “documented procedures” (see
0.2 should read: “... a certification body shall put into operation appropriate documented
Agreed. Documented procedures
1 MB = Member Body (enter the IAF Member acronym, e.g. RvA)2 Type of comment: ge = general te = technical ed = editorial NB Columns 1, 2, 4, 5 are compulsory.
Page 4 of 27IAF electronic balloting commenting template/version 2002-10
IAF/ILAC Template for comments – Certification of Multiple Sites Date: 2007-05-17 Document: IAF-GM-07-012 (NCD Z:200X)
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MB1 Part, Clause No./
Subclause No./
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Comment (justification for change) by the MB Proposed change by the MB Convener observationson each comment submitted
clause 4.2.1). From that, procedures need not to be documented in the CRB. The Guidance document should be reviewed accordingly.
procedures for sampling the sites at the initial audit and subsequent surveillance and recertification audits.”
referred to throughout
KAB 0 0.27th line
Change to criteria
This guidance addresses the conditions~
This Criteria addresses the conditions~ Agreed. Have used criteria or document as appropriate throughout
DAR/ TGA 0 0.3 te Multiple site organizations shall be ruled under similar processes, activities and products.
“The criteria in this document do not apply to the audits of organizations that have multi-sites where fundamental dissimilar processes, activities or products are used or produced at the different sites.”
Not agreed. Similar processes may be used to produce different products. An MS audit is of a process, not a product.
IQNet 0. 0.31st sentence
te This particular statement has been surrounded by much controversy. Suggest a better explanation of dissimilar processes.
We recommend to include definition of dissimilar processes in section 1 “Definitions”
1.6 Dissimilar processes
Dissimilar processes are the processes which are based on different technologies and produce different products.
Not agreed. See above. Similar argument applies. Dissimilar processes is self explanatory. They may be based on different technologies, which may or may not produce different products.
UKAS 0 0.3Line 3
te Combinations of sites may have similar processes Amend line 3 to read
at the different sites or a combination of sites,
Agreed
COFRAC 0 0.4 ed grammar Replace “under condition they are” by “under condition it is”
Agreed
UKAS 0 0.4Line6
te Refer to the confidence in the management system …same level of confidence in the conformity of management system across all the sites listed, can be obtained
Agreed
JAB 1 1.1 te Consistency with 17021. The term organization is used to designate any company or other client organization
Not agreed. "client organization" only used in ISO/IEC 17021 where there is
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Page 5 of 27IAF electronic balloting commenting template/version 2002-10
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owning a management system subject to audit and certification.
the possibility of confusion
COFRAC 1 1.2 ed For clarification and consistency with the following text
Replace “A site is a location where a client carries out work or a service” by “A site is a permanent location where a client carries out activities (work or a service)
Agreed
DAR/ TGA 1 1.2 ed The Guidance document should not divide between “organization” and “client”
A site is a location where an organization carries out work or service.
Agreed
COFRAC 1 1.3 ed For clarification and consistency with the following text
Replace “to perform specific work for a finite period of time and which will not become permanent site” by “to perform specific activity for a finite period of time and which will not become a site
Partially agreed. Consistent with 1.2 as drafted, but amended to include "service"
HKAS 1 1.3 te Who sets up a temporary site is irrelevant. It may be set up by a party other than the certified organisation. The definition for “temporary site” in the draft document is different from that in GD2:2005.
Use the definition in GD2:2005:
“A temporary site is a location other than the sites/locations identified in the certification document where activities, within the scope of certification, are implemented for a defined period of time. These sites could range from major project management sites to minor service/installation sites.”
GD2 is now obsolete and therefore no need to make us of an old definition
COFRAC 2 ge For clarity make a fusion of § 2 with the corresponding §1 subparagraphs, in one § entitled “definitions”
Merge 2.1 with 1.2, 2.2 with 1.3, and 2.3 with 1.5
Standards writing protocol prevents meeting this proposal
JAB 2 te Do we need to say ‘explanatory’ requirements? EXPLANATORY REQUIREMENTS Unchanged. Clear as drafted
COFRAC 2.1 2.1.2 ed For harmonisation Replace “certification/registration” by Agreed. Complete
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MB1 Part, Clause No./
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Note(e.g. Note 2)
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Comment (justification for change) by the MB Proposed change by the MB Convener observationson each comment submitted
“certification”
JAB 2.1 2.1.2 te - For consistency with 17021, certification/registration should be certification.
- Examples would be appreciated to justify ‘special cases.’
Where it is not practicable to define a location (e.g. for services), the coverage of the certification/registration should take into account the organization’s headquarters activities as well as delivery of its services. Where relevant, in special cases (e.g. ………………..), the Certification Body may decide that the certification/registration audit will be carried out only where the organization delivers its services. In such cases all the interfaces with its central office shall be identified and audited.
Agreed. All references to certification/registration amended to certification
Example can be inserted if provided.
