ISO Section 8 Audit Checklist

An ISO Section 8 Audit Checklist offers a structured method of assessing an organization’s compliance with ISO 9001 Quality Management standard. It helps auditors perform thorough evaluations of key processes and identify any nonconformities.

To avoid being the subject of an ISO audit blooper reel, it’s essential that you are well prepared. Here are a few tips to help prepare:

Measurement
An ISO audit checklist is a set of questions designed to aid an auditor in inspecting specific processes and ensuring they meet specified requirements. An invaluable asset in any laboratory, an ISO audit checklist can help increase efficiency overall and maximize productivity.

Preparing for an ISO 9001 certification audit involves performing internal ISO 9001 audits as part of your preparations. They help identify issues, uncover areas for improvement and ensure your processes meet requirements outlined for certification – not to mention helping avoid costly mistakes during an official certification audit!

An effective ISO 9001 audit checklist should encompass five main sections, including quality management system, section 4 management responsibilities, section 6 resource management and product realization. A quality-focused audit should also include a preventive action process which requires analysis of possible scenarios, developing measures to reduce likelihood of issues and documenting preventive actions; an effective preventive action process must also be documented and regularly reviewed for effectiveness.

Analysis
An ISO audit requires collecting and documenting all pertinent information pertaining to internal and external factors that could compromise the success of your quality management system, including customer requirements.

An effective ISO 9001 audit checklist should include questions about the quality management system and work performance criteria, such as its policy, objectives, manual, documentation control records and control documentation and records.

An internal ISO 9001 audit is an integral step towards ISO certification. It helps managers to identify areas for improvement, compare existing QMS with industry standards and regulatory requirements, as well as review processes to see if they qualify.

ISO inspections for certification tend to be far less threatening than FDA inspectors, yet still require careful preparation and planning. With Qualio’s cloud QMS solution it becomes easy to organize and track all paperwork related to compliance in an efficient manner.

Improvement
An effective ISO 13485 audit checklist should include sections 4 Quality management system, Section 5 Management responsibility, Section 6 Resource management, Product realization and Measurement analysis and improvement; it must also contain audit questions pertinent to each.

Document and track every nonconformance; identify its cause; take corrective action against future incidents using CAPA, complaint handling procedures, acceptance activities or purchasing controls to mitigate them; document and track them; identify root cause(s); take preventative steps against repeat; corrective measures should include CAPA use as well as complaint management techniques or purchasing controls to keep this from reoccurring; use CAPA when necessary and/or accept compliance to acceptable performance standards and accept acceptance activities and purchasing controls as means to mitigate against repeat incidents.

An ISO inspector doesn’t intend to fail your medical device manufacturing company immediately; rather, they’re going to look for issues that might impede production. With proper preparation and an audit tool like Qualio QMS that simplifies internal audits and enhances visibility – as well as helping your business pass an ISO inspection easily – nonconformances can be kept to a minimum and ensure you’re prepared for third party inspection. Learn more or take part in a free demo today.

Documentation
Audits are an integral component of ISO 13485 certification or simply implementing a quality management system (QMS), from ISO certification through to implementation. Regular internal audits help ensure your processes meet ISO standards while simultaneously providing insights into where improvements could be made within your organization.

Planning an audit begins well in advance of its actual commencement. You’ll need to get all parties involved ready – your organization and any others who might participate – by conducting interviews, inspecting evidence, and reviewing policies in this preparation phase.

Qualio created this comprehensive checklist designed for medical device manufacturers in Ireland by meeting all ISO 9001 requirements as well as related ones like FDA QSR requirements. It’s intended to be completed prior to an on-site audit by certifying auditors, and provides room to document corrective actions or any information requested by auditors – meeting ISO 9001’s requirement that documented information must be readily available to employees who execute processes.