Internal audit manual

Clause 4.1 General requirements: Quality management system applicable to all deptts.
1. Have you identified the management and operating processes of your function/ department?
2. Are the sequence and interaction of the processes understood and defined?
3. How do you ensure that your processes are effective?
4. What criteria do you use to determine the effectiveness of your processes?
5. What are the inputs to your process? and the resulting outputs?
6. Do you outsource any processes (process includes components and products)?
How do you ensure that the quality requirements of outsourced processes are achieved?

Clause 4.2 Documentation requirements

This section addresses the documentations requirements for establishing and maintaining an effective
quality management system. The clause is made up of four sub-clauses as follows:

4.2.1 stating the general requirements,

4.2.2 describes what the quality manual must contain,
4.2.3 how documents must be controlled and
4.2.4 how records must be maintained and controlled.

4.2.1 General requirements

The quality management system must comprise of the following documented statements, lists, manuals,
plans and procedures,

1. Quality policy statement.

2. Lists containing the organization’s quality objectives. These will include the broad objectives
of the organization as well as departmental, functional and individual objectives.
3. Quality manual describing the quality management system.
4. Quality system procedures.
addressing the 3 setions show you use documents and records to support effective and efficient operation
of your organization. A review of your procedures, work instructions, and records will determine if the
standard requirements are met.
4.2.3 Control of Documents

a) Are documents available to those that need to use them?

How is the most current version kept in the correct locations?
b) If documents such as reference books, users manuals and other outside documents are used, how are
they controlled?
c) How are old documents handled? Are they removed from use? Are they labeled? Is a copy maintained
for reference? Is there any chance that an old document could be used by accident?
4.2.4 Control of Quality Records
Records shall be maintained to provide evidence of conformity to requirements and of the effective
operation of the quality management system. Documented procedure to define the controls for
storage, protection, retrieval, retention time and disposition of records.
Where are records kept? Is this identified somewhere so users can easily find records? Can users identify
the records? Are the records legible?

Clause 4.2 Documentation requirements Ref: QSP 4.2

4.2.1

General
Where is the quality policy statement documented? Are quality objectives documented?
All
4.2. Quality manual All
2 What steps have you taken to implement quality manual? Have you
explained quality manual requirements to your people? Do they
understand?
4.2. Control of documents & records All
3 Is there a documented procedure/instruction for control of documents?
4.2. Are documents available at required locations?
4 What controls do you maintain for storage, protection, retrieval, retention
time and disposition of records?

5 Management responsibility QP 5
5.1 Management commitment All mgrs.
What is your role in continual improvement?
What is your role in the implementation and maintenance of the quality
management system?
How do you communicate the importance of meeting customer
requirements?
Are there any statutory or regulatory requirements that need to be
considered for your product?
How do you communicate the importance of meeting statutory and
regulatory requirements?
Have you established quality objectives for your organization?
What are your quality objectives?

5.2 Customer focus All mgrs.

Who are your customers? (Internal & External)
How are customer requirements determined?
How do you ensure that customer requirements are met?
How do you promote customer awareness in your organization?
Is there a customer focus within the organization?
How is customer satisfaction determined?

5.3 Quality policy QP 5.3 All

Does the quality policy statement include a commitment to comply with
requirements and continually improve the effectiveness of the quality
management system?
Have you explained quality policy requirements to your people? Do they
understand?
5.4 Planning QSP 5.4.1 Quality objectives
5.4. Quality objectives All mgrs.
1 Are quality objectives set at relevant functions/levels?
Do quality objectives include those needed to meet requirements for
product?
Are there implementation plans for the quality objectives?
How far down into your department are the quality objectives established?
What are the measurable performance indicators for quality objectives and
your target for them?
How frequently do you review the quality objectives and what is current
status of the quality objectives?
Are quality objectives consistent with the quality policy and organizational
goals?

5.4. Quality management system planning All mgrs.

2 Are quality objectives considered in planning?
When problems arise, how were these dealt with?

5.5 Responsibility, authority and communication QP 5

5.5. Management representative
2 Who is the ISO Management Representative?
Does his responsibility and authority include reporting on any need for
improvement to the QMS? Does it include ensuring the promotion of
awareness of customer requirements throughout the organization?
How frequently he interacts with you to report on the QMS performance?
Does he keep you informed of the improvement needs? around to CEO
see if people are paying attention. )

Do you actively initiate promotion of the awareness of customer MR

requirements and the need for strong customer focus throughout the
organization? How do you do it?
Do you schedule internal audits, management reviews and ensure that they
are adhered to? How do you follow up with the implementation of audit
findings and management review decisions?

