Auditing
Two types of auditing are required to become registered to the standard: auditing by an external certification body (external audit) and audits by internal staff trained for this process (internal audits). The aim is a continual process of review and assessment, to verify that the system is working as it's supposed to, find out where it can improve and to correct or prevent problems identified. It is considered healthier for internal auditors to audit outside their usual management line, so as to bring a degree of independence to their judgments.
Under the 1994 standard, the auditing process could be adequately addressed by performing "compliance auditing":
- Tell me what you do (describe the business process).
- Show me where it says that (reference the procedure manuals).
- Prove that that is what happened (exhibit evidence in documented records).
The ISO 19011 standard for auditing applies to ISO 9001 besides other management systems like EMS (ISO 14001), FSMS (ISO 22000) etc.
Industry-specific interpretations
The ISO 9001 standard is generalized and abstract. Its parts must be carefully interpreted, to make sense within a particular organization. Developing software is not like making cheese or offering counselling services; yet the ISO 9001 guidelines, because they are business management guidelines, can be applied to each of these. Diverse organizations—manufacturing companies, software development companies, trading organizations, service organizations, police departments, professional soccer teams and city councils —have successfully implemented ISO 9001:2000 systems.
Over time, various industry sectors have wanted to standardize their interpretations of the guidelines within their own marketplace. This is partly to ensure that their versions of ISO 9000 have their specific requirements, but also to try and ensure that more appropriately trained and experienced auditors are sent to assess them.
The TickIT guidelines are an interpretation of ISO 9000 produced by the UK Board of Trade to suit the processes of the information technology industry, especially software development.
AS 9000 is the Aerospace Basic Quality System Standard, an interpretation developed by major aerospace manufacturers. The current version is AS 9100.
ISO 13485:2003 is the medical industry's equivalent of ISO 9001:2015. While the standards it replaces were interpretations of how to apply ISO 9001 and ISO 9002 to medical devices, ISO 13485:2003 is a stand-alone standard. Compliance with ISO 13485 does not necessarily mean compliance with IS0 9001:2015.
Advantages of ISO 9001 certification
It is widely acknowledged that proper quality management improves business, often having a positive effect on investment, market share, sales growth, sales margins, competitive advantage, and avoidance of litigation. The quality principles in ISO 9000:2000 are also sound, according to Wade, and Barnes, who say "ISO 9000 guidelines provide a comprehensive model for quality management systems that can make any company competitive." Barnes also cites a survey by Lloyd's Register Quality Assurance which indicated that ISO 9000 increased net profit, and another by Deloitte-Touche which reported that the costs of registration were recovered in as less as three months. According to the Providence Business News, implementing ISO often gives the following advantages:
- Creates a more efficient, effective operation
- Increases customer satisfaction and retention
- Reduces audits
- Enhances marketing
- Improves employee motivation, awareness, and morale
- Promotes international trade
- Increases profit
- Reduces waste and increases productivity
In today's service-sector driven economy, more and more companies are using ISO 9000 as a business tool. Through the use of properly stated quality objectives, customer satisfaction surveys and a well-defined continual improvement program companies are using ISO 9000 processes to increase their efficiency and profitability.
What do we offer for ISO 9001 Certification for your organization?
With a team of highly qualified consultants and trainers having vast industrial experience, Unizen Certification Services assists organizations across the world to implement and achieve ISO 9001 certification. Our consultation approach is highly professional, time bound and effective resulting in the ease of implementation and adds value to the business processes of the client’s organization.
We offer ISO 9001 training, implementation, consultation, gap analysis, documentation, internal audits, preassessment audits, certification audit through best of the certification bodies and post certification enhancement / maintenance services to enable your organization to get the best out of ISO 9001 quality management system. Our services are globally accepted, authoritative and benchmarked in the field of ISO 9001 QMS:
Contact us at info@certindia.org to get your organization ISO 9001 certified.