MAJA LIPTAI

As the new year started, we’re delighted to announce qmsWrapper has been named High Performer in the G2 Spring Grid® Reports. qmsWrapper started its journey in 2016, it was purpose build by a Medical Device manufacturer to help achieve and maintain standard compliance in the highly regulated industries of life science and pharma.   qmsWrapper is...

Mandatory documents and records when it comes to the ISO 13485 implementation are previously discussed. It is turned to discuss the same regarding ISO 9001:2015 implementation.   These are the documents to produce in order to be compliant with ISO 9001:2015:   4. Context of the organization Clause 4.3: Scope of the QMS   5. Leadership Clause 5.2: Quality policy   6. Planning Clause 6.2: Quality...

Lecture summary: You must determine and select improvements and then put the action in place to meet customer’s requirements and enhance any customer satisfaction You have to react when nonconformity occurs, including nonconformities that were reported during a complaint You are required to continually improve your products and services  to meet customer requirements and to measure the effectiveness...

Lecture summary: Management review is a formal, structured meeting that involves top management Management review meeting minutes, agenda, program, and presentations should be retained as documented information It’s important to create an agenda that meets all the requirements of the standard   A management review is a management tool in the hands of the top management for evaluating the QMS....

Lecture summary: The internal audit is one instrument for self-review of whether requirements are achieved Specify the responsible parties that will participate in the audit The auditor should gather all the information, data, findings, nonconformities, and opportunities for improvement and present them together in one report   An internal audit is an effective tool that is used for self-assessment of...

Lecture summary: Measurement, monitoring, analysis, and evaluation are critical for the assessment of the performance of your QMS The activities of monitoring and measuring generate data that must be analyzed and evaluated It is important to document and retain as evidence the results of the evaluation of the performance of your QMS   ISO 9001 Standard considers this activity as...

Lecture summary: You must control nonconforming outputs in its processes, its products, or services. You should take appropriate action based on the nature of nonconformity and its impact on the conformity of products and services. You should also meet the reporting requirements of regulatory authorities for nonconforming outputs.   Treating and managing nonconformities is one of the basic objectives of...

Lecture summary: The ISO 9001 standard talks about the need to implement planned arrangements. You have to ensure that the product meets specifications and is fit for its purpose. Make sure you are able to show who made certain decisions and that they are authorized to do so.   Release of the product or services is about verification that the...

Lecture summary: The production and service provision  process needs to be performed under controlled conditions One of the methods you can use to control the production of products or services is identification and traceability. In case of changes in the production and service provision process, you must review and control the changes to ensure continuing conformity with...

Lecture summary: An external provider is an interested party in the organization, though independent from the organization’s QMS. You must communicate with the external supplier to ensure the level of quality of your product. You are expected to document this operation of processes as per clause 4.4.2 and a quality plan may be a good place to...

Lecture summary: D&D includes phases from planning, inputs, controls, outputs, and changes Practically, you need to have certain some type of design discipline as it relates to the design of processes to produce your products and services. All these steps and way of its implementation directly affects the quality of the product or service   On every activity that is...

Lecture summary: The ISO 9001 Standard requires the initiation of communication with the customer relating to products and services Must be ensured that requirements are defined so your organization can meet claims for the products and services it offers. You need to include a requirements review that arises from any relevant interested party.   Customer communication Communication with the customer is...

Lecture summary: Operational planning is about controlling the design and development process. Identify all the specifications and characteristics of a product including quality requirements. Define the controls that will ensure intended outcomes—validation and verification.   What does this mean? What does it include? It represents master planning. It means that you have to include objectives of planning, realizing, controlling, leading,...

Lecture summary: Documented information is all the information needed to plan and operate your QMS. When it comes to controlling documented information, there should not be a question of if you should do it, but rather why you should do it. Documented information is mostly used within organizations as either a form of communication or as a way...

Lecture summary: In quality management – communication means a process or activity for exchanging effectively information between everyone included  in the operation of the QMS Effective communications require mechanisms for information to flow top-down and bottom-up. Select an approach that fits your organization’s culture and strategy. Communication is also one of the key elements of QMS implementation and business...

Lecture summary: The implementation of awareness procedures should be a priority of your business Make the employee aware of the aspects and hazards, and the impacts and risks associated with their work When implementing ISO 9001, everyone must know what they are doing and why.   How important it is to be aware of the quality management system,...

Lecture summary: The company has to decide what particular competencies are needed to perform his/her job correctly Once you determine the competence, you will see if and what training is needs to be provided Keep the evidence In a quality management system, competence represents appropriate qualifications, skill set, and knowledge with the goals of achieving the intended results....

Lecture summary: The ISO 9001 Standard refers to five kinds of resources: human resources, knowledge, processes environment, infrastructures, and monitoring and measuring resources. Each one of them represents a support tool for the QMS to meet your organization’s goals You have to review each of the resources from time to time to determine whether the available resources are...

Lecture Summary:  When some changes happen in your QMS, you need to carry them out in a planned manner Changes are intended to be beneficial, but also relevant and achievable The need for a change to your QMS can be determined in many different ways   Why is so important to know how to manage and control changes? By...

Summary lecture: Quality objectives are one of the requirements of ISO 9001 standard and it aims to improve your company’s QMS One of the best ways to establish quality objectives is on S.M.A.R.T. way The goal is to reflect the quantitative and qualitative performance of the QMS and to report the degree to which processes meet their...

Lecture summary When planning how to address risks and opportunities the best way is risk-based thinking Risk-based thinking will guide your top management to make better decisions Plan actions to address risks then integrate them into processes and later evaluate the effectiveness of actions This part of the ISO 9001 standard highlights risk-based thinking. Why? Because it will...

Lecture summary: Top Management is by definition a person or group of people who instruct and control an organization at the highest level (within the scope of the quality management system) The requirements on responsibility and authority are divided into two parts: one general and the other relating to people with particular roles Each person responsible for elements...

Lecture summary: The quality policy is a document where you should state your commitment to your improvement You need to apply it throughout the organization and make the quality policy is available to any relevant interested parties You should keep it simple and keep it relevant to your company   A quality policy is a document that provides guidelines, intentions,...

Lecture summary: Top management will have to supply evidence for its actions and improvements of QMS if they want to prove their commitment ISO 9001 standard lays out the principles for delegating authorities and responsibilities Enhance customer satisfaction by ensuring you identify customer requirements   You probably heard the saying: “Commitment is the key to success”. So, in this...

Lecture summary: Understanding the context of your organization is key to a correct business strategy You need to consider only issues that can affect customer satisfaction You are responsible for monitoring and reviewing information about any interested parties and their relevant requirements. Even just understanding your company falls within the essential requirements of the ISO 9001 standard. Why is...