M0068122Q00200002_Amendment 002.pdf

M28310278113

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

The purpose of this amendment is to:

1.) Provide additional answ ers to tw o previous questions.

2.) Include a copy of current 9001:2015 Certif icates for both SMU and MEDLOG.

3.) Adjust verbiage and w ith in the SOW (changes in red).

4.) Extend the time for responses.

5.) Adjust Period of Performance.

All other terms and conditions remain unchanged.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 9

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY 25-May-2022

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X M0068122Q0020

X 9B. DATED (SEE ITEM 11)

09-May-2022

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer X is extended, is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

(a) By completing Items 8 and 15, and returning 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

25-May-2022

CODE

REGIONAL CONTRACTING OFFICE-MCIWEST

P O BOX 555027

CAMP PENDLETON CA 92055-5027

M00681 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

M0068122Q0020

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been deleted:

SOLICITATION AMENDMENT

SECTION SF 1449 - CONTINUATION SHEET

SOLICITATION/CONTRACT FORM

The required response date/time has changed from 23-May-2022 10:00 AM to 01-Jun-2022 10:00 AM.

DELIVERIES AND PERFORMANCE

The following Delivery Schedule item for CLIN 0001 has been changed from:

DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

POP 01-JUN-2022 TO

31-MAY-2023

N/A N/A

FOB: Destination

To:

DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

POP 20-JUN-2022 TO

19-JUN-2023

The following Delivery Schedule item for CLIN 0002 has been changed from:

CAGE

POP 01-JUN-2022 TO

31-MAY-2023

CAGE

POP 20-JUN-2022 TO

19-JUN-2023

The following Delivery Schedule item for CLIN 1001 has been changed from:

CAGE

POP 01-JUN-2023 TO

31-MAY-2024

CAGE

POP 20-JUN-2023 TO

19-JUN-2024

The following Delivery Schedule item for CLIN 1002 has been changed from:

CAGE

POP 01-JUN-2023 TO

31-MAY-2024

CAGE

POP 20-JUN-2023 TO

19-JUN-2024

The following Delivery Schedule item for CLIN 2001 has been changed from:

CAGE

POP 01-JUN-2024 TO

31-MAY-2025

CAGE

POP 20-JUN-2024 TO

19-JUN-2025

The following Delivery Schedule item for CLIN 2002 has been changed from:

CAGE

POP 01-JUN-2024 TO

31-MAY-2025

CAGE

POP 20-JUN-2024 TO

19-JUN-2025

The following Delivery Schedule item for CLIN 3001 has been changed from:

CAGE

POP 01-JUN-2025 TO

31-MAY-2026

CAGE

POP 20-JUN-2025 TO

19-JUN-2026

The following Delivery Schedule item for CLIN 3002 has been changed from:

CAGE

POP 01-JUN-2025 TO

31-MAY-2026

CAGE

POP 20-JUN-2025 TO

19-JUN-2026

The following Delivery Schedule item for CLIN 4001 has been changed from:

CAGE

POP 01-JUN-2026 TO

31-MAY-2027

CAGE

POP 20-JUN-2026 TO

19-JUN-2027

The following Delivery Schedule item for CLIN 4002 has been changed from:

CAGE

POP 01-JUN-2026 TO

31-MAY-2027

CAGE

POP 20-JUN-2026 TO

19-JUN-2027

The following have been added by full text:

P0001 AMENDMENT Q&A

Solicitation: M0068122Q0020 Title of Requirement: ISO 9001:2015 Auditing Services Q&A #1-10 as of 10 May 2022

Questions Answers 1 State the total number of FTE, PTE, and contracted personnel working within the scope of the QMS for each organization excluding vacancies.

SMU – 254

MEDLOG – 77 {NOTE: All personnel are FTE…no contractors}

2 Provide copies of the current ISO 9001 certificates for both organizations (please note that these are public documents and are not subject to FOIA. Certification Bodies are required to verify that the current certificates are free from suspension, revocation, or the

Copies will be provided upon award. Proof of copies has been verified by the Contracting Officer.

threat of suspension or revocation at the time of bidding).

3 State any areas of non-applicability to ISO 9001 for each organization (note: design is stated generally in the PWS. However, SMU has additional areas of non-applicability which must be provided as well).

MEDLOG – ISO 9001:2015 Clauses: 8.4, 8.4.3, and 8.5.3 SMU – ISO 9001:2015 Clauses: 7.1.5.2, 8.3, 8.5.1(f), 8.5.3, and 8.5.5

4 State whether each organization has in its possession the previous 3 years of audit reports (yes or no)

Yes

5 State whether each organization has in its possession the previous 3 years of corrective actions issued by the current Certification Bodies (yes or no).

