ISO 9001 Version 2008 Internal Audit Checklist Doc
soumya GhorpadeISO 9001 is one of the world’s most favored quality management system standards. It sets forth functional processes that produce repeatable, reliable products and services; additionally it helps businesses improve their bottom lines by managing risks effectively and eliminating waste.
No matter if it is your first third-party audit or you already hold certification, conducting mock internal audits to detect issues before they become serious is crucial for business. Here’s an excellent checklist that can help get you going!
Scope
ISO 9001 is an internationally-recognized quality management standard that has become widespread across industries and countries, with over one million companies and organizations certified to the standard worldwide. Based on PDCA (Plan, Do, Check and Act), its goal is to cover all aspects of business operations that contribute to providing customers with products or services that satisfy both regulatory requirements as well as customer demands.
An internal audit is an integral component of your quality management system and should be conducted on an ongoing basis. Our templates make this easy; just click to customize for any business type! This template will help assess your current process and identify areas for improvement as well as train employees on its use and increase commitment. It can also serve as an opportunity to train them on it and increase employee commitment to it. SafetyCulture’s internal audit software enables easy performance of audits while easily producing reports for review; they’re great tools!
Processes
Be it an external audit for certification, or internal audit processes you are looking to enhance, our ISO templates can assist in producing better results. Designed to facilitate effective planning, conducting, reporting and problem-solving activities these ISO 9001 internal audit checklist templates cover subclauses 9.2.1 and 9.2.2 of ISO 9001.
Make sure your documents can easily be identified so auditors can quickly locate and validate relevant information quickly, such as document numbering, metadata or tag systems. Documents should also be reviewed regularly to ensure they reflect current processes.
ISO 9001 requires management (or leadership) teams to commit themselves to the quality agenda through frequent review meetings and documented outcomes, and to identify, analyze and act upon risks and opportunities within their organizations. In order for ISO 9001 to be effective it must include an effective quality policy tailored to its own circumstances and suitable to its mission statement.
Documentation
Documented ISO audits can save valuable time and effort over the long haul. By helping identify problems and making necessary changes, as well as preventing costly mistakes from being repeated and saving money in the form of preventable costs, well-documented ISO audits provide significant time savings in terms of effort saved and money saved. Documentation needs to be accurate, objective and stand up against scrutiny of third party external auditors.
The 2015 version of ISO 9001 has some new requirements that include an emphasis on risk-based thinking and using PDCA for management. These changes do not necessitate revamping all internal audit procedures and forms however.
Review your audit plan to make sure all required documents are easily accessible, interview a cross section of employees to gain a fuller understanding of organization processes, and use results of these interviews as the basis for planning an internal audit. For extra help consider hiring an accredited Certified Auditors to perform this service.
Training
Your employees should be given training on ISO 9001 requirements, both mandatory and non-mandatory ones, in addition to receiving a quality manual containing policies necessary for complying with it. This will enable you to prepare successfully for certification audits.
ISO 9001 standards are not product or industry specific, making them suitable for use by any company. Their purpose is not regulatory or contractual but to assure quality for all stakeholders of your business and help establish competitive advantages. ISO 9001 certification also lets customers know that your products and services comply with international standards, providing another competitive edge over your competition.
To ensure your system complies with ISO 9001, consider hiring a consultant to perform a gap analysis. This will enable you to identify any necessary changes within your current system as well as creating an action plan to address any gaps that are revealed during this analysis.