ACCREDITATION UKAS/NABCB
UKAS
The United Kingdom Accreditation Service (UKAS) is the sole national accreditation body for the United Kingdom. UKAS is recognized by government, to assess against internationally agreed standards to organizations that provide certification, testing, inspection and calibration services.
Accreditation by UKAS demonstrates the competence, impartiality and performance capability of these evaluators. In short, UKAS ‘checks the checkers’. UKAS is a non-profit-distributing private company, limited by guarantee. UKAS is independent of Government.
UKAS is licensed by BEIS to use and confer the national accreditation symbols (formerly national accreditation marks) which symbolise Government recognition of the accreditation process.
UKAS accreditation provides an assurance of the competence, impartiality and integrity of conformity assessment bodies. UKAS accredited certification, testing, inspection and calibration reduces the need for suppliers to be assessed by each of their customers.
UKAS’ involvement in international groups such as EA, IAF and ILAC, provides for mutual recognition. This reduces the need for multiple assessments of suppliers, and as a consequence helps to reduce barriers to trade for organisations who have UKAS accreditation.
UKAS is a non-profit-distributing private company, limited by guarantee. UKAS is self-financing and charges fees to conformity assessment bodies to cover operational costs and other expenditure. BEIS sponsors UKAS and provides funding to undertake public interest activities (ie non-fee earning activities) in representing the UK’s interests in the accreditation system
NABCB
ACM EMB PVT LTD is now accredited by NABCB <National Accreditation board for certification bodies> in Quality Management system (ISO 9001:2015) & Medical Device Quality Management System (ISO 13485:2016)
NABCB is a constitution board of the Quality Council of India (QCI), and is the national accreditation body, which provides accreditation to certification, inspection and validation and verification bodies in accordance with ISO standards, International requirements/guidelines and NABCB Accreditation criteria.
NABCB is internationally recognized and represents the interests of the Indian industry at international forums through membership and active participation with the objective of becoming a signatory to international Multilateral / Mutual Recognition Arrangements (MLA / MRA)
NABCB is a member of International Accreditation Forum (IAF) & International Laboratory Accreditation Cooperation (ILAC) & & Asia Pacific Accreditation Cooperation (APAC) as well as signatory to its MRAs for Quality Management Systems, Environmental Management Systems, Product Certification. GlobalG.A.P., Food Safety Management Systems, Information Security Management Systems, Energy Management Systems, Inspection. NABCB is also MRA signatory of Asia Pacific Accreditation Cooperation (APAC) for Occupational Health Safety Management Systems.
What is the difference between IAF & non-IAF ISO certification bodies?
It is beyond any doubt that the ISO certification process gives an authentic recognition to an organisation as regards quality management and efficiency. As a matter of fact, every kind of recognition is considered authentic or genuine only if it is accredited by a globally recognised autonomous body. The task of accreditation of the business organisations worldwide is carried out by some highly acclaimed institutions called as accreditation bodies.
Accreditation bodies operate from various countries with the primary objective of ensuring that the ISO certified organisations aptly comply with the conformity assessment guidelines that are set by the International Organization for Standardization (ISO). On the basis of those clearly defined guidelines, different types of ISO certification in India are conferred to the applicant entities by the Accreditation bodies. These bodies strictly adhere to the directives of the ISO and make sure that the same is duly implemented by the certified entities.
Now the question arises-
1. Who does certify these accreditation bodies?
There’s a global federation for all the accreditation bodies worldwide, that regulates these accreditation bodies, which is known as International Accreditation Forum or IAF. The task of IAF is to check any sort of negligence by an accreditation body while implementation of the quality specifications and carrying out the ISO certification process.
2. What is meant by Accreditation?
Accreditation is the process of independent evaluation of entities against specified benchmarks to ensure their excellence and competence. Through the application of global standards, government, suppliers and consumers can gain trust in the validity of the audit, examination reports and ISO certification thus provided.
3. How does IAF ensure a fair process of certification by the Accreditation bodies?
For a quality management system (QMS) to be considered valid, the ISO certificate must be received from an unbiased, acclaimed Accreditation body upon quality assessment. The certificates can also be issued by unreliable bodies, and such certificates will be definitely questionable. IAF ensures uniform and unprejudiced implementation of ISO standard across all the Accreditation bodies that are its members. The IAF member bodies are required to conduct regular audits of the certified entities to ensure that they consistently conform to globally accepted quality standards.
4. Where is it necessary to get ISO certification services from IAF member body?
There are specific spheres where the preference is given only to the IAF approved ISO certificate. One such instance is of application for government tenders. Very importantly, the government and administrations approve civic work projects only to the IAF approved ISO certified companies, as they are deemed to be consistently compliant with global quality standards and fit for such works.