OAA 2.1 2.1.2 ED The term registration is no longer use. Where it is not practicable to define a location (e.g. for services), the coverage of the certification should take into account the organization’s headquarters activities as well as delivery of its services. Where relevant, in special cases, the certification body may decide that the certification audit will be carried out only where the organization delivers its services. In such cases all the interfaces with its central office shall be identified and audited
Agreed. Complete
IQNet 2.2 2.2.1Second Sentence
te Disagree with this statement. What if a site is temporary for 1, 2, 3 years etc. Temporary sites should be managed by the CB and it should be the CB’s/Client decision as to whether a temporary site is included on a certificate
Delete this sentence and replace with:
They may be however included within the scope of a multi-site certification subject to agreement between Certification Body and
Good idea. Agreed
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Page 7 of 27IAF electronic balloting commenting template/version 2002-10
IAF/ILAC Template for comments – Certification of Multiple Sites Date: 2007-05-17 Document: IAF-GM-07-012 (NCD Z:200X)
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MB1 Part, Clause No./
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Comment (justification for change) by the MB Proposed change by the MB Convener observationson each comment submitted
client.
DAR/ TGA 2.3 2.3.1Second item
te The multi site approach shall be restricted to companies producing similar products – even if certification is limited to the sales network.
Add: “Manufacturing companies producing similar products with a network of sales offices (this guidance would apply to the sales network)”.
Not agreed. The sales process could be similar for different products
INAB 2.3 2.3.1 Ed Consistency of style Semi-colons after each bullet All commas etc removed from lists
JAB 2.3 2.3.1 te - As well as continuous surveillance, reference to internal audits would be necessary.
- Normally the central office will require the sites to implement corrective actions rather than the central office’s direct implementation at the site.
A multi-site organization need not be a unique legal entity, but all sites shall have a legal or contractual link with the central office of the organization and be subject to a common management system, which is laid down, established and subject to continuous surveillance and internal audits by the central office. This means that the central office has rights to require that the sites implement corrective actions when needed in any site. Where applicable this should be set out in the contract between the central office and the sites.
Agreed
JAB 2.3 2.3.12nd bullet
te We agreed to change the term from ‘guidance.’ Manufacturing companies with a network of sales offices (this document guidance would apply to the sales network),
Agreed. Complete
UKAS 2.3 2.3.1Line 6
te Delete the contract, these may not exist between sites
Add - a formal agreement Agreed
ANAB 3 te Additional wording is needed to clarify that this is criteria for determining the eligibility of an organization for sampling
3. Eligibility criteria for the organization
Change to “3. Criteria for determining the
Agreed
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Page 8 of 27IAF electronic balloting commenting template/version 2002-10
IAF/ILAC Template for comments – Certification of Multiple Sites Date: 2007-05-17 Document: IAF-GM-07-012 (NCD Z:200X)
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MB1 Part, Clause No./
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eligibility of the organization for sampling”
ANAB 3 3.1.1 te As this relates to the certificate and not to eligibility, it better fits in section 4.4
Relocate 3.1.1 to 4.4.1 and renumber the subsequent clauses of this section
After relocation of the clause to 4.4.1, renumber the clauses in section 4.4
Agreed
COFRAC 3 3.1.1 ed For harmonisation Replace “registration” by “certification” Agreed. Complete
HKAS 3 3.1.1,
4.0.1
Note under 4.4.6
ed This “Normative Criteria” is not “guidance”. Replace the word “guidance” with “document”.
Agreed. "guidance" replaced with "document" or "criteria" as appropriate
Inmetro 3 3.1.1Last line
This document is intended to be a “Normative criteria”, however the term “guidance” appears on this item
“... in this normative criteria”. Agreed. "guidance" replaced with "document" or "criteria" as appropriate
JAB 3 3.1.1 te We agreed to change the term from ‘guidance.’ Certification documents can be issued covering multiple sites provided that each site included in the scope of registration has either been individually audited by the certification body or audited using the sample approach outlined in this document guidance.
Agreed. "guidance" replaced with "document" or "criteria" as appropriate
OAA 3 3.1.1 ED The term registration is no longer use. Certification documents can be issued covering multiple sites provided that each site included in the scope of certification has either been individually audited by the certification body or audited using the sample approach outlined in this guidance.
Agreed. Complete
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IAF/ILAC Template for comments – Certification of Multiple Sites Date: 2007-05-17 Document: IAF-GM-07-012 (NCD Z:200X)
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MB1 Part, Clause No./
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SCC 3 3.1.14 te “in accordance with the audit standard” may create confusion as the audit standard is often ISO 19011. This does not seem to be intent of this statement.
Replace “audit standard” by “ the standard under audit”
Agreed. See JAB note
COFRAC 3 3.1.2 te For clarity and harmonisation for the implementation of the document
After first sentence add “If it is not the case, the processes shall be categorised by the CB in groups on similar processes and the multi-site sampling realized on each group”
Interesting concept and worth trying.
DAR/ TGA 3 3.1.2 te Products and activities shall be included. Add: The activities and products provided from or produced at site have to be similar.
Disagree. Processes is used in preference to activities and these have to be similar. Products may be different.
INAB 3 3.1.2 Ge To ensure sites performing fewer but more important processes are audited.
providing that the site(s) which conduct the most processes, or critical processes, are subject to full audit.
Agreed
IQNet 3 3.1.24.1.3
te Many multinationals, particularly in the semi-conductor business, conduct their manufacturing using many linked locations which do not have the same processes (e.g. Wafer fab in USA, Assembly in Far East). These are often candidates for multi-site although technically locations are carrying out different (but linked) processes.
This has an effect on two areas:
3.1.2 / 4.1.3
or businesses which conduct their business through linked processes taking place in different locations.
