Introduction of ISO 9001 certification: Adaption of ISO 9001:2015 should be an planned Decision of any Organization; Design & Implementation & time required is basically depend on the following factor:
- · Organizational Environment
- · Its Changing need
- · Its particular Objective
- · Products or Services in which organisation dealt with.
- · The Process adopted
- · Size & organizational Structure
Benefit of ISO 9001:2015 Certification:
- ISO 9001:2015helps Organisation to produce Desired Outcome
- ISO 9001:2015ensures Ongoing Controls
- ISO 9001:2015Enhance Customer Satisfaction by meeting Customer requirement
- Continual Improvement through ISO 9001:2015
- Process through PDCA (plan Do Check Act)
- QMS Certificationalso help to Increase Profitability
- ISO 9001:2015help organization for avoidance of Risk
- QMSis Sustainable Approach of any Business
- ISO 9001:2015Help Business, Government & Society.
The ISO 9001:2015 is a standard for the “Quality Management System“. ISO 9001:2015 standards basically focus what the organization do to fulfill:
- Customer’s Quality Requirements,
- Applicable Legal & Regulatory requirements,
- Develop Customer Satisfaction,and
- Attain Continual Improvementof its performances in chase of these objective
Roadmap for QMS ISO 9001:2015: Roadmap and plan for ISO 9001 Certification basically depend on various factor, but mainly following are the main factors of the QMS (ISO 9001:2015) Certification.
Identify the requirements of ISO 9001:2015 to your organisation.
- Make Decision for ISO Implementation/Certification.
- Get skilled team or hire services of consultant.
- Identify GAP Analysis.
- Make Implementation Plan.
- Opt PDCA [Plan-Do-Check-Act] cycle.
- Design, implement, aware about the Quality Policy, QMS Manual & SOP (Standards Operating Procedure).
- Establish & evaluate the system and procedure.
- Identify the boundaries of the management system and produce documented procedures as required.
- Ensure these procedures are suitable and adhered to.
Once developed, internal audits are needed to ensure the system carries on working.
Assessment to ISO 9001:2015
|1||Application & Quotation.||2||Review of Application|
|3||Agreement between US & Client.||4||Stage-1 Audit|
|5||Stage-2 Audit||6||Surveillance Audit.|
|7||Special Audit (if required)||8||Extension Audit.|
What is the cost of an audit to ISO 9001:2015?
Charges for ISO 9001:2015 Certification may depend on the size, location, Complexity of operation, Processes and it’s inter relevance. Our produces a guidance price list based on company nature & size. For a Quotation please get in touch with us either by sending your inquiry through mail to firstname.lastname@example.org or call us at 08142383639.
There are mainly three type of charges applicable for ISO Certification Services:
- Audit Fees
- Registration fees
- Other Expenses Like Travel, Hotels & Misc. Exp
Integrated Management System:
QMS may be integrated with other similar standards, Family of the management system standards viz:
- QMS- ISO 9001:2015
- EMS-ISO 14001:2004
- OHSAS 18001;2007
- ISO 22000:2005
- ISO 20001:2005
- ISO 27001:2013
Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. The main risks are: unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects. GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process – every time a product is made. WHO has established detailed guidelines for good manufacturing practice. Many countries have formulated their own requirements for GMP based on WHO GMP. Others have harmonized their requirements, for example in the Association of South-East Asian Nations (ASEAN), in the European Union and through the Pharmaceutical Inspection Convention.
is GMP necessary if there is a quality control laboratory?
Yes. Good quality must be built in during the manufacturing process; it cannot be tested into the product afterwards. GMP prevents errors that cannot be eliminated through quality control of the finished product. Without GMP it is impossible to be sure that every unit of a medicine is of the same quality as the units of medicine tested in the laboratory
Costing of GMP: Can manufacturers afford to implement GMP?
Yes. Making poor quality products does not save money. In the long run, it is more expensive finding mistakes after they have been made than preventing them in the first place. GMP is designed to ensure that mistakes do not occur. Implementation of GMP is an investment in good quality medicines. This will improve the health of the individual patient and the community, as well as benefiting the pharmaceutical industry and health professionals. Making and distributing poor quality medicines leads to loss of credibility for everyone: both public and private health care and the manufacturer.
WHO works to strengthen GMP
WHO GMP guidelines are available online. If you require more information, please contact the WHO representative in your country, your WHO regional office or WHO headquarters.