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Iso 9001 quality manual exampleThe ISO 13485 Standard is widely used in the medical device manufacturing industry asa means of establishing compliance with Canadian Medical Device Regulation, EuropeanMedical Device Directive and other regulations. Since the majority of medical devicemanufacturers comply with both 21 CFR 820 QSR and ISO 13485 standards, it ispractical to consider establishing an integrated 21 CFR 820 and ISO 13485 QualityManagement System (QMS).Documentation StructureTo establish an integrated QSR and ISO 13485 QMS, an organization may useapproaches outlined in the ISO 10013 Standard, Guidelines for Developing QualityManuals. Among other suggestions, this standard gives an example of a documentationstructure that can be used for QSR and ISO 13485 quality management systems. Whilethe standard suggests using a three-level documentation structure, most organizationsimplement four-level structures to include quality records, as required by both QSRSubpart M - Records and ISO 13485, element 4.2.4. A typical four-level documentationstructure includes: Quality Manual, Procedures, Instructions, and Records.Actually, the documentation structure for an organization should most likely start fromthe quality policy, as the policy, among other commitments, defines the regulations andstandards that a company intends to comply with. If you choose to use this approach,your QMS will have five levels, as shown below: 1. Quality Policy - level 1 2. Quality Manual - level 2 3. Procedures - level 3 4. Instructions - level 4, and 5. Records - level 5Quality PolicyQSR, section 820.20 (a) and ISO 13485, element 5.3 require the establishment of aquality policy. To satisfy these requirements an organization may develop a qualitypolicy that meets requirements of both QSR and ISO 13485 standards. While QSRrequires a quality policy to include a commitment to quality and be "...understood,implemented, and maintained at all levels of the organization", ISO 13485 requirementsare somewhat broader. Therefore, an organization can adhere to the requirements of ISO13485 which requires that a quality policy include: • A commitment to comply with requirements,
• A commitment to maintain the effectiveness of the QMS, • A framework for establishing and reviewing quality objectivesThe organization shall also ensure that the quality policy is: • Appropriate for the organization, • Communicated and understood within the organization, and • Reviewed for continuing suitabilityDespite the fact that these requirements appear to be rather simple, many consultants andauditors find that most companies have difficulties with documenting their qualitypolicies by not addressing all the requirements above. It is important to establish a qualitypolicy that, at a minimum, addresses all the requirements above because that qualitypolicy will document a companys commitment to establish a QMS that complies with thegiven regulations and standards. To demonstrate this point, lets assume that ones qualitypolicy does not require its review "for continuing suitability" or does not include "aframework for establishing and reviewing quality objectives". If there are no "triggers",there is a good chance that these activities will not be performed. Lets take a look at afew examples of quality policies that did not address specified requirements."We Practice Continual Improvement to achieve Customer Delight by providingCustomer-Centric, Qualitative ... Solutions and Services on time"Assuming that this quality policy is appropriate to the purpose of the organization and iscommunicated, it does not appear to contain "a commitment to comply withrequirements", a "framework for establishing and reviewing quality objectives", and acommitment to quality. Based on these deficiencies, this policy does not meet ourrequirements.The second example of a quality policy states:"[Company] will earn customer loyalty by providing products, services, and interactionexperiences of the highest quality and greatest value. To achieve this result, we will: 1. Ensure that all of our products comply with relevant safety and regulatory requirements; 2. Ensure our products meet and/or exceed their published specifications; 3. Maintain and continually improve the effectiveness of our product and service business management systems; 4. Continually monitor the quality of our customer interactions, with the intent to improve our customers total experience; 5. Establish quality requirements for suppliers, partners, and contractors and hold them accountable to comply
• Treat customers in accordance with [Company]s Standards of Business Conduct and Privacy policies."This quality policy, while apparently very much customer-focused, still does not cover aframework for establishing and reviewing quality objectives and committing to review itfor continuing suitability. One of our clients came up with a quality policy that won our"The Worst Quality Policy" Grand Prize. Their quality policy simply stated:"I improve the Quality of Patient Care and all things [Company name]"This sorry example of a quality policy has been restated verbatim! (The company namehas been omitted). Obviously, this quality policy has met only one requirement: that ithas in fact been "established."Integrated 21 CFR 820- ISO 13485 Quality ManualWhile QSR does not specifically require the establishment of a quality manual, Section820.186 requires a manufacturer to establish a quality system record that: "...shall includeor refer to the location of procedures and the documentation of activities required by [theQSR]." This definition very closely resembles requirements for a quality manual for anISO 13485 compliant QMS. A quality manual is the top-level document of a QMS. Thereare at least two definitions of what a quality manual for a QMS should be.ISO 10013, Guidelines for Developing Quality Manuals, element 4.2, gives detailedsuggestions for creating a quality manual. It defines a quality manual, among otherrequirements, as a document that should "consist of, or refer to, the documented qualitysystem procedures intended for [the] planning and administration of activities which[have an] impact on quality". ISO 13485 2003, element 4.2.2 requires a quality manual toinclude: • The scope of the QMS, • Details of and justification for any exclusion or non-application, • The documented QMS procedures or references to them, • A description or interaction between the processes of the QMS; and • An outline of the structure of the documentation used in the QMS.The scope of the QMS is usually located in the corresponding section of the qualitymanual. It simply states which activities an organization performs within the scope of itscertification. For example: "My Company, Inc. designs, manufactures and distributeslaser generators for cosmetic surgery applications". If an organization does not performsome of the processes required by ISO 13485, clause 7, such as design or manufacture,this fact, with justification, is documented in the exclusions section of the manual.After we defined the scope and exclusions, lets describe used processes and references tothe corresponding procedures. The easiest way to start this is to transform 21 CFR 820cGMP and ISO 13485 standards from a set of requirements into your companys
