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Comprehensive ISO 9001:2015 Requirements Workbook

ISO 9001:2015 System Requirements DOCUMENT REFERENCE OR LOCATION


Quality Manual Procedure Other Means Comments
FARO Quality Manual
4 Context of the Organization ADM-000 Section 4
4.1 Understanding the organization and its context Section 4.1 All FARO Processes - BPs Management meetings,
and Supporting Docs Customer meeting,
Industry trends, etc.
4.2 Understanding the needs and expectations of interested parties Section 4.2 All FARO Processes - BPs Management/employee
and Supporting Docs meetings, Customer
meetings/discussions, etc.

4.3 Determining the scope of the management system Section 4.3 All FARO Processes - BPs
and Supporting Docs
4.4 Quality management system and its processes Section 4.4 All FARO Processes - BPs Process Interaction
and Supporting Docs Diagram
5 Leadership Section 5

5.1 Leadership and commitment Section 5.1 All FARO Processes - BPs
and Supporting Docs
5.1.1 General Section 5.1.1 All FARO Processes - BPs
and Supporting Docs
5.1.2 Customer focus Section 5.1.2 All FARO Processes - BPs
and Supporting Docs
5.2 Policy Section 5.2 Quality Policy Stmt
5.2.1 Establishing the quality policy Section 5.2.1 Quality Policy Stmt
5.2.2 Communicating the quality policy Section 5.2.2 BP-16 Postings, training
5.3 Organizational roles, responsibilities and authorities Section 5.3 All FARO Processes - BPs
and Supporting Docs
6 Planning Section 6

6.1 Actions to address risks and opportunities Section 6.1 All FARO Processes - BPs Preventive Actions
and Supporting Docs; BP- Management Review
15, BP-16 minutes
6.2 Quality objectives and planning to achieve them Section 6.2 BP-16 Management Review
minutes
6.3 Planning of changes Section 6.3 BP-16, BP-10
7 Support Section 7

7.1 Resources Section 7.1 All FARO Processes - BPs


and Supporting Docs;
7.1.1 General Section 7.1.1 All FARO Processes - BPs Management meetings
and Supporting Docs;
7.1.2 People Section 7.1.2 All FARO Processes - BPs Management meetings
and Supporting Docs; BP-
16
7.1.3 Infrastructure Section 7.1.3 BP-16, BP-13 Management meetings

7.1.4 Environment for the operation of processes Section 7.1.4 All FARO Processes - BPs Management meetings
and Supporting Docs; BP-
13, BP-16
7.1.5 Monitoring and measuring resources Section 7.1.5 BP-08 Calibration records
7.1.6 Organizational knowledge Section 7.1.6 All FARO Processes - BPs
and Supporting Docs; BP-
09
7.2 Competence Section 7.2 BP-09 Training Records
7.3 Awareness Section 7.3 BP-09 Training Records
7.4 Communication Section 7.4 BP-09 Training Records;
Employees meetings,
customer communication
7.5 Documented information Section 7.5 BP-10, BP-11 Masterlist/Record
Retention Matrix
7.5.1 General Section 7.5.1 BP-10, BP-11 Masterlist/Record
Retention Matrix
7.5.2 Creating and updating Section 7.5.2 BP-10, BP-11 Masterlist/Record
Retention Matrix
7.5.3 Control of documented information Section 7.5.3 BP-10, BP-11 Masterlist/Record
Retention Matrix
8 Operation Section 8

