ISO 9001 - Understanding ISO 9001 Requirements

8.2   Monitoring and Measurement

8.2.2 Internal Audit
Conduct internal audits of your QMS at planned intervals, to determine if it:

a)- Conforms to planned arrangements (see 7.1);
      - Conforms to ISO 9001 requirements;
      - Conforms to your organizations QMS requirements

b)Is effectively implemented and maintained

Plan and adjust your audit program taking into consideration the:
Þstatus and importance of the processes and areas to be audited
Þresults of previous audits

Your audit program must:
ÞHave a documented procedure that defines responsibilities and requirements for:
Þplanning and conducting audits
Þreporting results and maintaining records

Ensure that management responsible for the area audited takes corrective actions without undue delay to eliminate detected nonconformities and their causes.

Have follow-up activities that include verifying the actions taken and reporting verification results (see clause 8.5.2).

Define the audit criteria, scope, frequency, and methods to be used

Select auditors and conduct audits in a manner that ensures the objectivity & impartiality of the audit process.

Ensure that auditors do not audit their own work.

Note: See ISO 19011 for guidance

Key Explanation Points and Tips:
ÞInternal audit is the second important tool (required by this standard) used to gauge the health of your QMS. How effective is it in meeting ISO 9001, your own QMS; customer and regulatory requirements?

ÞYou must have a documented procedure for your internal audit process Your procedure must address each of the following control requirements:

ÞThe scope of your internal audit program must cover the:

ÞAudit of product realization processes (as planned under clause 7.1) - to determine conformity of both product and product realization processes to customer and applicable regulatory requirements.

ÞAudit of the QMS - to determine conformity to the ISO 9001 standard

ÞAudit of the QMS - to determine conformity to organizational requirements

ÞAudit of QMS processes and their interaction - to determine if the QMS has been effectively implemented and maintained.

ÞThe time frame during which the audits specified above will be conducted

ÞIn determining the time frame for your audit program, you should consider organization size, complexity of product and processes; health of the QMS; customer, registrar and regulatory requirements; etc. The most common time frame is one year.

ÞConsider adjusting the audit frequency (and perhaps even the audit scope), of specific processes or group of processes, when:
ÞYou experience internal or external nonconformities
ÞGet customer complaints
ÞHave critical or high risk processes
ÞHave frequent or significant changes to processes and product

ÞYour internal audit program should consider the following:

ÞInput from audited area and related areas

ÞKey customer oriented processes (see explanation points and tips to clause 4.1)

ÞProcess and product performance results and expectations

ÞOpportunities for continual improvement

ÞFeedback from customers