1. Understanding (and Untangling) Verification and Validation Requirements
ISO 9001 vs. CMMI-Dev 1.2

2. Objectives Discuss design verification vs. validation
Get a taste of both ISO 9001 and CMMI
Perform a quick comparison of the two standards (with a limited scope)
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3. Dissimilar Scope and Focus
CMMI for Development
ISO Generic
CMMI - “Improving Processes for Better Products”
ISO “Quality management systems – Requirements
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4. Validation vs. Verification
CMMI Says It Best
Verification = “You built (designed) it right”
Validation = “You built (designed) the right thing.”
“…verification addresses whether the work product properly reflects the specified requirements.”
“Validation demonstrates that the product, as provided, will fulfill its intended use…”
(CMMI-Dev 1.2, pp 483)
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5. How ISO 9000 Explains It
3.8.4 Verification - “Confirmation, through the provision of objective evidence (3.8.1), that specified requirements (3.1.2) have been fulfilled.
NOTE 1 The term “verified” is used to designate the corresponding status.
NOTE 2 Confirmation can comprise activities such as:
- performing alternative calculations,
- comparing a new design specification (3.7.3) with a similar proven design specification,
- undertaking tests (3.8.3) and demonstrations, and
- reviewing documents prior to issue.”
3.8.5 Validation – “Confirmation, through the provision of objective evidence (3.8.1), that the requirements (3.1.2) for a specific intended use or application have been fulfilled.
NOTE 1 The term “validated” is used to designate the corresponding status.
NOTE 2 The use conditions for validation can be real or simulated.”
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6. Source of Requirements
Verification
ISO 9001 section Design and Development Verification
CMMI Part Two, Verification (VER)
SG 1-3, SP 1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1, 3.2
Validation
ISO 9001 section Design and Development Validation
CMMI Part Two, Validation (VAL)
SG 1-2, SP 1.1, 1.2, 1.3, 2.1, 2.2
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7. Referenced Requirements
ISO 9001
7.3.1 Design and Development Planning
4.2.4 Control of Records
CMMI
Generic Goals
Generic Practices
(Limited to Levels 1-3 Capability/Maturity)
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8. Generic Goals & Practices (1)
GG 1 Achieve Specific Goals
The process supports and enables achievement of the specific goals of the process area by transforming identifiable input work products to produce identifiable output work products.
GP 1.1 Perform Specific Practices
Perform the specific practices of the process area to develop work products and provide services to achieve the specific goals of the process area.
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9. Generic Goals & Practices (2)
GG 2 Institutionalize a Managed Process
The process is institutionalized as a managed process.
GP 2.1 Establish an Organizational Policy
Establish and maintain an organizational policy for planning and performing the process.
GP 2.2 Plan the Process
Establish and maintain the plan for performing the process.
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10. Generic Goals & Practices (2) Cont.
GP 2.3 Provide Resources
Provide adequate resources for performing the process, developing the work products, and providing the services of the process.
GP 2.4 Assign Responsibility
Assign responsibility and authority for performing the process, developing the work products, and providing the services of the process.
GP 2.5 Train People
Train the people performing or supporting the process as needed.
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11. Generic Goals & Practices (2) Cont.
GP 2.6 Manage Configurations
Place designated work products of the process under appropriate levels of control.
GP 2.7 Identify and Involve Relevant Stakeholders
Identify and involve the relevant stakeholders of the process as planned.
GP 2.8 Monitor and Control the Process
Monitor and control the process against the plan for performing the process and take appropriate corrective action.
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12. Generic Goals & Practices (2) Cont.
GP 2.9 Objectively Evaluate Adherence
Objectively evaluate adherence of the process against its process description, standards, and procedures, and address noncompliance.
GP 2.10 Review Status with Higher Level Management
Review the activities, status, and results of the process with higher level management and resolve issues.
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13. Generic Goals & Practices (3)
GG 3 Institutionalize a Defined Process
The process is institutionalized as a defined process.
GP 3.1 Establish a Defined Process
Establish and maintain the description of a defined process.
GP 3.2 Collect Improvement Information
Collect work products, measures, measurement results, and improvement information derived from planning and performing the process to support the future use and improvement of the organization’s processes and process assets.
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14. ISO 9001 Verification
Verification shall be performed in accordance with planned arrangements (see 7.3.1)…
…to ensure that the design and development outputs have met the design and development input requirements.
Records of the results of the verification and any necessary actions shall be maintained (see 4.2.4).
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15. CMMI Verification (SG 1)
SG 1 Prepare for Verification, “Preparation for verification is conducted.”
SP 1.1 Select Work Products for Verification, “Select the work products to be verified and the verification methods that will be used for each.”
SP 1.2 Establish the Verification Environment, “Establish and maintain the environment needed to support verification.”
SP 1.3 Establish Verification Procedures and Criteria, “Establish and maintain verification procedures and criteria for the selected work products.”
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16. CMMI Verification (SG 2)
SG 2 Perform Peer Reviews, “Peer reviews are performed on selected work products.”
SP 2.1 Prepare for Peer Reviews, “Prepare for peer reviews of selected work products.”
SP 2.2 Conduct Peer Reviews, “Conduct peer reviews on selected work products and identify issues resulting from the peer review.”
SP 2.3 Analyze Peer Review Data, “Analyze data about preparation, conduct, and results of the peer reviews.”
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17. CMMI Verification (SG 3)
SG 3 Verify Selected Work Products, “Selected work products are verified against their specified requirements.”
SP 3.1 Perform Verification, “Perform verification on the selected work products.”
SP 3.2 Analyze Verification Results, “Analyze the results of all verification activities.”
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18. ISO 9001 Validation
Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1)…
…to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known.
Wherever practicable, validation shall be completed prior to the delivery or implementation of the product.
Records of the results of validation and any necessary actions shall be maintained (see 4.2.4).
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19. CMMI Validation (SG 1)
SG 1 Prepare for Validation, “Preparation for Validation is Conducted.”
SP 1.1 Select Products for Validation, “Select products and product components to be validated and the validation methods that will be used for each.”
SP 1.2 Establish the Validation Environment, “Establish and maintain the environment needed to support validation.”
SP 1.3 Establish Validation Procedures and Criteria, “Establish and maintain procedures and criteria for validation.”
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20. CMMI Validation (SG 2)
SG 2 Validate Product or Product Components, “The product or product components are validated to ensure that they are suitable for use in their intended operating environment.”
SP 2.1 Perform Validation, “Perform validation on the selected products and product components.”
SP 2.2 Analyze Validation Results, “Analyze the results of the validation activities.”
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21. How Do You Select? Do you need to select?
Worry about processes first, the standard second
Improve businesses first, satisfy the standard second
What does the customer want?
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22. More at
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23. Closing Credits Matt Leiphart Platinum Registration 303 639-9001
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