8.1 Operational planning and control Section 8.1 All FARO Processes - BPs
and Supporting Docs
8.2 Requirements for products and services Section 8.2 All FARO Processes - BPs
and Supporting Docs
8.2.1 Customer communication Section 8.2.1 BP-01, BP-02, BP-14
8.2.2 Determining the requirements for products and services Section 8.2.2 BP-01
8.2.3 Review of the requirements for products and services Section 8.2.3 BP-01
8.2.4 Changes to the requirements for products and services Section 8.2.4 BP-01
8.3 Design and development of products and services Section 8.3 - N.A. N.A.
8.3.1 General N.A. N.A.
8.3.2 Design and development planning N.A. N.A.
SQA 78 Rev. 02/10/2016
8.3.3 Design and development inputs N.A. N.A.
8.3.4 Design and development controls N.A. N.A.
8.3.5 Design and development outputs N.A. N.A.
8.3.6 Design and development changes N.A. N.A.
8.4 Control of externally provided processes, products and services Section 8.4 BP-01, BP-02, BP-07
8.4.1 General Section 8.4.1 BP-07
8.4.2 Type and extent of control Section 8.4.2 BP-07
8.4.3 Information for external providers Section 8.4.3 BP-07
8.5 Production and service provision Section 8.5 BP-02
8.5.1 Control of production and service provision Section 8.5.1 BP-02
8.5.2 Identification and traceability Section 8.5.2 BP-02
Section 8.5.3 BP-01, BP-02, BP-07, BP-
8.5.3 Property belonging to customers or external providers 12
8.5.4 Preservation Section 8.5.4 BP-02, BP-12
8.5.5 Post-delivery activities Section 8.5.5 BP-14
Section 8.5.6 Management review of
8.5.6 Control of changes BP-10 changes and approving
8.6 Release of products and services Section 8.6 BP-02
Nonconformance Report or
customer provided
8.7 Control of nonconforming outputs Section 8.7 BP-12 system/form
9 Performance evaluation Section 9

Daily reviews of customer


orders; Operations
Manager weekly reviews;
9.1 Monitoring, measurement, analysis and evaluation Section 9.1 BP-16 Management Reviews
Daily reviews of customer
orders; Operations
Manager weekly reviews;
9.1.1 General Section 9.1.1 BP-16 Management Reviews
Management Reviews;
9.1.2 Customer satisfaction Section 9.1.2 BP-16 Customer Surveys
Daily reviews of customer
orders; Operations
Manager weekly reviews;
9.1.3 Analysis and evaluation Section 9.1.3 BP-16 Management Reviews

9.2 Internal audit Section 9.2 BP-13 Audit Schedule/ ASR / AAR
Management Review
Meeting Minutes; FARO
9.3 Management review Section 9.3 BP-16 Metrics by site
Management Review
Meeting Minutes; FARO
9.3.1 General Section 9.3.1 BP-16 Metrics by site
Management Review
Meeting Minutes; FARO
9.3.2 Management review inputs Section 9.3.2 BP-16 Metrics by site
Management Review
Meeting Minutes; FARO
9.3.3 Management review outputs Section 9.3.3 BP-16 Metrics by site
10 Improvement Section 10

10.1 General Section 10.1 BP-14, BP-15, BP-16


10.2 Nonconformity and corrective action Section 10.2 BP-15 CAR
CAR, PAR, Management
10.3 Continual improvement Section 10.3 BP-14, BP-15, BP-16 Review Minutes

SQA 78 Rev. 02/10/2016


Summary of Processes

ISO 9001:2015 System Requirements LIST of PROCESS NAMES AND ASSOCIATED REQUIREMENTS (Replace "Process Name" below with the actual Process name) add
more Process columns if needed
Resource
Monitoring &
Management
Measurement
Customer Order Purchasing BP-08 Information Mgmt
Sales BP-01 BP-08, BP-12, BP- Process Name Process Name
Processing BP-02 Competency and BP-10, BP-11
13, BP-14, BP-15,
Training
BP-16
BP-09