5 Sampling
Where processes in each location are not similar but are linked, the sampling, each year, shall include at least one example of each process conducted by the organisation.
Interesting concept and worth trying.
UKAS 3 3.1.2Line 4
ed Reword ---providing that all the sites that conduct the substantial processes are subject to full audit
See INAB comment above. May be several sites conducting substantial processes which could be sampled
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Page 10 of 27IAF electronic balloting commenting template/version 2002-10
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MB1 Part, Clause No./
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DAR/ TGA 3 3.1.3 ed Wording of the first sentence is not unclear. The organization’s management system shall be centrally administered under a centrally controlled plan and be subject to central management review.
I find the original clearer than the proposal
EGAC 3 3.1.3 ge The organization’s management system shall under a centrally controlled and administered plan and be subject to central management review. All the relevant sites (including the central administration function) shall be subject to the organization’s internal audit program and have been audited in accordance with that program prior to the certification body starting its audit.
The organization’s management system shall be under a centrally controlled and administered plan and be subject to central management review. All the relevant sites (including the central administration function) shall be subject to the organization’s internal audit program and have been audited in accordance with that program prior to starting of the certification body’s audit.
Agreed. Different text
INAB 3 3.1.3 Ed Typographical error Shall be under Agreed
Inmetro 3 3.1.3First line
It seems as though the verb “be” is missing “... system shall be under ....” Agreed
UKAS 3 3.1.3Line 1
ed ---shall be under--- Agreed
UKAS 3 3.1.3Line 4
ed ----internal audit programme and all shall have
Agreed
DAR/ TGA 3 3.1.4 ed It should be clear that the “audit standard” is the management system standard.
“It shall be demonstrated that the central office of the organization has established a management system in accordance with a related management system standard and the whole organization meets the requirements described in the standard. Internal audit report have to be available for
Agreed. Simpler text used
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MB1 Part, Clause No./
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the CB prior to the audit.”
JAB 3 3.1.4 te ‘Audit standard’ could be misunderstood to mean 19011.
It shall be demonstrated that the central office of the organization has established a management system in accordance with the relevant management system requirements audit standard …
Agreed. Amended
EGAC 3 3.1.5 ge The organization should demonstrate its ability to collect and analyse data (including but not limited to the items listed below) from all sites including the central office and its authority and ability to initiate organizational change if required:
The organization should demonstrate its ability to collect and analyse data (including but not limited to the items listed below) from all sites including the central office and also demonstrate its authority and ability to initiate organizational change if required:
Agreed
EGAC 3 3.1.5Last bullet point
ge Differing legal requirements. (Different or changing) legal requirements. Agreed
JAB 3 3.1.5 ed Add EMS as abbreviation, which would be more familiar (as used in 5.1.4).
Changes to aspects and associated impacts for environmental management systems (EMS) and
Agreed
JAB 3 3.1.63.1.7
te These clauses should be stated much earlier in the text.
Suggest to move 3.1.6 - 3.1.7 to 1.5 or Notes to 1.5.
Not agreed. In the section on eligibility as drafted.
DAR/ TGA 3 3.1.7 ed Delete AS in the brackets or mention also the documents of the other sectors ..(AS 9100 series)...
..(9100 series)… Not agreed. Referring to "AS" aids clarity.
INAB 3 3.1.7 Ge Where specific rules apply, option provided by “should” shouldn’t be available
Shall take precedence Agreed
IQNet 3 3.1.72nd
te Delete reference to these two schemes. Not appropriate for this document
Not agreed. Use of examples aids understanding.
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sentence
OAA 3 3.1.7 ED The sectors schemes mentioned should only work as examples.
Not all management systems standards are suitable for consideration for multi-site certification. Specific rules apply for some sector schemes, for example those including automotive (TS 16949) and Aerospace (AS 9100 series) and the requirements of such schemes should take precedence.
Agreed
PCA 3 3.1.7 ge The specific requirements of ISO 22000 and ISO 27001 was not taken into account .
Specific rules apply for some sector schemes including automotive (TS 16949), Aerospace (AS 9100 series), FSMS (ISO 22000) and ISMS (ISO 27001) and the requirements of such schemes should take precedence.
Noted. However, they are only examples which can never be exhaustive
UKAS 3 3.1.7 te Multi site sampling for OHSAS is not appropriate Insert new sentence at end of paragraph. Multi site sampling for health and safety management systems cannot be applied where processes, buildings, facilities, local factors (eg transport, public contact etc) storage are very likely to be variable for each site.
Noted. However, need to avoid specifying too much for specific schemes. Text amended to reflect the intention relating to local variations
DAR/ TGA 3 3.1.8 ge See comment to 0.2. Certification bodies should have documented procedures ...
Agreed
SCC 3 3.1.8 te Change to Shall Certification bodies shall have procedures to restrict….