Yes

6 State whether either organization has been issued any MAJOR nonconformances during the previous 3 years (yes or no).

Yes

7 If Question #6 is YES, please indicate which organization received the MAJOR nonconformance and how many were issued.

SMU - 1

8 State whether each organization has all previous ISO 9001 certificates in their possession (yes or no).

SMU – All except 2014-2017 {Cannot Locate}

MEDLOG - YES

9 ISO 17021 governing Certification Bodies and certification activities requires one surveillance audit per calendar year (not fiscal year). The Period of Performance stated is not a calendar year. For example, the Base Year for SMU has a POP of June 1, 2022 to May 31, 2023. The surveillance audit must occur in calendar year 2022 which means that the period from January 1, 2023 to May 31, 2023 is useless. In addition, the recertification audit POP should be 60 days prior to the expiration of the current certificate and be stated as a month.

Note: The reason for the POP dates starting at 1 June 2022 is not in reference to FY. It is, however, IRT the contract expiration date being 31 May 2022. Vendor dates must consider current certification expiration to avoid lapse. It is understood that the audits must occur in calendar year 2022. The re-certification or surveillance should be for 1 year which should cover 1 Jan 2023-May 2023. I’m uncertain as to how to avoid starting at 2023 without a certification lapse.

The Federal Government begins the start of a period of performance upon date of award or shortly thereafter. We cannot back date contracts.

10 The Solicitation contains a table which includes audit durations. Audit durations are not and cannot be dictated by the client. Durations are determined by the mandatory use of IAF MD 5 after reviewing the quantity of personnel working within the scope of the QMS at each location along with the areas of non-applicability. The durations in the Solicitation must be removed.

Concur with removing the duration table.

P0002 AMENDMENT Q&A

Solicitation: M0068120Q0020

Title of Requirement: ISO 9001:2015 Auditing Services Q&A #1-2 as of 24 May 2022

Questions Answers 1 / Q: 2 on initial Q&A

An accredited Certification Body is required to verify the status of certification at the time of bidding and not post-award the validity of the certificates previously issued. The Contracting Office possessing these certificates does not satisfy these requirements.

The Offeror must contact the current CB to verify that the certificates are free from suspension, revocation or the threat of suspension or revocation.

These certificates are public documents and are not subject to FOIA. If the agency is unwilling to release these certificates to all offerors, our firm will file a GAO preaward protest.

Certificates are included as attachments on the solicitation

2 / Not on initial Q&A

ISO 9001:2015 will be revised to ISO 9001:2022 on September 15, 2022. The nature of those changes is unknown at this time. All organizations will have 3 years from September 15, 2022 to transition to ISO 9001:2022. The PWS is silent on this issue.

At this time inclusion of transition to 9001:2022 will not be included due as the next version has not been confirmed as to release date see below research found:

According to ISO, voting has just begun and will finish April 26. We expect the amendment to be released in May or June, 2022, after which it will be possible to (re)certify against it.

Q: When will the next edition of ISO 9001 be released?

A: Also allowing for a development period of 3 years, this would only result in a new edition of ISO 9001 being achieved towards the end of 2025. A further transition period of 3 years after publication, would see organizations only needing to meet the revised requirements by 2028.ISO.org has been contacted to verify this information

SOW UPDATED

STATEMENT OF WORK

1. Background

1.1 The Supply Management Unit (SMU) and the Medical Logistics Company (MEDLOG), 1st Supply Battalion, 1st Marine Logistics Group, I Marine Expeditionary Force, Camp Pendleton, California, has embarked on a mission to stabilize and normalize its processes and provide product quality assurance to its customers. Both entities, the SMU and MEDLOG have chosen the International Organization for Standardization (ISO) 9001:2015, as the methodology to attain its goal of normalization. The ISO sets out the requirements of a quality management system. The SMU and MEDLOG have taken necessary actions to implement ISO 9001:2015 into its processes and now must take the next step; recertification as appropriate of ISO 9001:2015.

The SMU and MEDLOG, 1st Supply Battalion has a requirement for ISO 9001:2015 service quality management assessment registration/certification without design by a third party auditing activity. The registration shall be two certifications at multiple sites. Contractor must have Accreditation from a member of the International Accreditation Forum (IAF) whose scope of accreditation includes management system certification.