4 Context of the Organization


4.1 Understanding the organization and its context X X X X X
4.2 Understanding the needs and expectations of interested parties
X X X X X
4.3 Determining the scope of the management system X X X X X
4.4 Quality management system and its processes X X X X X
5 Leadership
5.1 Leadership and commitment
5.1.1 General X X X X X
5.1.2 Customer focus X X X X X
5.2 Policy
5.2.1 Establishing the quality policy X X
5.2.2 Communicating the quality policy X X X
5.3 Organizational roles, responsibilities and authorities X X X X X
6 Planning
6.1 Actions to address risks and opportunities X X X X X
6.2 Quality objectives and planning to achieve them X X
6.3 Planning of changes X X
7 Support
7.1 Resources
7.1.1 General X X X X X
7.1.2 People X X X X X
7.1.3 Infrastructure X X X X X
7.1.4 Environment for the operation of processes X X X X X
7.1.5 Monitoring and measuring resources X
7.1.6 Organizational knowledge X X X X X
7.2 Competence X X
7.3 Awareness X X
7.4 Communication X X X
7.5 Documented information
7.5.1 General X
7.5.2 Creating and updating X
7.5.3 Control of documented information X
8 Operation
8.1 Operational planning and control X X X X X
8.2 Requirements for products and services
8.2.1 Customer communication X X X
8.2.2 Determining the requirements for products and services X X
8.2.3 Review of the requirements for products and services X X
8.2.4 Changes to the requirements for products and services X X
8.3 Design and development of products and services N.A.
8.3.1 General N.A.
8.3.2 Design and development planning N.A.
8.3.3 Design and development inputs N.A.
8.3.4 Design and development controls N.A.
8.3.5 Design and development outputs N.A.
8.3.6 Design and development changes N.A.
8.4 Control of externally provided processes, products and services

8.4.1 General X
8.4.2 Type and extent of control X
8.4.3 Information for external providers X
8.5 Production and service provision
8.5.1 Control of production and service provision X
8.5.2 Identification and traceability X
8.5.3 Property belonging to customers or external providers X X X
8.5.4 Preservation X
8.5.5 Post-delivery activities X
8.5.6 Control of changes X
8.6 Release of products and services X
8.7 Control of nonconforming outputs X
9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General X

SQA 78 Rev. 03/08/11 file:///conversion/tmp/scratch/444200538.xls


9.1.2 Customer satisfaction X
9.1.3 Analysis and evaluation X
9.2 Internal audit X
9.3 Management review
9.3.1 General X
9.3.2 Management review inputs X
9.3.3 Management review outputs X
10 Improvement
10.1 General X
10.2 Nonconformity and corrective action X
10.3 Continual improvement X

Groveport OH Jacksonville FL Groveport OH Groveport OH Groveport OH


Dallas TX
Sante Fe Springs CA

Norwalk CA(site extension


of Sante Fe Springs CA
Groveport OH
Columbus OH(site
extension of Groveport
OH)

SQA 78 Rev. 03/08/11 file:///conversion/tmp/scratch/444200538.xls


To help us plan a more effective audit, please complete table A (all) and, as applicable, Table B. Return these along with the cover page.
(See the bottom of page 3 for directions.)

For Customer to fill out


Company Name: FARO Logistics Solutions, Inc.
Contact's Name: Rich Greathouse/Rich Ashton
Contact's Title: COO/ ISO Consultant
Contact's E-mail: Rich.Greathouse@FAROUSA.com
Address: 7070 Pontius Rd (Building 1); 3275 Alum Creek Dr. (Building 2 - Extension)
City, State, Zip: Groveport, OH 43125 Columbus, OH 43207
Phone Number 614-3480818 / 614-365-0096
Fax Number 614-497-8318
Identify OASIS database
Administrator N.A.
Are there ITAR
Requirements? N.A.
Site employees: Groveport - 147 Columbus - 56
Number of Shifts: 2 shifts -
Shift hours: 7am - 3pm and 3:30 - 11pm
Number of Bldg. 2
% General Industries
business (ISO9001) 100%
% Aerospace Business
(AS91XX) 0%
% Automotive
Business (TS16949) 0%

For SQA use ONLY


IAF CODE(s)
Annual Audit-days
Project Number

A. Pre-audit Business Conditions Questionnaire (applicable to all):

Have your operations... In last six months Anticipated in next six months

Yes No Yes No

…been subjected to any type of customer sanctions (e.g., business X X


hold, parts containment, loss of business, etc.) or regulatory actions?

