Audit programme: arrangements for set of one or more audits planned for a specific time frame and directed

towards a specific
purpose.

Audit scope: extent and boundaries of an audit. E.g. products and services, processes, activities or organization.

Audit plan: description of the activities and arrangements for an audit.

Audit criteria: audit criteria are set of policies, procedures or requirement that are used as a reference against which audit
evidence is compared e.g. legislation, ISO 9001:2015, a regulation, a contract.

Audit objectives: the audit objective is the result to be achieved, e.g. does the QMS conforms to legislation or ISO 9001:2015.

Competence: ability to apply knowledge and skills to achieve intended results.

Design verification: is where design output is checked against the design input to ensure the output is correct.

Design Validation: is confirmation that the final product or service, that has been designed, will achieve its specified application
or intended use. This can mean product testing or trial service commissioning.

Monitoring: observing, supervising, checking or keeping under review, often over a period of time.

Measurement: ascertaining the size, amount or performance of something, using measuring equipment.

Risk: a risk is the effect of uncertainty. An effect is a deviation from expected- positive or negative.

Opportunity: is a favourable situation to getting an intended result. It may be taken or not,

Risk based auditing: the level of actual or perceived risk determine the priority, frequency and depth against which each
organizational area/function or process is audited. High risk areas are audited with a higher priority, more frequently and in
greater depth than low risk areas.

Open minded: means ready to accept anything new to you.

Evidence based decision making: clause which support QMS

6.2- quality objective and planning to achieve them. 7.1.2- monitoring and measurement resources

8.2.3- review of requirement related to products and services

8.4- control of externally provided processes, products and services

9.1.1- general (monitoring, measurement, analysis and evaluation). 9.1.2- customer satisfaction

9.1.3- analysis and evaluation. 9.3- management review. 10.2.1- nonconformity and corrective action

Importance of top management responsibilities or activities

Clause 5.1- leadership and commitment, 5.1.2- customer focus, 5.2- quality policy, 5.3- organizational roles, responsibilities and
authorities, 9.3- management review

Evidence based approach to auditing- the basis of any audit is that evidence of conformance or nonconformity is objective and
therefore verifiable at the time or at later date. An auditor can gather evidence by: interviewing people, sampling records and
documents, observing process and activities.

Working documents before an audit- 1) a checklist or similar document that acts as a prompt and which is based on the
requirements of the standard and the organization’s own arrangement. 2) it will be used to guide the auditor through the audit
in a structured way as below: to ensure coverage of all necessary requirements, as a memory jogger to ensure requirements of
the standards are covered, it can be used flexibly as a guide and not as rigid set of question, it can also be used to record the
audit findings.

Life cycle of Nonconformance:

Auditor raised NC- decision has to be taken, NC review by auditee only, NC will accepted by auditee, correction is taken by
auditee, root cause identify by auditee, corrective action planned by auditor, evaluation of effectiveness by auditee then
auditor, NC will close by auditor.

Purpose of the opening meeting: the purpose of the opening meeting is to confirm the audit plan, introduce the audit team,
and ensure that all planned audit activities can be performed. Agenda items: introduction of the participant, outline role of
each participant, confirmation of the audit objectives, confirm the audit scope, confirm the audit criteria, the audit timetable,
any changes to audit plan, sampling disclaimer, confidentiality etc..

Closing meeting: sampling disclaimer- to advise the management that the evidence was collected based on a sampling process
to communicate that although no findings were raised in some areas, they could still exist. Reporting methodology or grading
system- to ensure the auditee understands the significance of finding and consequences on the outcome and can priorities
corrective action. Presentation of the findings- to ensure they are understood and acknowledged by the auditee. Post audit
activities- to communicate the process for addressing the findings and verifying the corrective action.

Diplomatic: means tactful when dealing with people, e.g. auditor should not get involved in company politics, not discussing
from other department. If you will be not diplomatic auditee will not give more information and auditor will face difficulty.

Advantage of documented information/system: people have easy access to upto date information, helps to ensure that
process are performed consistently, can assist in training of new employees or those changing roles, provided a way of
capturing and sharing best practice in the organization.

Disadvantage of documented system: can be difficult to navigate around, leading to people bypassing the documentation, can
result in conflicting information-similar information is contained in a number of different places, it can become difficult to
maintain, as many different documents may need to be updated when change is made, can be difficult to people to find what
they are looking for.

Impartiality is about being neutral and fairly giving all sides an equal value without bias.

Objectivity is all about sticking to the observable facts without bias.

Being assertive is getting your wants fulfilled by other person by stating that he is correct

Being argumentative means to prove that the other person is totally wrong and possess wrong opinion about any particular
issue.

Customer satisfaction: clause 8.2.1 c) obtaining customer feedback relating to product and services, including customer
complaints.

Clause 9.1.2 requires an organization to monitor customers’ perception of the degree to which their needs and expectations

have been fulfilled. The organization shall determine the methods for obtaining, monitoring and reviewing this information.

Design and development verification: by inspection, by review of documents, laboratory test

verify that agreed corrective actions: by seeing document record, photo, video etc.., or go to site to actual condition on site

verification.