Clause Applicability Matrix R5 - 5 Handbook
Clause Applicability Matrix R5 - 5 Handbook
Clause Applicability Matrix R5 - 5 Handbook
The Organization is encouraged to use this Matrix for the planning of its internal audit program, to help ensure that all applicab
assessed at all relevant locations.
The Code of Practice for TL 9000 Certification Bodies requires the CB to obtain Pre-Audit Information from the Organization p
information is to include a cross-reference of applicable TL 9000 requirements to the Organization's processes, and a cross-re
sites (including virtual sites) at which they are performed. This Matrix is designed to conveniently capture the Pre-Audit Info re
although its use is not mandatory: the CB may accept this information in a different format. The CB uses the Pre-Audit Info to
of relevant processes and sites.
Note 1: The CB will make the final decision as to which requirements are assessed where.
Note 2: The clause matrix is not intended to drive clause-based auditing: the CB is required to perform process-based audits.
pplicability Matrix
nd its Certification Body (CB), to facilitate audit planning and the
V2 - 16-Jan-2017
Clauses by Process Processes
Instructions:
(1) Enter your organization's defined processes, one per
column, in the cells to the right (cells B2, C2, D2 etc.).
(2) In the column below each of the processes you just
entered in row 2, enter an 'X' in the cell on the row for each
requirement which is applicable to that process within your
organization's QMS.
See the next worksheet for a simple example.You should wind up with at
least one 'X' against each clause except those which you are declaring
as not applicable.
TL 9000 Measurements
Clauses by Process Processes
Management Processes
Infrastructure / Facilties
Information Technology
Clauses by Process: example
Quality Processes
Product Planning
Please note: Your organization may have fewer, more or
Manufacturing
different processes than shown in this example, and
Procurement
Engineering
different clause applicability. This is just an example.
Training
Service
Sales
4.0 Quality Management System
4.1 General requirements X X X X X X X X X X X
4.2 Documentation requirements
4.2.1 General X X
4.2.2 Quality manual X X
4.2.3 Control of documents X X X X X X X X X X X
4.2.3.C.1 Control of customer-supplied doc's and X X X X X X X
data of records
4.2.4 Control X X X X X X X X X X X
5.0 Management Responsibility
5.1 Management commitment X
5.2 Customer focus X
5.2.C.1 Customer relationship development X
5.2.C.2 Customer communication methods X
5.3 Quality policy X
5.4 Planning
5.4.1 Quality objectives X
5.4.1.C.1 Quality objectives X
5.4.2 Quality management system planning X
5.4.2.C.1 Long- and short-term quality planning X
5.4.2.C.2 Customer input X
5.4.2.C.3 Supplier input X
5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority X
5.5.2 Management representative X
5.5.3 Internal communication X
5.5.3.C.1 Organization performance feedback X
5.6 Management review
5.6.1 General X
5.6.2 Review input X
5.6.3 Review output X
6.0 Resource Management
6.1 Provision of resources X X X X X X X X X X X
6.2 Human resources
6.2.1 General X X X X X X X X X X X
6.2.2 Competence, awareness and training X X
6.2.2.C.1 Internal course development X
6.2.2.C.2 Quality and process improvement concepts X X
6.2.2.C.3 Prod. quality training opportunity X
awareness
6.2.2.C.4 Electrostatic discharge (ESD) training X
6.2.2.C.5 Advanced quality training X X
6.2.2.C.6 Hazardous conditions training content X
6.2.2.HV.1 Qualification of Personnel X
6.3 Infrastructure X X X X X X X X X X X
6.3.C.1 Infrastructure X X X
6.4 Work environment X X X X X X X X X X X
6.4.C.1 Work areas X X X X
7.0 Product Realization
7.1 Planning of product realization X X X X X X X
7.1.C.1 Life cycle model X X X X X X X
7.1.C.2 Disaster recovery X X X
7.1.C.3 Product security X X X X X X
7.1.C.4 End of life planning X X X X X X X
7.1.C.5 Tools management X X
7.1.HS.1 Configuration management plan X X
7.1.V.1 Service delivery plan X
7.2 Customer-related processes
7.2.1 Determination of requirements related to the product X X X X X X X
7.2.2 Review of requirements related to the product X X X X X X X
7.2.2.C.1 Closure tracking X X
7.2.2.C.2 Contract review X X
7.2.3 Customer communication X X X
7.2.3.C.1 Problem severity classification X X
7.2.3.C.2 Problem escalation X X
7.2.3.C.3 Problem report feedback X X
7.2.3.HS.1 Product replacement X X
7.2.3.HS.2 D&D process quality meas't data X
reporting
7.2.3.HS.3 Notification about critical problem reports X X
7.2.3.V.1 Notification about critical service disruption X X
7.3 Design and development
7.3.1 Design and development planning X X X