Not agreed. A CB shall have procedures for what it does, not what it does not do
UKAS 3 3.1.8Line 1
ed Delete site, replace with “such” Agreed
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1 2 (3) 4 5 (6) (7)
MB1 Part, Clause No./
Subclause No./
Annex/Figure/Table(e.g. 3.1, Table 2)
Paragraph/List item/
Note(e.g. Note 2)
Type of
com-ment2
Comment (justification for change) by the MB Proposed change by the MB Convener observationson each comment submitted
UKAS 3 3.1.84th bullet
Delete which replace with “that” Agreed
Inmetro 4 4.0.1Second line
This document is intended to be a “Normative criteria”, however the term “guidance” appears on this item
“... set out in this normative criteria...” Agreed. "guidance" replaced with "document" or "criteria" as appropriate
IQNet 4 4.011st sentence
te Do not agree with statement. The obligation should be for the certification body to obtain the relevant information from the organization to determine if the organization meets the criteria and to inform the organization as to the audit approach and reasoning behind the approach.
The certification body shall obtain information from the organization about the way they structured and operate and make decision on compliance of the organisation with any of the criteria set out in this guidance and the relevant audit standards before starting the audit process. The Certification body and should not proceed if any of the criteria are not met
Agree in principle only. However, CB must provide information to the client. Clause amended slightly.
JAB 4 4.0.1 te ‘Audit standard’ could be misunderstood to mean 19011.
The certification body shall provide information to the organization about the criteria set out in this guidance and the relevant management system requirements audit standards before starting the audit process,
Agreed. Simpler text used
INAB 4.1 4.1.2 Ed Full stop (period) missing at end of clause. Agreed
Inmetro 4.1 4.1.2Last line
The period is missing “ activities.” Agreed.
COFRAC 4.1 4.1.3 ed numbering Replace 2.1.2 by 3.1.2 Agreed. Now 3.1.1
HKAS 4.1 4.1.3 ed Incorrect cross reference “Clause 2.1.2” should be “clause 3.1.2” Agreed
JAB 4.1 4.1.3 ed - Incorrect reference See clause 3.1.2 2.1.2 for sites of which Agreed
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1 2 (3) 4 5 (6) (7)
MB1 Part, Clause No./
Subclause No./
Annex/Figure/Table(e.g. 3.1, Table 2)
Paragraph/List item/
Note(e.g. Note 2)
Type of
com-ment2
Comment (justification for change) by the MB Proposed change by the MB Convener observationson each comment submitted
- Comma should be placed for readability conduct fewer, but similar processes than other sites. Only after a positive examination by the certification body that all the sites proposed for inclusion in the multi-site exercise meet the criteria, may the sampling procedure be applied to the individual sites.
EGAC 4.1 4.1.4 ed the organization shall be required to inform the certification body in advance of the sites that it wants to be included in the certification and those which are to excluded
the organization shall be required to inform the certification body in advance of the sites that it wants to be included in the certification and those which are to be excluded
Agreed
INAB 4.1 4.1.4 Ed Two full stops at end of clause – remove one. Agreed
Inmetro 4.1 4.1.4Last line
There are two periods in the end of the sentence “.... excluded.” Agreed
JAB 4.1 4.1.4 ed - For improved clarity
- Punctuation
If information on all the sites of a service organization where the activity subject to certification is performed are not ready to be submitted for certification at the same time, the organization shall be required to inform the certification body, in advance, of the sites that it wants to be included in the certification and those which are to excluded..
Not agreed. Original is more clear than the proposal
SCC 4.1 4.1.4 and 4.4.3
ed Extra period in last sentence. Remove extra period. Agreed
DANAK 4.2 4.2.1 ed Reference to clause 2 should be clause 3 “2” to be replaced by “3”. Agreed
HKAS 4.2 4.2.1 ed Incorrect cross reference “Clause 2” should be “clause 3” Agreed
JAB 4.2 4.2.1 ed Incorrect reference … and that all the eligibility criteria for the Agreed
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1 2 (3) 4 5 (6) (7)
MB1 Part, Clause No./
Subclause No./
Annex/Figure/Table(e.g. 3.1, Table 2)
Paragraph/List item/
Note(e.g. Note 2)
Type of
com-ment2
Comment (justification for change) by the MB Proposed change by the MB Convener observationson each comment submitted
organization in clause 3 2 above are met.
SCC 4.2 4.2.1 ge “where electronic documents and/or process control, and/or other electronic processes are used” may lead to confusion. Are we talking about electronic process controls or simply process controls?
Suggest using this statement: “where information management and/or process controls through electronic means are used”
Not agreed. Proposal is more confusing than the original
UKAS 4.2 4.2.1 te The rationale for CB being satisfied must be recorded
Insert new sentence at end of paragraph.
Comprehensive information shall be detailed in the stage1 audit reports including the rationale and justification for proceeding with a multi site approach.
Mostly agreed. No need to refer to stage 1, but other elements included
KAB 4.2 4.2.15th line
ed Misquote
Eligibility criteria for the organization in clause 2 above are met.
Eligibility criteria for the organization in clause 3 above are met.
Agreed
INAB 4.3 4.3.1 Ge Organisation should not have option not to review impact of NCs at other sites
Therefore the Certification Body shall require the organisation to review the ncs …
Disagree. Proposal is very negative. If an organization can improve its MS, it should be allowed to do so.
SCC 4.3 4.3.1 te Change should to shall … from auditing by the certification body, investigation shall take place to determine whether the other sites may be affected. Therefore, the certification body shall require the organization to review the …
Not agreed. Proposal is a prescriptive "how"
UKAS 4.3 4.3.1Line 7
te Verification of corrective action --should be performed and verified.both at ---.
