The new standard expects organizations to identify and address the risks that could influence their ability to provide compliant products and services and to satisfy customers. The information can be in any format and come from various sources and media. Hi Luc, Your article is extensive and complete and very clear. Purchasing and purchased product contain many additional requirements around supplier control, more information needed in the purchasing information sent to suppliers, and an added control on purchased product that is released for use in a controlled way before all verification activities are done. Note: Addressing current and anticipated future needs can lead to the identification of improvement and innovation opportunities. They are not an accreditation body or certification body. Risk-based thinking ensures these risks are determined, considered and controlled throughout the design and use of the quality management system.Next
This will have implications for the organizations procurement and outsourcing activities and therefore has implications for suppliers. It helps to determine the organization how they will meet the needs of the customers. The books are not current ,though they do pass every 6 month audit. Also, knowledge management must be implemented in your organization. This is where we find the Requirement to identify processes that need to be controlled, and determine how they interrelate. » Objects, outputs, products and services Process Based Only The process model is expanded to include anything that affects quality. Their expertise and main responsibility is the development and adoption of standards in Australia.
Then it will take less time than when the quality management system has to be built from zero. Its flexibility means that you will be able to find a way of using it that fits your organization without requiring unnecessary paperwork. References are made to risk, identification of risks and opportunities and planning actions to address risks and opportunities identified. Two new clauses related to the context of the organization: 4. You do not need to convince me, I am fully agreed with you.Next
I hope this is an answer to your question. Diverse forms of evidence or documentation are therefore possible. Recording the distribution of documents is important; if a document is revised all previous revisions of the document must be replaced. The third party auditor observed that we are still exempted in 7. The new standard now expects you to control externally provided products and services if they are included in your products or services or if they are provided directly to customers. But unfortunately you have fraudsters everywhere and every system is as strong as its weakest link. Dear Wagih, Thank for your reaction.Next
Dear, thanks you for your comment. Context of the organization 4. First published on November 26, 2014. This is performed by accredited certification bodies. What are the additional requirements? To come back to your question … That you must decide by yourself.
That is how I built up my experience. You decide which documented procedures or work instructions are necessary, because it is depending on the size of your organization, type of activities, competence of persons, complexity of processes, products and services. Praxiom Research Group Limited 780-461-4514 Legal Restrictions on the Use of this Page Thank you for visiting this webpage. In other words, while documents and records were kicked out the front door, they were actually allowed back in through the back door. Dear Santosh, Thank you for your comment. But many of the questions about the transition are unanswered. They also facilitate Australian participation in international standards development.
This commitment increases confidence in your organization; 2 You achieve higher operating efficiency. Welcome to the forums Phillip. So, whenever the new standard refers to documented information and it asks you to maintain this information, it's talking about what used to be referred to as procedures, and whenever it asks you to retain this information, it's talking about what used to be called records. After my studies as a technical engineer, I worked successively as a Quality Test Engineer, Quality Control Manager, Quality Auditor and Quality Manager in various sectors. Important: a verification and validation period should not be overlooked, because your organization must comply with a three-month period of proof before you can start with certification! We cannot reproduce or publish its contents either wholly or partly, nor make it available either temporarily or permanently to third parties.Next
Documents must be reviewed on a regular basis to make sure they are up to date. The final changes include an additional requirement to take action on other processes and products when a non-conformance is found, and some further requirements on corrective actions like flow down of corrective action to suppliers. In theory at least, this greatly expands its scope. It focuses on the development and implementation of the process and goes on to require that they are managed and continually improved. Without struggle, stress and headaches.
Include a requirement in your procedure that says quality records must be legible. The Top Management of your company must show also leadership. The first big addition is in the requirements for planning for product realization. Note 2 When understanding the internal context the organization could consider those related to perceptions, values and culture of the organization. The last big changes relate to required actions for a non-conforming process and specific requirements on what needs to be considered for product monitoring and measurement such as criteria for rejection and special measurement instructions.Next