4.2.

3
4.2.3a
4.2.3b
4.2.3c
4.2.3d
4.2.3e
4.2.3f
4.2.3g

4.2.4

5
5.1

5.2

5.3

5.3

5.4
5.4.1
5.4.1-1
5.4.1-2
5.4.2
5.4.2-1
5.4.2-2

5.4.2-3
5.5
5.5.1
5.5.2
5.5.2a
5.5.2b
5.5.2c
5.5.3
5.6
5.6.1
5.6.1-1
5.6.1-2
5.6.1-3
5.6.1-4
5.6.2

5.6.2-1

6
6.1
6.2

6.2-1
6.2.2
6.2.2-1

6.2.2-2
6.2.2-3
6.3
6.4
7
7.1
7.1-1

7.1-2

7.2

7.2.1

7.2.2
7.2.2-1
7.2.2-2
7.2.2-3
7.2.2-4
7.2.2-5
7.2.2-6
7.2.2-7

7.2.3

7.3
7.4
7.4.1

7.4.1
7.4.1-2
7.4.1-3
7.4.1-4
7.4.2
7.4.2-1
7.4.2-2
7.4.2-3

Control of documents Is there a documented procedure?

Are documents reviewed, updated as necessary, and then re-approved?
Is there a method that identifies the current version status of documents?
Are documents (procedure, instructions) available at points of use (location where quality activities are performed)?
Are documents legible and readily identifiable?
Are external origin documents identifiable?
Are external origin documents identified and distribution controlled?
Are obsolete documents (retained for legal and/or knowledge purposes). Suitably identified to prevent unintended use.
Control of quality records
Is there a documented procedure in use for identifying, storing, retrieval, retention time and disposing of quality records?
Are the following records established and maintained?
Management review (5.6.1)
Personnel training (6.2.2e)
Realization process & product V/S requirement (7.1d)
Review of customer requirements(7.2.2)
Supplier evaluation (7.4.1)
Validation of special processes (7.5.2d)
Product identification (7.5.3)
Lost /damaged customer supplied product (7.4)
Basis of non-standard calibration (7.6a)
Result of calibration (7.6)
Validity of previous measurement when equipment out of calibration (7.6)
Result of internal audits (8.2.2)
Verification that product passed tests (8.2.4)
Nonconformance (8.3)
Result of corrective action (8.5.2e)
Result and preventive action (8.5.3d)
Management Responsibility
Management commitment
Is there evidence of top management commitment by:
a) Communicating the importance of meeting customer and regulatory requirements.
b) Establishing a quality policy and objectives.
c) Conducting management reviews and
d) Ensuring availability of resources.
Customer focus
Does top management ensure customer requirements are determined and fulfilled with an aim to enhance
customer satisfaction?
Quality Policy
a) Is the policy appropriate for the purpose of the organization?
b) Does the policy include commitment to comply with requirement and continually improve?

c) Does the policy statement provide a framework for establishing/reviewing objectives?

d) Has the quality policy been communicated, understood?
Planning
Quality objectives
Are objectives established at each relevant function and level/ Are the objectives measurable and consistent with the quality
policy including a commitment to continual improvement/
Do objectives include those needed to meet requirement to products and /or services?
Quality planning
Is planning performed to meet the quality objective requirements of 4.1?
Does quality planning include:
Process of the quality management system?
Resources needed?
Continual improvement?

Are organizational changes planned, controlled and is the integrity of the management system maintained during the change

Responsibility, authority and communication

Responsibility and Authority
Have responsibilities and authorities been defined and communicated?
Management representative
Has top management appointed a member within the Management with the defined authority and responsibility to ensure qu
management requirements are established, implemented and maintained?

Does the management rep. Have authority to report performance to management for review and improvement of the quality
system.
Does the management rep. have the authority to ensure awareness of customer requirement throughout the organization.
Internal communications:
Is information about quality management system effectiveness communicated to various levels and functions?
Management Review
General
Are management reviews conducted at planned intervals?
Does top management review the quality system to ensure its continuing suitability, adequacy and effectiveness?
Are opportunities for improvements and needed to changes to the quality management system policy objectives evaluated?
Are records maintained?
Review input
Does the review include
a) Results of audits.
b) Customer feedback
c) Process performance and product performance. d) Status of corrective and preventive action.
e) Follow up from prior reviews.
f) Changes that could affect the QMS and
g) Recommendations for improvement
Resource management
Provision of Resources
Are the resources determined and provided to:
a) Implement, maintain and continually improve the QMS.
b) Enhance customer satisfaction?
Human resources

General
Are personnel performing work affecting product quality competent (demonstrated the ability to apply knowledge and skills
competency based on education, training skills and experience?
Competence, awareness and training
Does the organization
1. Determine competency needs for those affecting product quality?
2. Provide training or take other actions?
3. Evaluate effectiveness of actions?
Ensure employees are aware of the importance of their activities and how they contribute to achievements of objectives?
Are training records of appropriate education training skills experience records maintained?
Infrastructure
Has the organization determined, provided and maintained infrastructure to achieve conformity to product requirements?
(building (workspace), process hardware/software and support services)?
Work Environment
Has the work environment, needed to achieve conformity to product requirements been determined and managed?
Product realization
Planning of realization processes
Are the process needed for the realization processes
planned and developed?
Has the following been determined:
a) Objectives for the product project or contract.
b) The need for establishing processes
c) Verification, validation, monitoring inspection test and associated criteria for acceptability
d) Records needed to establish requirements have been met.
Customer related processes
Determination of product requirements
a) Customer specified
b) Necessary but not customer stated
c) Statutory & regulatory
d) Additional requirements by the organization
Review of product requirement
Are requirements (contracts, tender and orders) reviewed prior to commitment?
Are records of review and follow-up actions maintained?
Are product requirements clearly defined?
Are contracts or order requirements that differ from previous expressed (those in the tender or offer) resolved?
Are customer requirements reviewed to ensure the organization has the ability to meet them?
When requirements are not written, are they confirmed before acceptance?
Are relevant documents amended and personnel notified of order changes?
Customer Communication
Has the organization defined communication requirements for
a) Product/service information
b) Enquiry contracts order handling and amendments
c) Customer feedback including customer complaints.
Design and/or development (Excluded)
Purchasing
Are there purchasing controls to ensure that incoming

purchased product/service conforms to requirement? Is the type and extent of control dependent on the effect on product
realization or final product?
Are supplier evaluated and selected on the basis of their ability to supply product that meets organization requirements?
Are there established criteria for evaluation revaluation and selection?
Do supplier records show results of evaluation and necessary follow up actions?
Purchasing information
Does purchasing information (contracts and purchase order) describe the product ordered?
If requirements are appropriate for approval of product, procedures, processes and equipment described?
If appropriate, is requirement for qualification of personnel identified?