Agreed – but must refer to NCRs as defined in 9.1.15 (b) of ISO/IEC 17021 – not 9.1.15 (c)
EGAC 4.3 4.3.2 te 4.3.2 The certification body shall require evidence of these actions and increase its sampling frequency
This phrase needs to be further explained e.g., in a note. This note should explain how
Not agreed. Proposal is a prescriptive "how". The document should not specify
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1 2 (3) 4 5 (6) (7)
MB1 Part, Clause No./
Subclause No./
Annex/Figure/Table(e.g. 3.1, Table 2)
Paragraph/List item/
Note(e.g. Note 2)
Type of
com-ment2
Comment (justification for change) by the MB Proposed change by the MB Convener observationson each comment submitted
and/or the size of sample until it is satisfied that control is re-established
this sampling frequency be increased. Examples should be given e.g., decreasing the surveillance period.
how an action is carried out.
DAR/ KBA 4.3 4.3.3 te According to 17021:06, clause 9.1.15, the certification can be denied only if a certain kind of non-conformities (see subclause b) has not been settled by verified corrections and corrective actions. In any other case, the certification must be granted if only plans for corrections/corrective actions are accepted (i.e. non-conformities are not settled yet)
At the time of the decision making process, clause 9.1.15 of ISO/IEC 17021:2006 must be applied to any single site.
See UKAS comment
IQNet 4.3 4.3.3 te This does not comply with ISO17021 which only requires a corrective action plan to be submitted and approved prior to granting of certification
At the time of the decision making process, if any site has a nonconformity and corrective action plan is not submitted and not approved, certification shall be denied to the whole network pending satisfactory corrective action.
Not agreed. CARs (majors) must be verified – reference to 17021 now included.
SCC 4.3 4.3.3 ge A definition of “network” would be useful here. Are we talking of a network in the sense of communications or multi-sites??
Define “network” "of listed sites" inserted
UKAS 4.3 4.3.3Line 1
te Ensure/re enforce nature of non conformities Insert at end of line 1 (ref ISO/IEC 17021 section 9.1.15 b)
Agreed
COFRAC 4.3 4.3.4 ed numbering Replace 3.1.4 by 4.1.4 Agreed
HKAS 4.3 4.3.4 ed Incorrect cross reference “Clause 3.1.4” should be “clause 4.1.4” Agreed
JAB 4.3 4.3.4 ed Incorrect reference Such exclusion can only be agreed in advance (See clause 4.1.4 3.1.4).
Agreed
OAA 4.3 4.3.4 TE I should be better clarify in which moment the It shall not be admissible that, in order to Resolved by change of reference as 1 MB = Member Body (enter the IAF Member acronym, e.g. RvA)2 Type of comment: ge = general te = technical ed = editorial NB Columns 1, 2, 4, 5 are compulsory.
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1 2 (3) 4 5 (6) (7)
MB1 Part, Clause No./
Subclause No./
Annex/Figure/Table(e.g. 3.1, Table 2)
Paragraph/List item/
Note(e.g. Note 2)
Type of
com-ment2
Comment (justification for change) by the MB Proposed change by the MB Convener observationson each comment submitted
exclusion should be agreed. overcome the obstacle raised by the existence of a nonconformity at a single site, the organization seeks to exclude from the scope the "problematic" site during the certification process. Such exclusion can only be agreed in the contract review.
above
DANAK 4.4 4.4.2 ed Reference to the certification documents seems to be missing in the second sentence.
Underlined text to be added:
The scope or other reference on the certification documents shall make clear that the certified activities are performed by the network of sites in the list. If the certification scope of the sites is only issued as part of the general scope of the organization, its applicability to all the sites shall be clearly stated.
Agreed.
HKAS 4.4 4.4.2 te To avoid misleading scope.
The third line, “The scope or other reference on..” is incomplete.
Add at the end of clause 4.4.2 the following:“For situation mentioned in clause 4.1.4, the certification scope should indicate that the certification is for a limited number of sites.”
Replace the incomplete phrase by “The scope or other reference stated on the document..”.
Text amended more simply
INAB 4.4 4.4.2 Ed Remove ‘on’ - Typographical error The scope or other reference No. Words were missing – see below
Inmetro 4.4 4.4.2Third line
The particle “on” does not make sense on the sentence
“...or other reference shall make clear...” No. Words were missing – see below
JAB 4.4 4.4.2 ed Words missing? The scope or other reference on the documents shall make clear that …
Agreed. See below
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1 2 (3) 4 5 (6) (7)
MB1 Part, Clause No./
Subclause No./
Annex/Figure/Table(e.g. 3.1, Table 2)
Paragraph/List item/
Note(e.g. Note 2)
Type of
com-ment2
Comment (justification for change) by the MB Proposed change by the MB Convener observationson each comment submitted
OAA 4.4 4.4.2 ED There are some word missing in “The scope or other reference on … shall make”
The documents shall contain the name and address of the central office of the organization and a list of all the sites to which the certification documents relate. The scope or other reference on the certification document shall make clear that the certified activities are performed by the network of sites in the list. If the certification scope of the sites is only issued as part of the general scope of the organization, its applicability to all the sites shall be clearly stated.