5. Which one of the 2 certifications should we opt for- IAF or non-IAF?
In case of cost consideration, getting a non-IAF ISO certification is much feasible as it does not require quality audits at regular intervals. The IAF member bodies are supposed to conduct regular audits, for which they charge huge amount as audit fee. Small businesses with limited resources need not get IAF certifications. Such certification is mandatory mainly in case of the application for government tenders.
What is ISO ?
ISO is a non-governmental organization that determines specifications for products, services and systems for quality and efficiency. Standards set forth by this organization are valuable to international trade as they have strict requirements that goods must meet. Their ultimate goal is to improve industrial welfare worldwide increasing the levels of safety and security for all.
It takes dedication and research to create a well-rounded standard. Experts in a particular subject area gather together to discuss ways of further improvement. At the end of these discussions, a voting process brings the organization to a consensus. The full process takes about three years on average. For the organization to create standards, the following four situations need to occur:
- A need in the market
- A gathering of global experts
- Development through a multi-stakeholder process
- All parties reach a consensus
- How to Gain ISO 13485 Certification
How to Gain ISO 13485 Certification
The quick answer is contact us, but there are common steps
- Review your operation compared to the Standard’s requirements & then document
- Implement, train & refine
- Check internally (Audit) & Management Review; Continue the refining
- External Check (UKAS accredited Assessor). When successful the Certification, then on-going yearly Surveillance visits
Three Format Options for your manual, documents, forms, process diagrams/ procedures and forms:
- Text – the traditional approach but limits the opportunity for Business Improvement
- Process Diagrams – assists with clearer understanding of processes and process interaction but often cumbersome to interlink electronically
- Integrated Per4ma Business Model – Opportunity for Business Improvement, with your latest processes, Manual, documents, forms, tasks, indicator graphs and blogs.
How Much does it Cost?
The cost of obtaining an ISO certificate in India depends upon various aspects, including in accreditation body from which you want to be ISO certified, nature of the business, size of organisation, level of ISO Compliance, etc. ISO certification cost vary body to body. Ask our adviser for best prevailing rate for get ISO Certificate.
Invest in your future by improving your Business. We have options to suit your situation including
- Price Right -The Cost Effective Solution – if the Cost of achieving ISO is the critical factor. We personalize & document your Systems to comply with the relevant Standard & check compliance before UKAS accredited Assessment
- Manage Right – The Time Effective Solution – We save you Time. If you do not have the internal resources for the Documenting, Project Management & Training, we assist.
- Risk Right If you do not have the internal resources for the Documenting, Project Management, Admin & Training, we can assist as Deputy Quality Management Representative
- Support Right – Support as & when you want it – whether Onsite assistance & Auditing / Convert documentation /Additional Standards (i.e. ISO , API Monogram & Q1, AS 9120 etc.) / Improvements / Refresh your System.
ISO 13485 training:–
Course Aim
Gain a better insight into the use of ISO 13485:2016 as the basis for a Quality Management System (QMS) implemented by medical device manufacturers.
Who should attend?
- Senior Management
- Quality Managers
- Regulatory Affairs Managers
- Internal and external Auditors
- Consultants and anyone involved with the implementation of the standard
How will you benefit?
This course will help you:
- Take the first steps towards ISO 13485:2016 certification
- Understand how you can better meet regulatory requirements leading to increased patient safety
- Find ways to increase efficiency and cost savings through quality management
- Monitor supply chains to achieve continuous improvement
- Develop safe and effective medical devices
- Motivate employees through CPD
What will you learn?
On completion, you should gain the knowledge and skills to:
- Explain the use of ISO 13485:2016 as the basis for a QMS for medical device manufacturers
- Identify the relationship between ISO 13485:2016 and European Medical Device Directives
- Recognize the use of ISO 13485:2016 as the basis of regulatory requirements worldwide
ISO 13485 Medical Devices Certification
ISO 13485 Certification assists Medical Device related Organisations in achieving their aims & improving their business by helping them to manage & improve (rather than fire-fight). For CE Mark of Medical Device/s, the business will require ISO 13485 Certification.
Contact us today to also benefit from ISO 13485 certification and accreditation with increased operational efficiency. The requirements are well tested and help improve operations, productivity and profitability.
Prerequisites
There are no formal prerequisites; however it will be useful for delegates to read the standard before attending the course.
ISO 13485:2016 Medical Devices Quality Management Implementation Training Course
Course Aim
Develop your knowledge and skills in the process of implementing ISO 13485:2016 within an organization that provides medical devices or services to support medical devices.