5.5. Internal communication All

3 How do you communicate effectiveness of QMS and need for improvement ma
to your people? Are records kept of important communications? nag
em
ent

5.6 Management review QSP 5.6

5.6. General Mgmt.
1 How frequently management reviews are held? Do these meetings address Rep
the adequacy of the QMS? Do senior managers actively participate and .
provide the necessary inputs to these meetings? &
Are opportunities for improvement and the need for any changes to the All Sr.
QMS, including the quality policy and quality objectives discussed? Mgrs.
Are time bound action plans prepared for implementing the decisions arrived
at? Are actions taken timely? Do senior managers review implementation
of the decisions?

5.6. Review input MR

2 Does the input to management review include:
- process performance and product conformity
- follow-up actions from previous management reviews
- changes that could affect the QMS
- recommendations for improvement
Are these standard agenda items for the MQC meetings?
5.6. Review output MR
3 Does the management review decide on
• improvements of the QMS and its processes?
• improvements of product related to customer requirements?
• decide on resource needs?
Are actions related to these items assigned and tracked to closure?
6 Resource management QP 6 QSP 6.2.2 Preventive maintenance
6.1 Provision of resources CEO &
Are resources provided/available for continually improving the De
QMS/processes? par
How are resource needs for improvements identified and evaluated? tm
Are resources provided to enhance customer satisfaction by meeting ent
customer requirements? al
hea
ds
6.2 Human resources
6.2. General CEO
1 Is competency of personnel determined on the basis of appropriate Sr.Manag
education, training, skills and experience? Are there records? ers

6.2. Competence, awareness and training QSP 6.2 Training CEO

2 Have the competency needs been determined for each position? Have they Sr.Manag
been recorded? Are people selected and assigned on the basis of their ers
competency appraisal? Are appraisal records available?
Are training needs identified on the basis of functions? Are appropriate
training provided? Are effectiveness of training determined?
How often is employee performance evaluated?
Are personnel aware of the relevance and importance of their activities and
how they contribute to the achievement of the quality objectives?
Are personnel aware of their contribution to the organization?
Are records maintained as appropriate for education, skills, and experience?

6.3 Infrastructure QSP 6.3 Preventive Maintenance CEO

Is the infrastructure in place appropriate to achieve conformity to product Sr.Manag
requirements? ers
Are adequate supporting services in place? (Maintenance, Housekeeping,
Transportation, communication, computers, security, safety, etc.)
Are the buildings, environmental controls, work space, equipment, etc.
adequate to support the work being done?
Are there any problems evident that can be attributed to a lack of a
sufficient infrastructure?

6.4 Work environment Sr.Manag

Are there aspects of the work environment that could affect conformity to ers
product requirements?
Is the work environment taken into consideration in quality planning?
Is the work environment under adequate control to support the work being
performed?
Are factors such as heat, noise, light, cleanliness, pollution, air flow,
ergonomics, safety, etc that may affect quality are adequately controlled?
7 Product realization QP 7
7.1 What is the department’s contribution to product realization? Are the
necessary processes planned, developed, implemented and controlled?
What quality objectives are applicable for product realization so far as the
departmental functions are concerned and have they been established,
reviewed and documented?
Has the verification, validation, monitoring and test activities required for
the product realization and product acceptance criteria been established and
documented?
7.2 Customer related processes QSP 7.2
7.2. Determination of requirements related to the product Sales &
1 How customer requirements, including those not specified by him but Expo
required for the specified product, are determined and documented? Are rt
verbal and telephonic orders recorded and confirmed to customer in writing?
Are there any statutory or regulatory requirements related to the product?

7.2. Review of requirements related to the product Sales &

2 Are requirements reviewed to ensure that they can be met? Are review Expo
records maintained where applicable? Are amendments to orders recorded, rt
confirmed and communicated internally in writing?

7.2. Customer communication Sales,

3 What is the process for communicating product information to the customer? Expo
 What is the process for handling inquiries from customers/potential rt &
customers? QA
How is customer feedback obtained?
How promptly are complaints acknowledged, investigated and results
communicated to the customers? Are efforts made to ascertain whether
the investigations and findings have been accepted by / satisfied the
customer?