Agreed. Simpler text used
SCC 4.4 4.4.2 ed Second sentence seems to be missing something Other reference on what? See above
UKAS 4.4 4.4.2Line 3
ed Delete “on” No. Words were missing – see above
Inmetro 4.4 4.4.3Last line
There are two periods in the end of the sentence “.... documentation.” Agreed.
PCA 4.4 4.4.3Add clause after
ge The problem of contracts with all sites is not addressed. Suggestion is made to include extra point after 4.4.3
The certification body shall have legally enforceable agreement, directly or through central office, with all the sites covered by the scope of the certification as required by 5.1.2 of ISO/IEC 17021.
Not necessary. Covered by 17021 which applies in full.
SCC 4.4 4.4.3 ge A definition of “sub-certification documents would be useful.
Define “sub-certification” documents Simplified to "Certification…."
EGAC 4.4 4.4.4 ed The certification documentation will be withdrawn in its entirety, if the central office or any of the sites does not/do not fulfil the necessary criteria for the maintenance of the certification
There is no need for do not in this sentence. Agreed.
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MB1 Part, Clause No./
Subclause No./
Annex/Figure/Table(e.g. 3.1, Table 2)
Paragraph/List item/
Note(e.g. Note 2)
Type of
com-ment2
Comment (justification for change) by the MB Proposed change by the MB Convener observationson each comment submitted
DAR/ TGA 4.4 4.4.6 ge See comment to 0.2. The Certification bodies shall have documented procedures for the addition of new sites.
Agreed.
INAB 4.4 4.4.6Note
Ge It conflicts with clause 2.2 which state that temporary sites shall not be included.
A risk analysis should be done of processes done at temporary sites to determine their inclusion in the scope.
Leave as is but remove conflicting statement in clause 2.2
Disagree. Some temporary sites could be quasi permanent (IQnet) – eg. in existence for a year or more. Note deleted.
Inmetro 4.4 4.4.6Note
This document is intended to be a “Normative criteria”, however the term “guidance” appears on this item
“...this normative criteria”. Note deleted
HKAS 5.1 5.1.1 te The samples selected should be representative. Replace the words “a range of different” with “a representative range of different” in the second line.
Agreed.
COFRAC 5.1 5.1.45th bullet
ed Consistency with text Replace “activities” by “processes” Agreed.
DANAK 5.1 5.1.4 te Differing legal requirements may also be criteria for selection of sites.
To be added:
Differing legal requirements
OK, but not included. List is not intended to be exhaustive "may include among others"
INAB 5.1 5.1.4 Ed Clarity (addition of commas), consistency of style (semi-colons after each bullet )
may include, among others, the following aspects
All commas etc removed
SWEDAC 5.1 5.1.4 point Significance….
ED Change wording to get the way of writing the document more harmonized
Change to: Significance and extent of environmental aspects and associated environmental impacts.
Amended. See OAA comment
SWEDAC 5.1 5.1.4 point Geographic
TE Clarification of geographical dispersion needed Change point to: Geographical dispersion, Not agreed. Separate issues
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1 2 (3) 4 5 (6) (7)
MB1 Part, Clause No./
Subclause No./
Annex/Figure/Table(e.g. 3.1, Table 2)
Paragraph/List item/
Note(e.g. Note 2)
Type of
com-ment2
Comment (justification for change) by the MB Proposed change by the MB Convener observationson each comment submitted
al… including legal requirements
SWEDAC 5.1 5.1.4 TE Important point in IAF GD 6/2006 for EMS has been taken out.
Add to list: - potential interaction with sensitive environment
9th bullet amended
PCA 5.1 5.1.6Add clause after
Te The problem of time gap between visits in central office and local offices is not addressed
5.1.7 The certification body shall have procedure(s) for determining the time frame for completion audit in all the sites. The central office shall be visited first, followed by the sites in any order chosen by lead auditor.
Not agreed. Proposal too prescriptive and no argument to necessarily audit the central office first.
SWEDAC 5.1 5.1.6 TE Important point in IAF GD 6/2006 for EMS has been taken out.
Add to this clause : the surveillance program should include visits, within a reasonable time, to all sites of the organization in accordance with the certification body’s sampling method.
Not agreed. This is not sampling of sites
OAA 5.1 5.1.4 Item 8
ED Environmental Management System reference is incorrect .
Significance and extent of aspects and associated impacts for environmental management systems
Agreed, but (EMS) is retained for clarity
DAR/ TGA 5.2 5.2.1 ge See comment to 0.2. The Certification bodies shall have a documented procedure for determining..
Agreed
Inmetro 5.2 5.2.1Last line
This document is intended to be a “Normative criteria”, however the term “guidance” appears on this item
“... in this normative criteria”. Agreed. "guidance" replaced with "document" or "criteria" as appropriate
DAR/ TGA 5.2 5.2.2 ge Records on how the sample approach has been adapted to the company shall be available in any multi-site certification – not only restricted when the certification body’s procedures result in a smaller sample as required from the guidance.
Delete the need for records in 5.2.2 and add: “The certification body shall have records on each application of multi-site sampling justifying that it is in accordance with this guidance.”