Who should attend?
- Anyone involved in defining, planning, or implementing an ISO 13485 based quality management system
- Management representatives
- Implementation team members
What will you learn?
On completion, you should gain the knowledge and skills to:
- Define a quality management system
- Identify the steps for defining, planning, organizing and scheduling necessary activities
- Implement an effective quality management system
- Conduct a base line review of an organization’s current position with regard to ISO 13485:2016
How will you benefit?
This course will help you:
- Understand how to implement a QMS as required by medical device directives
- Plan the implementation of ISO 13485:2016 within your organization
- Take the first steps towards ISO 13485:2016 certification
- Identify how you can better meet regulatory requirements
- Find ways to increase efficiency and add value through quality management
- Monitor supply chains to achieve continuous improvement
Prerequisites
You should have a good knowledge of ISO I3485:2016 and the key principles of a QMS. If not, we strongly recommend you attend our ISO 13485:2016 Introduction course.
ISO 13485:2016 Medical Devices Quality Management Internal Auditor Training Course
Course Aim
Learn how to audit the processes of an ISO 13485:2016 Quality Management System (QMS). This course provides guidance and practical experience in planning, executing, reporting and audit follow-up of an internal audit when monitoring the effectiveness and conformity of a ISO 13485:2016 compliant QMS.
Who should attend?
Medical device quality professionals with knowledge of quality management systems and ISO 13485:2016, as well as individuals interested in conducting first-party or second-party audits, management representatives, internal auditors and consultants.
What will you learn?
On completion, you should gain the knowledge and skills to:
- Explain the structure and scope of ISO 13485:2016 and how it applies to the organization seeking regulatory compliance
- Identify the key principles of auditing and auditor responsibilities
- Plan an internal audit
- Conduct an effective audit based on process identification, sampling and questioning
- Determine if corrective action has been effectively implemented
How will you benefit?
This course will help you:
- Maintain compliance with ISO 13485:2016
- Improve a global benchmark in quality standards
- Be confident that your organization can rely on competent auditors
- Motivate colleagues through CPD and ensure rigorous regulatory internal processes
- Write factual audit reports and suggest corrective actions
Prerequisites
You should have a good knowledge of ISO 13485:2016 and the key principles of a QMS. If not, we strongly recommend you attend our ISO 13485:2016 Introduction or Clause by Clause course.
Medical Devices – Quality Management Systems Auditor/Lead Auditor Training Course (ISO 13485:2016)
This course teaches the key principles and practices of effective quality management system audits in accordance with ISO 13485:2016 and ISO 19011, “Guidelines for auditing management systems”. Experienced instructors guide students through the entire audit process, from managing an audit programme to reporting on audit results. Participants will gain the knowledge and skills to plan, conduct, report and follow up a QMS audit that establishes conformity and enhances overall organizational performance.
Who should attend?
- Medical device quality professionals interested in conducting first-party, second-party, and/or third-party audits
- Management representatives
- Quality directors, managers, and engineers
- Consultants
What will I learn?
On completion of this training, participants will be able to:
- Gain the skills to plan, conduct, report and follow up an audit in accordance with ISO 19011
- Identify the purpose and benefits of an ISO 13485:2016 QMS
- Explain the role of an auditor to plan, conduct, report and follow up an audit in accordance with ISO 19011 (and ISO 17021 where appropriate).
How will I benefit?
- Identify the aims and benefits of an ISO 13485:2016 audit
- Interpret ISO 13485:2016 requirements for audit application
- Plan, conduct and follow-up auditing activities that add real value
- Grasp the application of risk-based thinking, leadership and process management
- Access the latest auditor techniques and identify appropriate use
- Build stakeholder confidence by managing processes in line with the latest requirements
- Understand the arrangements for BSI certification
Documentation Requirements
The ISO 13485:2016 standard requires that the QMS and all information required by the standard be documented and controlled. This includes the QMS policy and any supporting documents. The ISO 13485:2016training includes information regarding:
- Documentation of the Management System
- Establishing and communication a QMS Policy
- Document Control Requirements
- Medical device files
- Records Retention Requirements
How Much Documentation Do You Need?
Much depends on the size and complexity of your organization. You should have enough procedures to cover each section of the standard that applies to your business. Documented information is broken up into two types, documents, and records. A form is a kind of document. When the form is filled out it becomes a record. Quality manual, policy, procedure or work instructions are other kinds of documents.
The specific documents and records you are required to control are listed in the table below.