…been subjected to customer audit(s) or visit(s) X X


*Customer visits/audits
…had any negative “spikes” in quality or delivery performance? X X

…had any product recalls originating from end-user? X X

…had any changes to upper management? X X

…had a change in the identity of the Management Representative. X X

…had a change in ownership? …acquired new company? X X

…had any changes to its union/non-union status? X X

…had any strikes or a significant layoff of personnel? X X

…had a decrease in business of 25% or more? X X

…had an increase in business of 25% or more? X X

…installed any new processes? X X

…added new or closed existing facilities or operations? X X

…experienced significant changes in the preventive X X


maintenance program, e.g., actions delayed due to
production schedules, loss of trained personnel, etc.

B. Pre-audit audit performance metrics status (applicable to ALL certifications):

SQA 78 Rev. 02/10/2016


Instructions: Complete the following table(s) with current customer-supplied data (see the three options below).

TS 16949 Specific Instructions


On-time Automotive
Data OEMs % of
Automotive Customer Applicable PPM
Delivery current as Spec Req Automotive Supplier Code Notes
Supplier Code level Business
Chrysler Rating of:
Chrysler: 5 digits which could be followed by 1 or 2 capital letters
Ford: 5 characters, alphanumeric
Ford

SQA 78 Rev. 02/10/2016


General Motors GM: 9 digits without any blanks

BMW BMW: No format check

Fiat Fiat: No format check

Mercedes Benz Mercedes Benz: No format check


PSA PSA: Max length 10 positions with any characters
Renault Renault: No format check
Volkswagen Volkswagen: No format check
Other Automotive (i.e. Tier 1, 2, 3 etc.) Customers

Aerospace OEMs

SQA 78 Rev. 02/10/2016


To help us plan a more effective audit, please complete table A (all) and, as applicable, Table B. Return these along
(See the bottom of page 3 for directions.)

For Customer to fill out


Company Name: FARO Logistics Solutions, Inc.
Contact
's
Name: Rich Greathouse + Charlene Bartlett

Contact
's Title: COO + GM

Contact
's E-
mail: Rich.Greathouse@FAROUSA.com
Address: 1415 North Cockrell Road
City, State, Zip: Dallas Texas 75211
Phone Number 614-348-0818
Fax Number 614-497-8318
Identify
OASIS
database
Administrat
or N.A.
Are there
ITAR
Requireme
nts? N.A.
Site employees: 45
Number
of
Shifts: 2 shifts - Start times staggered
Shift
hours: 8 hours each

Number
of Bldg. 1

%
General
Industrie
s
business
(ISO9001
) 100%

%
Aerospac
e
Business
(AS91XX) 0%
%
Automoti
ve
Business
(TS16949
) 0%

For SQA use ONLY


IAF
CODE(s
)
Annual Audit-day

Project
Number

A. Pre-audit Business Conditions Questionnaire (applicable to all):

Have your operations... In last six months

Yes No

…been subjected to any type of customer sanctions (e.g., business X


hold, parts containment, loss of business, etc.) or regulatory actions?

…been subjected to customer audit(s) or visit(s) X

…had any negative “spikes” in quality or delivery performance? X

…had any product recalls originating from end-user? X

…had any changes to upper management? X

…had a change in the identity of the Management Representative. X

…had a change in ownership? …acquired new company? X

…had any changes to its union/non-union status? X

…had any strikes or a significant layoff of personnel? X

…had a decrease in business of 25% or more? X

…had an increase in business of 25% or more? X

…installed any new processes? X


…added new or closed existing facilities or operations? X

…experienced significant changes in the preventive X


maintenance program, e.g., actions delayed due to
production schedules, loss of trained personnel, etc.