Agreed
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1 2 (3) 4 5 (6) (7)
MB1 Part, Clause No./
Subclause No./
Annex/Figure/Table(e.g. 3.1, Table 2)
Paragraph/List item/
Note(e.g. Note 2)
Type of
com-ment2
Comment (justification for change) by the MB Proposed change by the MB Convener observationson each comment submitted
Inmetro 5.2 5.2.2Second line
This document is intended to be a “Normative criteria”, however the term “guidance” appears on this item
“...of the normative criteria set out...” Agreed. "guidance" replaced with "document" or "criteria" as appropriate
Inmetro 5.2 5.2.3Second, third and fourth paragraphs
The square root symbol is missing “ y = x “ Not understood. Square root sign appeared normal when I downloaded from IAF web-site. May be a "WORD" problem
JAB 5.2 5.2.3 te Consistency with 17021 Surveillance audit visit: …
Recertification audit: …
Agreed
JAB 5.2 5.2.3 te The letter ‘v’ is substituted for the square root. Correctly represent the square root (√) Not understood. Square root sign appeared normal when I downloaded from IAF web-site. May be a "WORD" problem
UKAS 5.2 5.2.3Line 1
te Low to medium risk activity. This is not defined .It will be different for different management system standards.
For environment and health and safety management systems, risk is a fundamental aspect of the standard and the scope of the standard i.e low medium risk of , for example, environmental pollution or harm to an individual’s occupational health and safety
For quality management systems what is low to medium risk,? Is it of the product failing to meet the customer requirements, or are we confusing the likely impact/consequence of a product failing. Eg a
Reword as follows.
The following calculation is based on the example of a single, or series of simple production/service processes with less than fifty employees at each site. Eg ? ? ?provide typical examples…
The minimum number……….
Initial
Surveillance
Re -certification
Noted. However, brief was to produce document without significant change. The proposal re-opens the whole debate on risk. Much of the proposal is covered in clause 9.1.4 of ISO/IEC 17021
Note added to require CBs to define risks of activities
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MB1 Part, Clause No./
Subclause No./
Annex/Figure/Table(e.g. 3.1, Table 2)
Paragraph/List item/
Note(e.g. Note 2)
Type of
com-ment2
Comment (justification for change) by the MB Proposed change by the MB Convener observationson each comment submitted
carpet or a bridge. ( or a small switch in the new motor car) The purchaser expects both to meet the specified requirements.
For QMS and FSMS there should be no low/medium risk of the system failing, certification is confidence that the product meets customer requirements.
Many “low risk “products have very complex processes
Establish a minimum number of sites based on a single process then CB will be required to increase the sample size based on more complex operations
Add at end of 5.2.3
An increased sample size will be required where complex processes are involved.
DANAK 5.2 5.2.5 te Other relevant factors may indicate the need for increase of the sample.
Underlined text to be added in the list of factors:
Variations in working practices, e.g. shift working
Differing legal requirements
Significance and extent of aspects and associated impacts for EMS management systems
Agreed
Not a factor on sample size
Agreed
EGAC 5.2 5.2.5 te 5.2.5 The size or frequency of the sample should be increased where the certification body’s risk analysis of the activity covered by the management system subject to certification indicates special circumstances in respect of factors such as
This phrase needs to be further explained e.g., in a note. This note should explain how this sampling frequency be increased. Examples should be given e.g., decreasing the surveillance period.
Disagree. Proposal is for prescriptive "how"
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1 2 (3) 4 5 (6) (7)
MB1 Part, Clause No./
Subclause No./
Annex/Figure/Table(e.g. 3.1, Table 2)
Paragraph/List item/
Note(e.g. Note 2)
Type of
com-ment2
Comment (justification for change) by the MB Proposed change by the MB Convener observationson each comment submitted
INAB 5.2 5.2.5 Ed Consistency of style Semi-colons after each bullet Agreed. All commas etc removed
DANAK 5.2 5.2.6 ed The number of National offices is missing The number to be added:
4 National offices: sample = 2: minimum 1 at random
Agreed
Inmetro 5.2 5.2.6Second line from the example
The number of “national offices” is missing “4 national offices “ Agreed
JAB 5.2 5.2.6 ed Typo (The number 4 is missing.) 4 national offices: sample=2 Agreed
OAA 5.2 5.2.6 Example
ED The number of National offices of the example is missing (4).
Example:
1 head office: visited at each audit cycle (initial/surveillance/recertification)
4 National offices: sample = 2: minimum 1 at random
27 regional offices: sample = 6: minimum 2 at random
1700 local branches: sample = 42: minimum 11 at random.
Agreed
COFRAC 5.3 5.3.2 ed For clarity to express that the calculation of audit duration time is realised site per site, using the appropriate IAF guidance on each site. “Normally “ is not necessary, the criteria is already a “should” one
“Normally the number of man-days per site, including the central office, should be consistent with the most recently published IAF guidance calculation of man-days for the relevant standard.” By “The number of man-days per site, including the central office,
Agreed
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1 2 (3) 4 5 (6) (7)
MB1 Part, Clause No./
Subclause No./
Annex/Figure/Table(e.g. 3.1, Table 2)
Paragraph/List item/
Note(e.g. Note 2)
Type of
com-ment2
Comment (justification for change) by the MB Proposed change by the MB Convener observationson each comment submitted
should be calculated using for each sit the most recently published IAF guidance for calculation of man-days for the relevant standard.”
HKAS 5.3 5.3.2 ed The document on auditor manday is not guidance Replace the word “guidance” with “criteria for”
Agreed.