2. Scope of Work

2.1 The contractor shall administer the recertification assessment, surveillance, and accreditation audit during the years of 2022, 2023, 2024, 2025, 2026. The recertification shall be valid for three years.

1) 2022 Annual Surveillance Audit will be conducted at SMU sites.

2) 2022 Recertification as appropriate will be conducted at MEDLOG sites.

3) 2023 Recertification audit as appropriate will be conducted at SMU sites.

4) 2023 1st Annual Surveillance Audit will be conducted at MEDLOG sites.

5) 2024 1st Annual Surveillance Audit will be conducted at SMU sites.

6) 2024 2nd Annual Surveillance Audit will be conducted at MEDLOG sites.

7) 2025 2nd Annual Surveillance Audit will be conducted at SMU sites.

8) 2025 Recertification audit as appropriate will be conducted at MEDLOG sites.

9) 2026 Recertification audit as appropriate will be conducted at SMU sites.

10) 2026 Annual Surveillance Audit will be conducted at MEDLOG sites.

2.2 The services shall be performed between the hours of 0800-1600, Monday through Friday unless otherwise specified by the Officer in Charge (OIC), SMU or the Commanding Officer, MEDLOG, respectively. Audit durations will be calculated in accordance with IAF MD 5.

2.3 Upon completion of the audits the contractor’s representative will report to the Technical Point of Contact (TPOC) Mr. Robert Broussard, in Bldg. 2251 (Phone number (760) 725-4422) or the Supply Officer (Phone number

(760) 725-3559) in Bldg. 22112, to have one of them sign for the services provided. Also provide Mr. Broussard or the Supply Officer with the copies of the audit reports and feedback at the conclusion of each stage and closeout.

3. Location of Work

3.1 All work shall be performed on site at the following locations aboard Marine Corps Base, Camp Pendleton:

1) Building 2251 SMU General Account (GA)

2) Building 2251 SMU Storage

3) Building 2251 SMU Customer Service

4) Building 2262 SMU Distribution Management Office (DMO)

5) Building 2246 SMU Preservation, Packaging, and Packing (P3)

6) Building 220110 MEDLOG Headquarters

7) Building 220111 MEDLOG Operations Facility

4. Period of Performance

4.1 The Period of Performance for this contact will be as follows:

1) 20 June 2022 – 19 June 2023 Base Year

2) 20 June 2023 – 19 June 2024 Option Year One (OY1)

3) 20 June 2024 – 19 June 2025 Option Year Two (OY2)

4) 20 June 2025 – 19 June 2026 Option Year Three (OY3)

5) 20 June 2026 – 19 June 2027 Option Year Four (OY4)

5. Deliverables

5.1 Per the scope of work the contractor shall perform audit reports and services.

5.2 The contractor shall furnish all labor, supervision, tools, materials, equipment, and transportation necessary to conduct the audits.

6. Specialized Requirements

6.1 The contractor must have experience with military organizations that have a high deployment rate.

7. Government Property

7.1 There will be no Government Furnished Property provided to the contractor for performance under this contract.

The vendor must provide all materials required to perform the registration/certification assessment.

8. Invoicing

8.1 The invoices may be submitted for payment after services has been rendered as no advanced payment/deposit is authorized. The vendor must present itemized necessary fees for Certification in the quote as a bottom line amount.

Fees that are not clearly itemized shall not be accepted. If fewer hours/days are used during the period of performance the Government will adjust the quantity to the actual number of hours/days used and de-obligate the difference of excess funds by means of a contract modification.

9.0 Government Technical Point of Contact (TPOC)

The Contracting Officer shall designate a Government Technical Point of Contact (TPOC) during the term of this contract. The TPOC will provide assistance in identification and resolution of problems, conflicts in priority, subtask requirement definitions, and other operations type problems within the scope of this Statement of Work.

The TPOC will provide technical clarification and assistance in support of the contract requirements. The TPOC DOES NOT have the authority to make changes and/or give direction under this contract. The only authority under this contract authorized to make changes, give direction, and/or provide monetary adjustments is the Contracting Officer from the Regional Contracting Officer MCI-West, Camp Pendleton, CA, see paragraph 10.

TBD at time of AWARD

10.0 Contracting Officer Authority – The Contracting Officer is the only person authorized to direct changes in any of the requirements under this contract, and notwithstanding any provisions contained elsewhere in this contract, said authority remains solely in the Contracting Officer (Reference Block 31 on the SF1449). In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change will be considered to have been made without authority and solely at the risk of the contractor.

(End of Summary of Changes)