B. Pre-audit audit performance metrics status (applicable to ALL certifications):

Instructions: Complete the following table(s) with current customer-supplied data (see the three options below).

TS 16949 Specific Instructions


Automotive OEMs
Automoti Applicabl On-time Data % of
ve e PPM Automotiv
Delivery current Spec Req Supplie
Custome Supplier level e
Rating as of: Business
r Code
Chrysler
Chrysler: 5 digits which could
Ford Ford: 5 characters, alphanum
General
Motors GM: 9 digits without any blank

BMW BMW: No format check

Fiat Fiat: No format check

Merced
es Benz
Mercedes Benz: No format ch
PSA PSA: Max length 10 positions
Renault Renault: No format check
Volkswagen Volkswagen: No format check
Other Automotive (i.e. Tier 1, 2, 3 etc.) Customers

Aerospace OEMs
1. If you are a supplier to Boeing, Northrup, Honeywell or others listed below, access the specific on-line system to o
2. Print the screen showing your performance levels for each of your aerospace customers providing such informati
3. If none of these are your customers, enter the names of your aerospace customers and fill in all boxes, inclu
Applicabl
Custome PPM On-time Data
e
r Delivery current Spec Req
level Supplier
Rating as of:
Code
Boeing
Northrup
Grumma
n

Honeywe
ll
Goodric
h
Bombar
dier
Textron

Embraer
Gulfstream

For Aerospace Clients Only 20


Organization Shift
Business 18
Organization Revenue
% of
19
Personnel Numbers Patterns
Revenue Total Employees
(optional) Revenue F/P/T* % of Total Workforce E/D/L/N**
Aviation
Space
Defense
Other

F=Full time, P=Part Time, T= Temporary **E= Early Shift, D=Day Shift, L=Late Shift, N=Night Shift

For Aerospace Clients Only


21
List of Major Current(C)/Potential(P) Aviation, Space, and Defense Major Customers

Customer Address Contact

Please sign below. Your signature is approval of the audit plan and attestation that the information you provided in T
Also, if applicable, enter a Purchase Order in the place provided.

Rich Greathouse
Client Approval Date Purchase Order # (if applicable)

Return the documents to your assigned auditor indicated below before the audit date or as otherwise arranged (e.g.

Assigned Auditor Email :


B. Return these along with the cover page.

out
Y

Anticipated in next six months

Yes No

X
X

ee options below).

Supplier Code Notes

Chrysler: 5 digits which could be followed by 1 or 2 capital letters


Ford: 5 characters, alphanumeric

GM: 9 digits without any blanks


BMW: No format check
Fiat: No format check

Mercedes Benz: No format check


PSA: Max length 10 positions with any characters
Renault: No format check
Volkswagen: No format check
tomers

cific on-line system to obtain performance data. Fill


roviding such information and make this available to
fill in all boxes, including the name of the customer.
20
Organization Shift
Patterns
Employees
E/D/L/N**

% of
Business

mation you provided in Tables A and B is correct.


Order # (if applicable)

herwise arranged (e.g., first day of audit).


To help us plan a more effective audit, please complete table A (all) and, as applicable, Table B. Return these along
(See the bottom of page 3 for directions.)

For Customer to fill out


Company Name: FARO Logistics Solutions, Inc.

Contact's
Name: Rich Greathouse + Kraig Frymier

Contact's Title: COO + GM

Contact's E-
mail: Rich.Greathouse@FAROUSA.com
Address: 14911 Valley View Ave (Building 1); 15625 Showmaker Ave (Building 2 - Extension)
City, State, Zip: Sante Fe Springs CA 90670 Norwalk, CA 90650
Phone Number 614-365-0096
Fax Number 614-497-8318

Identify OASIS
database
Administrator N.A.