SCC 5.3 5.3.2 ed Use of “man-days”. This is no longer acceptable as a term.
Please use “person days.” Disagree. Man days is common parlance worldwide and is not gender specific
DANAK 5.3 5.3.3 te Reductions is a common used possibility for certification bodies and any justification need to be recorded in order to maintain historical records, that will be present when there are change of personnel.
Text to be added:
“Reasons justifying reductions shall be recorded by the certification body. “
Agreed
DAR/ TGA 5.3 5.3.3 te Not all clauses of standard could be applied in the audit of central office – as it is the case for the local sites.
“Reductions can be applied to take into account the clauses that are not relevant to the central office and the local sites, or where there is considerable commonality of activities, products and processes at sites. However, certification body shall consider, that auditing the central office requires additional time when multi - site is applied.”
Agreed in part. Last sentence not justified
HKAS 5.3 5.3.3 te The reduction in audit time for “commonality of activities and processes at sites” has been accounted for by sampling. No further reduction should be allowed.
Delete the following from clause 5.3.3:“, or where there is considerable commonality of activities and processes at sites”
Agreed
HKAS 5.3 5.3.4New clause
te Clause 4.3.6 of GD2:2005 should be included for setting a minimum.
Insert a new clause:
5.3.4 The total time expended on initial
I do not support this clause, but it has been retained in simplified form after
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MB1 Part, Clause No./
Subclause No./
Annex/Figure/Table(e.g. 3.1, Table 2)
Paragraph/List item/
Note(e.g. Note 2)
Type of
com-ment2
Comment (justification for change) by the MB Proposed change by the MB Convener observationson each comment submitted
assessment and surveillance (understood as the total sum of the time spent at each site plus the central office) should never be less than that which would have been calculated for the size and complexity of the operation if all the work had been undertaken at a single site (i.e. with all the employees of the company in the same site). In most cases it will be considerably more.
objections from several parties. The last sentence is superfluous.
NAC 5.3 - Te 1. There are no man-day requirements for Multiple Sites and Temporary Sites as in GD2 and GD6.
2. The reductions for auditor time requirements are not clear.
1. It should be added man-day requirements for Multiple Sites and Temporary Sites in this IAF Normative Criteria.
2. It should be clarified for reductions for auditor time requirements.
Noted. This will be addressed in the new "stand alone " document for man day calculations
NAC 2.2 - Te There are no assessment requirements for Temporary Sites and also how to sampling as in GD2 and GD6.
It should be added and clarified. Not agreed. The calculation should be the same for any sites if they are included in the network of sites.
Late Comments
NABCB (ICL)
Cl 4.3.1 Line 3 Ed “Evaluation” is preferable to “investigation” Replace “investigation” with “evaluation” Noted but considered unnecessary
NABCB (ICL)
Cl 4.3.3 Line 1 Te Make a reference to ISO 17000 for definition of non-conformity
Add after non-conformity (refer to ISO 17000:2004)
Not agreed. Refereed back to 17021 as the relevant reference for certification
NABCB (ICL)
Cl 4.4.6 Line 2 Te Additional sites may be added as a part of enhancement of scope activities
Add after “surveillance/recertification” – “enhancement of scope”
Agreed
1 MB = Member Body (enter the IAF Member acronym, e.g. RvA)2 Type of comment: ge = general te = technical ed = editorial NB Columns 1, 2, 4, 5 are compulsory.
Page 26 of 27IAF electronic balloting commenting template/version 2002-10
IAF/ILAC Template for comments – Certification of Multiple Sites Date: 2007-05-17 Document: IAF-GM-07-012 (NCD Z:200X)
1 2 (3) 4 5 (6) (7)
MB1 Part, Clause No./
Subclause No./
Annex/Figure/Table(e.g. 3.1, Table 2)
Paragraph/List item/
Note(e.g. Note 2)
Type of
com-ment2
Comment (justification for change) by the MB Proposed change by the MB Convener observationson each comment submitted
NABCB (ICL)
Cl 5.1.4 Bullet point 8
Te This does not seem to be a relevant criteria for sampling of sites
Delete the bullet point Noted, but others think it is relevant
NABCB (ICL)
Cl 5.1.4 Te Add 2 new bullet points regarding differences in language, social norms etc, regulatory requirements
Add 2 bullet points – “Differences in language, work culture, social norms”
“Any differences in applicable regulatory/statutory requirements for different regions/countries
Agreed, but combined in other bullet points
NABCB (BVCI)
Cl 5.3 Entire clause
Te The document should clearly define the criteria to be used [viz. whether the mandays should be calculated individually per site and added OR should be calculated for the total cumulative manpower and distributed OR should be calculated based on the manpower in the sampled sites] for calculating the audit time. In the absence of uniform guidance, each CB will define its own criteria and hence the purpose of the guidance will be defeated.
An example shall be provided for manday calculation under all possible scenarios to avoid any misinterpretation or come out with a manday calculator like IATF has for TS scheme
Noted. However, it is considered that one example is enough. This is a minimum change document and changes have been kept to a minimum
1 MB = Member Body (enter the IAF Member acronym, e.g. RvA)2 Type of comment: ge = general te = technical ed = editorial NB Columns 1, 2, 4, 5 are compulsory.
Page 27 of 27IAF electronic balloting commenting template/version 2002-10