ISO 9001 2008 For Small Business Chapter Summary

7.1 How ISO 9000 can be used to check small business quality management system

• ISO 9001:2008 businesses have to prove that they meet the specification as they set their own QMS.
• The QMS has to be reviewed to reveal error spots and areas set for improvement.
• The organization goes through a Quality Procedure audit from the potential clients.
• Figure 7.1: The Quality assurance measurement has four stages; design, manufacturing, in-service and acceptance.

7.2. Internal Audit

• Comprises of the audit plan and quality assessment as in figure 2.
• The audit plan identifies the dangerous areas, eliminates loss and viability of the process.
• It defines the effectiveness of the QMS as stated in the ISO 9001:2008.
• The quality assessment sets the qualifications, verifies, documents and enables accessibility.
• Internal audit depends on the size of the business
• Internal audit compares the operations done with the stipulation and ensure effectiveness.

7.2.1. Audit Plan

Internal audit is undertaken by trained and quality control staff.

The organization undertakes a random selection for audit in three months after planning. It comprises

• The areas an operations for audit
• Reasons for internal audit
• State the minimum qualifications for the auditing staff
• Define the structure of the audit report.
• Figure 7.3 described the audit process: Scheduling, preparation & organization, execution, summary of audit, report, corrective process, remedial process and follow up going back to audit preparation and organization.

7.2 Internal Audit Program

Step 1 – audit schedule

• Planned and implemented by Quality Manager in regard to the status and relevance of operations
• Large businesses ought to undergo three audits annually.
• Small business undergo audit per four months.

Step 2 – Audit preparation and organization

• Quality manager performs or assigns the complex and large audits
• The manager sets the agenda for:
• Scope and intentions of audit.
• Audit of staff charged with process
• Reference of documents
• Identify lead auditor and assigned auditor(s)
• Date audit is done
• The lead and assigned auditor prepares audit checklists of areas met in the audit program.

Step 3 – Audit execution

• Large businesses have audit teams.
• The auditors, auditee(s) and quality manager discuss:
• Summary of methods and process for audit
• Method the audit and auditee communicate
• Confirmation of program
• The ISO 9001:2008 calls for all businesses to have a process for internal quality audits
• The process contrasts standards audit and procedures audit
• Standard assess effectiveness of use of ISO standard.
• Procedure audit assess effectiveness of businesses’ QPs, strategies and policies.
• Standard audit involves collection of evidence of compliance through interviewing auditee, data, manuals, operations and setting.
• The auditor in the process answers questions either as yes or no
• The auditor lists non-conformities and summary of evidence.
• The QP, policy, plan and work rules are assessed based on:
• Documentation
• Alignment to document
• Effectiveness
• The auditor response as yes or no
• The auditor records the observations and non-compliances in the worksheet, a part of the final audit report.