7.3.1.C.1 Project plan X X X
7.3.1.C.2 Requirements traceability X
7.3.1.C.3 Test planning X
7.3.1.C.4 Risk management planning X X X
7.3.1.C.5 Integration planning X
7.3.1.HS.1 Migration planning X
7.3.1.HS.2 D&D process quality meas't X
plan/implem'n
7.3.1.HS.3 Computer resources X
7.3.2 Design and development inputs X X X
7.3.2.C.1 Customer and supplier input X X X
7.3.2.C.2 Design and development requirements X X X
7.3.2.C.3 Requirements allocation X
7.3.2.H.1 Content of requirements X
7.3.2.S.1 Identification of software requirements X
7.3.3 Design and development outputs X
7.3.3.HS.1 Design and development output X
7.3.2.V.1 Services design and development output X X
7.3.4 Design and development review X
7.3.5 Design and development verification X
7.3.5.C.1 Verification of documentation X X
7.3.5.HS.1 Stress testing X
7.3.5.HS.2 Abnormal conditions X
7.3.5.HS.3 System testing X
7.3.6 Design and development validation X X X
7.3.6.HS.1 Release management X X X
7.3.7 Control of design and development changes X X X
7.3.7.C.1 Change management process X X X
7.3.7.C.2 Informing customers of design changes X X X
7.3.7.C.3 Problem resolution configuration mgmt. X
7.3.7.H.1 Component changes X
7.4 Purchasing
7.4.1 Purchasing process X
7.4.1.C.1 Purchasing procedure X
7.4.1.C.1 Supplier performance management X
7.4.2 Purchasing information X
7.4.3 Verification of purchased products X
7.5 Production and service provision
7.5.1 Control of production and service provision X X X
7.5.1.C.1 Customer Service resources X X
7.5.1.C.2 Product delivery X X
7.5.1.HS.1 Emergency service provisioning X X
7.5.1.HS.2 Installation plan X X
7.5.1.HV.1 Operational changes X X
7.5.1.S.1 Patching procedure X
7.5.1.S.2 Patch documentation X
7.5.1.S.3 Replication X
7.5.1.V.1 Software used in service delivery X X
7.5.1.V.2 Tool changes X X
7.5.2 Validation of processes for production/service provision X
7.5.3 Identification and traceability X X X
7.5.3.H.1 Traceability for recall X X X
7.5.3.H.2 Traceability of design changes X X X
7.5.3.HS.1 Product identification X X X
7.5.4 Customer property X
7.5.5 Preservation of product X
7.5.5.C.1 Electrostatic Discharge (ESD) Damage X
7.5.5.HS.1 Packaging and Labeling Verification X
7.5.5.HV.1 Deterioration X
7.5.5.S.1 Software Virus Protection X X
7.6 Control of monitoring and measuring equipment X X X
7.6.C.1 Equipment Identification X X X
8.0 Measurement, analysis and improvement
8.1 General X X X X X X X X X X X
8.2 Monitoring and measurement
8.2.1 Customer satisfaction X X
8.2.1.C.1 Customer satisfaction data X X
8.2.2 Internal audit X
8.2.3 Monitoring and measurement of processes X X X X X X X X X X X
8.2.3.C.1 Process measurement X X X X X X X X X X X
8.2.4 Monitoring and measurement of product X X
8.2.4.H.1 Periodic retesting X X
8.2.4.H.2 Content of testing X X
8.2.4 H.3 Frequency of testing X X
8.2.4 H.4 Testing of Repair and Return Products X X
8.2.4.HV.1 Inspection and test documentation X X X
8.2.4.HV.2 Inspection and test records X X X
8.2.4.S.1 Test documentation X X
8.3 Control of nonconforming product X X X X
8.4 Analysis of data X X X
8.4.C.1 Trend analysis of nonconforming product X X X X
8.4.HS.1 Field performance data X X X
8.4.V.1 Service performance data X X X X
8.5 Improvement
8.5.1 Continual improvement X X X X X X X X X X X
8.5.1.C.1 Continual improvement program(s) X X X X X X X X X X X
8.5.1.C.2 Employee participation X X X X X X X X X X X
8.5.2 Corrective action X X X X X X X X X X X
8.5.2.S.1 Problem resolution X
8.5.3 Preventive action X X X X X X X X X X X
TL 9000 Measurements X X
Processes by Site
Instructions:
(1) Enter your organization's defined processes, one per column, in the colored cells
in row 2 (cells D2, E2, F2 etc.).
(2) Enter your in-scope sites, one per row, in the colored cells in column A (cells A3,
A4, A5 etc.).
(3) For each site, enter the number of in-scope employees in column B, and the
products and services provided in column C.
(4) In the column below each of the processes you entered in row 2, enter an 'X' in
the cell on the row for each site where that process is performed.
See the next worksheet for a simple example.
Processes
Products
# of and
Sites Employees Services
Processes by site: example
Please note: Your organization may have fewer, more or different processes than
shown in this example. This is just an example. Processes
Management Processes
Infrastructure / Facilties
Information Technology
Quality Processes
Product Planning
Manufacturing
Procurement
Engineering
Products
Training
# of and
Service
Sales
Sites Employees Services
Raleigh NC (HQ) 62 Virtual PBX x x x x x x x x
Richardson TX 44 Set-top box x x x x x x x x x
San Jose CA 28 TAC, repair x x x x x