How to structure your QMS documentation
There is a separate standard, called “ISO 10013:2001 Guidelines for quality management system documentation,” which offers some direction as to the number and size of the documents your organization will likely need. It also provides guidance on the structure and contents of each document. The following is a summary of some of these ISO 10013 guidelines.
Quality Manual Clause 4.2.2 of ISO 13485:2016 states that the Quality Manual should include those clauses that are applicable to the organization, with a reason given for any clauses omitted. The contents of the manual, as well as the overall structure, are going to be dependent on the characteristics of the organization itself, such as size, operational complexity, and staff competencies. While a small company can probably document their entire Quality Management System in a single manual, a large multi-national company may need several Quality Manuals, plus all the other required documents.
A typical Quality Manual will include:
- title and table of contents
- information about document version and approvals
- a description of the QMS
- the scope of the QMS
- any exclusions from ISO 13485, and the reasoning behind them
- the company’s business process model
- roles and responsibilities of personnel
- references to additional relevant documents and appendices
- the Quality Policy and objectives
Mandatory documents and records required by ISO 13485:2016
Here are the documents needed for compliance with ISO 13485:2016. (Please note that some of the documents will not be mandatory if the company does not perform relevant processes.):
- Roles undertaken by the organization under applicable regulatory requirements (clause 4.1.1)
- Procedure and records for the validation of the application of computer software (clause 4.1.6)
- Quality Manual (clause 4.2.2)
- Medical device file (clause 4.2.3)
- Procedure for document control (clause 4.2.4)
- Procedure for record control (clause 4.2.5)
- Quality policy (clause 5.3)
- Quality objectives (clause 5.4.1)
- Responsibilities and authorities (clause 5.5.1)
- Procedure and records for management review (clause 5.6.1)
- Procedure for training (clause 6.2)
- Requirements for infrastructure and maintenance activities (clause 6.3)
- Requirements for work environment (clause 6.4.1)
- Arrangements for control of contaminated or potentially contaminated product (clause 6.4.2)
- Process for risk management in product realization (clause 7.1)
- Outputs of product realization planning (clause 7.1)
- Records of the results of the customer requirements review and actions arising from it (clause 7.2.2)
- Arrangements for communication with customers (clause 7.2.3)
- Procedure for design and development (clause 7.3.1)
- Design and development planning (clause 7.3.2)
- Design and development outputs (clause 7.3.4)
- Records of design and development review (clause 7.3.5)
- Design verification plans, results and conclusions (clause 7.3.6)
- Design validation plans, results and conclusions (clause 7.3.6)
- Procedure for transfer of design and development outputs to manufacturing (clause 7.3.8)
- Procedure and records for control of design and development changes (clause 7.3.9)
- Design and development file (clause 7.3.10)
- Procedure for purchasing (clause 7.4.1)
- Criteria and records for evaluation and selection of suppliers (clause 7.4.1)
- Record of verification of purchased product (clause 7.4.3)
- Record for each medical device or batch that provides traceability (clause 7.5.1)
- Requirements for cleanliness of product (clause 7.5.2)
- Requirements for medical device installation and acceptance criteria for verification of installation (clause 7.5.3)
- Records for medical device installation and verification of installation (clause 7.5.3)
- Procedure and records for servicing of the medical device (clause 7.5.4)
- Records of sterilization process (clause 7.5.5)
- Procedure and records of production and service provision process validation (clause 7.5.6)
- Procedure and records for validation of process for sterilization and sterile barriers systems (clause 7.5.7)
- Procedure for product identification (clause 7.5.8)
- Procedure for traceability (clause 7.5.9.1)
- Records of traceability and name and address of the shipping package consignee (clause 7.5.9.2)
- Report on changes on customer property (clause 7.5.10)
- Procedure for preserving the conformity of product (clause 7.5.11)
- Procedure for monitoring and measuring (clause 7.6)
- Record of calibration (clause 7.6)
- Procedure and records for validation of the application of computer software used for monitoring and measuring (clause 7.6)
- Procedure for customer feedback (clause 8.2.1)
- Procedure and records for complaint handling (clause 8.2.2)
- Records of reporting to regulatory authorities (clause 8.2.3)
- Procedure for internal audit (clause 8.2.4)
- Records of audits and their results (clause 8.2.4)
- Identity of the person authorizing release of product (clause 8.2.6)
- Procedure and record of control of nonconforming product (clause 8.3.1)
- Records of rework (clause 8.3.4)
- Procedure and records for data analysis (clause 8.4)
- Procedure and records for corrective action (clause 8.5.2)
- Procedure and records for preventive action (clause 8.5.3)