7.3 Design and development

Not applicable
7.4 Purchasing QSP 7.4
7.4. Purchasing process Purchase
1 What is the process for approving suppliers? Is there an approved
supplier’s list available? How are the supplier’s performance evaluated?
How frequently are they evaluated? What are the criteria for evaluation of
suppliers performance?

7.5 Production and service provision

7.5. Control of production and service provision Prodn &
1 Are production operations carried out are controlled conditions? QA
Are product characteristics documented and checked accordingly?
Are there records of product performance? Are work instructions available?
Are monitoring and measuring equipment available and do employees know
how to use them? Do they use them? Are the data recorded?
What characteristics are measured during final release of the product and
are they recorded and records controlled? Are operators trained
appropriately to control product quality?
7.5. Validation of process for production and service provision
2
Not applicable as resulting output of all processes are verified.
7.5. Identification and traceability QSP 7.5.3
3 How is the product identified through all stages of production and delivery?
7.5. Customer property: Not applicable
4
7.5. Preservation of product
5
How is the product quality and integrity is maintained through all stages of Prdn,
processing and delivery? QA,
Strs
7.6 Control of monitoring and measuring devices QSP 7.6
Are monitoring and measuring devices calibrated annually or more QA, Prdn
frequently where required? How are they calibrated? Are calibration
records maintained? Are calibration status identified on the
instruments?
Is a list of instruments to be calibrated and calibration schedule maintained?
When an instrument goes out of calibration, ist immediately removed
and sent for re-calibration or repair?
8 Measurement, analysis and improvement QP 8
8.1 General
How is conformity of the product monitored and measured?
What data is collected and analyzed? QA &
Prod
How do you measure/monitor performance of your processes? n
How do you improve your processes? Show us the records of a process
improvement? All
depa
 rt-
ment
s
8.2 Monitoring and measurement QP 8
8.2. Customer satisfaction
1 How do you get feedback from your customers (internal & external)?
Is the feedback documented? Analyzed and acted upon? All

How frequently are customer satisfaction surveyed? Are they analyzed and Sales &
the results acted upon? Do customers receive feedback from their Expo
inputs? Are efforts made to ensure regular feedbacks through rt
customer satisfaction surveys?
Who coordinates customer feedbacks for your organization?
What are your organization’s objectives for customer satisfaction?
How often is the customer satisfaction index communicated internally?

8.2. Internal audit QPS 8.2.2 MR and

2 Are results of previous audits taken into consideration when planning the audit
internal audit schedule? ors
Can extra audits be planned when indicated as needed by previous audit
results?
Are the audit criteria, scope, frequency and methods defined?

8.2. Monitoring and measurement of processes All

3 How is conformity of the product & processes monitored & measured?
What data are collected and analyzed?
How process performance are monitored and measured?
8.2. Monitoring and measurement of product QSP 8.2.4 Prdn &
4 Are monitoring and measurement of product carried out at required stages? QA
Are documented criteria for product measurement available?
Are records kept for product measurements?
8.3 Control of nonconforming product QSP 8.3 Prodn,
How non conforming products are identified, documented, kept segregated QA
and disposed? Purc
What happens when nonconforming product is detected after delivery or use hase
has started? &
What is the process for handling nonconformities detected after product has Stor
been delivered or is in use? es
Are the effects/potential effects of the nonconformity taken into
consideration in determining what actions to take?

8.5 Analysis of data All

How do you measure/monitor performance of your processes? funct
How are the suitability and effectiveness of your processes determined? ions
Are data collected and analyzed with respect to conformity to product
requirements, customer satisfaction, supplier performance, and
characteristics and trends of processes and products. Are preventive
actions planned from such data analysis? Are the results used for
continual improvement?

8.5 Improvement
8.5. Continual improvement All
1 What improvement processes are in place? funct
How do you improve your processes? ions
Have you been involved in any improvement processes?
Where are the records of improvements?
 Are quality policy, quality objectives, audit results, analysis of data,
corrective/preventive actions, and management reviews, audit findings
used for continual improvement?
Are employees encouraged in continual improvement activities? Are they
trained to participate in continual improvement activities?

8.5. Corrective action QSP 8.5.2 All

2 Are actions taken to eliminate causes of non conformity in product, process funct
and other functions and activities? ions
Are non conformities including customer feedbacks and complaints reviewed
for taking corrective actions?
Are appropriate training given to employees to recognize and correct
nonconformities?
8.5. Preventive action QSP 8.5.2
3 Are efforts made to detect causes for potential non conformities and actions
taken to eliminate such potential causes? How detection of potential
non conformities are planned?