Are there ITAR


Requirements? N.A.
Site employees: 80 total

Number of
Shifts: 2 shifts - Start times staggered

Shift hours: 8 hours each

Number of
Bldg. 2

% General
Industries
business
(ISO9001) 100%

% Aerospace
Business
(AS91XX) 0%
% Automotive
Business
(TS16949) 0%

For SQA use ONLY

IAF CODE(s)
Annual Audit-days

Project
Number

A. Pre-audit Business Conditions Questionnaire (applicable to all):

Have your operations... In last six months

Yes

…been subjected to any type of customer sanctions (e.g., business


hold, parts containment, loss of business, etc.) or regulatory actions?

…been subjected to customer audit(s) or visit(s)

…had any negative “spikes” in quality or delivery performance?

…had any product recalls originating from end-user?

…had any changes to upper management?

…had a change in the identity of the Management Representative.

…had a change in ownership? …acquired new company?

…had any changes to its union/non-union status?

…had any strikes or a significant layoff of personnel?

…had a decrease in business of 25% or more?

…had an increase in business of 25% or more?

…installed any new processes?


…added new or closed existing facilities or operations?

…experienced significant changes in the preventive


maintenance program, e.g., actions delayed due to
production schedules, loss of trained personnel, etc.

B. Pre-audit audit performance metrics status (applicable to ALL certifications):

Instructions: Complete the following table(s) with current customer-supplied data (see the three options below).

TS 16949 Specific Instructions


Automotive OEMs

Applicable On-time Data % of


PPM Automotiv
Supplier Delivery current Spec Req
Automotive level e
Code Rating as of: Business
Customer
Chrysler

Ford
General Motors

BMW
Fiat
Mercedes Benz

PSA
Renault
Volkswagen
Other Automotive (i.e. Tier 1, 2, 3 etc.) Customers

Aerospace OEMs
1. If you are a supplier to Boeing, Northrup, Honeywell or others listed below, access the specific on-line system to o
2. Print the screen showing your performance levels for each of your aerospace customers providing such informati
3. If none of these are your customers,Applicabl
enter the names of your aerospace customers and fill in all boxes, i
Aerospace On-time Data
e
Customer PPM level Delivery current Spec Req
Supplier
Rating as of:
Code
Boeing
Northrup
Grumman

Honeywell

Goodrich

Bombardier

Textron

Embraer
Gulfstream

For Aerospace Clients Only


Business 18
Organization Revenue
% of
19
Personnel Numbers
Revenue Total
(optional) Revenue F/P/T* % of Total Workforce
Aviation
Space
Defense
Other

F=Full time, P=Part Time, T= Temporary **E= Early Shift, D=Day Shift, L=Late Shift, N=Night Shift

For Aerospace Clients Only


21
List of Major Current(C)/Potential(P) Aviation, Space, and Defense Major Customers

Customer Address Contact

Please sign below. Your signature is approval of the audit plan and attestation that the information you provided in T
Also, if applicable, enter a Purchase Order in the place provided.

Rich Greathouse 1-Jun-17


Client Approval Date Purchase Order # (if ap

Return the documents to your assigned auditor indicated below before the audit date or as otherwise arranged (e.g.

Assigned Auditor Email :


e B. Return these along with the cover page.

mer to fill out

ng 2 - Extension)
use ONLY

In last six months Anticipated in next six months

No Yes No

X X

X X

X X

X X

X X

X X

X X

X X

X X

X X

X X

X X
X X

X X

hree options below).

Supplier Code Notes

Chrysler: 5 digits which could be followed by 1 or 2 capital letters


Ford: 5 characters, alphanumeric

GM: 9 digits without any blanks


BMW: No format check
Fiat: No format check

Mercedes Benz: No format check


PSA: Max length 10 positions with any characters
Renault: No format check
Volkswagen: No format check
Customers

ecific on-line system to obtain performance data. Fill in all


providing such information and make this available to the
s and fill in all boxes, including the name of the customer.
20
Organization Shift
Patterns
Employees
E/D/L/N**

% of
Contact Business

mation you provided in Tables A and B is correct.


Purchase Order # (if applicable)

therwise arranged (e.g., first day of audit).

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