commitments to satisfy those requirements. For example: If section 820.5, QualitySystem, requires that:"Each manufacturer shall establish and maintain a quality system that is appropriate forthe specific medical device(s) designed or manufactured, and that meets the requirementsof this part." our manual will state:"QW Medical, LLC. Has established and maintains a quality management system that isappropriate for the specific medical device(s) designed and manufactured, and thatmeets the requirements of 21 CFR 820 QSR."Following this approach by addressing all applicable sections of the QSR and the ISO13485 standard and referencing supporting procedures, we will establish a manual thatcan be used to meet requirements of 21 CFR 820 and ISO 13485.Interaction between the processes may be documented in a number of ways. Somecompanies choose to define interaction of the top-level processes by using variations ofFigure 1 in the ISO 9001 2008 Standard. Combining such a diagram with references toprocedures within the manual will, to a particular degree, define interactions betweenyour processes.The last requirement of the element 4.2.2 of ISO 13485 is to outline the structure of thedocumentation. Very often companies define their structures as four- or five-leveldocumentation structures in the documentation management section of the manual.Another important function of a quality manual, very often overlooked, is to be amarketing tool. Well written and professionally published, a quality manual may becomea powerful promotional instrument. It can communicate to your potential customers,suppliers and subcontractors that your company is not only a quality-consciousorganization, but that it also knows how to document and communicate its commitmentto quality and compliance with regulatory requirements.I always wonder what companies achieve by stamping their quality manuals in bold redcapitol letters "CONFIDENTIAL". As far as I am concerned, a quality manual is acompanys resume for quality, and if you hide your resume, there is a very good chancethat you will never get a job! All Quality Works customers are encouraged to make theirquality manuals public!Naming Your DocumentsAs you may have noticed, the titles of the documents above are quite short. It is a verytypical convention in the medical device manufacturing and other regulated industries tocall the second-level documentation "Standard Operating Procedures", known as SOPs.Unless one has a level called "Non-standard Operating Procedures," I really do not see apractical or economical reason for long titles. As long as a short title conveys the idea andleads a user to the right place within the system, lets use it. Quality Works relentlessly
promotes this optimization and reduction of waste approach throughout all ourpublications and consulting work. Lets not make things more complicated than they needto be. For example, one of our customers titled their quality manual as "QualityManagement System Quality Manual." I bet, just "Quality Manual" will mean the samefor users.Numbering Your DocumentsIt is not a specific requirement of 21 CFR 820 QSR or any other regulation or standard touniquely number a part or a document. It is a worldwide practice in most documentationsystems to give a document or a component a number and a title, and to identify itsrevision level. As long documentation titles that we discussed earlier, use of documentnumbering formats very often present opportunities for improvement.Once I worked with a cGMP compliant business of less than 100 people, manufacturingfairly simple surgical instruments. Their documentation system included a fewnumeration formats depending on the type of a document. One of the procedures had anumber 000023-001, which they simply called "twenty three." Drawings were numberedin a format like 987-323-11-02.Is it acceptable to have long and difficult to read and remember) document numbers?Yes, of course! Is it practical? I do not believe so! In the example above, the procedurenumber, without the tab, contained six digits. This meant that the system was prepared tohandle almost one million documents or part numbers. The company had approximately150 documents and about the same number of parts and probably would never go beyonddoubling those numbers. If nothing else, just reading these numbers with sequential zerosin the front may give one a headache. Surprisingly, this is not the worst case. Thebusiness that won our "The Worst Part Number" Grand Prize assigned twelve (!)characters to their part numbers in the alphanumeric format.If you are designing or manufacturing a sophisticated X-ray, CAT scan or other complexpiece of equipment, you will need thousands or even millions of parts and documents. Inthis case, a long part number format would be needed and will make business sense.Otherwise, save yourself the trouble of writing all those zeros and make your numberingsystem practical. One of my customers, who won my "The Best Part Number" GrandPrize, numbered their QMS documents as 101, 102, 103, and so on. Short and sweet!Most small- and medium-size companies will benefit from this optimization approach.After all, isnt the part title the best designator? Throughout my entire professional career,I worked only with a couple of companies that did not use document numbers. Theirdocuments were simply identified by unique titles and a two-digit revision level, likeQuality Manual 01.Another debatable issue with part-numbering formats is part number designation. Somemanagement systems associate a part number with a particular part type. For example,20-xxx indicates a procedure, 30-xxx indicates a drawing, P-xxx indicates a policy-leveldocument, and so on. My experience with a number of medical device manufacturers has
convinced me in the benefits of a "no designation" system. Three of our clients systemsthat used designation failed. Just recently, one of our clients reported that he ran out ofrange in his companys part-numbering format. The documentation system allowed forassigning materials through a two-digit designator within the part number. When thesystem was designed a few years ago, needing more than 99 materials was not consideredpossible. Unfortunately, companys needs change over time, and just a few years later, theQMS needed more than 99 materials causing the existing part number format to fail.An alternative approach to numbering parts and documents within your managementsystem is a "no designation" approach. In such a system, documents or parts are givensequential unique numbers within a specified format, regardless of their level, type,material, application or other attributes.If you want to download over free 50 ebook for iso 9001 standard, you can visit:http://iso9001ebooks.infoBest regards